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M.L. Laboratories PLC
25 January 2005
Embargoed until 0700 GMT 25 January 2005
ML Laboratories PLC
(`ML` or `the Company`)
Preliminary Audited Results for the Year Ended 30 September 2004
Operational highlights
• Positive results reported from US Phase III trial of Adept adhesion
reduction therapy; US Marketing Authorisation Application anticipated in Q1
2005
• European regulatory review ongoing for formoterol and budesonide
Clickhalers; outcome anticipated in H1 2005
• Meptin Clickhaler filed in Japan; approval and launch expected later in
2005
• Exclusive marketing agreement signed with a Japanese pharmaceutical
company for budesonide Clickhaler in Japan
• First commercial agreement for a New Chemical Entity (NCE) respiratory
compound in Clickhaler signed with Pliva, a multi-national pharmaceutical
company
• First commercial agreement for C200 inhaler signed with global
pharmaceutical group for combination of two established respiratory
medications
• Clinical development programmes continued to advance; commenced Phase
IIa study with Alpharen phosphate binder and Phase I/II study with CTL 102
in prosthesis repair
Financial highlights
• Raised additional funds of £14.4 million through a Rights Issue and
Issue For Cash
• Further disposals of non-core assets
• Pre-tax loss of £10.9 million (2003: £2.8 million, which reflected the
benefit of £7.3 million arising from transactions with Paul Capital (2004:
£0.5 million) and profit on divestments of £5.7 million (2004: £0.8
million))
• Net cash and short-term deposits as at 30 September 2004 of £10.9
million (30 September 2003: £6.6 million)
Commenting on the results, Stuart Sim, Executive Chairman, said:
`Last year the Group made considerable progress in the development and
commercialisation of its portfolio of pharmaceutical products and technologies.
In particular, our respiratory drug delivery subsidiary achieved significant
commercial success, which assisted us towards achieving our objective of growing
income from our portfolio in the near term. The pharmaceuticals division also
made good progress and, in particular, we were pleased to report that Adept
would be filed for approval in the key US market early in 2005. In all, the
achievements in 2004 make for an eventful year ahead, which offers the potential
for further significant news flow and, subject to anticipated milestone income,
maiden profitability.`
Enquiries:
ML Laboratories PLC (25/01/05) 020 7067 0700
Peter Shennan, Chief Operating Officer (Thereafter) 01925 844 700
& Finance Director
Stuart Sim, Executive Chairman
Weber Shandwick Square Mile 020 7067 0700
Kevin Smith / Sarah MacLeod
A presentation to analysts will take place at 9:30am today at the offices of
Weber Shandwick Square Mile, Fox Court, 14 Gray`s Inn Road, London WC1. Please
contact Hayley Smith on 020 7067 0700 for details.
Embargoed until 0700 GMT 25 January 2005
ML Laboratories PLC
(`ML` or `the Company`)
Preliminary Audited Results for the Year Ended 30 September 2004
CHAIRMAN`S STATEMENT
In January 2004 we successfully raised £14.4m by way of a fully underwritten
rights issue and an issue for cash. At that time we issued a circular describing
how the Board intended to use those proceeds and I am pleased to report on our
progress towards achieving the objectives identified.
Throughout the financial year ended 30th September 2004 and the subsequent
period to date, we have made considerable progress in the development and
commercialisation of our portfolio of pharmaceutical products and technologies
which resulted in the following principal outcomes:
Clinical and regulatory progress
• Adept
In December 2004 we announced the preliminary unaudited results of our pivotal
Phase III US multi-centre clinical trial of Adept, our adhesion reduction
therapy. This clinical trial was a landmark study as it was the first
double-blind randomised controlled clinical study with an adhesion reduction
agent, and the largest clinical laparoscopic second-look adhesions study ever
undertaken.
The data analysis demonstrated that those patients who received Adept showed
improvement over the comparator group in all measurements of efficacy whilst
maintaining a similar safety profile.
We therefore plan to file an application with the US Food and Drug
Administration (FDA) for a US marketing authorisation in the first quarter of
2005. The outcome of the application is anticipated in 2006 and if successful
will be followed by launch in the US subject to the appointment of a licensee
for that territory.
We consider it is likely that Japanese marketing approval will be facilitated by
data generated by the US study. Consequently, we are in discussions with
potential licensees for the US, Japanese and other Asian markets and we
anticipate that the appointment of licensees for these valuable territories
should generate substantial milestone receipts during 2005.
We are excited by the prospects for Adept and believe it has the potential to be
used routinely in all abdominal surgery due to its safety profile, ease of use
and potential cost advantage.
• ALPHARENTM*
Our collaboration with Ineos Silicas Healthcare Limited to develop its novel
compound for the treatment of hyperphosphataemia in kidney failure patients saw
the encouraging initial results of the Phase I study presented at both the
American Society of Nephrology in November 2003 and the European Dialysis and
Transplant Association meeting in May 2004. In addition we commenced a Phase IIa
clinical study in the period and progressed the design of the Phase IIb study.
We consider Alpharen could be a significant entrant to this rapidly growing
market segment given its substantial phosphate binding activity as demonstrated
in the Phase I study.
*ALPHAREN is a trade mark of Ineos Silicas Healthcare Ltd.
• FORMOTEROL CLICKHALER
Dialogue with the regulators regarding our application for European marketing
authorisation continued in the period and the outcome is anticipated shortly.
Approval of the product will trigger a significant milestone receipt from our
licensee, as will European marketing launch which is anticipated in H1 2005.
Application for marketing authorisation was also filed in Canada and launch of
the product in that country, which is anticipated in H2 2006 will trigger a
further significant milestone receipt. The product launches will be followed by
royalties on sales.
• BUDESONIDE CLICKHALER
The application for European marketing authorisation was filed in November 2003
triggering a significant milestone receipt from our licensee. European marketing
approval of this product is also anticipated shortly enabling launch in H1 2005.
Both events will trigger further significant milestone receipts and will be
followed by royalty income post launch.
• MEPTIN CLICKHALER
Otsuka Pharmaceutical Co. Ltd., a leading Japanese healthcare company, has an
exclusive licence for the delivery of Meptin, its asthma treatment, in
Clickhaler in Japan and Spain. In May 2004 we announced that data produced by
Otsuka had been filed with the Japanese regulator triggering a further milestone
receipt. Approval and launch of Meptin Clickhaler in Japan are anticipated in
2005 which will trigger further milestone receipts and income from the supply of
Clickhalers to Otsuka.
• CTL 102 in Prostate Cancer
We commenced the treatment phase of our Phase II study to evaluate the efficacy
and safety of our novel treatment of prostate cancer during the year. The trial,
which is the first of its kind in prostate cancer in the UK, has progressed
during the period and we anticipate reporting the outcome in H1 2006.
• CTL 102 in Prosthesis Repair
In collaboration with the University of Leiden, we commenced a Phase I/II study
to evaluate the potential for the cell killing capability of CTL 102 to be used
in prosthesis revision surgery to facilitate the refixing of loosened
prostheses.
The object of the study, which will be undertaken in 12 inoperable patients, is
to assess the response to therapy in respect of mobility and pain, and we expect
the study will complete in H2 2005.
• CTL 901
In December 2003 the first patient was entered into the Phase I/II clinical
trial of our treatment of skin cancer (advanced melanoma) by our collaborators
at Birmingham University. Recruitment has continued and we expect the trial to
complete in H1 2005.
Commercialisation progress
Innovata Biomed (`IB`), our respiratory drug delivery subsidiary, achieved
considerable commercial success in the period which, significantly, included the
signing of both the first commercialisation agreement for our new C200
combination inhaler and the first agreement for a New Chemical Entity (NCE) to
be delivered in Clickhaler.
• C200 multi-dose breath-actuated inhaler
Combination delivery of inhaled drugs is increasingly being seen as the most
effective means of controlling asthma and the C200 device, coupled with IB`s
formulation expertise, provides a fast development route to this rapidly growing
sector. The market for combination asthma therapy is currently valued globally
at over $5 billion p.a. and projected to exceed $6 billion p.a. by 2006 (source:
Datamonitor).
In June 2004 we announced an exclusive agreement with a global pharmaceutical
group whereby IB will develop a respiratory treatment comprising a combination
of two established respiratory medications in C200. Our licensee will market and
distribute the product in Europe and certain other specified countries with IB
having retained the rights for all other territories including the US and Japan.
The agreement, which is the second with this licensee, provides for IB to
receive access fees and milestone receipts totalling £7.5 million. In addition,
IB will conduct the development programme on behalf of the licensee which could
generate development fees of up to a further £9 million. IB will receive
royalties on sales, with first launch anticipated in 2008, and will supply C200
inhalers to the licensee on commercial terms.
We believe the C200 technology could be used to deliver a number of inhaled
products in combination with new, or established, molecules and IB continues to
seek collaborations with other pharmaceutical companies with the object of
securing further valuable licensing deals for the C200 device.
• CLICKHALER
Budesonide Clickhaler Japan
In September 2004 we announced that IB had signed an exclusive agreement with a
Japanese pharmaceutical company for marketing rights to budesonide Clickhaler
for that territory. We are delighted that following extensive evaluation the
company selected IB`s budesonide Clickhaler.
Under the terms of the agreement, IB received an access fee and will receive
subsequent milestone receipts. IB will provide assistance to the company in
completing the necessary clinical studies to obtain regulatory approval in
Japan, where the company expects to launch the product in 2008. IB will supply
the product to the company on commercial terms thereafter.
This agreement is the second licence of Clickhaler in Japan and should generate
important income for the Group.
Pliva Clickhaler
In December 2003 IB entered into an agreement with Pliva, a multi-national
pharmaceutical company, to develop a novel asthma medication based on Pliva`s
NCE steroid and Clickhaler. Under the agreement, IB will receive development
fees, milestone receipts and royalties on sales. In addition, IB will supply
Clickhalers on commercial terms.
This agreement is significant in that it represents the first agreement for an
NCE to be delivered in Clickhaler and sets IB on the pathway to achieving its
objective of becoming a leading independent provider of dry powder inhalation
technologies for the delivery of NCE respiratory compounds.
Disposals
In December 2003 we sold the balance of our shareholding in Cobra
Biomanufacturing Plc (CBM) realising a further £1.2m net of expenses bringing
the total gross sum realised from the divestment of that business to circa
£8.2m. In February 2004 we disposed of our loss making educational training
business where the consideration received was in the form of shares in the
purchaser which we have retained as a £0.2m investment.
Financial results
The loss before tax in the year of £10.9m compares with a loss of £2.8m in the
previous year which reflected the benefit of £7.3m resulting from accounting for
transactions with Paul Capital and profit on divestments of £5.7m compared with
£0.5m and £0.8m respectively in the year under review. The financial results are
fully described in the Financial Review.
Funding
Our activities in the year were financed by a combination of the fundraising of
£14.4m net of expenses, royalty and milestone income generated by those of our
products that have been commercialised, and proceeds from the disposal of
assets.
Working capital
The cash flow projections of the Group include significant receipts of milestone
income and proceeds from the potential disposal of assets. Historically we have
demonstrated that we are able to generate receipts from such sources and we
anticipate that we will continue to be able to do so. Consequently, we have a
reasonable expectation that the Group will have sufficient working capital for
the foreseeable future. However, given the difficulty in predicting accurately
the timing and amount of such future receipts we will continue to keep the
adequacy of our working capital under regular review.
Panos acquisition
In January 2004 we informed shareholders that we had agreed an arrangement
whereby we may in due course acquire Panos, from whom we license our interest in
Devacade, for a consideration to be paid in shares.
This arrangement remains in place, albeit still subject to contract.
Prospects
ML is currently generating income from products it has successfully developed
and licensed to other pharmaceutical companies which we have achieved by
utilising our core skills in clinical development, regulatory affairs and
product commercialisation. Our development activities are focussed on products
and technologies with the potential to produce income in the relatively near
term. We continue to believe that each of our products in development is of
potentially high value with an acceptable risk profile and, accordingly, has a
reasonable probability of generating income for the Group. Our potential for
growth is supported by our established track record of sourcing a development
pipeline through in-house initiatives, in-licensing and joint development
agreements, all of which we will continue to pursue actively. Consequently we
believe that the business is capable of achieving profitability in the near term
and delivering value to shareholders over the long term. Therefore the Directors
view the future prospects of the Group with confidence.
Corporate objective
Our objective is to develop and commercialise pharmaceutical products and
technologies for specialist markets derived from intellectual property generated
by our own research, in-licensed from third parties and through joint
development programmes.
In the January 2004 circular to shareholders we stated that providing milestone
income is received in line with current projections ML would be in a position to
consider developing certain products through Phase III, adopting alternative
commercialisation strategies and/or seeking to expand the pharmaceutical
portfolio by in-licensing additional appropriate products, and I can confirm
that this continues to be the case.
I would like to take this opportunity to thank all shareholders for their
continuing support of the company and our employees whose hard work and
dedication continue to deliver the products and technologies essential for the
progress of the business.
S.W. Sim
Executive Chairman
25th January 2005
OPERATIONAL REVIEW
OPERATIONAL STRUCTURE
The Group`s activities are organised into two principal operations - ML
Pharmaceuticals and Innovata Biomed, the Group`s respiratory subsidiary.
ML Pharmaceuticals is a pharmaceutical product development business with a track
record of successful clinical development, regulatory approval and licensing of
pharmaceutical products and a development pipeline of future products targeted
at specialist markets. Its activities are supported by revenue streams generated
from products which have been successfully developed and licensed to other
pharmaceutical companies.
Innovata Biomed is an independent provider of inhaled drug delivery technology
to the pharmaceutical industry. IB`s proven delivery technology is available for
proof of principle testing and as a `fast-to-market` drug delivery solution.
Existing licence agreements generate development fees, royalty income and
milestone receipts which support the business`s ongoing development programmes.
Both businesses operate as distinct divisions with their own research, clinical
development and business development capabilities, supported by centrally
provided services which include regulatory affairs, intellectual property
management, finance and administration.
PRODUCT DEVELOPMENT REVIEW
ML PHARMACEUTICALS
EXTRANEAL - a solution of Icodextrin for use in Peritoneal Dialysis treatment
Icodextrin solution is used in peritoneal dialysis for the treatment of renal
failure patients, wherein waste products and excess fluid pass from the
patient`s blood into a dialysis solution which has been infused into the
abdominal cavity, all of which is subsequently drained out. ML holds patents
over Icodextrin, the active ingredient, in all appropriate major countries.
The product has been licensed on an exclusive worldwide basis to Baxter
Healthcare, a market leader in renal disease treatments. Baxter has launched the
product under its trade name, Extraneal, firstly in the UK in 1996 and
subsequently in a further 35 countries, including the two major markets of USA
and Japan in 2003, which offer the prospect of significant royalty income. As a
result Extraneal is now commercially available in all of the world`s major
pharmaceutical markets.
Currently more than 15,000 patients worldwide are using the solution on a daily
basis and over 50,000 patient-years experience in routine clinical use has been
gained to date.
ADEPT - a solution of Icodextrin for the reduction of post-operative adhesions
Adhesions are a serious and frequent complication following abdominal and
gynaecological surgery and are acknowledged as a major surgical problem.
Adhesions are expensive to treat, often requiring further surgery and
hospitalisation. Currently available treatments are both expensive and difficult
to administer, often requiring specific training. Adept offers significant
advantages in that it is an easy to use, low viscosity solution which can be
delivered via a laparoscope in minimally invasive (keyhole) surgery and is
readily incorporated into routine surgical procedures.
Shire Pharmaceuticals PLC (`Shire`), our licensee for Europe, is achieving
growing use of this product with gynaecologists and with general surgeons
carrying out colorectal operations. ML retains all rights to Adept for the rest
of the world.
The clinical development of Adept has been concentrated in the US where we
recently completed the pivotal Phase III clinical trial, (`the PAMELA study`),
the object of which was to determine the efficacy and safety of Adept in the
reduction of post surgical adhesions after laparoscopic surgery. The preliminary
results of this study were announced in December 2004 and confirmed that Adept
demonstrated significant benefits over the control therapy in reducing adhesions
and improving the status of gynaecological patients.
The analysis demonstrated that those patients who received Adept showed
improvement over the comparator group in all measurements of efficacy whilst
maintaining a similar safety profile. We therefore have sufficient confidence to
progress the filing of an application with the US FDA for a US Marketing
Authorisation.
The PAMELA study was an evaluation of Adept as an adjunct to adhesiolysis
surgery conducted in 16 gynaecology units in the US. The study was a double
blind comparison of Adept and an optimised control therapy using Ringer`s
lactate solution (RLS). A total of 449 patients were randomised to treatment.
The detailed analysis demonstrated that Adept significantly reduced the number
of adhesions in patients undergoing adhesiolysis. Adept demonstrated a 30%
improvement when compared to the control patients who received the optimised
therapy using RLS. In addition, Adept treatment resulted in significantly fewer
patients with newly formed adhesions.
In routine clinical use the safety of icodextrin, the active ingredient in
Adept, has been firmly established in peritoneal dialysis (over 50,000
patient-years experience worldwide) and in adhesion reduction in over 100,000
surgical patients in Europe. In addition, the PAMELA study showed that the
overall incidence of adverse events in the Adept and control groups was similar.
Unusually, the study protocol included several statistically defined primary
endpoints. Whilst not all were achieved, the significant benefits demonstrated
and the positive responses of the clinical investigators have confirmed to us
that Adept represents a valuable therapeutic product.
In addition the PAMELA trial data will form the basis for advanced stage ongoing
negotiations with potential licensees for the US and Japan and for the
negotiation of the remaining milestone payment from Shire.
Our view is that uptake of available competitive treatments for adhesions has
been hampered by their complexity of use and cost. We consider that an ideal
anti-adhesion agent should be safe, cost effective, easy to use and capable of
reducing adhesion formation at the operating site and throughout the peritoneal
cavity. The preliminary results of the PAMELA study suggest that Adept fits this
profile and can assist in reducing the burden of adhesions.
We anticipate filing an application with the FDA for a US marketing
authorisation in the first quarter of 2005 following completion and audit of the
full statistical analysis and compilation of the final clinical report of the
study.
ALPHARENTM - a Phosphate Binder for the treatment of Hyperphosphataemia
Abnormally high and damaging levels of phosphate in the blood occur when failing
kidneys are unable to rid the body of excess phosphate absorbed from food.
Patients suffering from end-stage renal failure usually need to take a phosphate
binding product to prevent absorption of phosphate and reduce blood
concentrations. The novel compound we are co-developing with Ineos Silicas
Healthcare Limited has been shown in pre-clinical and Phase I human volunteer
tests to have substantial phosphate binding activity. Furthermore, the product
does not contain aluminium or calcium ions which could cause safety concerns in
long term use, therefore also rendering Alpharen potentially applicable for use
in pre-dialysis renal failure patients.
A Phase I study has demonstrated that healthy volunteers were able to tolerate
the drug in doses sufficient to cause a significant reduction in phosphate
absorption from the diet. A Phase IIa study is underway.
This product meets our product selection criteria ideally, as its clinical
efficacy can be readily demonstrated in a relatively small number of kidney
failure patients.
Gene Therapy Products
CTL102 in Prostate Cancer
Prostate cancer is the most common cancer in men in the UK with over 24,700 new
cases a year. The lifetime risk for being diagnosed with prostate cancer is 1 in
14*. The treatment technique uses gene therapy technology to deliver a cancer
killing toxin direct to the tumour site in a two stage process. The mode of
action is the delivery of the gene for a bacterial enzyme, nitroreductase, to
cancer cells such that a separately administered, relatively harmless drug,
CB1954, will be activated in the tumour to kill the cancer cells. In November
2003 we announced the commencement of the treatment stage of our Phase II
clinical trial of prostate cancer and we expect to report the outcome of the
trial in H1 2006.
We are hopeful that the novelty of the product could establish a marketable
platform from which gene therapy products can be developed by third party
licensees for the treatment of other tumours.
CTL 102 in Prosthesis repair
In collaboration with the University of Leiden, we are evaluating the potential
for the cell killing capability of CTL 102 to be used in prosthesis revision
surgery.
Patients with artificial joints have a tendency for the prosthesis to work loose
over time. The consequences of such loosening include pain and discomfort and
often result in the patient having to undergo further lengthy operations to
repair or replace the prosthesis. Many patients, particularly the elderly, may
be unable to be subjected to such operations which are also very expensive. In
some countries, prosthetic implants such as hips are not offered to younger
patients because of the frequency with which they become loose and the cost of
subsequent surgery.
The product concept is designed to enable orthopaedic surgeons to destroy the
rubbery interface tissue surrounding loose prostheses which cannot, otherwise,
be easily removed. Once destroyed, the tissue can be aspirated to enable
replacement bone cement to be injected into the area, thereby refixing the
prosthesis.
A Phase I/II study is underway to assess the response to therapy of 12
inoperable patients in respect of mobility and pain. The study is expected to
complete in H2 2005.
*Source: Statistics from Cancer Research UK
CTL 901 in Melanoma
A Phase I/II clinical trial is being conducted by our collaborators at the
Cancer Research UK Institute for Cancer Studies at Birmingham University on our
treatment for malignant melanoma. This treatment is based on the delivery of
genes encoding tumour associated antigens to antigen presenting cells known as
dendritic cells, a component of the immune system. In the trial, dendritic cells
isolated from the patients` blood are modified using our proprietary antigen
delivery system, CL22. The modified dendritic cells are returned to the patients
by injection in order to induce the patients` immune system to attack tumour
cells. Pre-clinical data suggest that this treatment will specifically attack
skin cancers as well as the cancerous cells which leave the tumour and spread
the disease throughout the body. We consider that our CL22 system is a platform
technology that may prove to be capable of modifying dendritic cells for the
treatment of other advanced forms of cancer for which no effective treatments
are available.
Gene Expression Technology
Agreements have been signed with a number of biotechnology and pharmaceutical
companies to evaluate the UCOE technology for facilitating gene expression and
thereby increasing the efficiency of therapeutic protein production. In addition
we have an agreement with Medarex to apply our UCOE gene expression technology
for antibody production. We consider that the licensing of this technology will
continue to generate revenues in the near term in the form of licence fees and
potentially, in the long term, in the form of royalties on the sale of products
using this technology.
DEVACADE - for enhancing the pain relief produced by morphine
Pre-clinical studies with Devacade demonstrated that this new chemical entity
(`NCE`) has the ability to enhance the pain relieving properties of drugs such
as morphine without increasing the disturbing and dangerous side-effects
experienced with such drugs. In a Phase II programme Devacade, when given as an
adjunct to those drugs, reduced pain levels and patients reported reduced levels
of sleep disturbance from their pain and reduced interference in activities
owing to pain.
Further clinical programmes are being designed to assess the efficacy and
required dose levels for the use of Devacade as an adjunct to opioid analgesia
in a number of pain states.
We continue actively to seek a licensee who is able to complete the required
clinical programme and market this novel product.
EMMELLE intravaginal gel
In September 2004 we announced that the Medical Research Council was not
prepared to take Emmelle forward into its Phase III microbicide programme for
the prevention of transmission of HIV. Therefore, given the poor potential for
an acceptable financial return to ML were it to take the product forward, we
discontinued our activities related to this programme.
A preclinical programme is underway to evaluate the activity of Emmelle against
chlamydia and herpes simplex virus.
INNOVATA BIOMED
CLICKHALER - a fast-to-market dry powder inhaler for new asthma therapies
Clickhaler is a proven, industrialised dry powder inhaler (DPI) with many
established advantages over standard asthma inhalers. Clickhaler has been
extensively studied and shown to be highly acceptable to patients, regulators
and potential licensees. Furthermore, it is already marketed by Celltech with
standard asthma therapies (salbutamol and beclomethasone) in the UK, Ireland and
France.
In September 2002 we announced that we had entered into an exclusive licence
agreement with a major global pharmaceutical group for the rights to market the
two asthma therapy molecules, budesonide and formoterol, in Clickhaler in Europe
and a number of other territories. Taking into account monies already received
we anticipate this agreement will generate £10m in access fees and milestone
receipts plus double digit royalties on future product sales.
In November 2002 the first application for marketing authorisation for
formoterol Clickhaler in Europe was submitted, which was followed by application
to the Canadian regulators in November 2003. We anticipate reaching the European
and Canadian markets through our licensee in 2005 and 2006 respectively. The
application for European marketing authorisation for budesonide Clickhaler was
filed in November 2003 with launch expected in 2005. Revenues from both
budesonide and formoterol Clickhaler are expected to flow from sales for the
commercial life of the products.
Negotiations were completed in March 2003 for the delivery of Otsuka
Pharmaceutical Company`s established drug, Meptin, using IB`s Clickhaler, in
Japan and Spain. This drug is already being sold by Otsuka in a CFC metered dose
inhaler format and they expect to be able to commence substitution of sales of
their existing product with Clickhaler once approval is granted by the Japanese
regulators, which we anticipate will be received in H1 2005.
In December 2003 an agreement was entered into with PLIVA to develop a novel
asthma medication based on PLIVA`s NCE steroid and Clickhaler.
In September 2004 an agreement was entered into with a Japanese company for the
rights to budesonide Clickhaler for Japan. We believe this agreement further
cements Clickhaler`s reputation as a leading independently provided dry powder
inhaler.
In addition, further formulation studies have been undertaken by IB, both alone
and with potential partner companies, to evaluate the performance of Clickhaler
in the laboratory. These studies include the assessment of novel and established
molecules as well as new formulation technologies designed to enhance the
performance of the device with certain drugs.
IB continues to build a library of data on the capabilities of its own device
and formulation technologies, as well as third party formulation technologies,
to enable it to provide an enhanced offering to the global pharmaceutical
industry.
C200 Device - building on the CLICKHALER technology
IB has recognised the opportunity offered by developments in the treatment of
asthma by combining two drugs in the same inhaler.
Patents have already been granted in Europe on the C200 device, which is a novel
adaptation of the proven dose-metering `engine` of Clickhaler, whereby in the
same device two separate drug reservoirs feed two separate drug formulations to
separate metering chambers from which they are delivered to the patient in the
same breath. The ability to formulate the drugs separately permits optimisation
of each individually, thereby offering the potential to overcome significant
formulation challenges.
This concept allows for flexibility in the formulation of each active ingredient
and enables IB to develop a portfolio of formulations which can be tailored to
fit with NCE`s from its partners` research and development programmes.
The C200 technology is designed to assist a number of established and new drugs
to compete in the lucrative combination inhaled drug sector using device and
formulation technologies being developed by IB.
In June 2004 IB announced an exclusive agreement with a major global
pharmaceutical group to market and distribute a combination of two established
respiratory medications in the C200 dry powder inhaler. The agreement covers
Europe and certain other specified countries, with IB having retained the rights
for all remaining territories including the US and Japan.
During the period under review, IB has worked with a number of drug formulations
and device designs in order to optimise the first product which is planned to
enter clinical trials in early 2006.
This agreement for our new C200 platform is significant for IB as we consider it
represents a further step towards fulfilling IB`s objective of becoming the
leading, independent provider of dry powder inhalation solutions to the global
pharmaceutical industry.
We believe that this advance in the core technology offering of IB presents an
exciting opportunity to partner companies by providing a device which can
deliver either more dose units or a larger dose pay load (thereby reducing cost
to the manufacturer and healthcare provider), or can deliver a novel molecule in
combination with an established drug to address the rapidly growing inhalation
market.
P.J. Shennan
Chief Operating Officer and Finance Director
25th January 2005
Biotech zum schnäppchenpreis und mit super aussichten.
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M.L. Laboratories PLC
25 January 2005
Embargoed until 0700 GMT 25 January 2005
ML Laboratories PLC
(`ML` or `the Company`)
Preliminary Audited Results for the Year Ended 30 September 2004
Operational highlights
• Positive results reported from US Phase III trial of Adept adhesion
reduction therapy; US Marketing Authorisation Application anticipated in Q1
2005
• European regulatory review ongoing for formoterol and budesonide
Clickhalers; outcome anticipated in H1 2005
• Meptin Clickhaler filed in Japan; approval and launch expected later in
2005
• Exclusive marketing agreement signed with a Japanese pharmaceutical
company for budesonide Clickhaler in Japan
• First commercial agreement for a New Chemical Entity (NCE) respiratory
compound in Clickhaler signed with Pliva, a multi-national pharmaceutical
company
• First commercial agreement for C200 inhaler signed with global
pharmaceutical group for combination of two established respiratory
medications
• Clinical development programmes continued to advance; commenced Phase
IIa study with Alpharen phosphate binder and Phase I/II study with CTL 102
in prosthesis repair
Financial highlights
• Raised additional funds of £14.4 million through a Rights Issue and
Issue For Cash
• Further disposals of non-core assets
• Pre-tax loss of £10.9 million (2003: £2.8 million, which reflected the
benefit of £7.3 million arising from transactions with Paul Capital (2004:
£0.5 million) and profit on divestments of £5.7 million (2004: £0.8
million))
• Net cash and short-term deposits as at 30 September 2004 of £10.9
million (30 September 2003: £6.6 million)
Commenting on the results, Stuart Sim, Executive Chairman, said:
`Last year the Group made considerable progress in the development and
commercialisation of its portfolio of pharmaceutical products and technologies.
In particular, our respiratory drug delivery subsidiary achieved significant
commercial success, which assisted us towards achieving our objective of growing
income from our portfolio in the near term. The pharmaceuticals division also
made good progress and, in particular, we were pleased to report that Adept
would be filed for approval in the key US market early in 2005. In all, the
achievements in 2004 make for an eventful year ahead, which offers the potential
for further significant news flow and, subject to anticipated milestone income,
maiden profitability.`
Enquiries:
ML Laboratories PLC (25/01/05) 020 7067 0700
Peter Shennan, Chief Operating Officer (Thereafter) 01925 844 700
& Finance Director
Stuart Sim, Executive Chairman
Weber Shandwick Square Mile 020 7067 0700
Kevin Smith / Sarah MacLeod
A presentation to analysts will take place at 9:30am today at the offices of
Weber Shandwick Square Mile, Fox Court, 14 Gray`s Inn Road, London WC1. Please
contact Hayley Smith on 020 7067 0700 for details.
Embargoed until 0700 GMT 25 January 2005
ML Laboratories PLC
(`ML` or `the Company`)
Preliminary Audited Results for the Year Ended 30 September 2004
CHAIRMAN`S STATEMENT
In January 2004 we successfully raised £14.4m by way of a fully underwritten
rights issue and an issue for cash. At that time we issued a circular describing
how the Board intended to use those proceeds and I am pleased to report on our
progress towards achieving the objectives identified.
Throughout the financial year ended 30th September 2004 and the subsequent
period to date, we have made considerable progress in the development and
commercialisation of our portfolio of pharmaceutical products and technologies
which resulted in the following principal outcomes:
Clinical and regulatory progress
• Adept
In December 2004 we announced the preliminary unaudited results of our pivotal
Phase III US multi-centre clinical trial of Adept, our adhesion reduction
therapy. This clinical trial was a landmark study as it was the first
double-blind randomised controlled clinical study with an adhesion reduction
agent, and the largest clinical laparoscopic second-look adhesions study ever
undertaken.
The data analysis demonstrated that those patients who received Adept showed
improvement over the comparator group in all measurements of efficacy whilst
maintaining a similar safety profile.
We therefore plan to file an application with the US Food and Drug
Administration (FDA) for a US marketing authorisation in the first quarter of
2005. The outcome of the application is anticipated in 2006 and if successful
will be followed by launch in the US subject to the appointment of a licensee
for that territory.
We consider it is likely that Japanese marketing approval will be facilitated by
data generated by the US study. Consequently, we are in discussions with
potential licensees for the US, Japanese and other Asian markets and we
anticipate that the appointment of licensees for these valuable territories
should generate substantial milestone receipts during 2005.
We are excited by the prospects for Adept and believe it has the potential to be
used routinely in all abdominal surgery due to its safety profile, ease of use
and potential cost advantage.
• ALPHARENTM*
Our collaboration with Ineos Silicas Healthcare Limited to develop its novel
compound for the treatment of hyperphosphataemia in kidney failure patients saw
the encouraging initial results of the Phase I study presented at both the
American Society of Nephrology in November 2003 and the European Dialysis and
Transplant Association meeting in May 2004. In addition we commenced a Phase IIa
clinical study in the period and progressed the design of the Phase IIb study.
We consider Alpharen could be a significant entrant to this rapidly growing
market segment given its substantial phosphate binding activity as demonstrated
in the Phase I study.
*ALPHAREN is a trade mark of Ineos Silicas Healthcare Ltd.
• FORMOTEROL CLICKHALER
Dialogue with the regulators regarding our application for European marketing
authorisation continued in the period and the outcome is anticipated shortly.
Approval of the product will trigger a significant milestone receipt from our
licensee, as will European marketing launch which is anticipated in H1 2005.
Application for marketing authorisation was also filed in Canada and launch of
the product in that country, which is anticipated in H2 2006 will trigger a
further significant milestone receipt. The product launches will be followed by
royalties on sales.
• BUDESONIDE CLICKHALER
The application for European marketing authorisation was filed in November 2003
triggering a significant milestone receipt from our licensee. European marketing
approval of this product is also anticipated shortly enabling launch in H1 2005.
Both events will trigger further significant milestone receipts and will be
followed by royalty income post launch.
• MEPTIN CLICKHALER
Otsuka Pharmaceutical Co. Ltd., a leading Japanese healthcare company, has an
exclusive licence for the delivery of Meptin, its asthma treatment, in
Clickhaler in Japan and Spain. In May 2004 we announced that data produced by
Otsuka had been filed with the Japanese regulator triggering a further milestone
receipt. Approval and launch of Meptin Clickhaler in Japan are anticipated in
2005 which will trigger further milestone receipts and income from the supply of
Clickhalers to Otsuka.
• CTL 102 in Prostate Cancer
We commenced the treatment phase of our Phase II study to evaluate the efficacy
and safety of our novel treatment of prostate cancer during the year. The trial,
which is the first of its kind in prostate cancer in the UK, has progressed
during the period and we anticipate reporting the outcome in H1 2006.
• CTL 102 in Prosthesis Repair
In collaboration with the University of Leiden, we commenced a Phase I/II study
to evaluate the potential for the cell killing capability of CTL 102 to be used
in prosthesis revision surgery to facilitate the refixing of loosened
prostheses.
The object of the study, which will be undertaken in 12 inoperable patients, is
to assess the response to therapy in respect of mobility and pain, and we expect
the study will complete in H2 2005.
• CTL 901
In December 2003 the first patient was entered into the Phase I/II clinical
trial of our treatment of skin cancer (advanced melanoma) by our collaborators
at Birmingham University. Recruitment has continued and we expect the trial to
complete in H1 2005.
Commercialisation progress
Innovata Biomed (`IB`), our respiratory drug delivery subsidiary, achieved
considerable commercial success in the period which, significantly, included the
signing of both the first commercialisation agreement for our new C200
combination inhaler and the first agreement for a New Chemical Entity (NCE) to
be delivered in Clickhaler.
• C200 multi-dose breath-actuated inhaler
Combination delivery of inhaled drugs is increasingly being seen as the most
effective means of controlling asthma and the C200 device, coupled with IB`s
formulation expertise, provides a fast development route to this rapidly growing
sector. The market for combination asthma therapy is currently valued globally
at over $5 billion p.a. and projected to exceed $6 billion p.a. by 2006 (source:
Datamonitor).
In June 2004 we announced an exclusive agreement with a global pharmaceutical
group whereby IB will develop a respiratory treatment comprising a combination
of two established respiratory medications in C200. Our licensee will market and
distribute the product in Europe and certain other specified countries with IB
having retained the rights for all other territories including the US and Japan.
The agreement, which is the second with this licensee, provides for IB to
receive access fees and milestone receipts totalling £7.5 million. In addition,
IB will conduct the development programme on behalf of the licensee which could
generate development fees of up to a further £9 million. IB will receive
royalties on sales, with first launch anticipated in 2008, and will supply C200
inhalers to the licensee on commercial terms.
We believe the C200 technology could be used to deliver a number of inhaled
products in combination with new, or established, molecules and IB continues to
seek collaborations with other pharmaceutical companies with the object of
securing further valuable licensing deals for the C200 device.
• CLICKHALER
Budesonide Clickhaler Japan
In September 2004 we announced that IB had signed an exclusive agreement with a
Japanese pharmaceutical company for marketing rights to budesonide Clickhaler
for that territory. We are delighted that following extensive evaluation the
company selected IB`s budesonide Clickhaler.
Under the terms of the agreement, IB received an access fee and will receive
subsequent milestone receipts. IB will provide assistance to the company in
completing the necessary clinical studies to obtain regulatory approval in
Japan, where the company expects to launch the product in 2008. IB will supply
the product to the company on commercial terms thereafter.
This agreement is the second licence of Clickhaler in Japan and should generate
important income for the Group.
Pliva Clickhaler
In December 2003 IB entered into an agreement with Pliva, a multi-national
pharmaceutical company, to develop a novel asthma medication based on Pliva`s
NCE steroid and Clickhaler. Under the agreement, IB will receive development
fees, milestone receipts and royalties on sales. In addition, IB will supply
Clickhalers on commercial terms.
This agreement is significant in that it represents the first agreement for an
NCE to be delivered in Clickhaler and sets IB on the pathway to achieving its
objective of becoming a leading independent provider of dry powder inhalation
technologies for the delivery of NCE respiratory compounds.
Disposals
In December 2003 we sold the balance of our shareholding in Cobra
Biomanufacturing Plc (CBM) realising a further £1.2m net of expenses bringing
the total gross sum realised from the divestment of that business to circa
£8.2m. In February 2004 we disposed of our loss making educational training
business where the consideration received was in the form of shares in the
purchaser which we have retained as a £0.2m investment.
Financial results
The loss before tax in the year of £10.9m compares with a loss of £2.8m in the
previous year which reflected the benefit of £7.3m resulting from accounting for
transactions with Paul Capital and profit on divestments of £5.7m compared with
£0.5m and £0.8m respectively in the year under review. The financial results are
fully described in the Financial Review.
Funding
Our activities in the year were financed by a combination of the fundraising of
£14.4m net of expenses, royalty and milestone income generated by those of our
products that have been commercialised, and proceeds from the disposal of
assets.
Working capital
The cash flow projections of the Group include significant receipts of milestone
income and proceeds from the potential disposal of assets. Historically we have
demonstrated that we are able to generate receipts from such sources and we
anticipate that we will continue to be able to do so. Consequently, we have a
reasonable expectation that the Group will have sufficient working capital for
the foreseeable future. However, given the difficulty in predicting accurately
the timing and amount of such future receipts we will continue to keep the
adequacy of our working capital under regular review.
Panos acquisition
In January 2004 we informed shareholders that we had agreed an arrangement
whereby we may in due course acquire Panos, from whom we license our interest in
Devacade, for a consideration to be paid in shares.
This arrangement remains in place, albeit still subject to contract.
Prospects
ML is currently generating income from products it has successfully developed
and licensed to other pharmaceutical companies which we have achieved by
utilising our core skills in clinical development, regulatory affairs and
product commercialisation. Our development activities are focussed on products
and technologies with the potential to produce income in the relatively near
term. We continue to believe that each of our products in development is of
potentially high value with an acceptable risk profile and, accordingly, has a
reasonable probability of generating income for the Group. Our potential for
growth is supported by our established track record of sourcing a development
pipeline through in-house initiatives, in-licensing and joint development
agreements, all of which we will continue to pursue actively. Consequently we
believe that the business is capable of achieving profitability in the near term
and delivering value to shareholders over the long term. Therefore the Directors
view the future prospects of the Group with confidence.
Corporate objective
Our objective is to develop and commercialise pharmaceutical products and
technologies for specialist markets derived from intellectual property generated
by our own research, in-licensed from third parties and through joint
development programmes.
In the January 2004 circular to shareholders we stated that providing milestone
income is received in line with current projections ML would be in a position to
consider developing certain products through Phase III, adopting alternative
commercialisation strategies and/or seeking to expand the pharmaceutical
portfolio by in-licensing additional appropriate products, and I can confirm
that this continues to be the case.
I would like to take this opportunity to thank all shareholders for their
continuing support of the company and our employees whose hard work and
dedication continue to deliver the products and technologies essential for the
progress of the business.
S.W. Sim
Executive Chairman
25th January 2005
OPERATIONAL REVIEW
OPERATIONAL STRUCTURE
The Group`s activities are organised into two principal operations - ML
Pharmaceuticals and Innovata Biomed, the Group`s respiratory subsidiary.
ML Pharmaceuticals is a pharmaceutical product development business with a track
record of successful clinical development, regulatory approval and licensing of
pharmaceutical products and a development pipeline of future products targeted
at specialist markets. Its activities are supported by revenue streams generated
from products which have been successfully developed and licensed to other
pharmaceutical companies.
Innovata Biomed is an independent provider of inhaled drug delivery technology
to the pharmaceutical industry. IB`s proven delivery technology is available for
proof of principle testing and as a `fast-to-market` drug delivery solution.
Existing licence agreements generate development fees, royalty income and
milestone receipts which support the business`s ongoing development programmes.
Both businesses operate as distinct divisions with their own research, clinical
development and business development capabilities, supported by centrally
provided services which include regulatory affairs, intellectual property
management, finance and administration.
PRODUCT DEVELOPMENT REVIEW
ML PHARMACEUTICALS
EXTRANEAL - a solution of Icodextrin for use in Peritoneal Dialysis treatment
Icodextrin solution is used in peritoneal dialysis for the treatment of renal
failure patients, wherein waste products and excess fluid pass from the
patient`s blood into a dialysis solution which has been infused into the
abdominal cavity, all of which is subsequently drained out. ML holds patents
over Icodextrin, the active ingredient, in all appropriate major countries.
The product has been licensed on an exclusive worldwide basis to Baxter
Healthcare, a market leader in renal disease treatments. Baxter has launched the
product under its trade name, Extraneal, firstly in the UK in 1996 and
subsequently in a further 35 countries, including the two major markets of USA
and Japan in 2003, which offer the prospect of significant royalty income. As a
result Extraneal is now commercially available in all of the world`s major
pharmaceutical markets.
Currently more than 15,000 patients worldwide are using the solution on a daily
basis and over 50,000 patient-years experience in routine clinical use has been
gained to date.
ADEPT - a solution of Icodextrin for the reduction of post-operative adhesions
Adhesions are a serious and frequent complication following abdominal and
gynaecological surgery and are acknowledged as a major surgical problem.
Adhesions are expensive to treat, often requiring further surgery and
hospitalisation. Currently available treatments are both expensive and difficult
to administer, often requiring specific training. Adept offers significant
advantages in that it is an easy to use, low viscosity solution which can be
delivered via a laparoscope in minimally invasive (keyhole) surgery and is
readily incorporated into routine surgical procedures.
Shire Pharmaceuticals PLC (`Shire`), our licensee for Europe, is achieving
growing use of this product with gynaecologists and with general surgeons
carrying out colorectal operations. ML retains all rights to Adept for the rest
of the world.
The clinical development of Adept has been concentrated in the US where we
recently completed the pivotal Phase III clinical trial, (`the PAMELA study`),
the object of which was to determine the efficacy and safety of Adept in the
reduction of post surgical adhesions after laparoscopic surgery. The preliminary
results of this study were announced in December 2004 and confirmed that Adept
demonstrated significant benefits over the control therapy in reducing adhesions
and improving the status of gynaecological patients.
The analysis demonstrated that those patients who received Adept showed
improvement over the comparator group in all measurements of efficacy whilst
maintaining a similar safety profile. We therefore have sufficient confidence to
progress the filing of an application with the US FDA for a US Marketing
Authorisation.
The PAMELA study was an evaluation of Adept as an adjunct to adhesiolysis
surgery conducted in 16 gynaecology units in the US. The study was a double
blind comparison of Adept and an optimised control therapy using Ringer`s
lactate solution (RLS). A total of 449 patients were randomised to treatment.
The detailed analysis demonstrated that Adept significantly reduced the number
of adhesions in patients undergoing adhesiolysis. Adept demonstrated a 30%
improvement when compared to the control patients who received the optimised
therapy using RLS. In addition, Adept treatment resulted in significantly fewer
patients with newly formed adhesions.
In routine clinical use the safety of icodextrin, the active ingredient in
Adept, has been firmly established in peritoneal dialysis (over 50,000
patient-years experience worldwide) and in adhesion reduction in over 100,000
surgical patients in Europe. In addition, the PAMELA study showed that the
overall incidence of adverse events in the Adept and control groups was similar.
Unusually, the study protocol included several statistically defined primary
endpoints. Whilst not all were achieved, the significant benefits demonstrated
and the positive responses of the clinical investigators have confirmed to us
that Adept represents a valuable therapeutic product.
In addition the PAMELA trial data will form the basis for advanced stage ongoing
negotiations with potential licensees for the US and Japan and for the
negotiation of the remaining milestone payment from Shire.
Our view is that uptake of available competitive treatments for adhesions has
been hampered by their complexity of use and cost. We consider that an ideal
anti-adhesion agent should be safe, cost effective, easy to use and capable of
reducing adhesion formation at the operating site and throughout the peritoneal
cavity. The preliminary results of the PAMELA study suggest that Adept fits this
profile and can assist in reducing the burden of adhesions.
We anticipate filing an application with the FDA for a US marketing
authorisation in the first quarter of 2005 following completion and audit of the
full statistical analysis and compilation of the final clinical report of the
study.
ALPHARENTM - a Phosphate Binder for the treatment of Hyperphosphataemia
Abnormally high and damaging levels of phosphate in the blood occur when failing
kidneys are unable to rid the body of excess phosphate absorbed from food.
Patients suffering from end-stage renal failure usually need to take a phosphate
binding product to prevent absorption of phosphate and reduce blood
concentrations. The novel compound we are co-developing with Ineos Silicas
Healthcare Limited has been shown in pre-clinical and Phase I human volunteer
tests to have substantial phosphate binding activity. Furthermore, the product
does not contain aluminium or calcium ions which could cause safety concerns in
long term use, therefore also rendering Alpharen potentially applicable for use
in pre-dialysis renal failure patients.
A Phase I study has demonstrated that healthy volunteers were able to tolerate
the drug in doses sufficient to cause a significant reduction in phosphate
absorption from the diet. A Phase IIa study is underway.
This product meets our product selection criteria ideally, as its clinical
efficacy can be readily demonstrated in a relatively small number of kidney
failure patients.
Gene Therapy Products
CTL102 in Prostate Cancer
Prostate cancer is the most common cancer in men in the UK with over 24,700 new
cases a year. The lifetime risk for being diagnosed with prostate cancer is 1 in
14*. The treatment technique uses gene therapy technology to deliver a cancer
killing toxin direct to the tumour site in a two stage process. The mode of
action is the delivery of the gene for a bacterial enzyme, nitroreductase, to
cancer cells such that a separately administered, relatively harmless drug,
CB1954, will be activated in the tumour to kill the cancer cells. In November
2003 we announced the commencement of the treatment stage of our Phase II
clinical trial of prostate cancer and we expect to report the outcome of the
trial in H1 2006.
We are hopeful that the novelty of the product could establish a marketable
platform from which gene therapy products can be developed by third party
licensees for the treatment of other tumours.
CTL 102 in Prosthesis repair
In collaboration with the University of Leiden, we are evaluating the potential
for the cell killing capability of CTL 102 to be used in prosthesis revision
surgery.
Patients with artificial joints have a tendency for the prosthesis to work loose
over time. The consequences of such loosening include pain and discomfort and
often result in the patient having to undergo further lengthy operations to
repair or replace the prosthesis. Many patients, particularly the elderly, may
be unable to be subjected to such operations which are also very expensive. In
some countries, prosthetic implants such as hips are not offered to younger
patients because of the frequency with which they become loose and the cost of
subsequent surgery.
The product concept is designed to enable orthopaedic surgeons to destroy the
rubbery interface tissue surrounding loose prostheses which cannot, otherwise,
be easily removed. Once destroyed, the tissue can be aspirated to enable
replacement bone cement to be injected into the area, thereby refixing the
prosthesis.
A Phase I/II study is underway to assess the response to therapy of 12
inoperable patients in respect of mobility and pain. The study is expected to
complete in H2 2005.
*Source: Statistics from Cancer Research UK
CTL 901 in Melanoma
A Phase I/II clinical trial is being conducted by our collaborators at the
Cancer Research UK Institute for Cancer Studies at Birmingham University on our
treatment for malignant melanoma. This treatment is based on the delivery of
genes encoding tumour associated antigens to antigen presenting cells known as
dendritic cells, a component of the immune system. In the trial, dendritic cells
isolated from the patients` blood are modified using our proprietary antigen
delivery system, CL22. The modified dendritic cells are returned to the patients
by injection in order to induce the patients` immune system to attack tumour
cells. Pre-clinical data suggest that this treatment will specifically attack
skin cancers as well as the cancerous cells which leave the tumour and spread
the disease throughout the body. We consider that our CL22 system is a platform
technology that may prove to be capable of modifying dendritic cells for the
treatment of other advanced forms of cancer for which no effective treatments
are available.
Gene Expression Technology
Agreements have been signed with a number of biotechnology and pharmaceutical
companies to evaluate the UCOE technology for facilitating gene expression and
thereby increasing the efficiency of therapeutic protein production. In addition
we have an agreement with Medarex to apply our UCOE gene expression technology
for antibody production. We consider that the licensing of this technology will
continue to generate revenues in the near term in the form of licence fees and
potentially, in the long term, in the form of royalties on the sale of products
using this technology.
DEVACADE - for enhancing the pain relief produced by morphine
Pre-clinical studies with Devacade demonstrated that this new chemical entity
(`NCE`) has the ability to enhance the pain relieving properties of drugs such
as morphine without increasing the disturbing and dangerous side-effects
experienced with such drugs. In a Phase II programme Devacade, when given as an
adjunct to those drugs, reduced pain levels and patients reported reduced levels
of sleep disturbance from their pain and reduced interference in activities
owing to pain.
Further clinical programmes are being designed to assess the efficacy and
required dose levels for the use of Devacade as an adjunct to opioid analgesia
in a number of pain states.
We continue actively to seek a licensee who is able to complete the required
clinical programme and market this novel product.
EMMELLE intravaginal gel
In September 2004 we announced that the Medical Research Council was not
prepared to take Emmelle forward into its Phase III microbicide programme for
the prevention of transmission of HIV. Therefore, given the poor potential for
an acceptable financial return to ML were it to take the product forward, we
discontinued our activities related to this programme.
A preclinical programme is underway to evaluate the activity of Emmelle against
chlamydia and herpes simplex virus.
INNOVATA BIOMED
CLICKHALER - a fast-to-market dry powder inhaler for new asthma therapies
Clickhaler is a proven, industrialised dry powder inhaler (DPI) with many
established advantages over standard asthma inhalers. Clickhaler has been
extensively studied and shown to be highly acceptable to patients, regulators
and potential licensees. Furthermore, it is already marketed by Celltech with
standard asthma therapies (salbutamol and beclomethasone) in the UK, Ireland and
France.
In September 2002 we announced that we had entered into an exclusive licence
agreement with a major global pharmaceutical group for the rights to market the
two asthma therapy molecules, budesonide and formoterol, in Clickhaler in Europe
and a number of other territories. Taking into account monies already received
we anticipate this agreement will generate £10m in access fees and milestone
receipts plus double digit royalties on future product sales.
In November 2002 the first application for marketing authorisation for
formoterol Clickhaler in Europe was submitted, which was followed by application
to the Canadian regulators in November 2003. We anticipate reaching the European
and Canadian markets through our licensee in 2005 and 2006 respectively. The
application for European marketing authorisation for budesonide Clickhaler was
filed in November 2003 with launch expected in 2005. Revenues from both
budesonide and formoterol Clickhaler are expected to flow from sales for the
commercial life of the products.
Negotiations were completed in March 2003 for the delivery of Otsuka
Pharmaceutical Company`s established drug, Meptin, using IB`s Clickhaler, in
Japan and Spain. This drug is already being sold by Otsuka in a CFC metered dose
inhaler format and they expect to be able to commence substitution of sales of
their existing product with Clickhaler once approval is granted by the Japanese
regulators, which we anticipate will be received in H1 2005.
In December 2003 an agreement was entered into with PLIVA to develop a novel
asthma medication based on PLIVA`s NCE steroid and Clickhaler.
In September 2004 an agreement was entered into with a Japanese company for the
rights to budesonide Clickhaler for Japan. We believe this agreement further
cements Clickhaler`s reputation as a leading independently provided dry powder
inhaler.
In addition, further formulation studies have been undertaken by IB, both alone
and with potential partner companies, to evaluate the performance of Clickhaler
in the laboratory. These studies include the assessment of novel and established
molecules as well as new formulation technologies designed to enhance the
performance of the device with certain drugs.
IB continues to build a library of data on the capabilities of its own device
and formulation technologies, as well as third party formulation technologies,
to enable it to provide an enhanced offering to the global pharmaceutical
industry.
C200 Device - building on the CLICKHALER technology
IB has recognised the opportunity offered by developments in the treatment of
asthma by combining two drugs in the same inhaler.
Patents have already been granted in Europe on the C200 device, which is a novel
adaptation of the proven dose-metering `engine` of Clickhaler, whereby in the
same device two separate drug reservoirs feed two separate drug formulations to
separate metering chambers from which they are delivered to the patient in the
same breath. The ability to formulate the drugs separately permits optimisation
of each individually, thereby offering the potential to overcome significant
formulation challenges.
This concept allows for flexibility in the formulation of each active ingredient
and enables IB to develop a portfolio of formulations which can be tailored to
fit with NCE`s from its partners` research and development programmes.
The C200 technology is designed to assist a number of established and new drugs
to compete in the lucrative combination inhaled drug sector using device and
formulation technologies being developed by IB.
In June 2004 IB announced an exclusive agreement with a major global
pharmaceutical group to market and distribute a combination of two established
respiratory medications in the C200 dry powder inhaler. The agreement covers
Europe and certain other specified countries, with IB having retained the rights
for all remaining territories including the US and Japan.
During the period under review, IB has worked with a number of drug formulations
and device designs in order to optimise the first product which is planned to
enter clinical trials in early 2006.
This agreement for our new C200 platform is significant for IB as we consider it
represents a further step towards fulfilling IB`s objective of becoming the
leading, independent provider of dry powder inhalation solutions to the global
pharmaceutical industry.
We believe that this advance in the core technology offering of IB presents an
exciting opportunity to partner companies by providing a device which can
deliver either more dose units or a larger dose pay load (thereby reducing cost
to the manufacturer and healthcare provider), or can deliver a novel molecule in
combination with an established drug to address the rapidly growing inhalation
market.
P.J. Shennan
Chief Operating Officer and Finance Director
25th January 2005
Zitat
Antwort
0
Hi
Die Aktie hat endlich die 20p marke geknackt somit ist viel luft nach oben.
Der aktuelle kurs an der LSE 20,25p oder 11% plus.
News von heute:
ML Laboratories PLC
(`ML` or `the Company`)
Board Restructuring
The employment of Stuart Sim, ML`s Executive Chairman, has been terminated by
the Board, and Mr Sim has ceased to be a director, with immediate effect.
The Company also announces that Mr Ian Kent and Mr Kieran Murphy have joined the
board as Executive Chairman and Chief Executive respectively.
Mr Kent was a director of Biofocus PLC from 2001 to 2003 and of Vernalis PLC
from 2002 to 2003. Mr Murphy was a director of Cobequid Life Sciences, a public
company quoted in Canada, from 1998 to 2000.
Gruss
B.M.
Die Aktie hat endlich die 20p marke geknackt somit ist viel luft nach oben.
Der aktuelle kurs an der LSE 20,25p oder 11% plus.
News von heute:
ML Laboratories PLC
(`ML` or `the Company`)
Board Restructuring
The employment of Stuart Sim, ML`s Executive Chairman, has been terminated by
the Board, and Mr Sim has ceased to be a director, with immediate effect.
The Company also announces that Mr Ian Kent and Mr Kieran Murphy have joined the
board as Executive Chairman and Chief Executive respectively.
Mr Kent was a director of Biofocus PLC from 2001 to 2003 and of Vernalis PLC
from 2002 to 2003. Mr Murphy was a director of Cobequid Life Sciences, a public
company quoted in Canada, from 1998 to 2000.
Gruss
B.M.
Zitat
Antwort
0
Hi
Herrlich wie meine aktien aus U.K. steigen.
Ml Lab. steigt heute wieder um knapp 10% nachdem der Director 3mio aktien erworben hat zum preis von 21,25p
aktuell 23,25p.Die Aktie ist trotzdem immer noch billig.
Es stehen noch reichlich kurstreibende nachrichten aus:
• Positive results reported from US Phase III trial of Adept adhesion
reduction therapy; US Marketing Authorisation Application anticipated in Q1
2005
• European regulatory review ongoing for formoterol and budesonide
Clickhalers; outcome anticipated in H1 2005
• Meptin Clickhaler filed in Japan; approval and launch expected later in
2005
• Exclusive marketing agreement signed with a Japanese pharmaceutical
company for budesonide Clickhaler in Japan
• First commercial agreement for a New Chemical Entity (NCE) respiratory
compound in Clickhaler signed with Pliva, a multi-national pharmaceutical
company
• First commercial agreement for C200 inhaler signed with global
pharmaceutical group for combination of two established respiratory
medications
• Clinical development programmes continued to advance; commenced Phase
IIa study with Alpharen phosphate binder and Phase I/II study with CTL 102
in prosthesis repair
Gruss
B.M.
Herrlich wie meine aktien aus U.K. steigen.
Ml Lab. steigt heute wieder um knapp 10% nachdem der Director 3mio aktien erworben hat zum preis von 21,25p
aktuell 23,25p.Die Aktie ist trotzdem immer noch billig.
Es stehen noch reichlich kurstreibende nachrichten aus:
• Positive results reported from US Phase III trial of Adept adhesion
reduction therapy; US Marketing Authorisation Application anticipated in Q1
2005
• European regulatory review ongoing for formoterol and budesonide
Clickhalers; outcome anticipated in H1 2005
• Meptin Clickhaler filed in Japan; approval and launch expected later in
2005
• Exclusive marketing agreement signed with a Japanese pharmaceutical
company for budesonide Clickhaler in Japan
• First commercial agreement for a New Chemical Entity (NCE) respiratory
compound in Clickhaler signed with Pliva, a multi-national pharmaceutical
company
• First commercial agreement for C200 inhaler signed with global
pharmaceutical group for combination of two established respiratory
medications
• Clinical development programmes continued to advance; commenced Phase
IIa study with Alpharen phosphate binder and Phase I/II study with CTL 102
in prosthesis repair
Gruss
B.M.
Zitat
Antwort
0
Hi
ML Laboratories PLC
(`ML` or `the Company`)
ML`s CLICKHALER APPROVED IN JAPAN
ML Laboratories plc (MLB.L) announced today that its respiratory subsidiary,
Innovata Biomed (`IB`) has received news from its licensee Otsuka Pharmaceutical
Co, Ltd. that its Meptin Clickhaler product has been approved in Japan.
Under the terms of its Agreement with Otsuka, IB will receive a milestone
payment on approval. Clickhalers will be supplied to Otsuka on a commercial
basis. It is anticipated that Meptin Clickhaler will be introduced to the market
later in 2005.
Commenting for IB, Paul Ballington, Managing Director noted, `This is a
significant event for IB, and demonstrates how products incorporating our
technologies can be successfully developed in the hands of our licensees. Otsuka
is a powerful competitor in the Japanese asthma market and a valuable licensee
for Clickhaler.`
ML Laboratories PLC
(`ML` or `the Company`)
ML`s CLICKHALER APPROVED IN JAPAN
ML Laboratories plc (MLB.L) announced today that its respiratory subsidiary,
Innovata Biomed (`IB`) has received news from its licensee Otsuka Pharmaceutical
Co, Ltd. that its Meptin Clickhaler product has been approved in Japan.
Under the terms of its Agreement with Otsuka, IB will receive a milestone
payment on approval. Clickhalers will be supplied to Otsuka on a commercial
basis. It is anticipated that Meptin Clickhaler will be introduced to the market
later in 2005.
Commenting for IB, Paul Ballington, Managing Director noted, `This is a
significant event for IB, and demonstrates how products incorporating our
technologies can be successfully developed in the hands of our licensees. Otsuka
is a powerful competitor in the Japanese asthma market and a valuable licensee
for Clickhaler.`
Zitat
Antwort
0
Hi
M.L. Laboratories PLC
18 March 2005
ML Laboratories PLC (the `Company`)
Notification of Major Interests in Shares
Section 198 to 202 Companies Act 1985
The Company received a notification today from AVIVA plc on behalf of itself and
Morley Fund Management Limited informing it that following share purchases of
1,000,000 shares on 16 March 2005, they have in interest in 23,392,806 shares
representing 10.23% of the Company`s issued ordinary share capital.
18 March 2005
M.L. Laboratories PLC
18 March 2005
ML Laboratories PLC (the `Company`)
Notification of Major Interests in Shares
Section 198 to 202 Companies Act 1985
The Company received a notification today from AVIVA plc on behalf of itself and
Morley Fund Management Limited informing it that following share purchases of
1,000,000 shares on 16 March 2005, they have in interest in 23,392,806 shares
representing 10.23% of the Company`s issued ordinary share capital.
18 March 2005
Zitat
Antwort
0
Hi
ML Laboratories plc
22.3.2005
Marketing Approvals Received for Two Separate Asthma Compounds in First European Market
ML Laboratories plc (MLB.L) has received news from its licensing partner that
its innovative dry powder inhaler, Clickhaler(R), has been granted two marketing
approvals in its first European market for use with budesonide and formoterol
respectively, two widely-prescribed asthma therapies. This is the first country
in Europe to approve these two Clickhaler products and applications in other
European markets are progressing.
The budesonide and formoterol Clickhaler products were licensed by ML to an
undisclosed major pharmaceutical partner in September 2002. Under the terms of
this agreement, ML receives milestone payments on receipt of marketing
approvals, followed by further milestones on product launches and double digit
royalties on sales.
Sales of comparable budesonide products in Europe total £200 million while the
European market for comparable formoterol products is estimated at more than
£100 million. Both Clickhaler products will be launched at the earliest
opportunity.
Clickhaler products are now approved in one or more European countries for
salbutamol, beclomethasone, budesonide and formoterol, with the Meptin
Clickhaler (Otsuka`s procaterol) recently approved in Japan.
Paul Ballington, Director of Marketing and Business Development, commented:
`Clickhaler has now been approved with a number of asthma treatments, each
representing a substantial market opportunity. The European markets for both
budesonide and formoterol are predominantly in dry powder delivery devices and
we believe that Clickhaler`s ease of use and reliability will enable it to gain
a significant share of these markets.`
ML Laboratories plc
22.3.2005
Marketing Approvals Received for Two Separate Asthma Compounds in First European Market
ML Laboratories plc (MLB.L) has received news from its licensing partner that
its innovative dry powder inhaler, Clickhaler(R), has been granted two marketing
approvals in its first European market for use with budesonide and formoterol
respectively, two widely-prescribed asthma therapies. This is the first country
in Europe to approve these two Clickhaler products and applications in other
European markets are progressing.
The budesonide and formoterol Clickhaler products were licensed by ML to an
undisclosed major pharmaceutical partner in September 2002. Under the terms of
this agreement, ML receives milestone payments on receipt of marketing
approvals, followed by further milestones on product launches and double digit
royalties on sales.
Sales of comparable budesonide products in Europe total £200 million while the
European market for comparable formoterol products is estimated at more than
£100 million. Both Clickhaler products will be launched at the earliest
opportunity.
Clickhaler products are now approved in one or more European countries for
salbutamol, beclomethasone, budesonide and formoterol, with the Meptin
Clickhaler (Otsuka`s procaterol) recently approved in Japan.
Paul Ballington, Director of Marketing and Business Development, commented:
`Clickhaler has now been approved with a number of asthma treatments, each
representing a substantial market opportunity. The European markets for both
budesonide and formoterol are predominantly in dry powder delivery devices and
we believe that Clickhaler`s ease of use and reliability will enable it to gain
a significant share of these markets.`
Zitat
Antwort
0
Hi
Aviva erhöht position in Ml Laboratories.
http://moneyextra.uk-wire.com/cgi-bin/articles/2005032214225…
M.L. Laboratories PLC
22 March 2005
Letter to: ML Laboratories PLC
Dated: 21 March 2005
ML LABORATORIES PLC (THE `COMPANY`) - SEDOL 0555470
This notification supersedes our previous notification to you dated 17 March
2005 and is prompted by purchases totalling 2,500,000 on 18 March 2005.
This notification relates to issued ordinary shares of GBP0.01 each in the
capital of the Company (the `shares`) and is given in fulfilment of the
obligations imposed by sections 198 to 202 of the Companies Act 1985 (the
`Act`).
1. Notification on behalf of Morley Fund Management Limited (a subsidiary of
Aviva plc).
1.1 We hereby notify you on behalf of Morley Fund Management Limited that
immediately after the time when the obligation to make this notification
arose Morley Fund Management Limited were interested in 26,392,806 shares.
1.2 The identity of the registered holders of the shares to which this
notification relates and the number of shares held by each of them are set
out in the Appendix below: Morley Fund Management Limited.
2. Notification on behalf of Aviva plc.
2.1 We hereby notify you on behalf of Aviva plc that immediately after the
time when the obligation to make this notification arose Aviva plc were
interested in 26,392,806 shares giving the Aviva group a total percentage
interest in the shares of 11.54%.
2.2 The identity of the registered holders of the shares to which this
notification relates and the number of shares held by each of them are set
out in the Appendix below: Aviva plc.
From: Aviva PLC
APPENDIX: MORLEY FUND MANAGEMENT LIMITED
REGISTERED HOLDERS NUMBER OF SHARES HELD
BNY Norwich Union Nominees Ltd 845,163 (Material)
Chase GA Group Nominees Ltd 4,656,093 (Material)
CUIM Nominee Ltd 1,506,596 (Material)
Chase Nominees Ltd 5,300,000
Credit Agricole Indosuez 1,700,000
Vidacos Nominees Ltd 12,384,954
TOTAL PERCENTAGE INTEREST OF MORLEY FUND MANAGEMENT LIMITED: 11.54%
ISSUED SHARE CAPITAL ON WHICH THIS NOTIFICATION IS BASED: 228,710,703
APPENDIX: AVIVA PLC
REGISTERED HOLDERS NUMBER OF SHARES HELD
BNY Norwich Union Nominees Ltd 845,163 (Material)
Chase GA Group Nominees Ltd 4,656,093 (Material)
CUIM Nominee Ltd 1,506,596 (Material)
Chase Nominees Ltd 5,300,000
Credit Agricole Indosuez 1,700,000
Vidacos Nominees Ltd 12,384,954
TOTAL PERCENTAGE INTEREST OF AVIVA PLC: 11.54%
ISSUED SHARE CAPITAL ON WHICH THIS NOTIFICATION IS BASED: 228,710,703
Aviva erhöht position in Ml Laboratories.
http://moneyextra.uk-wire.com/cgi-bin/articles/2005032214225…
M.L. Laboratories PLC
22 March 2005
Letter to: ML Laboratories PLC
Dated: 21 March 2005
ML LABORATORIES PLC (THE `COMPANY`) - SEDOL 0555470
This notification supersedes our previous notification to you dated 17 March
2005 and is prompted by purchases totalling 2,500,000 on 18 March 2005.
This notification relates to issued ordinary shares of GBP0.01 each in the
capital of the Company (the `shares`) and is given in fulfilment of the
obligations imposed by sections 198 to 202 of the Companies Act 1985 (the
`Act`).
1. Notification on behalf of Morley Fund Management Limited (a subsidiary of
Aviva plc).
1.1 We hereby notify you on behalf of Morley Fund Management Limited that
immediately after the time when the obligation to make this notification
arose Morley Fund Management Limited were interested in 26,392,806 shares.
1.2 The identity of the registered holders of the shares to which this
notification relates and the number of shares held by each of them are set
out in the Appendix below: Morley Fund Management Limited.
2. Notification on behalf of Aviva plc.
2.1 We hereby notify you on behalf of Aviva plc that immediately after the
time when the obligation to make this notification arose Aviva plc were
interested in 26,392,806 shares giving the Aviva group a total percentage
interest in the shares of 11.54%.
2.2 The identity of the registered holders of the shares to which this
notification relates and the number of shares held by each of them are set
out in the Appendix below: Aviva plc.
From: Aviva PLC
APPENDIX: MORLEY FUND MANAGEMENT LIMITED
REGISTERED HOLDERS NUMBER OF SHARES HELD
BNY Norwich Union Nominees Ltd 845,163 (Material)
Chase GA Group Nominees Ltd 4,656,093 (Material)
CUIM Nominee Ltd 1,506,596 (Material)
Chase Nominees Ltd 5,300,000
Credit Agricole Indosuez 1,700,000
Vidacos Nominees Ltd 12,384,954
TOTAL PERCENTAGE INTEREST OF MORLEY FUND MANAGEMENT LIMITED: 11.54%
ISSUED SHARE CAPITAL ON WHICH THIS NOTIFICATION IS BASED: 228,710,703
APPENDIX: AVIVA PLC
REGISTERED HOLDERS NUMBER OF SHARES HELD
BNY Norwich Union Nominees Ltd 845,163 (Material)
Chase GA Group Nominees Ltd 4,656,093 (Material)
CUIM Nominee Ltd 1,506,596 (Material)
Chase Nominees Ltd 5,300,000
Credit Agricole Indosuez 1,700,000
Vidacos Nominees Ltd 12,384,954
TOTAL PERCENTAGE INTEREST OF AVIVA PLC: 11.54%
ISSUED SHARE CAPITAL ON WHICH THIS NOTIFICATION IS BASED: 228,710,703
Zitat
Antwort
0
Hi
M.L. Laboratories PLC
23 March 2005
Letter to: ML Laboratories PLC
Dated: 23 March 2005
ML LABORATORIES PLC (THE `COMPANY`) - SEDOL 0555470
This notification supersedes our previous notification to you dated 21 March
2005 and is prompted by purchases totalling 1,000,000 on 22 March 2005.
This notification relates to issued ordinary shares of GBP0.01 each in the
capital of the Company (the `shares`) and is given in fulfilment of the
obligations imposed by sections 198 to 202 of the Companies Act 1985 (the
`Act`).
1. Notification on behalf of Morley Fund Management Limited (a subsidiary of
Aviva plc).
1.1 We hereby notify you on behalf of Morley Fund Management Limited that
immediately after the time when the obligation to make this notification
arose Morley Fund Management Limited were interested in 27,892,806 shares.
1.2 The identity of the registered holders of the shares to which this
notification relates and the number of shares held by each of them are set
out in the Appendix below: Morley Fund Management Limited.
2. Notification on behalf of Aviva plc.
2.1 We hereby notify you on behalf of Aviva plc that immediately after the
time when the obligation to make this notification arose Aviva plc were
interested in 27,892,806 shares giving the Aviva group a total percentage
interest in the shares of 12.20%.
2.2 The identity of the registered holders of the shares to which this
notification relates and the number of shares held by each of them are set
out in the Appendix below: Aviva plc.
From: Aviva PLC
APPENDIX: MORLEY FUND MANAGEMENT LIMITED
REGISTERED HOLDERS NUMBER OF SHARES HELD
BNY Norwich Union Nominees Ltd 1,003,832 (Material)
Chase GA Group Nominees Ltd 5,528,317 (Material)
CUIM Nominee Ltd 1,789,440 (Material)
Chase Nominees Ltd 5,300,000
Credit Agricole Indosuez 1,700,000
Vidacos Nominees Ltd 12,571,217
TOTAL PERCENTAGE INTEREST OF MORLEY FUND MANAGEMENT LIMITED: 12.20%
ISSUED SHARE CAPITAL ON WHICH THIS NOTIFICATION IS BASED: 228,710,703
APPENDIX: AVIVA PLC
REGISTERED HOLDERS NUMBER OF SHARES HELD
BNY Norwich Union Nominees Ltd 1,003,832 (Material)
Chase GA Group Nominees Ltd 5,528,317 (Material)
CUIM Nominee Ltd 1,789,440 (Material)
Chase Nominees Ltd 5,300,000
Credit Agricole Indosuez 1,700,000
Vidacos Nominees Ltd 12,571,217
TOTAL PERCENTAGE INTEREST OF AVIVA PLC: 12.20%
ISSUED SHARE CAPITAL ON WHICH THIS NOTIFICATION IS BASED: 228,710,703
M.L. Laboratories PLC
23 March 2005
Letter to: ML Laboratories PLC
Dated: 23 March 2005
ML LABORATORIES PLC (THE `COMPANY`) - SEDOL 0555470
This notification supersedes our previous notification to you dated 21 March
2005 and is prompted by purchases totalling 1,000,000 on 22 March 2005.
This notification relates to issued ordinary shares of GBP0.01 each in the
capital of the Company (the `shares`) and is given in fulfilment of the
obligations imposed by sections 198 to 202 of the Companies Act 1985 (the
`Act`).
1. Notification on behalf of Morley Fund Management Limited (a subsidiary of
Aviva plc).
1.1 We hereby notify you on behalf of Morley Fund Management Limited that
immediately after the time when the obligation to make this notification
arose Morley Fund Management Limited were interested in 27,892,806 shares.
1.2 The identity of the registered holders of the shares to which this
notification relates and the number of shares held by each of them are set
out in the Appendix below: Morley Fund Management Limited.
2. Notification on behalf of Aviva plc.
2.1 We hereby notify you on behalf of Aviva plc that immediately after the
time when the obligation to make this notification arose Aviva plc were
interested in 27,892,806 shares giving the Aviva group a total percentage
interest in the shares of 12.20%.
2.2 The identity of the registered holders of the shares to which this
notification relates and the number of shares held by each of them are set
out in the Appendix below: Aviva plc.
From: Aviva PLC
APPENDIX: MORLEY FUND MANAGEMENT LIMITED
REGISTERED HOLDERS NUMBER OF SHARES HELD
BNY Norwich Union Nominees Ltd 1,003,832 (Material)
Chase GA Group Nominees Ltd 5,528,317 (Material)
CUIM Nominee Ltd 1,789,440 (Material)
Chase Nominees Ltd 5,300,000
Credit Agricole Indosuez 1,700,000
Vidacos Nominees Ltd 12,571,217
TOTAL PERCENTAGE INTEREST OF MORLEY FUND MANAGEMENT LIMITED: 12.20%
ISSUED SHARE CAPITAL ON WHICH THIS NOTIFICATION IS BASED: 228,710,703
APPENDIX: AVIVA PLC
REGISTERED HOLDERS NUMBER OF SHARES HELD
BNY Norwich Union Nominees Ltd 1,003,832 (Material)
Chase GA Group Nominees Ltd 5,528,317 (Material)
CUIM Nominee Ltd 1,789,440 (Material)
Chase Nominees Ltd 5,300,000
Credit Agricole Indosuez 1,700,000
Vidacos Nominees Ltd 12,571,217
TOTAL PERCENTAGE INTEREST OF AVIVA PLC: 12.20%
ISSUED SHARE CAPITAL ON WHICH THIS NOTIFICATION IS BASED: 228,710,703
Zitat
Antwort
0
ML Laboratories PLC
Presents Phase III Trial Data on Adept(R) and Hosts Symposium on Reduction of
Surgical Adhesions at London Gynecologic Endoscopy Congress
St Albans, UK, 4 April 2005 - ML Laboratories PLC (LSE: MLB) is today presenting
data from the first ever double-blind, randomised, study in abdominal surgery
with Adept at the 14th Annual Congress of the International Society of
Gynecologic Endoscopy in London. The Company is also hosting a symposium on the
need for improved adhesion reduction agents in abdominal surgery, with
presentations from some of the world`s leading opinion leaders in gynaecological
adhesions.
Use of many available adhesion reduction agents has generally been limited due
to cost, safety issues and technical difficulties, especially in abdominal
surgery. Available in Europe since 2000, Adept is a 4% icodextrin solution that
has been used in adhesion reduction in over 100,000 surgical patients. Benefits
over existing treatments include cost-effectiveness and ease of use,
particularly where there have been deficiencies with other anti-adhesion agents.
Prof Gere diZerega, MD, Professor of Obstetrics and Gynecology at the Los
Angeles County University of Southern California, USA, will present data from
the 440 patient, pivotal Phase III trial, which examined the efficacy of Adept
in a comparative study. The results of this landmark study will be submitted to
the Food and Drug Administration for US marketing authorisation in the coming
months.
Geoffrey Trew, MRCOG, Consultant in Reproductive Medicine and Surgery at
Hammersmith Hospital, London, UK, will consider the risk of adhesion-related
problems to a patient and the practical implementation of adhesion prevention in
routine surgery.
Adrian Lower, FRCOG, Consultant Gynaecologist for the London Clinic, London, and
Medical Director of the ISIS Fertility Centre, Colchester, UK will review recent
findings from an epidemiological study, which identifies gynaecological surgical
procedures, related diseases and other factors defining high-risk populations at
whom anti-adhesion strategies should be targeted routinely.
Commenting, Geoff Trew, MRCOG, said:
`This is biggest and best constructed study ever undertaken with an
anti-adhesion agent and I find the results very exciting. Adept is one of the
most important surgical device developments in the last decade, filling a niche
where there is currently really nothing at all. It is safe, easy to use and
inexpensive, and these study results have confirmed what many people suspected -
that is an effective agent.`
A copy of the presentations from today`s symposium is available on request.
Presents Phase III Trial Data on Adept(R) and Hosts Symposium on Reduction of
Surgical Adhesions at London Gynecologic Endoscopy Congress
St Albans, UK, 4 April 2005 - ML Laboratories PLC (LSE: MLB) is today presenting
data from the first ever double-blind, randomised, study in abdominal surgery
with Adept at the 14th Annual Congress of the International Society of
Gynecologic Endoscopy in London. The Company is also hosting a symposium on the
need for improved adhesion reduction agents in abdominal surgery, with
presentations from some of the world`s leading opinion leaders in gynaecological
adhesions.
Use of many available adhesion reduction agents has generally been limited due
to cost, safety issues and technical difficulties, especially in abdominal
surgery. Available in Europe since 2000, Adept is a 4% icodextrin solution that
has been used in adhesion reduction in over 100,000 surgical patients. Benefits
over existing treatments include cost-effectiveness and ease of use,
particularly where there have been deficiencies with other anti-adhesion agents.
Prof Gere diZerega, MD, Professor of Obstetrics and Gynecology at the Los
Angeles County University of Southern California, USA, will present data from
the 440 patient, pivotal Phase III trial, which examined the efficacy of Adept
in a comparative study. The results of this landmark study will be submitted to
the Food and Drug Administration for US marketing authorisation in the coming
months.
Geoffrey Trew, MRCOG, Consultant in Reproductive Medicine and Surgery at
Hammersmith Hospital, London, UK, will consider the risk of adhesion-related
problems to a patient and the practical implementation of adhesion prevention in
routine surgery.
Adrian Lower, FRCOG, Consultant Gynaecologist for the London Clinic, London, and
Medical Director of the ISIS Fertility Centre, Colchester, UK will review recent
findings from an epidemiological study, which identifies gynaecological surgical
procedures, related diseases and other factors defining high-risk populations at
whom anti-adhesion strategies should be targeted routinely.
Commenting, Geoff Trew, MRCOG, said:
`This is biggest and best constructed study ever undertaken with an
anti-adhesion agent and I find the results very exciting. Adept is one of the
most important surgical device developments in the last decade, filling a niche
where there is currently really nothing at all. It is safe, easy to use and
inexpensive, and these study results have confirmed what many people suspected -
that is an effective agent.`
A copy of the presentations from today`s symposium is available on request.
Zitat
Antwort
0
ML Laboratories PLC
Adept(R) PMA filing accepted by the US FDA
St Albans, UK, 11 May 2005 -- ML Laboratories PLC (LSE: MLB) today announces
that the Pre-Market Approval (PMA) for Adept, ML`s product for the reduction of
adhesions following abdominal surgery, has been formally accepted for filing by
the US Food and Drug Administration (FDA).
The FDA notification confirms the filing date as March 16th 2005 and that a
substantive review of the application will now take place.
Kieran Murphy, Chief Executive Officer of ML Laboratories, commented:
`The completion of the US PMA filing is a major milestone for ML. It takes us
one step closer to achieving our objective of breaking into the important US
market with Adept. We expect to have further discussions with the FDA as they
examine our data and in the meantime we will continue our licensing discussions
for the US market.`
The current US anti-adhesion product market is estimated at approximately $65
million and is expected to grow to approximately $135 million by 2010 (Frost and
Sullivan 2005).
Adept has been available in Europe since 2000 and is currently marketed by Shire
Pharmaceuticals. It is a 4% icodextrin solution that has been used in adhesion
reduction in over 100,000 surgical patients.
Adept(R) PMA filing accepted by the US FDA
St Albans, UK, 11 May 2005 -- ML Laboratories PLC (LSE: MLB) today announces
that the Pre-Market Approval (PMA) for Adept, ML`s product for the reduction of
adhesions following abdominal surgery, has been formally accepted for filing by
the US Food and Drug Administration (FDA).
The FDA notification confirms the filing date as March 16th 2005 and that a
substantive review of the application will now take place.
Kieran Murphy, Chief Executive Officer of ML Laboratories, commented:
`The completion of the US PMA filing is a major milestone for ML. It takes us
one step closer to achieving our objective of breaking into the important US
market with Adept. We expect to have further discussions with the FDA as they
examine our data and in the meantime we will continue our licensing discussions
for the US market.`
The current US anti-adhesion product market is estimated at approximately $65
million and is expected to grow to approximately $135 million by 2010 (Frost and
Sullivan 2005).
Adept has been available in Europe since 2000 and is currently marketed by Shire
Pharmaceuticals. It is a 4% icodextrin solution that has been used in adhesion
reduction in over 100,000 surgical patients.
Zitat
Antwort
0
Hallo
Die Aktie litt unter der führung des ex-chairman der glücklicherweise in märz ausgetauscht worden ist.
Das ist der grund für die schlechte performance ,aber es sieht jetzt viel besser aus und bald wird sich das auch auf den kurs auswirken.
ML Labs chairman survives rebel vote
By Harriet Meyer (Filed: 28/02/2005)
Stuart Sim was still executive chairman of the biotechnology company ML Laboratories last night after he survived a special board meeting called to discuss his potential ousting.
The meeting was convened to debate calls from rebel shareholders to remove Mr Sim and install in his place Ian Kent, a well-known figure in the biotech industry who has held senior roles in industry and Government. The rebels want also want another familiar biotech figure, Kieran Murphy, as chief executive.
However, no decision was taken on either at the meeting, though it is understood that Mr Sim is still likely to leave and to be replaced. Among the issues are Mr Sim`s compensation, as, under his two-year contract, he is entitled to about £640,000, twice his annual salary.
The rebels represent more than 40pc of ML`s shares and are headed by Jersey-based property investor David Kirch and advised by Code Securities. The company`s shares have fallen from 267¾ in 2001 to 19p on Friday. It ran out of capital last year and was forced to raise £14m in an emergency fundraising.
Mr Sim became chief executive of ML in 1997. He became executive chairman in 2002.
-----------------------------
M.L. Laboratories PLC
03 March 2005
Embargoed Until 0700 3 March 2005
ML Laboratories PLC
(`ML` or `the Company`)
Board Restructuring
The employment of Stuart Sim, ML`s Executive Chairman, has been terminated by
the Board, and Mr Sim has ceased to be a director, with immediate effect.
The Company also announces that Mr Ian Kent and Mr Kieran Murphy have joined the
board as Executive Chairman and Chief Executive respectively.
Mr Kent was a director of Biofocus PLC from 2001 to 2003 and of Vernalis PLC
from 2002 to 2003. Mr Murphy was a director of Cobequid Life Sciences, a public
company quoted in Canada, from 1998 to 2000.
Schon in ein paar monaten soll Ml Labs profitabel sein.
In moment machen übernahme gerüchte die runde:
M.L. Laboratories PLC
08 June 2005
ML Laboratories PLC
Response to Press Comment
St Albans, UK, 8 June 2005 - In response to recent speculation in the press, ML
Laboratories PLC (`ML`) confirms that it is in discussions which may or may not
lead to ML making an acquisition of a profitable company involved in the
development of inhaled therapies. A further announcement will be made in due
course.
Einige News die noch bevorstehen bzw.schon erreicht sind.
News Expected for 2005
Adept phase III US trials due to be submitted for US regulatory approval.Q1 2005
Alpharen (renal disease treatment - 50-50 venture with Ineos): currently in phase II and expected to enter phase III in H2 05. City Capital suggests massive potential with a licensing deal possibly in H2 05 of £9M to MLB on signing and £18M milestones on approval; with royalties of 10% to MLB. H2 2005
EU regulatory approval for clickhaler Clearance. Similar milestones to Formetoral are expected if clearance and launch is achieved; H1 2005
Meptin – IB submitted Meptin for Japanese approval which is expected in H2 05 which will trigger a milestone plus royalties on sales; H2 2005
Alles in allem ist Ml Labs ein schnäppchen.
Die Aktie litt unter der führung des ex-chairman der glücklicherweise in märz ausgetauscht worden ist.
Das ist der grund für die schlechte performance ,aber es sieht jetzt viel besser aus und bald wird sich das auch auf den kurs auswirken.
ML Labs chairman survives rebel vote
By Harriet Meyer (Filed: 28/02/2005)
Stuart Sim was still executive chairman of the biotechnology company ML Laboratories last night after he survived a special board meeting called to discuss his potential ousting.
The meeting was convened to debate calls from rebel shareholders to remove Mr Sim and install in his place Ian Kent, a well-known figure in the biotech industry who has held senior roles in industry and Government. The rebels want also want another familiar biotech figure, Kieran Murphy, as chief executive.
However, no decision was taken on either at the meeting, though it is understood that Mr Sim is still likely to leave and to be replaced. Among the issues are Mr Sim`s compensation, as, under his two-year contract, he is entitled to about £640,000, twice his annual salary.
The rebels represent more than 40pc of ML`s shares and are headed by Jersey-based property investor David Kirch and advised by Code Securities. The company`s shares have fallen from 267¾ in 2001 to 19p on Friday. It ran out of capital last year and was forced to raise £14m in an emergency fundraising.
Mr Sim became chief executive of ML in 1997. He became executive chairman in 2002.
-----------------------------
M.L. Laboratories PLC
03 March 2005
Embargoed Until 0700 3 March 2005
ML Laboratories PLC
(`ML` or `the Company`)
Board Restructuring
The employment of Stuart Sim, ML`s Executive Chairman, has been terminated by
the Board, and Mr Sim has ceased to be a director, with immediate effect.
The Company also announces that Mr Ian Kent and Mr Kieran Murphy have joined the
board as Executive Chairman and Chief Executive respectively.
Mr Kent was a director of Biofocus PLC from 2001 to 2003 and of Vernalis PLC
from 2002 to 2003. Mr Murphy was a director of Cobequid Life Sciences, a public
company quoted in Canada, from 1998 to 2000.
Schon in ein paar monaten soll Ml Labs profitabel sein.
In moment machen übernahme gerüchte die runde:
M.L. Laboratories PLC
08 June 2005
ML Laboratories PLC
Response to Press Comment
St Albans, UK, 8 June 2005 - In response to recent speculation in the press, ML
Laboratories PLC (`ML`) confirms that it is in discussions which may or may not
lead to ML making an acquisition of a profitable company involved in the
development of inhaled therapies. A further announcement will be made in due
course.
Einige News die noch bevorstehen bzw.schon erreicht sind.
News Expected for 2005
Adept phase III US trials due to be submitted for US regulatory approval.Q1 2005
Alpharen (renal disease treatment - 50-50 venture with Ineos): currently in phase II and expected to enter phase III in H2 05. City Capital suggests massive potential with a licensing deal possibly in H2 05 of £9M to MLB on signing and £18M milestones on approval; with royalties of 10% to MLB. H2 2005
EU regulatory approval for clickhaler Clearance. Similar milestones to Formetoral are expected if clearance and launch is achieved; H1 2005
Meptin – IB submitted Meptin for Japanese approval which is expected in H2 05 which will trigger a milestone plus royalties on sales; H2 2005
Alles in allem ist Ml Labs ein schnäppchen.
Zitat
Antwort
0
Hallo
M.L. Laboratories PLC
16 June 2005
ML Laboratories plc
Interim Results for the Six Months Ended 31 March 2005
St Albans, UK, 16 June 2005 - ML Laboratories plc (MLB.L) (`ML` or `the
Company`) today announces interim results for the six months ended 31 March 2005.
Operational Highlights
• Proposed acquisition of Quadrant Technologies Ltd for a total
consideration of approximately £46.7 million (see separate
announcement today)
• Adept for the reduction of adhesions following abdominal surgery
o Reported results of US Phase III clinical study of Adept
o Pre-Marketing Approval acceptance for filing by the US Food and Drug
Administration (FDA)
• Clickhaler dry powder inhaler
o Budesonide and formoterol Clickhalers approved in a first European
market
o Meptin Clickhaler filed and approved in Japan triggering milestone
payment to ML by partner Otsuka
• C200 next generation inhaler for fixed combination asthma products
o Strengthened IP position: core European patent granted and first US
patent granted
• Restructuring to reduce costs and streamline operations, generating
annual savings of approximately £4.0 million (April 2005)
o Announced plans to divest non core assets
• Reorganisation of ML Board following the appointment of Kieran Murphy
as CEO and Ian Kent as Executive Chairman on 3 March 2005 (May 2005)
Financial Highlights
• Placing to raise approximately £26 million (see separate announcement
today)
• Turnover increased to £6.4 million (2004: £2.9 million)
• Exceptional charge of £0.4 million arising from restructuring events
prior to the period end
• Pre-tax loss narrowed to £4.0 million (2004: £6.1 million)
• Cash balance of £6.1 million (30 September 2004: £10.9 million)
Commenting on the results Kieran Murphy, Chief Executive Officer, said:
`Since being appointed in March, the Chairman and I have moved rapidly to reduce
costs and place greater focus on ML`s revenue-generating respiratory business,
Innovata Biomed. The proposed acquisition of Quantity, announced separately
today, will further strengthen our position in the large and fast growing
markets for inhaled therapies and respiratory disease products. Together, these
moves have transformed the ML business, creating a powerful new force in
pulmonary product development.`
Contacts:
ML Laboratories plc Tel: 01727 739300
Kieran Murphy, Chief Executive Officer
Peter Shennan, Finance Director
Financial Dynamics Tel: 020 7831 3113
David Yates / Julia Phillips
A presentation for analysts will be held at Financial Dynamics, Holborn Gate, 26
Southampton Buildings, London WC2 at 10.00am today, 16 June 2005. Please call
Mo Noonan at Financial Dynamics on 020 7269 7116 for further details.
Notes to Editors
ML specialises in the development of high value pharmaceutical products. Its
respiratory division, Innovata Biomed (IB) is a leading independent provider of
inhaled drug delivery technologies to the global pharmaceutical industry,
formulating dry powders and developing proprietary inhaler systems through to
full industrialisation. IB`s proven delivery technologies are available for
proof-of-principle testing and as fast-to-market drug delivery solutions. It has
a number of respiratory products both in development and marketed by
pharmaceutical company licensees including Celltech, Otsuka and Pliva. The
Company`s other products include Extraneal for the treatment of renal failure,
which has been licensed to Baxter, and Adept for the reduction of adhesions in
abdominal surgery, which is marketed by Shire in Europe.
ML Laboratories plc
Interim Results
The interim results for the six months to 31 March 2005 show a loss for the
period before tax of £4.0 million compared with a loss of £6.1 million in the
comparative period to 31 March 2004.
Turnover & gross profit
Turnover was higher at £6.4 million (2004: £2.9 million) as a result of an
increase in licensing and evaluation fees, development income, royalties and
pharmaceutical product sales. Licensing and evaluation fees of £2.5 million
(2004: £0.4 million) included milestones on the approvals of the budesonide and
formoterol Clickhalers in the first European country, and of the meptin
Clickhaler in Japan. Development fees charged to licensees, mainly in relation
to the C200 development programme, were £1.7 million (2004: £0.6 million).
Royalties, which are stated net of Paul Capital`s entitlement where appropriate,
were £1.4 million (2004: £1.3 million) and product sales, principally of
Clickhaler devices, increased to £0.5 million (2004: £0.3 million). Other
turnover was £0.3 million (2004: £0.3 million). Gross profit increased to £4.3
million (2004: £1.9 million).
Operating costs
Research and development expenditure of £5.5 million (2004: £6.7 million) was
reduced principally as a result of the completion of the Adept US pivotal trial
and reduced spending on Clickhaler programmes. Selling, market and distribution
costs of £0.2 million (2004: £0.2 million) and administrative expenses of £2.3
million (2004: £2.3 million) were at similar levels to the comparative period.
Loss for the period
The operating loss was £3.7 million (2004: £6.9 million). After an exceptional
cost of £0.4 million arising from restructuring events which took place before
31 March, and net interest income of £0.1 million (2004: £0.1 million), the loss
before tax was £4.0 million (2004: £6.1 million). The loss after tax was £3.8
million (2004: £5.5 million), giving a loss per ordinary share of 1.67p (2004:
3.14p). Tax credits in relation to eligible research and development
expenditure estimated to be receivable in respect of the period, net of
withholding taxes suffered on income received, were £0.2 million (2004: £0.6
million).
Net assets
Net assets at 31 March 2005 were £9.1 million reduced from 30 September 2004 by
the loss for the period. Intangible assets continued to be amortised. The
increase in net tangible fixed assets to £3.5 million (2004: £2.9 million) arose
principally from additional spending on C200 tooling. Increased stocks of £0.5
million (2004: £0.3 million) related to Clickhaler devices. The increase in
debtors to £7.9 million (2004: £5.5 million) reflected principally outstanding
milestone receipts. Total creditors of £10.6 million (2004: £9.3 million)
increased principally as a result of an increase in leasing liabilities related
to C200 tooling. Deferred income of £1.5 million (2004: £0.7 million) represents
the long term element of licensing and evaluation fees and development income
received but not yet recognised in the profit and loss account.
Cash balances and cash flow
Net cash outflow from operations was £5.8 million. After net interest receipts
of £0.2 million, R&D tax credit receipts of £1.1 million, net lease finance
received of £0.5 million and net cash outflow on capital expenditure of £0.8
million, net cash outflow before management of liquid resources was £4.8
million. We ended the period with a net cash balance of £6.1 million.
Subsequent events
Since 31 March 2005 we have announced a number of important developments for the
future of the Group. These include the acceptance by the FDA of our filing of
Adept, the settlement of our dispute with Novex and the restructuring and
consolidation of our operations. Since the announcement of the restructuring on
25 April 2005 we have held consultations with employees and confirmed the
closures or divestments of the sites at Keele, Liverpool, Warrington and Blaby
with effect from the end of July 2005 and at Tewkesbury by 31 December 2005,
together with the loss of 65 jobs principally in administrative and R&D
functions.
Current trading and prospects
We are currently in discussion with potential licensees for Adept in the US and
Japan. We are also in discussions regarding a potential further licensing deal
for the C200 device. The development programme under the existing C200 licensing
deal continues to progress with the prospect of triggering a further milestone
event. The approvals in the period to 31 March 2005 of the formoterol,
budesonide and meptin Clickhalers give rise to the prospect of further milestone
receipts from product launches. Whilst this commercial activity is encouraging
and the cost reduction benefits arising from the previously announced
substantial restructuring of the Group will begin to be felt towards the end of
the current financial year, the Group anticipates that it will incur a net loss
for the year.
Quadrant Technologies Limited
The restructuring announced on 25 April 2005 signalled the intent to place
greater focus on the Group`s respiratory business. We have announced separately
today the proposed acquisition of Quadrant Technologies Limited which will be a
significant step in fulfilling our intentions to exploit further the large and
growing market for pulmonary drug delivery products.
CONSOLIDATED PROFIT AND LOSS ACCOUNT (UNAUDITED)
for the half year ended 31 March 2005
Notes Unaudited Unaudited Unaudited
half year to half year to half year to
31/03/2005 31/03/2005 31/03/2005
Continuing Discontinued Total
£ £ £
Turnover 4 6,360,236 - 6,360,236
Cost of sales (2,052,366) - (2,052,366)
_____ _____ _____
Gross profit 4,307,870 - 4,307,870
Research and development expenditure (5,513,993) - (5,513,993)
Selling, marketing and distribution (202,019) - (202,019)
costs
Administrative expenditure (2,309,481) - (2,309,481)
Other operating income 5 - - -
_____ _____ _____
Operating loss (3,717,623) - (3,717,623)
Exceptional items 3 (400,000)
_____
Loss before interest (4,117,623)
Interest receivable 208,194
Interest payable (68,745)
_____
Loss on ordinary activities before tax (3,978,174)
Taxation 6 155,708
_____
Loss for period (3,822,466)
_____
Loss per ordinary share 7 (1.67p)
_____
Notes Unaudited Unaudited Unaudited
half year to half year to half year to
31/03/2004 31/03/2004 31/03/2004
Continuing Discontinued Total
£ £ £
Turnover 4 2,699,731 198,237 2,897,968
Cost of sales (923,834) (97,835) (1,021,669)
_____ _____ _____
Gross profit 1,775,897 100,402 1,876,299
Research and development expenditure (6,737,264) - (6,737,264)
Selling, marketing and distribution (203,884) (7,375) (211,259)
costs
Administrative expenditure (2,077,560) (247,135) (2,324,695)
Other operating income 5 508,436 - 508,436
_____ _____ _____
Operating loss (6,734,375) (154,108) (6,888,483)
Exceptional items 3 754,694
_____
Loss before interest (6,133,789)
Interest receivable 108,227
Interest payable (33,377)
_____
Loss on ordinary activities before tax (6,058,939)
Taxation 6 557,816
_____
Loss for period (5,501,123)
_____
Loss per ordinary share 7 (3.14p)
_____
Notes Audited Audited Audited
half year to half year to half year to
30/09/2004 30/09/2004 30/09/2004
Continuing Discontinued Total
£ £ £
Turnover 4 7,695,995 198,237 7,894,232
Cost of sales (2,369,685) (97,835) (2,467,520)
_____ _____ _____
Gross profit 5,326,310 100,402 5,426,712
Research and development expenditure (12,902,888) - (12,902,888)
Selling, marketing and distribution (486,445) (7,375) (493,820)
costs
Administrative expenditure (4,273,123) (247,123) (4,520,258)
Other operating income 5 508,436 - 508,436
_____ _____ _____
Operating loss (11,827,710) (154,108) (11,981,818)
Exceptional items 3 754,694
_____
Loss before interest (11,227,124)
Interest receivable 390,325
Interest payable (67,990)
_____
Loss on ordinary activities before tax (10,904,789)
Taxation 6 1,858,658
_____
Loss for period (9,046,131)
_____
Loss per ordinary share 7 (4.48p)
_____
CONSOLIDATED BALANCE SHEET at 31 March 2005
Unaudited Unaudited Audited
Half year Half year Full year
NOTES At 31/03/2005 At 31/03/2004 At 30/09/2004
£ £ £
Fixed Assets
Intangible assets 3,000.404 3,200,431 3,100,417
Tangible assets 3,539,524 2,020,862 2,857,669
Investments 249,639 249,639 249,639
_____ _____ _____
6,789,567 5,470,932 6,207,725
_____ _____ _____
Current Assets
Stocks 517,529 527,833 328,552
Debtors 7,858,688 3,853,821 5,533,900
Investments 129 1,039 129
Cash and short term deposits 6,098,166 15,361,204 10,867,712
_____ _____ _____
14,474,512 19,743,897 16,730,293
Current Liabilities
Creditors: amounts falling due within one year (9,497,550) (8,117,495) (9,012,119)
_____ _____ _____
Net Current Assets 4,976,962 11,626,402 7,718,174
_____ _____ _____
Total Assets less Current Liabilities 11,766,529 17,097,334 13,925,899
Creditors: amounts falling due after more than (1,148,721) (277,708) (321,784)
one year
_____ _____ _____
10,617,808 16,819,626 13,604,115
Deferred Income (1,508,685) (343,029) (672,526)
_____ _____ _____
Net Assets 9,109,123 16,476,597 12,931,589
_____ _____ _____
Capital and Reserves
Share capital 8 2,287,107 2,287,107 2,287,107
Share premium account 8 50,154,469 50,154,469 50,154,469
Merger reserve 8 8,335,897 8,335,897 8,335,897
Profit and loss account 8 (51,668,350) (44,300,876) (47,845,884)
_____ _____ _____
Equity Shareholders` Funds 8 9,109,123 16,476,597 12,931,589
_____ _____ _____
CONSOLIDATED CASH FLOW STATEMENT (UNAUDITED)
for the half year ended 31 March 2005
Unaudited Unaudited Audited
Half year to Half year to Full year to
NOTES 31/03/2005 31/03/2004 30/09/2004
£ £ £
Net Cash Outflow from Operating Activities 9 (5,792,762) (7,426,441) (10,802,165)
Returns on Investments and Servicing of Finance
Interest received 234,292 91,780 354,706
Interest paid (10,235) (7,205) (16,047)
Interest paid on finance leases (62,902) (26,258) (47,639)
_____ _____ _____
Net Cash Inflow from Returns on Investments and Servicing 161,155 58,317 291,020
of Finance
_____ _____ _____
Taxation
UK Corporation tax recovered 1,101,581 917,706 816,473
_____ _____ _____
Capital Expenditure and Financial Investment
Purchase of tangible assets (930,544) (362,467) (1,437,912)
Receipts from sale of current asset investments - - 1,870
Receipts from sale of tangible assets 94,900 38,000 77,950
_____ _____ _____
Net Cash Outflow from Capital Expenditure and Financial (835,644) (324,467) (1,358,092)
Investment
_____ _____ _____
Disposals
Net proceeds from disposal of shares - 1,231,249 1,231,249
Disposal of subsidiary - (402,212) (402,212)
_____ _____ _____
Net Cash Inflow from Disposals - 829,037 829,037
_____ _____ _____
Net Cash Outflow before Management of Liquid Resources (5,365,670) (5,945,848) (10,223,727)
and Financing
_____ _____ _____
Management of Liquid Resources
Cash withdrawn from/ (placed on) short term deposits 4,355,000 (9,115,753) (4,207,753)
_____ _____ _____
Net Cash Inflow/ (Outflow) from Management of Liquid 4,355,000 (9,115,753) (4,207,753)
Resources
_____ _____ _____
Financing
Issue of ordinary share capital - 15,519,270 15,519,270
Expenses paid in connection with share issue - (1,162,370) (1,162,370)
_____ _____ _____
- 14,356,900 14,356,900
_____ _____ _____
Capital element of finance lease rental payments (413,877) (254,558) (431,634)
Lease finance acquired 1,432,697 - 161,506
New unsecured loan finance (473,375) - 473,375
Capital element of unsecured loan payments (4,701) (42,547) (49,387)
_____ _____ _____
Decrease in debt and lease financing 10 540,744 (297,105) 153,860
_____ _____ _____
Net Cash Inflow from Financing 540,744 14,059,795 14,510,760
_____ _____ _____
(Decrease)/ Increase in Net Cash in Period 10 (469,926) (1,001,806) 79,281
_____ _____ _____
NOTES TO THE INTERIM FINANCIAL STATEMENTS
for half year ended 31st March 2005 (UNAUDITED)
1. Basis of preparing the interim financial statements - going concern
The interim financial statements have been prepared on a going concern basis.
This basis is supported by the cash flow projections of the Group. The
projections include receipt of significant milestone and similar income the
Group anticipates will arise on the commercialisation of its products and
divestment proceeds arising from the potential disposal of assets.
The Directors recognise that the timing and amount of such receipts is uncertain
and not guaranteed and that as a result the Group`s financial position cannot be
certain. However, the Directors have a reasonable expectation that the Group
will have sufficient working capital for the foreseeable future and consequently
believe that it is appropriate for the interim financial statements to be
prepared on a going concern basis. The interim financial statements do not
contain any adjustments that would arise if the interim financial statements
were not drawn up on a going concern basis. If required these adjustments would
be made to the balance sheet of the Group to increase or reduce the balance
sheet values of assets to their recoverable amounts, to provide for further
liabilities that might arise and to reclassify fixed assets and long term
liabilities as current assets and liabilities.
2. Discontinued activities
On 6th February 2004 the Group completed the disposal of its subsidiary,
Healthcare Education Services Limited. The results of this business have been
included, up until the date of disposal, in the Group`s consolidated profit and
loss accounts for the half year ended 31st March 2004 and the year ended 30th
September 2004 as a discontinued activity.
3. Exceptional items
An exceptional profit arose during the half year ended 31st March 2004 on the
sale of the Group`s remaining holding of one million Cobra Biomanufacturing Plc
(`CBM`) shares at a price
of £1.25 per share, generating net proceeds, after expenses, of £1,231,249 and a
profit for the Group of £754,694.
The exceptional charge in the half year ended 31st March 2005 of £400,000
represents a restructuring cost.
4. Segmented analysis by class of business
The analysis by class of business of the Group`s turnover, research and
development expenditure, other expenses, exceptional items, loss before taxation
and net assets is set out below:
Segmental Reporting
Unaudited half year to Research
31st March 2005 and Other Loss
Development Other Operating Before Net
Turnover Expenditure Expenses Income Taxation Assets
£ £ £ £ £ £
Licensing and evaluation 2,460,339 - - - - -
fees
Deployment fees 1,707,006 - - - - -
Royalties 1,361,615 - - - - -
Product Sales 544,474 - - - - -
_____ _____ _____ _____ _____ _____
Total Pharmaceutical 6,073,434 (5,496,945) (4,384,176) - (4,082,055) 8,741,510
Activities
Other Activities 286,802 (17,048) (179,690) - 103,881 367,613
_____ _____ _____ _____ _____ _____
Total 6,360,236 (5,513,993) (4,563,866) - (3,978,174) 9,109,123
_____ _____ _____ _____ _____ _____
Unaudited half year to Research
31st March 2004 and Other Loss
Development Other Operating Before Net
Turnover Expenditure Expenses Income Taxation Assets
£ £ £ £ £ £
Licensing and evaluation 451,451 - - - - -
fees
Deployment fees 557,806 - - - - -
Royalties 1,266,930 - - - - -
Product Sales 287,158 - - - - -
_____ _____ _____ _____ _____ _____
Total Pharmaceutical 2,563,345 (5,243,267) (4,514,992) 508,436 (5,867,968) 16,370,439
Activities
Other Activities 334,623 (10,583) (526,045) - (190,971) 106,158
_____ _____ _____ _____ _____ _____
Total 2,897,968 (5,253,850) (5,041,037) 508,436 (6,058,939) 16,476,597
_____ _____ _____ _____ _____ _____
Audited full year to Research
30th September 2004 and Other Loss
Development Other Operating Before Net
Turnover Expenditure Expenses Income Taxation Assets
£ £ £ £ £ £
Licensing and 2,737,769 - - - - -
evaluation fees
Deployment fees 1,558,253 - - - - -
Royalties 2,540,302 - - - - -
Product Sales 602,081 - - - - -
_____ _____ _____ _____ _____ _____
Total Pharmaceutical 7,438,405 (12,890,045) (6,753,883) 508,436 (10,664,705) 12,779,335
Activities
Other Activities 455,827 (12,843) (727,715) - (240,084) 152,254
_____ _____ _____ _____ _____ _____
Total 7,894,232 (12,902,888) (7,481,598) 508,436 (10,904,789) 12,931,589
_____ _____ _____ _____ _____ _____
5. Segmental reporting re Discontinued Activities
Other
Unaudited half year to 31st March 2005 Turnover Expenses
£ £
Product Sales - -
_____ _____
Total Pharmaceutical activities - -
Other activities - -
_____ _____
Total - -
_____ _____
Other
Unaudited half year to 31st March 2004 Turnover Expenses
£ £
Other activities 198,237 (352,345)
_____ _____
Total 198,237 (325,345)
_____ _____
Other
Audited full year to 30th September 2004 Turnover Expenses
£ £
Other activities 198,237 (352,345)
_____ _____
Total 198,237 (325,345)
_____ _____
6. Other Operating Income
Other operating income in the half year to 31st March 2004 and the year to 30th
September 2004 comprised the release to the consolidated profit and loss account
of the remaining portion of monies received from Paul Capital Royalty
Acquisition Fund (`PCRAF`) in earlier years and carried in the balance sheet as
deferred income in order to match its release with associated spending
obligations.
A total of £22.5m was received from PCRAF under two transactions in 2001 and
2002 as a result of which PCRAF is entitled to receive until 30th September 2010
a proportion of the royalties and revenue streams arising from Adept and
Extraneal. As at 30th September 2004, the amounts received from PCRAF had been
released in full to the consolidated profit and loss account.
While the risk relating to that proportion of the future royalty and revenue
streams receivable by PCRAF has effectively been transferred to PCRAF, under
certain specified circumstances (including change of control of M L Laboratories
PLC, certain major corporate transactions, and events of default material in the
context of the PCRAF transaction) PCRAF has the right to require the Group to
re-purchase PCRAF`s interests in the royalty and income streams concerned for a
consideration calculated to give PCRAF an agreed minimum rate of return.
7. Taxation
The current period tax credit represents refundable R & D tax credits less
withholding taxes suffered. There is no charge to corporation tax during the
period nor is there any provision required for deferred taxation. Accumulated
tax losses have not been recognised as deferred tax assets as there is
insufficient certainty as to their future recoverability.
As at 31st March 2005, the total tax losses in Group companies amounted to
(£xxm) (2004 £59.1m). These losses are available for offset against future
profits in the companies concerned, subject to agreement with the Inland
Revenue.
Analysis of Charge in period £
UK Corporation Tax - R & D Tax Credit - current period 250,000
Withholding Taxes (94,272)
_____
155,708
_____
8. Loss per ordinary share
Unaudited Unaudited Audited
Half Year Half Year Full Year
to 31/3/2005 to 31/3/2004 To 30/9/2004
£ £ £
Loss on ordinary activities after taxation and minority (3,822,466) (5,501,123) (9,046,131)
interests
_____ _____ _____
Average number of shares 228,710,703 175,333,506 201,948,984
_____ _____ _____
Loss per ordinary share (1.67p) (3.14p) (4.48p)
_____ _____ _____
The calculation of basic earnings per share for the period is based on the loss
on ordinary activities after taxation and minority interests and on 228,710,703
ordinary shares, being the weighted average, calculated on a time basis, of the
number of ordinary shares in issue. For the purpose of the comparative figures
the calculation of the number of ordinary shares in issue prior to the Rights
Issue and Issue for Cash takes account of the notional bonus issue element
arising on the Rights Issue and Issue for Cash from the difference between the
mid-market price on the last day on which shares were quoted cum-rights and the
theoretical ex-rights price.
The effect of dilutive share options outstanding and not yet exercised at 31st
March 2005 would be to reduce the loss per ordinary share.
9. Movement in capital and reserves
Share Share premium Merger Profit & Loss Equity
The movement in capital and Capital Account Reserve Account Shareholders`
reserves during the period was Fund
as follows: £ £ £ £ £
As at 1st October 2004 2,287,107 50,154,469 8,335,897 (47,845,884) 12,931,589
Loss for period - - - (3,822,466) (3,822,466)
_____ _____ _____ _____ _____
As at 31st March 2005 2,287,107 50,154,469 8,335,897 (51,668,350) 9,109,123
_____ _____ _____ _____ _____
10. Reconciliation of operating loss to net cash flow from operating activities
Unaudited Unaudited Audited
Half Year Half Year Full Year
To 31/3/2005 To 31/3/2004 To 30/9/2004
£ £ £
Operating Loss (4,117,622) (6,888,483) (11,981,818)
Depreciation of tangible fixed assets 384,352 356,910 768,048
Amortisation of goodwill 100,013 100,013 200,027
Net Profit on disposal of current asset investments - - (960)
Net Profit on disposal of tangible fixed assets (11,226) (26,452) (50,418)
(Increase) / Decrease in stocks (188,978) 208,812 408,093
Increase in debtors (3,247,800) (1,077,490) (1,307,413)
Increase in creditors 452,340 371,828 1,304,358
Increase / (Decrease) in deferred income 836,159 (471,579) (142,082)
_____ _____ _____
Net cash outflow from operating activities (5,792,762) (7,426,441) (10,802,165)
_____ _____ _____
11. Reconciliation of net cash flow to movement in funds
Unaudited Unaudited Audited
Half Year Half Year Full Year
To 31/3/2004 To 31/3/2004 To 30/9/2004
£ £ £
(Decrease) / Increase in cash in period (469,925) (1,001,806) 79,281
Movement in short term deposits (4,355,000) 9,115,753 4,207,753
Movement in borrowings (540,745) 297,105 (153,860)
_____ _____ _____
Change in net funds resulting from cash flows (5,365,670) 8,411,052 4,133,174
New Finance leases (219,614) (215,604) (392,812)
_____ _____ _____
Movement in net funds (5,585,284) 8,195,448 3,740,362
Operating net funds 9,757,902 6,017,540 6,017,540
_____ _____ _____
Closing net funds 4,172,618 14,212,988 9,757,902
_____ _____ _____
12. Analysis of net funds
Other
Cash Non cash
30/09/2004 Flow Changes 31/03/2005
£ £ £ £
Cash at bank and in hand 415,712 (414,546) - 1,166
Bank overdraft - (55,378) - (55,378)
_____ _____ _____ _____
415,712 (469,924) - (54,212)
Short term deposits 10,452,000 (4,355,000) - 6,097,000
Unsecured loans (478,075) 4,701 473,374 -
Finance leases due within one year (309,950) (339,930) (71,569) (721,449)
Finance leases due in more than one year (321,784) (678,891) (148,046) (1,148,721)
_____ _____ _____ _____
9,757,903 (5,839,044) 253,759 4,172,618
_____ _____ _____ _____
13. Preparation of interim financial statements
The interim financial statements have been prepared on the basis of the
accounting policies set out in the Group`s 2004 statutory accounts and are not
audited. The foregoing financial information does not amount to full accounts
within the meaning of Section 240 of the Companies Act 1985 (as amended). The
financial information in respect of the year to 30th September 2004 has been
abridged from the full Group accounts, which include the Auditors` report which,
whilst unqualified, contained a modification referring to uncertainty regarding
going concern and which have been delivered to the Registrar of Companies. The
Auditors` report did not contain a statement under either section 237(2) or
section 237(3) of the Companies Act 1985.
14. Dividends
The Directors have not declared an interim dividend.
Copies of this interim report are being sent to all shareholders and are also
available to the public at the Company`s registered office, 17 Hanover Square,
London, W1S 1HU.
M.L. Laboratories PLC
16 June 2005
ML Laboratories plc
Interim Results for the Six Months Ended 31 March 2005
St Albans, UK, 16 June 2005 - ML Laboratories plc (MLB.L) (`ML` or `the
Company`) today announces interim results for the six months ended 31 March 2005.
Operational Highlights
• Proposed acquisition of Quadrant Technologies Ltd for a total
consideration of approximately £46.7 million (see separate
announcement today)
• Adept for the reduction of adhesions following abdominal surgery
o Reported results of US Phase III clinical study of Adept
o Pre-Marketing Approval acceptance for filing by the US Food and Drug
Administration (FDA)
• Clickhaler dry powder inhaler
o Budesonide and formoterol Clickhalers approved in a first European
market
o Meptin Clickhaler filed and approved in Japan triggering milestone
payment to ML by partner Otsuka
• C200 next generation inhaler for fixed combination asthma products
o Strengthened IP position: core European patent granted and first US
patent granted
• Restructuring to reduce costs and streamline operations, generating
annual savings of approximately £4.0 million (April 2005)
o Announced plans to divest non core assets
• Reorganisation of ML Board following the appointment of Kieran Murphy
as CEO and Ian Kent as Executive Chairman on 3 March 2005 (May 2005)
Financial Highlights
• Placing to raise approximately £26 million (see separate announcement
today)
• Turnover increased to £6.4 million (2004: £2.9 million)
• Exceptional charge of £0.4 million arising from restructuring events
prior to the period end
• Pre-tax loss narrowed to £4.0 million (2004: £6.1 million)
• Cash balance of £6.1 million (30 September 2004: £10.9 million)
Commenting on the results Kieran Murphy, Chief Executive Officer, said:
`Since being appointed in March, the Chairman and I have moved rapidly to reduce
costs and place greater focus on ML`s revenue-generating respiratory business,
Innovata Biomed. The proposed acquisition of Quantity, announced separately
today, will further strengthen our position in the large and fast growing
markets for inhaled therapies and respiratory disease products. Together, these
moves have transformed the ML business, creating a powerful new force in
pulmonary product development.`
Contacts:
ML Laboratories plc Tel: 01727 739300
Kieran Murphy, Chief Executive Officer
Peter Shennan, Finance Director
Financial Dynamics Tel: 020 7831 3113
David Yates / Julia Phillips
A presentation for analysts will be held at Financial Dynamics, Holborn Gate, 26
Southampton Buildings, London WC2 at 10.00am today, 16 June 2005. Please call
Mo Noonan at Financial Dynamics on 020 7269 7116 for further details.
Notes to Editors
ML specialises in the development of high value pharmaceutical products. Its
respiratory division, Innovata Biomed (IB) is a leading independent provider of
inhaled drug delivery technologies to the global pharmaceutical industry,
formulating dry powders and developing proprietary inhaler systems through to
full industrialisation. IB`s proven delivery technologies are available for
proof-of-principle testing and as fast-to-market drug delivery solutions. It has
a number of respiratory products both in development and marketed by
pharmaceutical company licensees including Celltech, Otsuka and Pliva. The
Company`s other products include Extraneal for the treatment of renal failure,
which has been licensed to Baxter, and Adept for the reduction of adhesions in
abdominal surgery, which is marketed by Shire in Europe.
ML Laboratories plc
Interim Results
The interim results for the six months to 31 March 2005 show a loss for the
period before tax of £4.0 million compared with a loss of £6.1 million in the
comparative period to 31 March 2004.
Turnover & gross profit
Turnover was higher at £6.4 million (2004: £2.9 million) as a result of an
increase in licensing and evaluation fees, development income, royalties and
pharmaceutical product sales. Licensing and evaluation fees of £2.5 million
(2004: £0.4 million) included milestones on the approvals of the budesonide and
formoterol Clickhalers in the first European country, and of the meptin
Clickhaler in Japan. Development fees charged to licensees, mainly in relation
to the C200 development programme, were £1.7 million (2004: £0.6 million).
Royalties, which are stated net of Paul Capital`s entitlement where appropriate,
were £1.4 million (2004: £1.3 million) and product sales, principally of
Clickhaler devices, increased to £0.5 million (2004: £0.3 million). Other
turnover was £0.3 million (2004: £0.3 million). Gross profit increased to £4.3
million (2004: £1.9 million).
Operating costs
Research and development expenditure of £5.5 million (2004: £6.7 million) was
reduced principally as a result of the completion of the Adept US pivotal trial
and reduced spending on Clickhaler programmes. Selling, market and distribution
costs of £0.2 million (2004: £0.2 million) and administrative expenses of £2.3
million (2004: £2.3 million) were at similar levels to the comparative period.
Loss for the period
The operating loss was £3.7 million (2004: £6.9 million). After an exceptional
cost of £0.4 million arising from restructuring events which took place before
31 March, and net interest income of £0.1 million (2004: £0.1 million), the loss
before tax was £4.0 million (2004: £6.1 million). The loss after tax was £3.8
million (2004: £5.5 million), giving a loss per ordinary share of 1.67p (2004:
3.14p). Tax credits in relation to eligible research and development
expenditure estimated to be receivable in respect of the period, net of
withholding taxes suffered on income received, were £0.2 million (2004: £0.6
million).
Net assets
Net assets at 31 March 2005 were £9.1 million reduced from 30 September 2004 by
the loss for the period. Intangible assets continued to be amortised. The
increase in net tangible fixed assets to £3.5 million (2004: £2.9 million) arose
principally from additional spending on C200 tooling. Increased stocks of £0.5
million (2004: £0.3 million) related to Clickhaler devices. The increase in
debtors to £7.9 million (2004: £5.5 million) reflected principally outstanding
milestone receipts. Total creditors of £10.6 million (2004: £9.3 million)
increased principally as a result of an increase in leasing liabilities related
to C200 tooling. Deferred income of £1.5 million (2004: £0.7 million) represents
the long term element of licensing and evaluation fees and development income
received but not yet recognised in the profit and loss account.
Cash balances and cash flow
Net cash outflow from operations was £5.8 million. After net interest receipts
of £0.2 million, R&D tax credit receipts of £1.1 million, net lease finance
received of £0.5 million and net cash outflow on capital expenditure of £0.8
million, net cash outflow before management of liquid resources was £4.8
million. We ended the period with a net cash balance of £6.1 million.
Subsequent events
Since 31 March 2005 we have announced a number of important developments for the
future of the Group. These include the acceptance by the FDA of our filing of
Adept, the settlement of our dispute with Novex and the restructuring and
consolidation of our operations. Since the announcement of the restructuring on
25 April 2005 we have held consultations with employees and confirmed the
closures or divestments of the sites at Keele, Liverpool, Warrington and Blaby
with effect from the end of July 2005 and at Tewkesbury by 31 December 2005,
together with the loss of 65 jobs principally in administrative and R&D
functions.
Current trading and prospects
We are currently in discussion with potential licensees for Adept in the US and
Japan. We are also in discussions regarding a potential further licensing deal
for the C200 device. The development programme under the existing C200 licensing
deal continues to progress with the prospect of triggering a further milestone
event. The approvals in the period to 31 March 2005 of the formoterol,
budesonide and meptin Clickhalers give rise to the prospect of further milestone
receipts from product launches. Whilst this commercial activity is encouraging
and the cost reduction benefits arising from the previously announced
substantial restructuring of the Group will begin to be felt towards the end of
the current financial year, the Group anticipates that it will incur a net loss
for the year.
Quadrant Technologies Limited
The restructuring announced on 25 April 2005 signalled the intent to place
greater focus on the Group`s respiratory business. We have announced separately
today the proposed acquisition of Quadrant Technologies Limited which will be a
significant step in fulfilling our intentions to exploit further the large and
growing market for pulmonary drug delivery products.
CONSOLIDATED PROFIT AND LOSS ACCOUNT (UNAUDITED)
for the half year ended 31 March 2005
Notes Unaudited Unaudited Unaudited
half year to half year to half year to
31/03/2005 31/03/2005 31/03/2005
Continuing Discontinued Total
£ £ £
Turnover 4 6,360,236 - 6,360,236
Cost of sales (2,052,366) - (2,052,366)
_____ _____ _____
Gross profit 4,307,870 - 4,307,870
Research and development expenditure (5,513,993) - (5,513,993)
Selling, marketing and distribution (202,019) - (202,019)
costs
Administrative expenditure (2,309,481) - (2,309,481)
Other operating income 5 - - -
_____ _____ _____
Operating loss (3,717,623) - (3,717,623)
Exceptional items 3 (400,000)
_____
Loss before interest (4,117,623)
Interest receivable 208,194
Interest payable (68,745)
_____
Loss on ordinary activities before tax (3,978,174)
Taxation 6 155,708
_____
Loss for period (3,822,466)
_____
Loss per ordinary share 7 (1.67p)
_____
Notes Unaudited Unaudited Unaudited
half year to half year to half year to
31/03/2004 31/03/2004 31/03/2004
Continuing Discontinued Total
£ £ £
Turnover 4 2,699,731 198,237 2,897,968
Cost of sales (923,834) (97,835) (1,021,669)
_____ _____ _____
Gross profit 1,775,897 100,402 1,876,299
Research and development expenditure (6,737,264) - (6,737,264)
Selling, marketing and distribution (203,884) (7,375) (211,259)
costs
Administrative expenditure (2,077,560) (247,135) (2,324,695)
Other operating income 5 508,436 - 508,436
_____ _____ _____
Operating loss (6,734,375) (154,108) (6,888,483)
Exceptional items 3 754,694
_____
Loss before interest (6,133,789)
Interest receivable 108,227
Interest payable (33,377)
_____
Loss on ordinary activities before tax (6,058,939)
Taxation 6 557,816
_____
Loss for period (5,501,123)
_____
Loss per ordinary share 7 (3.14p)
_____
Notes Audited Audited Audited
half year to half year to half year to
30/09/2004 30/09/2004 30/09/2004
Continuing Discontinued Total
£ £ £
Turnover 4 7,695,995 198,237 7,894,232
Cost of sales (2,369,685) (97,835) (2,467,520)
_____ _____ _____
Gross profit 5,326,310 100,402 5,426,712
Research and development expenditure (12,902,888) - (12,902,888)
Selling, marketing and distribution (486,445) (7,375) (493,820)
costs
Administrative expenditure (4,273,123) (247,123) (4,520,258)
Other operating income 5 508,436 - 508,436
_____ _____ _____
Operating loss (11,827,710) (154,108) (11,981,818)
Exceptional items 3 754,694
_____
Loss before interest (11,227,124)
Interest receivable 390,325
Interest payable (67,990)
_____
Loss on ordinary activities before tax (10,904,789)
Taxation 6 1,858,658
_____
Loss for period (9,046,131)
_____
Loss per ordinary share 7 (4.48p)
_____
CONSOLIDATED BALANCE SHEET at 31 March 2005
Unaudited Unaudited Audited
Half year Half year Full year
NOTES At 31/03/2005 At 31/03/2004 At 30/09/2004
£ £ £
Fixed Assets
Intangible assets 3,000.404 3,200,431 3,100,417
Tangible assets 3,539,524 2,020,862 2,857,669
Investments 249,639 249,639 249,639
_____ _____ _____
6,789,567 5,470,932 6,207,725
_____ _____ _____
Current Assets
Stocks 517,529 527,833 328,552
Debtors 7,858,688 3,853,821 5,533,900
Investments 129 1,039 129
Cash and short term deposits 6,098,166 15,361,204 10,867,712
_____ _____ _____
14,474,512 19,743,897 16,730,293
Current Liabilities
Creditors: amounts falling due within one year (9,497,550) (8,117,495) (9,012,119)
_____ _____ _____
Net Current Assets 4,976,962 11,626,402 7,718,174
_____ _____ _____
Total Assets less Current Liabilities 11,766,529 17,097,334 13,925,899
Creditors: amounts falling due after more than (1,148,721) (277,708) (321,784)
one year
_____ _____ _____
10,617,808 16,819,626 13,604,115
Deferred Income (1,508,685) (343,029) (672,526)
_____ _____ _____
Net Assets 9,109,123 16,476,597 12,931,589
_____ _____ _____
Capital and Reserves
Share capital 8 2,287,107 2,287,107 2,287,107
Share premium account 8 50,154,469 50,154,469 50,154,469
Merger reserve 8 8,335,897 8,335,897 8,335,897
Profit and loss account 8 (51,668,350) (44,300,876) (47,845,884)
_____ _____ _____
Equity Shareholders` Funds 8 9,109,123 16,476,597 12,931,589
_____ _____ _____
CONSOLIDATED CASH FLOW STATEMENT (UNAUDITED)
for the half year ended 31 March 2005
Unaudited Unaudited Audited
Half year to Half year to Full year to
NOTES 31/03/2005 31/03/2004 30/09/2004
£ £ £
Net Cash Outflow from Operating Activities 9 (5,792,762) (7,426,441) (10,802,165)
Returns on Investments and Servicing of Finance
Interest received 234,292 91,780 354,706
Interest paid (10,235) (7,205) (16,047)
Interest paid on finance leases (62,902) (26,258) (47,639)
_____ _____ _____
Net Cash Inflow from Returns on Investments and Servicing 161,155 58,317 291,020
of Finance
_____ _____ _____
Taxation
UK Corporation tax recovered 1,101,581 917,706 816,473
_____ _____ _____
Capital Expenditure and Financial Investment
Purchase of tangible assets (930,544) (362,467) (1,437,912)
Receipts from sale of current asset investments - - 1,870
Receipts from sale of tangible assets 94,900 38,000 77,950
_____ _____ _____
Net Cash Outflow from Capital Expenditure and Financial (835,644) (324,467) (1,358,092)
Investment
_____ _____ _____
Disposals
Net proceeds from disposal of shares - 1,231,249 1,231,249
Disposal of subsidiary - (402,212) (402,212)
_____ _____ _____
Net Cash Inflow from Disposals - 829,037 829,037
_____ _____ _____
Net Cash Outflow before Management of Liquid Resources (5,365,670) (5,945,848) (10,223,727)
and Financing
_____ _____ _____
Management of Liquid Resources
Cash withdrawn from/ (placed on) short term deposits 4,355,000 (9,115,753) (4,207,753)
_____ _____ _____
Net Cash Inflow/ (Outflow) from Management of Liquid 4,355,000 (9,115,753) (4,207,753)
Resources
_____ _____ _____
Financing
Issue of ordinary share capital - 15,519,270 15,519,270
Expenses paid in connection with share issue - (1,162,370) (1,162,370)
_____ _____ _____
- 14,356,900 14,356,900
_____ _____ _____
Capital element of finance lease rental payments (413,877) (254,558) (431,634)
Lease finance acquired 1,432,697 - 161,506
New unsecured loan finance (473,375) - 473,375
Capital element of unsecured loan payments (4,701) (42,547) (49,387)
_____ _____ _____
Decrease in debt and lease financing 10 540,744 (297,105) 153,860
_____ _____ _____
Net Cash Inflow from Financing 540,744 14,059,795 14,510,760
_____ _____ _____
(Decrease)/ Increase in Net Cash in Period 10 (469,926) (1,001,806) 79,281
_____ _____ _____
NOTES TO THE INTERIM FINANCIAL STATEMENTS
for half year ended 31st March 2005 (UNAUDITED)
1. Basis of preparing the interim financial statements - going concern
The interim financial statements have been prepared on a going concern basis.
This basis is supported by the cash flow projections of the Group. The
projections include receipt of significant milestone and similar income the
Group anticipates will arise on the commercialisation of its products and
divestment proceeds arising from the potential disposal of assets.
The Directors recognise that the timing and amount of such receipts is uncertain
and not guaranteed and that as a result the Group`s financial position cannot be
certain. However, the Directors have a reasonable expectation that the Group
will have sufficient working capital for the foreseeable future and consequently
believe that it is appropriate for the interim financial statements to be
prepared on a going concern basis. The interim financial statements do not
contain any adjustments that would arise if the interim financial statements
were not drawn up on a going concern basis. If required these adjustments would
be made to the balance sheet of the Group to increase or reduce the balance
sheet values of assets to their recoverable amounts, to provide for further
liabilities that might arise and to reclassify fixed assets and long term
liabilities as current assets and liabilities.
2. Discontinued activities
On 6th February 2004 the Group completed the disposal of its subsidiary,
Healthcare Education Services Limited. The results of this business have been
included, up until the date of disposal, in the Group`s consolidated profit and
loss accounts for the half year ended 31st March 2004 and the year ended 30th
September 2004 as a discontinued activity.
3. Exceptional items
An exceptional profit arose during the half year ended 31st March 2004 on the
sale of the Group`s remaining holding of one million Cobra Biomanufacturing Plc
(`CBM`) shares at a price
of £1.25 per share, generating net proceeds, after expenses, of £1,231,249 and a
profit for the Group of £754,694.
The exceptional charge in the half year ended 31st March 2005 of £400,000
represents a restructuring cost.
4. Segmented analysis by class of business
The analysis by class of business of the Group`s turnover, research and
development expenditure, other expenses, exceptional items, loss before taxation
and net assets is set out below:
Segmental Reporting
Unaudited half year to Research
31st March 2005 and Other Loss
Development Other Operating Before Net
Turnover Expenditure Expenses Income Taxation Assets
£ £ £ £ £ £
Licensing and evaluation 2,460,339 - - - - -
fees
Deployment fees 1,707,006 - - - - -
Royalties 1,361,615 - - - - -
Product Sales 544,474 - - - - -
_____ _____ _____ _____ _____ _____
Total Pharmaceutical 6,073,434 (5,496,945) (4,384,176) - (4,082,055) 8,741,510
Activities
Other Activities 286,802 (17,048) (179,690) - 103,881 367,613
_____ _____ _____ _____ _____ _____
Total 6,360,236 (5,513,993) (4,563,866) - (3,978,174) 9,109,123
_____ _____ _____ _____ _____ _____
Unaudited half year to Research
31st March 2004 and Other Loss
Development Other Operating Before Net
Turnover Expenditure Expenses Income Taxation Assets
£ £ £ £ £ £
Licensing and evaluation 451,451 - - - - -
fees
Deployment fees 557,806 - - - - -
Royalties 1,266,930 - - - - -
Product Sales 287,158 - - - - -
_____ _____ _____ _____ _____ _____
Total Pharmaceutical 2,563,345 (5,243,267) (4,514,992) 508,436 (5,867,968) 16,370,439
Activities
Other Activities 334,623 (10,583) (526,045) - (190,971) 106,158
_____ _____ _____ _____ _____ _____
Total 2,897,968 (5,253,850) (5,041,037) 508,436 (6,058,939) 16,476,597
_____ _____ _____ _____ _____ _____
Audited full year to Research
30th September 2004 and Other Loss
Development Other Operating Before Net
Turnover Expenditure Expenses Income Taxation Assets
£ £ £ £ £ £
Licensing and 2,737,769 - - - - -
evaluation fees
Deployment fees 1,558,253 - - - - -
Royalties 2,540,302 - - - - -
Product Sales 602,081 - - - - -
_____ _____ _____ _____ _____ _____
Total Pharmaceutical 7,438,405 (12,890,045) (6,753,883) 508,436 (10,664,705) 12,779,335
Activities
Other Activities 455,827 (12,843) (727,715) - (240,084) 152,254
_____ _____ _____ _____ _____ _____
Total 7,894,232 (12,902,888) (7,481,598) 508,436 (10,904,789) 12,931,589
_____ _____ _____ _____ _____ _____
5. Segmental reporting re Discontinued Activities
Other
Unaudited half year to 31st March 2005 Turnover Expenses
£ £
Product Sales - -
_____ _____
Total Pharmaceutical activities - -
Other activities - -
_____ _____
Total - -
_____ _____
Other
Unaudited half year to 31st March 2004 Turnover Expenses
£ £
Other activities 198,237 (352,345)
_____ _____
Total 198,237 (325,345)
_____ _____
Other
Audited full year to 30th September 2004 Turnover Expenses
£ £
Other activities 198,237 (352,345)
_____ _____
Total 198,237 (325,345)
_____ _____
6. Other Operating Income
Other operating income in the half year to 31st March 2004 and the year to 30th
September 2004 comprised the release to the consolidated profit and loss account
of the remaining portion of monies received from Paul Capital Royalty
Acquisition Fund (`PCRAF`) in earlier years and carried in the balance sheet as
deferred income in order to match its release with associated spending
obligations.
A total of £22.5m was received from PCRAF under two transactions in 2001 and
2002 as a result of which PCRAF is entitled to receive until 30th September 2010
a proportion of the royalties and revenue streams arising from Adept and
Extraneal. As at 30th September 2004, the amounts received from PCRAF had been
released in full to the consolidated profit and loss account.
While the risk relating to that proportion of the future royalty and revenue
streams receivable by PCRAF has effectively been transferred to PCRAF, under
certain specified circumstances (including change of control of M L Laboratories
PLC, certain major corporate transactions, and events of default material in the
context of the PCRAF transaction) PCRAF has the right to require the Group to
re-purchase PCRAF`s interests in the royalty and income streams concerned for a
consideration calculated to give PCRAF an agreed minimum rate of return.
7. Taxation
The current period tax credit represents refundable R & D tax credits less
withholding taxes suffered. There is no charge to corporation tax during the
period nor is there any provision required for deferred taxation. Accumulated
tax losses have not been recognised as deferred tax assets as there is
insufficient certainty as to their future recoverability.
As at 31st March 2005, the total tax losses in Group companies amounted to
(£xxm) (2004 £59.1m). These losses are available for offset against future
profits in the companies concerned, subject to agreement with the Inland
Revenue.
Analysis of Charge in period £
UK Corporation Tax - R & D Tax Credit - current period 250,000
Withholding Taxes (94,272)
_____
155,708
_____
8. Loss per ordinary share
Unaudited Unaudited Audited
Half Year Half Year Full Year
to 31/3/2005 to 31/3/2004 To 30/9/2004
£ £ £
Loss on ordinary activities after taxation and minority (3,822,466) (5,501,123) (9,046,131)
interests
_____ _____ _____
Average number of shares 228,710,703 175,333,506 201,948,984
_____ _____ _____
Loss per ordinary share (1.67p) (3.14p) (4.48p)
_____ _____ _____
The calculation of basic earnings per share for the period is based on the loss
on ordinary activities after taxation and minority interests and on 228,710,703
ordinary shares, being the weighted average, calculated on a time basis, of the
number of ordinary shares in issue. For the purpose of the comparative figures
the calculation of the number of ordinary shares in issue prior to the Rights
Issue and Issue for Cash takes account of the notional bonus issue element
arising on the Rights Issue and Issue for Cash from the difference between the
mid-market price on the last day on which shares were quoted cum-rights and the
theoretical ex-rights price.
The effect of dilutive share options outstanding and not yet exercised at 31st
March 2005 would be to reduce the loss per ordinary share.
9. Movement in capital and reserves
Share Share premium Merger Profit & Loss Equity
The movement in capital and Capital Account Reserve Account Shareholders`
reserves during the period was Fund
as follows: £ £ £ £ £
As at 1st October 2004 2,287,107 50,154,469 8,335,897 (47,845,884) 12,931,589
Loss for period - - - (3,822,466) (3,822,466)
_____ _____ _____ _____ _____
As at 31st March 2005 2,287,107 50,154,469 8,335,897 (51,668,350) 9,109,123
_____ _____ _____ _____ _____
10. Reconciliation of operating loss to net cash flow from operating activities
Unaudited Unaudited Audited
Half Year Half Year Full Year
To 31/3/2005 To 31/3/2004 To 30/9/2004
£ £ £
Operating Loss (4,117,622) (6,888,483) (11,981,818)
Depreciation of tangible fixed assets 384,352 356,910 768,048
Amortisation of goodwill 100,013 100,013 200,027
Net Profit on disposal of current asset investments - - (960)
Net Profit on disposal of tangible fixed assets (11,226) (26,452) (50,418)
(Increase) / Decrease in stocks (188,978) 208,812 408,093
Increase in debtors (3,247,800) (1,077,490) (1,307,413)
Increase in creditors 452,340 371,828 1,304,358
Increase / (Decrease) in deferred income 836,159 (471,579) (142,082)
_____ _____ _____
Net cash outflow from operating activities (5,792,762) (7,426,441) (10,802,165)
_____ _____ _____
11. Reconciliation of net cash flow to movement in funds
Unaudited Unaudited Audited
Half Year Half Year Full Year
To 31/3/2004 To 31/3/2004 To 30/9/2004
£ £ £
(Decrease) / Increase in cash in period (469,925) (1,001,806) 79,281
Movement in short term deposits (4,355,000) 9,115,753 4,207,753
Movement in borrowings (540,745) 297,105 (153,860)
_____ _____ _____
Change in net funds resulting from cash flows (5,365,670) 8,411,052 4,133,174
New Finance leases (219,614) (215,604) (392,812)
_____ _____ _____
Movement in net funds (5,585,284) 8,195,448 3,740,362
Operating net funds 9,757,902 6,017,540 6,017,540
_____ _____ _____
Closing net funds 4,172,618 14,212,988 9,757,902
_____ _____ _____
12. Analysis of net funds
Other
Cash Non cash
30/09/2004 Flow Changes 31/03/2005
£ £ £ £
Cash at bank and in hand 415,712 (414,546) - 1,166
Bank overdraft - (55,378) - (55,378)
_____ _____ _____ _____
415,712 (469,924) - (54,212)
Short term deposits 10,452,000 (4,355,000) - 6,097,000
Unsecured loans (478,075) 4,701 473,374 -
Finance leases due within one year (309,950) (339,930) (71,569) (721,449)
Finance leases due in more than one year (321,784) (678,891) (148,046) (1,148,721)
_____ _____ _____ _____
9,757,903 (5,839,044) 253,759 4,172,618
_____ _____ _____ _____
13. Preparation of interim financial statements
The interim financial statements have been prepared on the basis of the
accounting policies set out in the Group`s 2004 statutory accounts and are not
audited. The foregoing financial information does not amount to full accounts
within the meaning of Section 240 of the Companies Act 1985 (as amended). The
financial information in respect of the year to 30th September 2004 has been
abridged from the full Group accounts, which include the Auditors` report which,
whilst unqualified, contained a modification referring to uncertainty regarding
going concern and which have been delivered to the Registrar of Companies. The
Auditors` report did not contain a statement under either section 237(2) or
section 237(3) of the Companies Act 1985.
14. Dividends
The Directors have not declared an interim dividend.
Copies of this interim report are being sent to all shareholders and are also
available to the public at the Company`s registered office, 17 Hanover Square,
London, W1S 1HU.
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M.L. Laboratories PLC
16 June 2005
ML Laboratories PLC
Proposed Acquisition of Quadrant Technologies Ltd
Proposed Vendor Placing
Proposed Placing and Open Offer to raise approximately £26 million
Proposed Acquisition of outstanding minority of Innovata Biomed Ltd
Proposed name change to Innovata plc
St Albans, UK, 16 June 2005 - ML Laboratories PLC (LSE: MLB) (`ML`, `ML
Laboratories` or the `Company`) is pleased to announce the proposed acquisition
of Quadrant Technologies Ltd (`Quadrant`) for a total consideration of
approximately £46.7 million (`the Acquisition`). In conjunction with the
Acquisition, the Company plans to raise approximately £26 million in a Vendor
Placing and a Placing and Open Offer which has been underwritten by Code
Securities.
The Company also announces the acquisition of the outstanding minority of
Innovata Biomed, its respiratory subsidiary, for a consideration of £1.85
million in cash and ML shares.
On the basis of these transactions, the `ML Laboratories` name no longer
reflects the business of the Group and the Board of ML proposes that the name be
changed to Innovata plc.
The Acquisitions, Vendor Placing, Placing and Open Offer and change of name to
Innovata plc are all subject to the approval of ML Shareholders. A circular
containing further information is being posted to shareholders today.
Reasons for the Quadrant Acquisition
• The Directors are of the opinion that Quadrant represents an excellent
strategic fit for the newly re-focused ML business. With Quadrant`s strength and
experience in pulmonary delivery, the Enlarged Group will have a full complement
of capabilities to tackle new products for respiratory disease and inhaled
therapeutics.
• The Quadrant Group is profitable with a royalty stream from a licence
with Baxter Inc. and income generated from other pharmaceutical company
collaborations. This will add to the Company`s financial stability.
• Quadrant`s scientific staff and laboratory facilities will provide the
Enlarged Group with the ability to take control of formulation development and
will also provide synergies through savings in infrastructure.
• The integration of the Quadrant management team into ML will provide
greater strength in R&D and licensing.
• Quadrant`s unit dose disposable and unit dose reusable devices will
broaden the device options the Enlarged Group will be able to offer its clients.
Key Acquisition Terms of the Quadrant Acquisition
Key terms of the Quadrant Acquisition are as follows:
• 50:50 acquisition valuing Quadrant at £46.7 million (based on a
closing share price of 20.625 pence) comprising cash consideration of
approximately £19.5 million with the remainder in shares.
• Vendors are subject to a 12 month lock-in in respect of their ML
shares
Details of Vendor Placing and Placing and Open Offer
• Vendor Placing and Placing and Open Offer of 137,499,998 new Ordinary
Shares at the Issue Price of 19p to raise approximately £24 million (net of
expenses)
• Proceeds to be used to fund the cash consideration of the Acquisitions
and to provide additional working capital for the Enlarged Group
• Qualifying Shareholders can apply for Placing and Open Offer Shares on
the basis of 1 Placing and Open Offer Share for every 5 existing Ordinary Shares
held
• Placing and Open Offer Shares have been conditionally placed with
institutional investors subject to Qualifying Shareholders` rights to take up
their entitlements under the Open Offer
• Vendor Placing Shares have been placed firm with institutional
shareholders by Code Securities
• Vendor Placing and Placing and Open Offer have been underwritten by
Code Securities
Key Terms of the Innovata Biomed Acquisition
ML intends to acquire the outstanding 18.75 per cent minority of Innovata Biomed
that it does not already own for a consideration of £1.85 million in cash and ML
shares from Dr Nick Boyes, one of the former directors of the Company. The
acquisition of this minority stake will allow the Company to have full control
of Innovata Biomed, which will become a wholly-owned subsidiary of the Company.
Interim results for ML for the six months to 31 March 2005 were also announced
today (see separate release).
Commenting on today`s announcement, Kieran Murphy, Chief Executive Officer of
ML, said:
`The acquisition of Quadrant is a transforming transaction for ML with a
compelling strategic logic. We believe that the combination of the two companies
will enable us to participate in the significant upside potential of the fast
growing market for inhaled therapies and respiratory disease. By combining the
complementary skills and expertise of the two companies and building on the
pharmaceutical collaborations already in place, we will create a powerful,
integrated offering capable of delivering high quality revenue streams, early
profitability and substantial growth potential.`
Contacts:
ML Laboratories plc Tel: 01727 837 341
Kieran Murphy, Chief Executive Officer
Code Securities Tel: 020 7024 2000
Juliet Thompson / Richard Potts
Financial Dynamics Tel: 020 7831 3113
David Yates / Julia Phillips
Code Securities Limited, which is regulated in the United Kingdom by the
Financial Services Authority, is acting exclusively for ML Laboratories PLC as
sponsor, placing agent and underwriter in relation to the Vendor Placing, the
Placing and Open Offer, the Quadrant Acquisition and the Innovata Acquisition.
Code Securities Limited is not acting for, and will not be responsible to any
person other than ML Laboratories plc for providing the protections afforded to
customers of Code Securities Limited or for advising any other person on the
contents of this document or any transaction or arrangement referred to herein.
ML Laboratories PLC
Proposed acquisition of Quadrant
Proposed Vendor Placing
Proposed Placing and Open Offer
Proposed acquisition of the minority interest in Innovata Biomed
Proposed grant of options and proposed change of name
Introduction
The Board of ML Laboratories announces that it has agreed terms for the proposed
acquisition of Quadrant Technologies Limited. ML Laboratories has today entered
into a conditional agreement pursuant to which it will acquire the entire issued
share capital of Quadrant for an aggregate consideration of £46.7 million, to be
satisfied as to £27.2 million by the issue of 131,932,394 new Ordinary Shares at
an issue price of 20.625 pence per new Ordinary Share (being the Closing Price
on 15 June 2005, the date on which the Quadrant Acquisition Agreement was
entered into) as to £19.5 million in cash to be funded out of the proceeds of
the Vendor Placing and Placing and Open Offer. The Quadrant Acquisition
constitutes a class 1 transaction for the purposes of the Listing Rules and, as
such, requires the prior approval of Shareholders.
Quadrant is a privately owned company based near Nottingham. It provides
specialist drug formulation and stabilisation technologies to the pharmaceutical
and biotechnology industries with particular emphasis on dry powder drug
delivery to the lungs.
The Board also announces the proposed acquisition of the outstanding minority
interest in Innovata Biomed currently owned by Dr R.N. Boyes, a former director
of the Company. This interest, representing approximately 18.75 per cent of the
issued share capital of Innovata Biomed, is to be acquired for an aggregate
consideration of £1.85 million payable as to £925,000 by the allotment of the
Innovata Consideration Shares at an issue price of 20.625 pence per new Ordinary
Share (being the Closing Price on 15 June 2005, the date on which the Innovata
Acquisition Agreement was entered into) and as to the balance of £925,000 in
cash. The Innovata Acquisition constitutes a related party transaction for the
purposes of the Listing Rules and, as such, requires the prior approval of
Shareholders.
The Board also announces that the Company is intending to raise approximately
£23.7 million (net of expenses) by way of a Vendor Placing of 91,758,315 new
Ordinary Shares and a Placing and Open Offer of 45,741,683 new Ordinary Shares,
each at the Issue Price of 19 pence. The net proceeds of the Vendor Placing will
be paid to the Vendors pursuant to the Quadrant Acquisition Agreement and the
net proceeds of the Placing and Open Offer will be used to fund the remaining
cash consideration of £2.1 million payable to the Vendors pursuant to the
Quadrant Acquisition Agreement, to fund the cash consideration of £925,000
payable under the Innovata Acquisition and to provide the Company with £2.9
million of additional working capital (net of expenses). Qualifying Shareholders
can apply for Placing and Open Offer Shares on the basis of 1 Placing and Open
Offer Share for every 5 Existing Ordinary Shares held. The Vendor Placing Shares
have been conditionally placed by Code Securities on behalf of the Vendors with
institutional investors and are not subject to the Open Offer. The Placing and
Open Offer Shares have been conditionally placed with institutional investors
subject to Qualifying Shareholders` right to take up their entitlements under
the Open Offer. The Placing and Open Offer has been underwritten by Code
Securities.
The Board also announces the proposed change of the Company`s name to Innovata
plc and proposals to grant options to the Company`s Executive Chairman and Chief
Executive Officer.
The Company today released its interim results for the six months ended 31 March
2005. (See separate announcement).
Each of the Acquisitions, the Vendor Placing, the Placing and Open Offer, the
Option Proposals and the proposed change of name is conditional, inter alia, on
the passing by Shareholders of the relevant requisite resolutions at an
Extraordinary General Meeting of the Company being convened for 10.00 a.m. on 14
July 2005.
Recent developments and strategic review
ML Laboratories has in recent years focused on the development and
commercialisation of its portfolio of pharmaceutical products through its core
competences: the design and project management of product development
programmes, regulatory affairs, product licensing and product management.
In March 2004, the Company raised £14.37 million to facilitate further progress
with the development and commercialisation of its product range. The Group`s
progress since then has included:
• the publication of preliminary results of a Phase III clinical study
in the US of the Company`s surgically-induced adhesion prevention therapy (Adept
(R)), together with the formal acceptance for filing by the FDA of the
Pre-Market Approval for this product;
• the conclusion of a licensing agreement with a leading European
pharmaceutical company, specialising in generic products, for the development of
a respiratory treatment using Innovata Biomed`s C200 inhaler;
• the grant of marketing approvals for the use of the Clickhaler(R)
device with budesonide and formoterol in a first European market;
• the filing and subsequent approval of the Company`s Clickhaler(R)
device containing procaterol in Japan which was achieved in conjunction with the
Company`s Japanese licensee, Otsuka Pharmaceutical Co. Ltd, and triggered a
further milestone payment to the Company;
• the grant of a core European patent and a first US patent for the C200
inhaler; and
• the conclusion of an exclusive agreement with a Japanese
pharmaceutical company for the marketing rights to the budesonide Clickhaler(R).
On 3 March 2005, in response to shareholder concerns, Ian Kent and Kieran Murphy
joined the Company as Executive Chairman and Chief Executive Officer
respectively and replaced the Company`s then Executive Chairman, Stuart Sim.
Following these appointments a review of the strategy and operations of the
business was undertaken. Further board changes have been made, including the
appointment of three new non-executive directors with extensive experience in
the sectors in which the Group operates.
The Company announced the results of its strategic review on 25 April 2005 and
set out a restructuring plan to consolidate the Group`s existing operations into
the current headquarters of its respiratory business, Innovata Biomed, in St
Albans, Hertfordshire to reduce costs and improve efficiency.
The new management`s strategy is to place greater focus on the Group`s
revenue-generating respiratory business, building on the collaborations already
in place to exploit the large and growing market for pulmonary drug delivery
products. The Board has identified the acquisition of Quadrant, with its focus
on pulmonary drug delivery, as a significant step in implementing this strategy.
Quadrant`s business, as further described below, brings revenue streams,
complementary scientific expertise, intellectual property, collaborative
partnerships, management experience and facilities.
Additionally, as the Group`s respiratory business is conducted through Innovata
Biomed, the Board considers it to be an important element of its corporate
strategy to acquire the outstanding shares in Innovata Biomed not already owned
by the Company. The Company is therefore proposing to acquire this minority
interest pursuant to the Innovata Acquisition Agreement and further details on
this acquisition are set out below.
The Enlarged Group will be a product development business with formulation,
stabilisation and device technologies, with a supporting intellectual property
portfolio and a skilled set of employees focused on the efficient delivery of
new and existing therapies, both singly and in combination, to and via the lung.
It is planned that, following completion of the Acquisitions, all of the
Enlarged Group`s activities will be based at the current Quadrant facilities in
Ruddington, near Nottingham. It is also proposed that, given the greater
emphasis now being placed on inhaled therapies the Company`s name be changed to
Innovata plc.
On completion of the Quadrant Acquisition, it is proposed that Terence Chadwick
and Colin Dalton will join the Board as executive directors and Rajan Uppal will
join the Board as a non-executive director. Ian Kent will continue as Executive
Chairman of the Board, although, as contemplated by his service contract, it is
anticipated that he will move to a non-executive capacity before 31 December
2005. Paul Ballington will stand down as an executive Director of the Company
but will continue as an important executive officer of the Group.
The inhaled therapies market
The majority of treatments for asthma and COPD are delivered by inhalation, with
many patients taking more than one type of therapy. In 2003, the asthma market
was valued at $11.5 billion, of which 78 per cent was inhaled, and, the COPD
market was valued at $2.3 billion, of which 86 per cent was inhaled. These
markets are forecast to grow rapidly achieving sales in 2010 of $20.9 billion
for asthma, of which 79 per cent would be inhaled, and $7.4 billion for COPD, of
which 82 per cent would be inhaled. The inhaled drug market is categorised by
ING Financial Markets as being large (collectively worth $13.8 billion in 2003)
and is growing quickly, and expected to double by 2010. Driving this growth are
two main trends: the use of fixed combination therapies and the treatment of
COPD.
Inhaled fixed combination asthma therapy is the use of two drugs in a fixed dose
combination in one inhaler. The two major operators in this market have
combinations of long acting beta agonists together with corticosteroids, which
have been well received by patients and prescribers. GlaxoSmithKline`s Seretide
(Advair in the USA) (one such combination for the treatment of asthma) is now
the 7th biggest selling pharmaceutical product worldwide, with sales of $4.7
billion in 2004, growing at 22.5 per cent per annum. Fixed combination therapy
is forecast to be integral to both the asthma and COPD sectors.
Unlike asthma, for which the treatment options are extremely effective, COPD
responds relatively poorly to the same medications. Therefore the COPD market is
historically less well developed. Recently introduced treatments for COPD, such
as Boehringer Ingelheim`s Spiriva, have invigorated this sector and are driving
the growth forecasts. Fixed combination treatments are also being increasingly
used in the treatment of COPD.
Within both the asthma and COPD sectors the choice of inhaler has also been
changing. Dry powder inhaler products are now achieving sales values in excess
of pressurized meter dose inhalers.
Over recent years, the delivery of medicines via the inhalation route has
evolved to include a variety of new approaches and disease states. Nebulised
solutions of Roche`s dornase-alpha (Pulmozyme(R)), used to reduce the viscosity
of mucus and Chiron`s tobramycin (TOBI(R)), an inhaled antibiotic used to treat
chest infections with pseudomonas aeruginosa, both indicated for use in cystic
fibrosis, have entered the market.
During the last decade, several companies, including Quadrant, have focused on
developing products capable of delivering medicines into the blood stream via
the inhalation route in order to over come the need for needle based injections
or to shorten the time to onset of effect. One such product, Exubera, an inhaled
insulin used to treat diabetes mellitus, has been filed for marketing approval
in both Europe and the USA during 2004 and 2005 respectively and others are in
development.
The Board believes these new approaches offer a market opportunity for
inhalation product development outside the traditional areas of Asthma and COPD
and that the Company will be well placed to exploit these potentially lucrative
opportunities.
Information on Quadrant
Background
The Quadrant Group is a profitable business primarily focused on pulmonary drug
delivery. It provides specialist drug formulation and stabilisation technologies
to the pharmaceutical and biotechnology industries with a particular emphasis on
dry powder formulations for drug delivery to and via the lungs. The Quadrant
Group has existing collaborations and licensing agreements for its various
technologies with a number of leading pharmaceutical companies, such as the
Bristol-Myers Squibb Company, Baxter and GlaxoSmithKline.
The Quadrant Group is based in a modern 30,000 sq. ft. laboratory and office
facility near Nottingham and has recently made substantial investments in its
laboratories to ensure it and its collaborators benefit from the latest
equipment and techniques.
Quadrant has a total of 35 employees including a scientific team with
considerable experience in the development of dry powder formulations suitable
for administration to the respiratory tract.
Technologies
Pulmonary formulation
Quadrant is able to produce dry powder formulations either by utilising its
spray drying techniques or conventional particle size reduction methodologies.
In addition, Quadrant has proprietary technologies which give the drug
formulations attractive attributes such as improved stability and controlled and
sustained release.
Quadrant`s proprietary stabilisation technologies, which have been applied to a
wide range of peptides and proteins, involve formulating a drug with polyols,
particularly the naturally occurring disaccharide sugar, trehalose. Controlled
and sustained release is achieved using either sugar derivatives or hyaluronic
acid.
Dry powder inhaler
Quadrant is developing a dry powder inhaler (the S2 bead inhaler (`S2`)) aimed
at the highly efficient delivery of drug formulations to the lung. The S2 is
designed to be easy to use whilst at the same time being inexpensive to produce.
It is based on innovative powder dispersion technology, which should ensure high
efficiency drug delivery to the lungs. Key advantages of this system include the
capacity to deliver a wide range of drugs, the capability to deliver high
concentration drug formulations and highly efficient powder dispersion with low
patient inspiratory effort. It also delivers a relatively consistent dose of
drug, independent of inspiratory flow rate, unlike most other passive inhalers
(being those with no external power source such as a battery or compressed air).
The S2 for multidose applications is licensed exclusively to Valois SAS whilst
disposable or reusable unit dose rights remain with Quadrant.
Other applications of Quadrant`s technologies
Quadrant`s ability to stabilise molecules (including peptides and proteins) and
its ability to alter the kinetics of release in a solid delivery format can be
applied to other non-pulmonary routes of delivery and is used in diagnostic
products.
Collaborations and licensees
Quadrant has entered into collaborations with and has licensed its technology
(both pulmonary and non-pulmonary) to a number of major healthcare and
pharmaceutical companies. Examples of such arrangements include:
Pulmonary
Bristol-Myers Squibb Company
In November 1999, Quadrant established a joint venture with MicroDose
Technologies Inc. (`MicroDose`) to combine Quadrant`s formulation and particle
engineering technologies with MicroDose`s dry powder inhaler and filling
capabilities. This joint venture was established by the incorporation of QDose
Limited (`QDose`) which is owned in equal shares by Quadrant and MicroDose and
has focused on the development of a rapid acting inhaled insulin product. In
September 2003, QDose entered into a licence, collaboration and development
agreement with Bristol-Myers Squibb Company (`BMS`) in respect of its rapid
acting inhaled insulin product. The terms of this agreement provide for BMS to
have exclusive worldwide rights to the QDose product and for BMS to take on the
lead role in developing, manufacturing and commercialising it. QDose received an
initial licence fee of $1 million and could receive up to $29 million in
milestone payments dependent on the achievement of certain development and
regulatory events. QDose is also entitled to a royalty on product sales.
Valois SAS
During 2003, Valois SAS, a company specialising in the design and manufacture of
nasal and pulmonary drug delivery devices, acquired from Quadrant certain
intellectual property rights and equipment related to the S2 multidose device.
Quadrant is continuing to support the development of this device through the
provision of its expertise in dry powder formulations and device testing.
Innovata Biomed
In 2003, Quadrant began working with Innovata Biomed providing pharmaceutical
support to the development of Innovata Biomed`s platform technologies and
formulation development services for two drugs.
CoTherix, Inc.
During March 2005, Quadrant entered into a collaborative research and
development agreement with CoTherix, Inc. (`CoTherix`) to develop an
extended-release formulation of CoTherix`s product, Ventavis(R) (iloprost)
Inhalation Solution. The goal of this initiative is to reduce the frequency and
duration of dosing of iloprost by incorporating the active molecule in one of
Quadrant`s drug delivery matrices and delivering it in a convenient dry powder
format.
Non-pulmonary
Outside its activities in pulmonary drug delivery, Quadrant has licensed
technologies to a number of major healthcare and pharmaceutical companies.
Baxter
The most significant by value of these is in respect of a licence granted to
Baxter during 2000, whereby Baxter has been granted both exclusive and
non-exclusive worldwide rights to use certain Quadrant stabilisation patents
relating to Factor VIII, used in the treatment of haemophilia A. This technology
has been utilised in Baxter`s product Advate, which was granted FDA approval in
August 2003 and is now also approved in the EU, Switzerland and Australia.
Quadrant currently receives a royalty stream based upon sales of Advate, which
in 2004 generated income of £2.8 million. Baxter has estimated worldwide sales
of Advate to be in excess of $500 million for 2005.
GlaxoSmithKline plc
Quadrant has also entered into a broad-based licence for non-invasive vaccine
delivery with GlaxoSmithKline plc. Quadrant is entitled to receive significant
payments dependent on development and regulatory milestones and on a royalty on
product sales.
Other licence agreements
Additional licence agreements include those entered into with Avant
Immunotherapeutics, Inc., BD Diagnostics, Inc., Roche Diagnostics and the
Hayashibara Group.
Intellectual Property
Patents
The Quadrant Group protects its intellectual property rights with a substantial
patent portfolio of more than 60 patent families containing over 400 granted
cases globally, with patents in the key territories of the US, Japan and the
main EU member states. In the US, the Quadrant Group has over 50 issued patents.
A number of licences have been granted for worldwide rights to certain patents
of the Quadrant Group; the main licensees are Baxter, Bristol-Myers Squibb
Company and GlaxoSmithKline. These licences are for multiple patent families,
which include granted patents in the US and main EU member states.
The Quadrant Group has a large patent portfolio covering several technologies
that may present freedom to operate issues for unlicensed third parties. Ten
granted patents of the Quadrant Group are being opposed in the European Patent
Office (`EPO`). The opponents are Aventis Pharma Deutschland GmbH, Boehringer
Ingelheim Pharma GmbH & Co, Chiron Corporation, Advanced Inhalation Research,
Inc., (an affiliate of Alkermes, Inc.), Bracco Research S.A., Nektar
Therapeutics (`Nektar`) and Anhydro Limited. PowderMed Limited and the National
Blood Authority are now licensed under certain Quadrant patents and have
withdrawn their oppositions.
Nektar is involved in three of the patent oppositions referred to above. In
addition, a patent application of Nektar and a patent of the Quadrant Group are
involved in interference proceedings in the United States Patent and Trademark
Office. The Quadrant Group is aware that Nektar has licensed its inhaled insulin
product to Pfizer, Inc. and that marketing authorisations have been applied for
in both the EU and the US.
Third Party Rights
The Quadrant Group is opposing two patents of Nektar in the EPO, which are
entitled `Methods and compositions for pulmonary delivery of insulin` and `
Stable glassy state powder formulations`. The other opponents of the first
patent are Eli Lilly and Co, Vectura Limited and Advanced Inhalation Research,
Inc. The second patent has also been opposed by Advanced Inhalation Research,
Inc. The Quadrant Group has been advised that there is a good chance of
achieving revocation or a significant limitation of the claims of these patents.
Financial information on Quadrant
The audited results of Quadrant for the year ended 31 December 2002, the
financial period ended 10 July 2003, the financial period ended 31 December 2003
and the year ended 31 December 2004 will be set out in the accountants` report
in Part III of the Prospectus. Quadrant had consolidated net assets as at 31
December 2004 of £4.48 million. A summary of the trading results for Quadrant as
extracted from the accountants` report to be set out in Part III of the
Prospectus is set out below.
12 months 1 January 11 July 12 months
ended 2003 to 2003 to ended
31 December 10 July 31 December 31 December
2002 2003 2003 2004
£`000 £`000 £`000 £`000
Turnover 4,583 1,417 3,457 5,662
_____ _____ _____ _____
Earnings before interest, tax, depreciation, (1,493) (1206) 2,671 2,030
amortisation and exceptional items
Depreciation and impairment of fixed assets (794) (216) (58) (193)
Amortisation of goodwill (4,564) - (268) (706)
Exceptional (charges)/credits (net) (36,513) (1859) - -
Net interest and similar items 526 2415 184 203
_____ _____ _____ _____
(Loss)/profit on ordinary activities before (42,838) (1136) 2,529 1,334
taxation
_____ _____ _____ _____
The results for the year ended 31 December 2002 and for the period 1 January
2003 to 10 July 2003 relate to the period during which the Quadrant business was
owned by Elan. The turnover for the year ended 31 December 2002 includes an
amount of £2.5 million (10 July 2003: £0.5 million) relating to turnover charged
to other Elan companies mainly in connection with the development of the S2
device which was owned by Elan during this period. The results for these periods
includes a number of exceptional items and in particular there was an
exceptional charge of £36.5 million in respect of the impairment of goodwill for
the year ended 31 December 2002.
The results for the period 11 July 2003 to 31 December 2003 and for the year
ended 31 December 2004 represents the activities of Quadrant following the
management buyout from Elan on 10 July 2003. There were no sales to Elan during
this period with turnover in the year ended 31 December 2004 consisting of
licence fees and milestone payments of £0.2 million (2003: £2.0 million),
royalties on product sales of £2.8 million (2003: £0.5 million) and development
fees of £2.7 million (2003: £1.0 million).
Current trading and prospects
During the current financial year the Quadrant Group has continued to be
profitable and in the three months to 31 March 2005 generated revenues,
comprising royalty payments, contract revenues and an option payment.
Principal terms of the Quadrant Acquisition
The consideration for the Quadrant Acquisition is £46.7million, which is to be
satisfied as to £27.2 million by the allotment of the Quadrant Consideration
Shares at the Issue Price of 20.625 pence per share (being the Closing Price on
15 June 2005), and as to the £19.5 million in cash.
The Listing Rules require that the Quadrant Acquisition (being a Class 1
transaction for the purposes of the Listing Rules) be approved by the members of
the Company in general meeting.
The other principal terms of the Quadrant Acquisition are as follows:
• three of the Vendors (Rajan Uppal, Dr Terence Chadwick and Dr Colin
Dalton (together the `Warrantors`)) have provided standard commercial warranties
in relation to the Quadrant Group and a taxation covenant in relation to
Quadrant since the date of its incorporation. The liability of the Warrantors
under warranties, indemnities and the tax covenants is limited to £2 million in
the case of Rajan Uppal, £500,000 in the case of Dr Terence Chadwick and
£100,000 in the case of Dr Colin Dalton;
• Rajan Uppal and Dr Terence Chadwick have entered into non-compete and
non-solicitation covenants to protect the goodwill of the Enlarged Group`s
business for a period of two years following the date of completion of the
Quadrant Acquisition;
• the Vendors have entered into lock-in agreements, pursuant to which
they have agreed not to sell the Quadrant Consideration Shares for a period of
12 months following completion of the Quadrant Acquisition (subject to certain
limited exceptions); and
• the Quadrant Acquisition Agreement is conditional, inter alia, on the
publication and despatch of the Prospectus, the passing of the Resolution
numbered 1 in the notice meeting set out at the end of the Prospectus at the
Extraordinary General Meeting, the Placing Agreement (and, accordingly, the
Vendor Placing and the Placing and Open Offer) having become unconditional (save
for any condition relating to completion of the Quadrant Acquisition Agreement
or Admission) and not having been terminated in accordance with its terms and
the admission of all the New Ordinary Shares (other than Innovata Consideration
Shares) to the Official List and to trading on the London Stock Exchanges Market
for listed securities.
The Innovata Acquisition
One of the Group`s principal subsidiaries, Innovata Biomed, is currently owned
as to approximately 18.75 per cent by Dr R. N. Boyes, one of the former
directors of the Company. On 15 June 2005, the Company entered into the Innovata
Acquisition Agreement pursuant to which the Company has conditionally agreed to
purchase from Dr Boyes his shares in Innovata Biomed. The aggregate
consideration payable under the Innovata Acquisition Agreement is £1.85 million,
to be satisfied as to £925,000 by the allotment of the Innovata Consideration
Shares at an Issue Price of 20.625 pence per share (being the Closing Price on
15 June 2005) and as to the balance of £925,000 in cash.
Pursuant to the terms of the Innovation Acquisition Agreement, Dr Boyes will be
subject to `lock-in` provisions in relation to the Innovata Consideration Shares
to be issued as consideration for the Innovata Acquisition. These provisions
will serve to prevent Dr Boyes from disposing of these shares within 12 months
of their allotment (subject to certain exceptions).
The Listing Rules require that the Innovata Acquisition be approved by the
members of the Company in general meeting. Dr Boyes has irrevocably undertaken
to the Company that he will abstain from voting on such resolution and will take
all reasonable steps to ensure that any associates (as defined by paragraph 11.1
(d) of the Listing Rules) of Dr Boyes similarly abstain.
The Directors believe that the completion of the Innovata Acquisition is in the
best interests of the Company, as it would afford the Company full control over
Innovata Biomed, which would become a wholly-owned subsidiary of the Company.
The Directors are of the opinion that the terms of the Innovata Acquisition
Agreement are fair and reasonable so far as the Shareholders of the Company are
concerned and have been so advised by Code Securities.
Reasons for the Vendor Placing and the Placing and Open Offer
The Vendor Placing will raise £17.4 million and has been arranged so as to
enable the Vendors to realise a greater proportion of the consideration payable
to them under the Quadrant Acquisition in the form of cash.
The Placing and Open Offer will raise up to £8.69 million for the Company (net
of expenses), of which £2.1 million will be used by the Company to fund the
balance of the cash payable to Vendors under the Quadrant Acquisition. A further
£925,000 will be used to fund the cash element of the consideration payable
under the Innovata Acquisition Agreement. The balance of £2.87 million will be
retained by the Company for general working capital purposes to assist in the
general funding of operating expenses.
Upon completion of the Acquisitions, the Vendor Placing and the Placing and Open
Offer the Quadrant Consideration Shares will represent approximately 26.2 per
cent of the Company`s enlarged issued share capital and the Existing Ordinary
Shares will represent approximately 45.5 per cent of the Company`s enlarged
issued share capital. Following issue of all of the New Ordinary Shares to be
allotted pursuant of the Acquisitions, the Vendor Placing and Open Offer,
Qualifying Shareholders who take up their entitlements under the Open Offer will
suffer an immediate dilution of approximately 45.4 per cent in their interests
in the Company and Qualifying Shareholders who do not take up their entitlements
under the Open Offer will suffer an immediate dilution of approximately 54.5 per
cent in their interests in the Company.
Principal terms of the Vendor Placing
Pursuant the Vendor Placing, a total of 91,758,315 New Ordinary Shares will be
placed with institutional investors at the issue price of 19 pence per share,
raising a total of approximately £17.4 million. All of the net proceeds of
Vendor Placing will be paid to the Vendors under the Quadrant Acquisition
Agreement. The Vendor Placing Shares will rank pari passu in all respects with
the Existing Ordinary Shares and the other new Ordinary Shares proposed to be
allotted pursuant to the proposals referred to in the Listing Particulars.
The Vendor Placing Shares are not subject to the Open Offer and all of the
Vendor Placing Shares will be conditionally placed firm with institutional
investors by Code Securities on behalf of the Vendors. The number of Vendor
Placing Shares represents the number of New Ordinary Shares that Code Securities
has advised the Company should be placed firm in order to secure certain
significant new investors in the Company.
Code Securities agreed, pursuant the Placing Agreement, to use reasonable
endeavours to place the Vendor Placing Shares with institutional investors,
subject to the Placing Agreement becoming unconditional in all respects. To the
extent that Code Securities is unable to procure subscribers for the Vendor
Placing Shares, Code Securities has itself agreed to subscribe for such shares,
subject to the Placing Agreement becoming unconditional in all respects.
The Vendor Placing is conditional on, inter alia, (i) Admission taking place not
later than 8.30am on 15 July 2005 or such later time and/or date as the Company,
Code Securities and the Vendors may agree (not being later than 8.30am on 22
July 2005) and (ii) the Placing Agreement becoming unconditional in all respects
and not having been terminated in accordance with its terms prior to Admission.
Principal terms of the Placing and Open Offer
The Placing and Open Offer will raise approximately £6.3 million after expenses.
In order to give Qualifying Shareholders the opportunity to participate in the
issue of the Placing and Open Offer Shares, ML Laboratories has arranged for
Code Securities as its agent to invite applications from Qualifying Shareholders
to acquire Placing and Open Offer Shares at the Issue Price under the Open
Offer. Qualifying Shareholders may apply for Placing and Open Offer Shares on
the basis of:
1 Placing and Open Offer Share for every 5 Existing Ordinary Shares
held at the Record Date and so in proportion for any other number of Existing
Ordinary Shares so held. The Placing and Open Offer Shares will rank pari passu
in all respects with the Existing Ordinary Shares and the other new Ordinary
Shares proposed to be allotted pursuant to the other proposals referred to in
this announcement.
Individual entitlements will be rounded down to the nearest whole number of
Placing and Open Offer Shares. Fractions of Placing and Open Offer Shares that
would otherwise arise will not be allotted.
Code Securities has also agreed to use reasonable endeavours to place the
balance of the Placing and Open Offer Shares with institutional investors,
subject to clawback to satisfy valid applications from the Qualifying
Shareholders under the Open Offer and subject to the Placing Agreement becoming
unconditional in all respects. To the extent that Code Securities is unable to
procure subscribers for the Placing and Open Offer Shares which are not acquired
by Qualifying Shareholders under the Open Offer, Code Securities has agreed
itself to subscribe for such shares, subject to the Placing Agreement becoming
unconditional in all respects.
The Placing and Open Offer is conditional on, inter alia, (i) Admission taking
place not later than 8.30 a.m. on 15 July 2005 or such later time and/or date as
the Company and Code Securities may agree (being not later than 8.30 a.m. on 22
July 2005) and (ii) the Placing Agreement becoming unconditional in all respects
and not having been terminated in accordance with its terms prior to Admission.
Qualifying Shareholders should note that the Open Offer is not a rights issue
and that Placing and Placing and Open Offer Shares not applied for under the
Open Offer will not be sold in the market for the benefit of Qualifying
Shareholders who do not apply under the Open Offer. Entitlements under the Open
Offer are not transferable except to satisfy a bona fide market claim and the
Application Form, not being a document of title, cannot be traded.
Information on ML Laboratories
ML Laboratories currently operates through two divisions, Innovata Biomed and ML
Laboratories which are financed through the Group`s operating income.
ML Laboratories currently has a total of 115 employees although, as announced on
25 April 2005, this is expected to be reduced to approximately 50 (prior to the
acquisition of Quadrant) as part of the implementation of the Group`s new
strategy.
Innovata Biomed
Innovata Biomed is the respiratory division of ML Laboratories. Its core
competency is in the design, formulation, development and industrialisation of
innovative technologies and products for delivering compounds to the lungs.
Innovata Biomed`s business is based around the Clickhaler, a multi-dose
reservoir dry powder inhaler, and the C200, a dry powder inhaler for delivering
two separate drugs to the lungs simultaneously. The C200 provides a novel
solution to fixed combination inhalation therapy.
Clickhaler(R)
The Clickhaler is a proven, industrialised dry powder inhaler, developed by
Innovata Biomed, which has been extensively studied and shown to be highly
acceptable to patients, regulators and potential licensees.
The first two Clickhaler products are Asmasal (salbutamol sulphate) and Asmabec
(beclomethasone dipropionate) which are distributed by Celltech plc (now part of
UCB Pharma) in the UK, France and the Republic of Ireland.
In 2002, ML Laboratories entered into an exclusive licence agreement with a
leading European pharmaceutical company for the rights to market two other
asthma products, budesonide and formoterol fumarate, in the Clickhaler in Europe
and a number of other territories. The terms of this licensing agreement provide
for the payment to Innovata Biomed of up to £10 million in access fees and
milestone receipts (of which £6 million has been received), along with
double-digit royalty payments on subsequent sales.
In March 2005, Innovata Biomed announced that its licensing partner had been
informed that the Clickhaler had received marketing approval in its first
European country for use with budesonide and formoterol. The Directors expect
that it will be launched in that country by the end of 2005. Sales of comparable
budesonide products (such as the Pulmicort Turbohaler) in Europe total £200
million annually, and the Directors estimate that the size of the European
market for comparable formoterol fumarate products (such as the Oxis Turbohaler)
is £100 million annually.
In March 2003, Innovata Biomed granted an exclusive licence to the Clickhaler
device to Otsuka Pharmaceutical Co Ltd of Japan (`Otsuka`) for the delivery of
Otsuka`s asthma treatment, Meptin, in both Japan and Spain.
In March 2005, Innovata Biomed announced that it had been informed by Otsuka
that the Meptin Clickhaler product had been approved in Japan. Innovata Biomed
received a milestone payment and commenced the supply of Clickhaler units to
Otsuka on commercial terms. The Directors anticipate that the Meptin Clickhaler
will be introduced to the market by the end of 2005 at which point a further
milestone payment will be received.
Innovata Biomed signed an exclusive licence agreement in September 2004 with an
undisclosed Japanese pharmaceutical company for marketing rights to Innovata
Biomed`s budesonide Clickhaler. Innovata Biomed received an access fee and will
receive subsequent milestone payments. Innovata Biomed is assisting the Japanese
company in developing the data necessary for regulatory approval in Japan.
Innovata Biomed will supply Clickhaler units to the Japanese company on
commercial terms.
C200
The C200 is Innovata Biomed`s entry into the rapidly growing combination therapy
inhaler market. It is a novel adaptation of the Clickhaler and is being
developed so that in the same device two separate drug reservoirs feed two
separate drug formulations to separate metering chambers from which they are
delivered to the patient in the same breath. The ability to formulate the drugs
separately permits optimisation of each formulation individually, thereby
offering the potential to overcome significant formulation challenges. Recently,
there has been a move by major pharmaceutical companies in the direction of
fixed combination therapy which it is thought offers a more convenient method
for patients to take combined medications.
The principal strength of the C200 lies in offering a device solution which
avoids the need for drugs to be pre-mixed in a complicated formulation whilst
enabling the two drugs to be delivered simultaneously. This is advantageous as
it is simpler to formulate two drugs separately than to formulate two drugs that
are pre-mixed. The C200 therefore offers the Company the opportunity to take
advantage of the growing market for combination therapy.
In June 2004, Innovata Biomed entered into an exclusive agreement with a leading
European pharmaceutical company for the marketing and distribution of a
combination of two established respiratory medicines in the C200 device. This
agreement covers Europe and other named countries, with Innovata Biomed
retaining the rights for all remaining territories, including Japan and the US.
Pursuant to this agreement, Innovata Biomed received an access fee of £1.5
million and is entitled to receive further milestone payments of up to £6.0
million. Further, Innovata Biomed will be entitled to receive royalty income
from sales of the product incorporated in this device (with launch planned for
2008/9) and will receive development fees for conducting the development
programme on behalf of the licensee. In addition, Innovata Biomed will supply
the device to the licensee on commercial terms.
Innovata Biomed announced in February 2005 that it had received the grant in the
US of the first of a series of patent applications in relation to the C200
device following earlier grant in Europe. In addition, a second contract is at
an advanced stage of negotiation.
ML Pharmaceuticals
ML Pharmaceuticals is the division of ML Laboratories which concentrates on the
development and commercialisation of specialist pharmaceutical products. The
most significant of these products are Extraneal and Adept.
Extraneal(R)
In the 1990s, ML Laboratories developed a peritoneal dialysis solution
containing icodextrin. In 1996, the Company entered into an agreement with
Baxter for the licensing of this product which Baxter markets under its trade
name, Extraneal. The product has been launched in over 45 countries worldwide
including, in 2003, the major markets of the US and Japan. Baxter is currently
negotiating the reimbursement price for Extraneal with the US authorities. The
Directors believe successful negotiation will result in a significant increase
in sales from the US market. ML Laboratories receives a royalty income from
sales of Extraneal (although royalties for European sales will cease in the
second half of 2006). In the unaudited results for the six months to 31 March
2005, the Group`s income from this source amounted to £1.3 million.
Adept(R)
ML Laboratories has also developed Adept, a solution used during surgery to
prevent post-surgical adhesions. Adhesions are a serious and frequent
complication following gynaecological and other abdominal surgery and are
acknowledged as a major surgical problem. Adhesions are expensive to treat,
often requiring further treatment and hospitalisation.
In October 2001, ML Laboratories granted Shire Pharmaceuticals plc (`Shire`)
pan-European marketing rights to Adept, and Shire subsequently launched the
product in 19 countries. Under the terms of this agreement, ML Laboratories
received an access fee and may receive a further milestone payment. ML
Laboratories continues to receive royalty payments from Shire in respect of
sales of Adept. Negotiations are underway with Shire for the termination of
these distribution arrangements and the Company is in discussions for potential
alternative licence arrangements in Europe.
In addition, the Company is currently in negotiations with potential licensees
for the distribution and marketing of Adept in the US and Japan.
Adept has recently undergone a Phase III US study and the results of this trial
were announced in December 2004. In May 2005, the Company announced that a Pre
Market Approval including the results from this study was formally accepted for
filing by the FDA.
Intellectual Property
ML Laboratories`s extensive portfolio of patents has been fundamental to its
commercialisation success and provides the Board with confidence in the
Company`s ability to support its commercialised products and, furthermore,
commercialise its research and development programmes. The Group maintains six
patent families in support of its commercialised products Extraneal(R), Adept(R)
and Clickhaler(R) with 95 patent grants and 11 grants pending. In addition,
there are three further patent families, two of which have notices of allowances
in Europe and are pending grant in 11 countries. This will increase the level of
protection for the key products. The Group`s respiratory platform technology
C200 is covered by three patent families, with 57 patent grants and 28 grants
pending. This platform will also receive protection from supporting technology
which is the subject of two additional pending patent families.
The territorial focus for each family of patents reflects the major
pharmaceutical markets of Europe, North America and Japan with increasing
emphasis on China to reflect the growing status of this market. Research and
development programmes and technologies involve a further 12 patent families
with 83 patent grants and 48 grants pending including Europe in the case of five
of these families. In addition, 14 patent families are pending grant, each of
which will involve protection in the major pharmaceutical markets. ML
Laboratories maintains a portfolio of registered trademarks across the UK,
Europe, the US and Japan with a number of pending trademarks for products in
development.
Planned divestments
The corporate review undertaken earlier in 2005 identified assets which would be
divested or partnered to reduce research and development costs. These included
Devacade, a drug for enhancing the pain relief produced by morphine, the gene
therapy products CTL 102 and CTL 901, and the UCOE gene expression technology.
Since the decision was taken to discontinue work on Devacade, the proposed
acquisition of Panos (mentioned in the Company`s last annual report) will no
longer take place. The divestiture of the other non-core programmes is underway.
AlpharenTM
AlpharenTM is a phosphate binder for the treatment of hyperphosphataemia, which
occurs when abnormally high and potentially damaging levels of phosphate are
found in the blood, due to the kidneys being unable to rid the body of excess
phosphate absorbed from food. ML Laboratories is currently engaged in
co-developing this novel compound with Ineos Silicas Healthcare Limited `Ineos`.
A Phase I study has shown the compound to have substantial phosphate binding
activity and to cause a significant reduction in the level of phosphate absorbed
from the diet in healthy volunteers. A Phase IIa study is presently underway,
with plans in place for a Phase IIb study.
Discussions with Ineos continue regarding the options for further development
and the commercialisation of the product which, as it is not a core product of
the Group, may include returning some or all of the rights to the product to
Ineos.
Paul Capital financing arrangements
In 2001 and 2002, the Company entered into royalty sharing arrangements with
Paul Capital under which Paul Capital provided funding totalling £22.5 million
in return for which it receives a share of the revenues earned by the Group from
the commercialisation of Extraneal and Adept in the period from commencement of
these arrangements up to 30 September 2010.
Under the operation of this royalty sharing arrangement, monies receivable from
licensees of these products are paid into a `Lock-Box` bank account, out of
which Paul Capital and the Company are paid their respective shares of revenue
by the Lock-Box bank.
In the case of Extraneal, Paul Capital`s entitlement to a share in revenues is
calculated as a percentage of royalties received in respect of that product into
the Lock-Box account. In the case of Adept, Paul Capital`s entitlement to a
share in revenues is calculated as a percentage of total licensee sales of that
product, and this percentage is subject to a ratchet by reference to the extent
to which such sales fall short of the projections made at the time the agreement
was entered into in 2001. The effect of this is that amounts due to Paul Capital
in respect of Adept may exceed royalty payments made by licensees into the
Lock-Box. Any such shortfalls are recoverable by Paul Capital by way of an
increase in its share of the Extraneal royalties paid into the Lock-Box account.
Milestone receipts payable in respect of Extraneal and Adept are paid into a
separate Lock-Box account and can be applied against any outstanding shortfalls
in the payment of Paul Capital`s interest in royalties for the time being.
However, Paul Capital is not otherwise entitled to participate in milestone
receipts.
In respect of the period from 1 October 2001 up to 31 December 2004, the amounts
received into the Lock-Box account in respect of Extraneal and Adept (excluding
milestone payments which have subsequently been received by the Company) have
been shared as to 62 per cent by Paul Capital and as to 38 per cent by the
Company. Taking into account milestone payments, aggregate amounts received
during that period have been shared as to approximately 46 per cent by Paul
Capital and as to approximately 54 per cent by the Company. The proportion of
future revenue sharing is dependent on the level of sales of Adept and the rates
of royalties negotiated with licencees.
In terms of the Company`s accounting treatment of these arrangements, over the
period from commencement of these arrangements up to the financial year ended 30
September 2004, the Company has accounted in full for the £22.5 million received
from Paul Capital in its profit and loss account as other operating income. The
Company includes as turnover within its profit and loss account only its net
share of the royalties received by it from the Lock-Box account. The Company
anticipates continuing to adopt this accounting treatment until the arrangements
come to an end on 30 September 2010.
Directors
Mr Ian Kent (Executive Chairman)
Ian Kent, aged 61, joined ML Laboratories as Executive Chairman in March 2005.
He brings significant experience in the life sciences sector having acted as
chairman and non-executive director of a number of successful public and private
companies. He is currently chairman of three venture capital backed biotech
companies, Argenta Discovery Limited, Intercytex Limited and Piramed Limited. He
is also chairman of LGC, a buy out from the Department of Trade and Industry in
1996 and now the leading analytical science company in the UK. He was founder
and chairman of Ardana Biosciences Limited and is now a non-executive director
of that company. He was founder and chairman of Imutran which was sold to
Novartis in 1997. His previous non-executive appointments include Vernalis plc,
Biofocus plc, Adprotech Limited and Roslin Biomed Limited.
Mr Kieran Murphy, MSc (Chief Executive Officer)
Kieran Murphy, aged 42, joined ML Laboratories as Chief Executive in March 2005
with over 15 years` experience within the life sciences sector. He was
previously chief executive of Adprotech Limited, a privately owned UK biotech
company which was acquired by Inflazyme Pharmaceuticals, Inc. in 2004. Prior to
Adprotech he was chief executive officer of Novartis Animal Vaccines where he
led a merger and acquisitions strategy to build a food animal vaccines business.
He was previously chief executive of Vericore Holdings Limited which he
restructured and sold to Novartis AG in 2000. Before Vericore, he spent six
years at Mallinckrodt where he held a variety of senior management positions and
latterly served as managing director for the UK and Ireland businesses. He
started his career in the sector working in sales and marketing positions at
Janssen UK.
Mr Paul Ballington, BSc (Director of Marketing and Business Development and
Managing Director of Innovata Biomed)
Paul Ballington, aged 50, became a member of the Board on 29 June 2004. He
joined the Group in 1994 from Abbott Laboratories where he held divisional
management and business development roles. Prior to that he has worked in a
commercial capacity for Baxter Healthcare and Schering Ag. Mr Ballington is also
managing director of Innovata Biomed.
Mr Peter Shennan, BA, FCA, MSI (Finance Director)
Peter Shennan, aged 54, became Finance Director on 30 November 1997. He
qualified as a Chartered Accountant in 1977 and is a Member of the Securities
Institute. He joined the Group in June 1997 from Coopers and Lybrand.
Dr Susan Foden, MA, DPhil (Non-executive Director)
Dr Susan Foden, aged 52, joined the Board on 16 May 2005. She holds a number of
non-executive directorships with both public and private companies and public
funding bodies in the biotech and healthcare field. Prior to this Dr Foden held
positions in venture capitalism, technology transfer and UK biotech. From 2000
to 2003, she was an Investor Director with the London-based venture capitalist
firm Merlin Biosciences Limited. From 1987 to 2000 she was chief executive
officer of the technology transfer company, Cancer Research Campaign Technology
Limited, and from 1998 to 2000 also of Cancer Research Ventures. From 1983 to
1987 Dr Foden headed up the academic liaison function at what was then Celltech
Limited, dealing with some of the earliest tech transfer deals in the UK and the
precedents that these set. She studied biochemistry at the University of Oxford
from where she obtained her MA and DPhil degrees.
Dr John Fromson, BSc, PhD (Non-executive Director)
John Fromson, aged 63, joined the Board on 16 May 2005 as a non-executive
director and has 18 years experience in multinational pharmaceutical companies
and was directly involved in the development of three major products. He was
formerly Executive Chairman of Ultrafine Limited which he substantially
restructured and sold to Sigma-Aldrich, Inc. in 2004. He was formerly Chief
Scientific Officer at DevCo Limited and Vice President Pre-Clinical Development
at Vanguard Medica. He has drug development experience from Hoechs
Pharmaceuticals where he worked for 13 years in increasingly senior roles. He
now runs a healthcare consultancy focusing on due diligence and strategic
planning for venture capital and technology transfer companies.
Mr Fred Hallsworth, BAcc, CA (Non-executive Director)
Fred Hallsworth, aged 52, joined the Board on 6 April 2005 and was Senior Client
Service Partner at Deloitte from 2002 until the end of January 2005. Prior to
this, Mr Hallsworth spent 25 years with Andersen where he held a number of
senior management positions, including Managing Partner of the Cambridge office,
and latterly Managing Partner of Scotland. His recent life sciences experience
includes working with Inveresk Research Group Inc on the 1999 management buyout,
the 2001 acquisition of Clintrials Research Inc., the IPO on NASDAQ in 2002, and
the $3.5 billion merger with Charles River Laboratories, Inc in 2004. Mr
Hallsworth is a Non-Executive Director of Scottish Enterprise and has held a
number of other Board positions, including at CBI Scotland, Scottish Institute
for Enterprise and the University of Cambridge Finance Committee.
Proposed Directors
Mr Rajan Uppal, ACA (Non-Executive Director)
Rajan Uppal, aged 42, is a Chartered Accountant with significant corporate
finance and business development experience. After qualifying as a Chartered
Accountant, Mr Uppal joined Price Waterhouse based in the London office before
his first move into industry in 1989 as the CFO of a European printing and
packaging group, Ferry Pickering Group plc, which was quoted on the London Stock
Exchange. Following the successful disposal of this group, Mr Uppal joined the
board of QHL in 1996 which at the time was a small venture capital backed drug
delivery company based in Cambridge. Mr Uppal`s responsibilities as CFO of QHL
included finance, commercial and intellectual property and he was instrumental
in a number of significant commercial transactions and the flotation of QHL on
the official list of the London Stock Exchange prior to its eventual sale to
Elan in 2000. Following the acquisition by Elan, Mr Uppal joined Elan`s Drug
Delivery Division as senior vice president where he carried out a number of
commercial roles prior to leading the management buy out of the Quadrant
business. Mr Uppal is also a non-executive director of Oxford Biomedica plc, a
biopharmaceutical company listed on the London Stock Exchange specialising in
the development of novel gene-based therapeutics.
Dr Colin Dalton, BTech(Hons), PhD (Executive Director)
Dr Colin Dalton, aged 55, was Director of Business Development for five years at
GSK Biologicals, the worldwide vaccine leader, prior to re-joining Quadrant in
January 2005. He managed a group responsible for licensing of new products and
technologies, collaborations and alliances. Previous jobs were in business
development at Quadrant Healthcare, British Sugar plc, a senior consultant in
the Biotechnology Practice of PA Consulting and fermentation scientist at BP Co.
Ltd. He trained as an applied biologist at Brunel University and obtained his
PhD at Leicester University. His technological background is combined with
fifteen years experience in deal making both in large pharma and biotech
companies. He previously spent five years with Quadrant from 1994 to 1999.
Dr Terence Chadwick, BSc, MB, ChB, MRCP, MFPM (Executive Director)
Dr Terence Chadwick, aged 54, is currently Senior Vice President for Research
and Development in Quadrant. He was previously vice president of Elan,
responsible for Research and Development in Elan Drug Delivery-UK, prior to
taking part in the management buy out which led to the formation of Quadrant in
July 2003. He trained as a physician in the UK, obtained honours degrees in
Medical Microbiology and Medicine and is a Member of the Royal College of
Physicians and the Faculty of Pharmaceutical Medicine. Dr Chadwick worked in
hospital-based internal medicine and endocrinology for 7 years before joining
the pharmaceutical industry. He has over 23 years experience in the
pharmaceutical and biotechnology sector and has held senior international posts
in research and development in Novo Nordisk (UK and Copenhagen), Fisons plc and
Rhone-Poulenc Rorer (Paris and Philadelphia). He joined Quadrant Healthcare in
1998 as a main board director with responsibility for Research and Development.
Dr Chadwick has extensive experience of developing products in a variety of
therapeutic areas including diabetes, endocrinology, respiratory, CVS, CNS and
allergy.
Option Proposals
On their appointment to the Board in March 2005, Ian Kent and Kieran Murphy were
granted options under the Company`s 1999 Executive Share Option Scheme over 1
million and 2 million Ordinary Shares respectively. These options are
exercisable three years after grant and only if the performance criteria set out
in the rules of the scheme (which are described in the Prospectus) are achieved.
The remuneration committee of the Board has been considering the level of
incentivisation for these key executives and has concluded that additional
appropriate incentives are required to reflect the challenges that they face
within the Enlarged Group. It is proposed, therefore, that additional options
are granted to Ian Kent over 1 mi
Aktie reagiert positiv darauf.
M.L. Laboratories PLC
16 June 2005
ML Laboratories PLC
Proposed Acquisition of Quadrant Technologies Ltd
Proposed Vendor Placing
Proposed Placing and Open Offer to raise approximately £26 million
Proposed Acquisition of outstanding minority of Innovata Biomed Ltd
Proposed name change to Innovata plc
St Albans, UK, 16 June 2005 - ML Laboratories PLC (LSE: MLB) (`ML`, `ML
Laboratories` or the `Company`) is pleased to announce the proposed acquisition
of Quadrant Technologies Ltd (`Quadrant`) for a total consideration of
approximately £46.7 million (`the Acquisition`). In conjunction with the
Acquisition, the Company plans to raise approximately £26 million in a Vendor
Placing and a Placing and Open Offer which has been underwritten by Code
Securities.
The Company also announces the acquisition of the outstanding minority of
Innovata Biomed, its respiratory subsidiary, for a consideration of £1.85
million in cash and ML shares.
On the basis of these transactions, the `ML Laboratories` name no longer
reflects the business of the Group and the Board of ML proposes that the name be
changed to Innovata plc.
The Acquisitions, Vendor Placing, Placing and Open Offer and change of name to
Innovata plc are all subject to the approval of ML Shareholders. A circular
containing further information is being posted to shareholders today.
Reasons for the Quadrant Acquisition
• The Directors are of the opinion that Quadrant represents an excellent
strategic fit for the newly re-focused ML business. With Quadrant`s strength and
experience in pulmonary delivery, the Enlarged Group will have a full complement
of capabilities to tackle new products for respiratory disease and inhaled
therapeutics.
• The Quadrant Group is profitable with a royalty stream from a licence
with Baxter Inc. and income generated from other pharmaceutical company
collaborations. This will add to the Company`s financial stability.
• Quadrant`s scientific staff and laboratory facilities will provide the
Enlarged Group with the ability to take control of formulation development and
will also provide synergies through savings in infrastructure.
• The integration of the Quadrant management team into ML will provide
greater strength in R&D and licensing.
• Quadrant`s unit dose disposable and unit dose reusable devices will
broaden the device options the Enlarged Group will be able to offer its clients.
Key Acquisition Terms of the Quadrant Acquisition
Key terms of the Quadrant Acquisition are as follows:
• 50:50 acquisition valuing Quadrant at £46.7 million (based on a
closing share price of 20.625 pence) comprising cash consideration of
approximately £19.5 million with the remainder in shares.
• Vendors are subject to a 12 month lock-in in respect of their ML
shares
Details of Vendor Placing and Placing and Open Offer
• Vendor Placing and Placing and Open Offer of 137,499,998 new Ordinary
Shares at the Issue Price of 19p to raise approximately £24 million (net of
expenses)
• Proceeds to be used to fund the cash consideration of the Acquisitions
and to provide additional working capital for the Enlarged Group
• Qualifying Shareholders can apply for Placing and Open Offer Shares on
the basis of 1 Placing and Open Offer Share for every 5 existing Ordinary Shares
held
• Placing and Open Offer Shares have been conditionally placed with
institutional investors subject to Qualifying Shareholders` rights to take up
their entitlements under the Open Offer
• Vendor Placing Shares have been placed firm with institutional
shareholders by Code Securities
• Vendor Placing and Placing and Open Offer have been underwritten by
Code Securities
Key Terms of the Innovata Biomed Acquisition
ML intends to acquire the outstanding 18.75 per cent minority of Innovata Biomed
that it does not already own for a consideration of £1.85 million in cash and ML
shares from Dr Nick Boyes, one of the former directors of the Company. The
acquisition of this minority stake will allow the Company to have full control
of Innovata Biomed, which will become a wholly-owned subsidiary of the Company.
Interim results for ML for the six months to 31 March 2005 were also announced
today (see separate release).
Commenting on today`s announcement, Kieran Murphy, Chief Executive Officer of
ML, said:
`The acquisition of Quadrant is a transforming transaction for ML with a
compelling strategic logic. We believe that the combination of the two companies
will enable us to participate in the significant upside potential of the fast
growing market for inhaled therapies and respiratory disease. By combining the
complementary skills and expertise of the two companies and building on the
pharmaceutical collaborations already in place, we will create a powerful,
integrated offering capable of delivering high quality revenue streams, early
profitability and substantial growth potential.`
Contacts:
ML Laboratories plc Tel: 01727 837 341
Kieran Murphy, Chief Executive Officer
Code Securities Tel: 020 7024 2000
Juliet Thompson / Richard Potts
Financial Dynamics Tel: 020 7831 3113
David Yates / Julia Phillips
Code Securities Limited, which is regulated in the United Kingdom by the
Financial Services Authority, is acting exclusively for ML Laboratories PLC as
sponsor, placing agent and underwriter in relation to the Vendor Placing, the
Placing and Open Offer, the Quadrant Acquisition and the Innovata Acquisition.
Code Securities Limited is not acting for, and will not be responsible to any
person other than ML Laboratories plc for providing the protections afforded to
customers of Code Securities Limited or for advising any other person on the
contents of this document or any transaction or arrangement referred to herein.
ML Laboratories PLC
Proposed acquisition of Quadrant
Proposed Vendor Placing
Proposed Placing and Open Offer
Proposed acquisition of the minority interest in Innovata Biomed
Proposed grant of options and proposed change of name
Introduction
The Board of ML Laboratories announces that it has agreed terms for the proposed
acquisition of Quadrant Technologies Limited. ML Laboratories has today entered
into a conditional agreement pursuant to which it will acquire the entire issued
share capital of Quadrant for an aggregate consideration of £46.7 million, to be
satisfied as to £27.2 million by the issue of 131,932,394 new Ordinary Shares at
an issue price of 20.625 pence per new Ordinary Share (being the Closing Price
on 15 June 2005, the date on which the Quadrant Acquisition Agreement was
entered into) as to £19.5 million in cash to be funded out of the proceeds of
the Vendor Placing and Placing and Open Offer. The Quadrant Acquisition
constitutes a class 1 transaction for the purposes of the Listing Rules and, as
such, requires the prior approval of Shareholders.
Quadrant is a privately owned company based near Nottingham. It provides
specialist drug formulation and stabilisation technologies to the pharmaceutical
and biotechnology industries with particular emphasis on dry powder drug
delivery to the lungs.
The Board also announces the proposed acquisition of the outstanding minority
interest in Innovata Biomed currently owned by Dr R.N. Boyes, a former director
of the Company. This interest, representing approximately 18.75 per cent of the
issued share capital of Innovata Biomed, is to be acquired for an aggregate
consideration of £1.85 million payable as to £925,000 by the allotment of the
Innovata Consideration Shares at an issue price of 20.625 pence per new Ordinary
Share (being the Closing Price on 15 June 2005, the date on which the Innovata
Acquisition Agreement was entered into) and as to the balance of £925,000 in
cash. The Innovata Acquisition constitutes a related party transaction for the
purposes of the Listing Rules and, as such, requires the prior approval of
Shareholders.
The Board also announces that the Company is intending to raise approximately
£23.7 million (net of expenses) by way of a Vendor Placing of 91,758,315 new
Ordinary Shares and a Placing and Open Offer of 45,741,683 new Ordinary Shares,
each at the Issue Price of 19 pence. The net proceeds of the Vendor Placing will
be paid to the Vendors pursuant to the Quadrant Acquisition Agreement and the
net proceeds of the Placing and Open Offer will be used to fund the remaining
cash consideration of £2.1 million payable to the Vendors pursuant to the
Quadrant Acquisition Agreement, to fund the cash consideration of £925,000
payable under the Innovata Acquisition and to provide the Company with £2.9
million of additional working capital (net of expenses). Qualifying Shareholders
can apply for Placing and Open Offer Shares on the basis of 1 Placing and Open
Offer Share for every 5 Existing Ordinary Shares held. The Vendor Placing Shares
have been conditionally placed by Code Securities on behalf of the Vendors with
institutional investors and are not subject to the Open Offer. The Placing and
Open Offer Shares have been conditionally placed with institutional investors
subject to Qualifying Shareholders` right to take up their entitlements under
the Open Offer. The Placing and Open Offer has been underwritten by Code
Securities.
The Board also announces the proposed change of the Company`s name to Innovata
plc and proposals to grant options to the Company`s Executive Chairman and Chief
Executive Officer.
The Company today released its interim results for the six months ended 31 March
2005. (See separate announcement).
Each of the Acquisitions, the Vendor Placing, the Placing and Open Offer, the
Option Proposals and the proposed change of name is conditional, inter alia, on
the passing by Shareholders of the relevant requisite resolutions at an
Extraordinary General Meeting of the Company being convened for 10.00 a.m. on 14
July 2005.
Recent developments and strategic review
ML Laboratories has in recent years focused on the development and
commercialisation of its portfolio of pharmaceutical products through its core
competences: the design and project management of product development
programmes, regulatory affairs, product licensing and product management.
In March 2004, the Company raised £14.37 million to facilitate further progress
with the development and commercialisation of its product range. The Group`s
progress since then has included:
• the publication of preliminary results of a Phase III clinical study
in the US of the Company`s surgically-induced adhesion prevention therapy (Adept
(R)), together with the formal acceptance for filing by the FDA of the
Pre-Market Approval for this product;
• the conclusion of a licensing agreement with a leading European
pharmaceutical company, specialising in generic products, for the development of
a respiratory treatment using Innovata Biomed`s C200 inhaler;
• the grant of marketing approvals for the use of the Clickhaler(R)
device with budesonide and formoterol in a first European market;
• the filing and subsequent approval of the Company`s Clickhaler(R)
device containing procaterol in Japan which was achieved in conjunction with the
Company`s Japanese licensee, Otsuka Pharmaceutical Co. Ltd, and triggered a
further milestone payment to the Company;
• the grant of a core European patent and a first US patent for the C200
inhaler; and
• the conclusion of an exclusive agreement with a Japanese
pharmaceutical company for the marketing rights to the budesonide Clickhaler(R).
On 3 March 2005, in response to shareholder concerns, Ian Kent and Kieran Murphy
joined the Company as Executive Chairman and Chief Executive Officer
respectively and replaced the Company`s then Executive Chairman, Stuart Sim.
Following these appointments a review of the strategy and operations of the
business was undertaken. Further board changes have been made, including the
appointment of three new non-executive directors with extensive experience in
the sectors in which the Group operates.
The Company announced the results of its strategic review on 25 April 2005 and
set out a restructuring plan to consolidate the Group`s existing operations into
the current headquarters of its respiratory business, Innovata Biomed, in St
Albans, Hertfordshire to reduce costs and improve efficiency.
The new management`s strategy is to place greater focus on the Group`s
revenue-generating respiratory business, building on the collaborations already
in place to exploit the large and growing market for pulmonary drug delivery
products. The Board has identified the acquisition of Quadrant, with its focus
on pulmonary drug delivery, as a significant step in implementing this strategy.
Quadrant`s business, as further described below, brings revenue streams,
complementary scientific expertise, intellectual property, collaborative
partnerships, management experience and facilities.
Additionally, as the Group`s respiratory business is conducted through Innovata
Biomed, the Board considers it to be an important element of its corporate
strategy to acquire the outstanding shares in Innovata Biomed not already owned
by the Company. The Company is therefore proposing to acquire this minority
interest pursuant to the Innovata Acquisition Agreement and further details on
this acquisition are set out below.
The Enlarged Group will be a product development business with formulation,
stabilisation and device technologies, with a supporting intellectual property
portfolio and a skilled set of employees focused on the efficient delivery of
new and existing therapies, both singly and in combination, to and via the lung.
It is planned that, following completion of the Acquisitions, all of the
Enlarged Group`s activities will be based at the current Quadrant facilities in
Ruddington, near Nottingham. It is also proposed that, given the greater
emphasis now being placed on inhaled therapies the Company`s name be changed to
Innovata plc.
On completion of the Quadrant Acquisition, it is proposed that Terence Chadwick
and Colin Dalton will join the Board as executive directors and Rajan Uppal will
join the Board as a non-executive director. Ian Kent will continue as Executive
Chairman of the Board, although, as contemplated by his service contract, it is
anticipated that he will move to a non-executive capacity before 31 December
2005. Paul Ballington will stand down as an executive Director of the Company
but will continue as an important executive officer of the Group.
The inhaled therapies market
The majority of treatments for asthma and COPD are delivered by inhalation, with
many patients taking more than one type of therapy. In 2003, the asthma market
was valued at $11.5 billion, of which 78 per cent was inhaled, and, the COPD
market was valued at $2.3 billion, of which 86 per cent was inhaled. These
markets are forecast to grow rapidly achieving sales in 2010 of $20.9 billion
for asthma, of which 79 per cent would be inhaled, and $7.4 billion for COPD, of
which 82 per cent would be inhaled. The inhaled drug market is categorised by
ING Financial Markets as being large (collectively worth $13.8 billion in 2003)
and is growing quickly, and expected to double by 2010. Driving this growth are
two main trends: the use of fixed combination therapies and the treatment of
COPD.
Inhaled fixed combination asthma therapy is the use of two drugs in a fixed dose
combination in one inhaler. The two major operators in this market have
combinations of long acting beta agonists together with corticosteroids, which
have been well received by patients and prescribers. GlaxoSmithKline`s Seretide
(Advair in the USA) (one such combination for the treatment of asthma) is now
the 7th biggest selling pharmaceutical product worldwide, with sales of $4.7
billion in 2004, growing at 22.5 per cent per annum. Fixed combination therapy
is forecast to be integral to both the asthma and COPD sectors.
Unlike asthma, for which the treatment options are extremely effective, COPD
responds relatively poorly to the same medications. Therefore the COPD market is
historically less well developed. Recently introduced treatments for COPD, such
as Boehringer Ingelheim`s Spiriva, have invigorated this sector and are driving
the growth forecasts. Fixed combination treatments are also being increasingly
used in the treatment of COPD.
Within both the asthma and COPD sectors the choice of inhaler has also been
changing. Dry powder inhaler products are now achieving sales values in excess
of pressurized meter dose inhalers.
Over recent years, the delivery of medicines via the inhalation route has
evolved to include a variety of new approaches and disease states. Nebulised
solutions of Roche`s dornase-alpha (Pulmozyme(R)), used to reduce the viscosity
of mucus and Chiron`s tobramycin (TOBI(R)), an inhaled antibiotic used to treat
chest infections with pseudomonas aeruginosa, both indicated for use in cystic
fibrosis, have entered the market.
During the last decade, several companies, including Quadrant, have focused on
developing products capable of delivering medicines into the blood stream via
the inhalation route in order to over come the need for needle based injections
or to shorten the time to onset of effect. One such product, Exubera, an inhaled
insulin used to treat diabetes mellitus, has been filed for marketing approval
in both Europe and the USA during 2004 and 2005 respectively and others are in
development.
The Board believes these new approaches offer a market opportunity for
inhalation product development outside the traditional areas of Asthma and COPD
and that the Company will be well placed to exploit these potentially lucrative
opportunities.
Information on Quadrant
Background
The Quadrant Group is a profitable business primarily focused on pulmonary drug
delivery. It provides specialist drug formulation and stabilisation technologies
to the pharmaceutical and biotechnology industries with a particular emphasis on
dry powder formulations for drug delivery to and via the lungs. The Quadrant
Group has existing collaborations and licensing agreements for its various
technologies with a number of leading pharmaceutical companies, such as the
Bristol-Myers Squibb Company, Baxter and GlaxoSmithKline.
The Quadrant Group is based in a modern 30,000 sq. ft. laboratory and office
facility near Nottingham and has recently made substantial investments in its
laboratories to ensure it and its collaborators benefit from the latest
equipment and techniques.
Quadrant has a total of 35 employees including a scientific team with
considerable experience in the development of dry powder formulations suitable
for administration to the respiratory tract.
Technologies
Pulmonary formulation
Quadrant is able to produce dry powder formulations either by utilising its
spray drying techniques or conventional particle size reduction methodologies.
In addition, Quadrant has proprietary technologies which give the drug
formulations attractive attributes such as improved stability and controlled and
sustained release.
Quadrant`s proprietary stabilisation technologies, which have been applied to a
wide range of peptides and proteins, involve formulating a drug with polyols,
particularly the naturally occurring disaccharide sugar, trehalose. Controlled
and sustained release is achieved using either sugar derivatives or hyaluronic
acid.
Dry powder inhaler
Quadrant is developing a dry powder inhaler (the S2 bead inhaler (`S2`)) aimed
at the highly efficient delivery of drug formulations to the lung. The S2 is
designed to be easy to use whilst at the same time being inexpensive to produce.
It is based on innovative powder dispersion technology, which should ensure high
efficiency drug delivery to the lungs. Key advantages of this system include the
capacity to deliver a wide range of drugs, the capability to deliver high
concentration drug formulations and highly efficient powder dispersion with low
patient inspiratory effort. It also delivers a relatively consistent dose of
drug, independent of inspiratory flow rate, unlike most other passive inhalers
(being those with no external power source such as a battery or compressed air).
The S2 for multidose applications is licensed exclusively to Valois SAS whilst
disposable or reusable unit dose rights remain with Quadrant.
Other applications of Quadrant`s technologies
Quadrant`s ability to stabilise molecules (including peptides and proteins) and
its ability to alter the kinetics of release in a solid delivery format can be
applied to other non-pulmonary routes of delivery and is used in diagnostic
products.
Collaborations and licensees
Quadrant has entered into collaborations with and has licensed its technology
(both pulmonary and non-pulmonary) to a number of major healthcare and
pharmaceutical companies. Examples of such arrangements include:
Pulmonary
Bristol-Myers Squibb Company
In November 1999, Quadrant established a joint venture with MicroDose
Technologies Inc. (`MicroDose`) to combine Quadrant`s formulation and particle
engineering technologies with MicroDose`s dry powder inhaler and filling
capabilities. This joint venture was established by the incorporation of QDose
Limited (`QDose`) which is owned in equal shares by Quadrant and MicroDose and
has focused on the development of a rapid acting inhaled insulin product. In
September 2003, QDose entered into a licence, collaboration and development
agreement with Bristol-Myers Squibb Company (`BMS`) in respect of its rapid
acting inhaled insulin product. The terms of this agreement provide for BMS to
have exclusive worldwide rights to the QDose product and for BMS to take on the
lead role in developing, manufacturing and commercialising it. QDose received an
initial licence fee of $1 million and could receive up to $29 million in
milestone payments dependent on the achievement of certain development and
regulatory events. QDose is also entitled to a royalty on product sales.
Valois SAS
During 2003, Valois SAS, a company specialising in the design and manufacture of
nasal and pulmonary drug delivery devices, acquired from Quadrant certain
intellectual property rights and equipment related to the S2 multidose device.
Quadrant is continuing to support the development of this device through the
provision of its expertise in dry powder formulations and device testing.
Innovata Biomed
In 2003, Quadrant began working with Innovata Biomed providing pharmaceutical
support to the development of Innovata Biomed`s platform technologies and
formulation development services for two drugs.
CoTherix, Inc.
During March 2005, Quadrant entered into a collaborative research and
development agreement with CoTherix, Inc. (`CoTherix`) to develop an
extended-release formulation of CoTherix`s product, Ventavis(R) (iloprost)
Inhalation Solution. The goal of this initiative is to reduce the frequency and
duration of dosing of iloprost by incorporating the active molecule in one of
Quadrant`s drug delivery matrices and delivering it in a convenient dry powder
format.
Non-pulmonary
Outside its activities in pulmonary drug delivery, Quadrant has licensed
technologies to a number of major healthcare and pharmaceutical companies.
Baxter
The most significant by value of these is in respect of a licence granted to
Baxter during 2000, whereby Baxter has been granted both exclusive and
non-exclusive worldwide rights to use certain Quadrant stabilisation patents
relating to Factor VIII, used in the treatment of haemophilia A. This technology
has been utilised in Baxter`s product Advate, which was granted FDA approval in
August 2003 and is now also approved in the EU, Switzerland and Australia.
Quadrant currently receives a royalty stream based upon sales of Advate, which
in 2004 generated income of £2.8 million. Baxter has estimated worldwide sales
of Advate to be in excess of $500 million for 2005.
GlaxoSmithKline plc
Quadrant has also entered into a broad-based licence for non-invasive vaccine
delivery with GlaxoSmithKline plc. Quadrant is entitled to receive significant
payments dependent on development and regulatory milestones and on a royalty on
product sales.
Other licence agreements
Additional licence agreements include those entered into with Avant
Immunotherapeutics, Inc., BD Diagnostics, Inc., Roche Diagnostics and the
Hayashibara Group.
Intellectual Property
Patents
The Quadrant Group protects its intellectual property rights with a substantial
patent portfolio of more than 60 patent families containing over 400 granted
cases globally, with patents in the key territories of the US, Japan and the
main EU member states. In the US, the Quadrant Group has over 50 issued patents.
A number of licences have been granted for worldwide rights to certain patents
of the Quadrant Group; the main licensees are Baxter, Bristol-Myers Squibb
Company and GlaxoSmithKline. These licences are for multiple patent families,
which include granted patents in the US and main EU member states.
The Quadrant Group has a large patent portfolio covering several technologies
that may present freedom to operate issues for unlicensed third parties. Ten
granted patents of the Quadrant Group are being opposed in the European Patent
Office (`EPO`). The opponents are Aventis Pharma Deutschland GmbH, Boehringer
Ingelheim Pharma GmbH & Co, Chiron Corporation, Advanced Inhalation Research,
Inc., (an affiliate of Alkermes, Inc.), Bracco Research S.A., Nektar
Therapeutics (`Nektar`) and Anhydro Limited. PowderMed Limited and the National
Blood Authority are now licensed under certain Quadrant patents and have
withdrawn their oppositions.
Nektar is involved in three of the patent oppositions referred to above. In
addition, a patent application of Nektar and a patent of the Quadrant Group are
involved in interference proceedings in the United States Patent and Trademark
Office. The Quadrant Group is aware that Nektar has licensed its inhaled insulin
product to Pfizer, Inc. and that marketing authorisations have been applied for
in both the EU and the US.
Third Party Rights
The Quadrant Group is opposing two patents of Nektar in the EPO, which are
entitled `Methods and compositions for pulmonary delivery of insulin` and `
Stable glassy state powder formulations`. The other opponents of the first
patent are Eli Lilly and Co, Vectura Limited and Advanced Inhalation Research,
Inc. The second patent has also been opposed by Advanced Inhalation Research,
Inc. The Quadrant Group has been advised that there is a good chance of
achieving revocation or a significant limitation of the claims of these patents.
Financial information on Quadrant
The audited results of Quadrant for the year ended 31 December 2002, the
financial period ended 10 July 2003, the financial period ended 31 December 2003
and the year ended 31 December 2004 will be set out in the accountants` report
in Part III of the Prospectus. Quadrant had consolidated net assets as at 31
December 2004 of £4.48 million. A summary of the trading results for Quadrant as
extracted from the accountants` report to be set out in Part III of the
Prospectus is set out below.
12 months 1 January 11 July 12 months
ended 2003 to 2003 to ended
31 December 10 July 31 December 31 December
2002 2003 2003 2004
£`000 £`000 £`000 £`000
Turnover 4,583 1,417 3,457 5,662
_____ _____ _____ _____
Earnings before interest, tax, depreciation, (1,493) (1206) 2,671 2,030
amortisation and exceptional items
Depreciation and impairment of fixed assets (794) (216) (58) (193)
Amortisation of goodwill (4,564) - (268) (706)
Exceptional (charges)/credits (net) (36,513) (1859) - -
Net interest and similar items 526 2415 184 203
_____ _____ _____ _____
(Loss)/profit on ordinary activities before (42,838) (1136) 2,529 1,334
taxation
_____ _____ _____ _____
The results for the year ended 31 December 2002 and for the period 1 January
2003 to 10 July 2003 relate to the period during which the Quadrant business was
owned by Elan. The turnover for the year ended 31 December 2002 includes an
amount of £2.5 million (10 July 2003: £0.5 million) relating to turnover charged
to other Elan companies mainly in connection with the development of the S2
device which was owned by Elan during this period. The results for these periods
includes a number of exceptional items and in particular there was an
exceptional charge of £36.5 million in respect of the impairment of goodwill for
the year ended 31 December 2002.
The results for the period 11 July 2003 to 31 December 2003 and for the year
ended 31 December 2004 represents the activities of Quadrant following the
management buyout from Elan on 10 July 2003. There were no sales to Elan during
this period with turnover in the year ended 31 December 2004 consisting of
licence fees and milestone payments of £0.2 million (2003: £2.0 million),
royalties on product sales of £2.8 million (2003: £0.5 million) and development
fees of £2.7 million (2003: £1.0 million).
Current trading and prospects
During the current financial year the Quadrant Group has continued to be
profitable and in the three months to 31 March 2005 generated revenues,
comprising royalty payments, contract revenues and an option payment.
Principal terms of the Quadrant Acquisition
The consideration for the Quadrant Acquisition is £46.7million, which is to be
satisfied as to £27.2 million by the allotment of the Quadrant Consideration
Shares at the Issue Price of 20.625 pence per share (being the Closing Price on
15 June 2005), and as to the £19.5 million in cash.
The Listing Rules require that the Quadrant Acquisition (being a Class 1
transaction for the purposes of the Listing Rules) be approved by the members of
the Company in general meeting.
The other principal terms of the Quadrant Acquisition are as follows:
• three of the Vendors (Rajan Uppal, Dr Terence Chadwick and Dr Colin
Dalton (together the `Warrantors`)) have provided standard commercial warranties
in relation to the Quadrant Group and a taxation covenant in relation to
Quadrant since the date of its incorporation. The liability of the Warrantors
under warranties, indemnities and the tax covenants is limited to £2 million in
the case of Rajan Uppal, £500,000 in the case of Dr Terence Chadwick and
£100,000 in the case of Dr Colin Dalton;
• Rajan Uppal and Dr Terence Chadwick have entered into non-compete and
non-solicitation covenants to protect the goodwill of the Enlarged Group`s
business for a period of two years following the date of completion of the
Quadrant Acquisition;
• the Vendors have entered into lock-in agreements, pursuant to which
they have agreed not to sell the Quadrant Consideration Shares for a period of
12 months following completion of the Quadrant Acquisition (subject to certain
limited exceptions); and
• the Quadrant Acquisition Agreement is conditional, inter alia, on the
publication and despatch of the Prospectus, the passing of the Resolution
numbered 1 in the notice meeting set out at the end of the Prospectus at the
Extraordinary General Meeting, the Placing Agreement (and, accordingly, the
Vendor Placing and the Placing and Open Offer) having become unconditional (save
for any condition relating to completion of the Quadrant Acquisition Agreement
or Admission) and not having been terminated in accordance with its terms and
the admission of all the New Ordinary Shares (other than Innovata Consideration
Shares) to the Official List and to trading on the London Stock Exchanges Market
for listed securities.
The Innovata Acquisition
One of the Group`s principal subsidiaries, Innovata Biomed, is currently owned
as to approximately 18.75 per cent by Dr R. N. Boyes, one of the former
directors of the Company. On 15 June 2005, the Company entered into the Innovata
Acquisition Agreement pursuant to which the Company has conditionally agreed to
purchase from Dr Boyes his shares in Innovata Biomed. The aggregate
consideration payable under the Innovata Acquisition Agreement is £1.85 million,
to be satisfied as to £925,000 by the allotment of the Innovata Consideration
Shares at an Issue Price of 20.625 pence per share (being the Closing Price on
15 June 2005) and as to the balance of £925,000 in cash.
Pursuant to the terms of the Innovation Acquisition Agreement, Dr Boyes will be
subject to `lock-in` provisions in relation to the Innovata Consideration Shares
to be issued as consideration for the Innovata Acquisition. These provisions
will serve to prevent Dr Boyes from disposing of these shares within 12 months
of their allotment (subject to certain exceptions).
The Listing Rules require that the Innovata Acquisition be approved by the
members of the Company in general meeting. Dr Boyes has irrevocably undertaken
to the Company that he will abstain from voting on such resolution and will take
all reasonable steps to ensure that any associates (as defined by paragraph 11.1
(d) of the Listing Rules) of Dr Boyes similarly abstain.
The Directors believe that the completion of the Innovata Acquisition is in the
best interests of the Company, as it would afford the Company full control over
Innovata Biomed, which would become a wholly-owned subsidiary of the Company.
The Directors are of the opinion that the terms of the Innovata Acquisition
Agreement are fair and reasonable so far as the Shareholders of the Company are
concerned and have been so advised by Code Securities.
Reasons for the Vendor Placing and the Placing and Open Offer
The Vendor Placing will raise £17.4 million and has been arranged so as to
enable the Vendors to realise a greater proportion of the consideration payable
to them under the Quadrant Acquisition in the form of cash.
The Placing and Open Offer will raise up to £8.69 million for the Company (net
of expenses), of which £2.1 million will be used by the Company to fund the
balance of the cash payable to Vendors under the Quadrant Acquisition. A further
£925,000 will be used to fund the cash element of the consideration payable
under the Innovata Acquisition Agreement. The balance of £2.87 million will be
retained by the Company for general working capital purposes to assist in the
general funding of operating expenses.
Upon completion of the Acquisitions, the Vendor Placing and the Placing and Open
Offer the Quadrant Consideration Shares will represent approximately 26.2 per
cent of the Company`s enlarged issued share capital and the Existing Ordinary
Shares will represent approximately 45.5 per cent of the Company`s enlarged
issued share capital. Following issue of all of the New Ordinary Shares to be
allotted pursuant of the Acquisitions, the Vendor Placing and Open Offer,
Qualifying Shareholders who take up their entitlements under the Open Offer will
suffer an immediate dilution of approximately 45.4 per cent in their interests
in the Company and Qualifying Shareholders who do not take up their entitlements
under the Open Offer will suffer an immediate dilution of approximately 54.5 per
cent in their interests in the Company.
Principal terms of the Vendor Placing
Pursuant the Vendor Placing, a total of 91,758,315 New Ordinary Shares will be
placed with institutional investors at the issue price of 19 pence per share,
raising a total of approximately £17.4 million. All of the net proceeds of
Vendor Placing will be paid to the Vendors under the Quadrant Acquisition
Agreement. The Vendor Placing Shares will rank pari passu in all respects with
the Existing Ordinary Shares and the other new Ordinary Shares proposed to be
allotted pursuant to the proposals referred to in the Listing Particulars.
The Vendor Placing Shares are not subject to the Open Offer and all of the
Vendor Placing Shares will be conditionally placed firm with institutional
investors by Code Securities on behalf of the Vendors. The number of Vendor
Placing Shares represents the number of New Ordinary Shares that Code Securities
has advised the Company should be placed firm in order to secure certain
significant new investors in the Company.
Code Securities agreed, pursuant the Placing Agreement, to use reasonable
endeavours to place the Vendor Placing Shares with institutional investors,
subject to the Placing Agreement becoming unconditional in all respects. To the
extent that Code Securities is unable to procure subscribers for the Vendor
Placing Shares, Code Securities has itself agreed to subscribe for such shares,
subject to the Placing Agreement becoming unconditional in all respects.
The Vendor Placing is conditional on, inter alia, (i) Admission taking place not
later than 8.30am on 15 July 2005 or such later time and/or date as the Company,
Code Securities and the Vendors may agree (not being later than 8.30am on 22
July 2005) and (ii) the Placing Agreement becoming unconditional in all respects
and not having been terminated in accordance with its terms prior to Admission.
Principal terms of the Placing and Open Offer
The Placing and Open Offer will raise approximately £6.3 million after expenses.
In order to give Qualifying Shareholders the opportunity to participate in the
issue of the Placing and Open Offer Shares, ML Laboratories has arranged for
Code Securities as its agent to invite applications from Qualifying Shareholders
to acquire Placing and Open Offer Shares at the Issue Price under the Open
Offer. Qualifying Shareholders may apply for Placing and Open Offer Shares on
the basis of:
1 Placing and Open Offer Share for every 5 Existing Ordinary Shares
held at the Record Date and so in proportion for any other number of Existing
Ordinary Shares so held. The Placing and Open Offer Shares will rank pari passu
in all respects with the Existing Ordinary Shares and the other new Ordinary
Shares proposed to be allotted pursuant to the other proposals referred to in
this announcement.
Individual entitlements will be rounded down to the nearest whole number of
Placing and Open Offer Shares. Fractions of Placing and Open Offer Shares that
would otherwise arise will not be allotted.
Code Securities has also agreed to use reasonable endeavours to place the
balance of the Placing and Open Offer Shares with institutional investors,
subject to clawback to satisfy valid applications from the Qualifying
Shareholders under the Open Offer and subject to the Placing Agreement becoming
unconditional in all respects. To the extent that Code Securities is unable to
procure subscribers for the Placing and Open Offer Shares which are not acquired
by Qualifying Shareholders under the Open Offer, Code Securities has agreed
itself to subscribe for such shares, subject to the Placing Agreement becoming
unconditional in all respects.
The Placing and Open Offer is conditional on, inter alia, (i) Admission taking
place not later than 8.30 a.m. on 15 July 2005 or such later time and/or date as
the Company and Code Securities may agree (being not later than 8.30 a.m. on 22
July 2005) and (ii) the Placing Agreement becoming unconditional in all respects
and not having been terminated in accordance with its terms prior to Admission.
Qualifying Shareholders should note that the Open Offer is not a rights issue
and that Placing and Placing and Open Offer Shares not applied for under the
Open Offer will not be sold in the market for the benefit of Qualifying
Shareholders who do not apply under the Open Offer. Entitlements under the Open
Offer are not transferable except to satisfy a bona fide market claim and the
Application Form, not being a document of title, cannot be traded.
Information on ML Laboratories
ML Laboratories currently operates through two divisions, Innovata Biomed and ML
Laboratories which are financed through the Group`s operating income.
ML Laboratories currently has a total of 115 employees although, as announced on
25 April 2005, this is expected to be reduced to approximately 50 (prior to the
acquisition of Quadrant) as part of the implementation of the Group`s new
strategy.
Innovata Biomed
Innovata Biomed is the respiratory division of ML Laboratories. Its core
competency is in the design, formulation, development and industrialisation of
innovative technologies and products for delivering compounds to the lungs.
Innovata Biomed`s business is based around the Clickhaler, a multi-dose
reservoir dry powder inhaler, and the C200, a dry powder inhaler for delivering
two separate drugs to the lungs simultaneously. The C200 provides a novel
solution to fixed combination inhalation therapy.
Clickhaler(R)
The Clickhaler is a proven, industrialised dry powder inhaler, developed by
Innovata Biomed, which has been extensively studied and shown to be highly
acceptable to patients, regulators and potential licensees.
The first two Clickhaler products are Asmasal (salbutamol sulphate) and Asmabec
(beclomethasone dipropionate) which are distributed by Celltech plc (now part of
UCB Pharma) in the UK, France and the Republic of Ireland.
In 2002, ML Laboratories entered into an exclusive licence agreement with a
leading European pharmaceutical company for the rights to market two other
asthma products, budesonide and formoterol fumarate, in the Clickhaler in Europe
and a number of other territories. The terms of this licensing agreement provide
for the payment to Innovata Biomed of up to £10 million in access fees and
milestone receipts (of which £6 million has been received), along with
double-digit royalty payments on subsequent sales.
In March 2005, Innovata Biomed announced that its licensing partner had been
informed that the Clickhaler had received marketing approval in its first
European country for use with budesonide and formoterol. The Directors expect
that it will be launched in that country by the end of 2005. Sales of comparable
budesonide products (such as the Pulmicort Turbohaler) in Europe total £200
million annually, and the Directors estimate that the size of the European
market for comparable formoterol fumarate products (such as the Oxis Turbohaler)
is £100 million annually.
In March 2003, Innovata Biomed granted an exclusive licence to the Clickhaler
device to Otsuka Pharmaceutical Co Ltd of Japan (`Otsuka`) for the delivery of
Otsuka`s asthma treatment, Meptin, in both Japan and Spain.
In March 2005, Innovata Biomed announced that it had been informed by Otsuka
that the Meptin Clickhaler product had been approved in Japan. Innovata Biomed
received a milestone payment and commenced the supply of Clickhaler units to
Otsuka on commercial terms. The Directors anticipate that the Meptin Clickhaler
will be introduced to the market by the end of 2005 at which point a further
milestone payment will be received.
Innovata Biomed signed an exclusive licence agreement in September 2004 with an
undisclosed Japanese pharmaceutical company for marketing rights to Innovata
Biomed`s budesonide Clickhaler. Innovata Biomed received an access fee and will
receive subsequent milestone payments. Innovata Biomed is assisting the Japanese
company in developing the data necessary for regulatory approval in Japan.
Innovata Biomed will supply Clickhaler units to the Japanese company on
commercial terms.
C200
The C200 is Innovata Biomed`s entry into the rapidly growing combination therapy
inhaler market. It is a novel adaptation of the Clickhaler and is being
developed so that in the same device two separate drug reservoirs feed two
separate drug formulations to separate metering chambers from which they are
delivered to the patient in the same breath. The ability to formulate the drugs
separately permits optimisation of each formulation individually, thereby
offering the potential to overcome significant formulation challenges. Recently,
there has been a move by major pharmaceutical companies in the direction of
fixed combination therapy which it is thought offers a more convenient method
for patients to take combined medications.
The principal strength of the C200 lies in offering a device solution which
avoids the need for drugs to be pre-mixed in a complicated formulation whilst
enabling the two drugs to be delivered simultaneously. This is advantageous as
it is simpler to formulate two drugs separately than to formulate two drugs that
are pre-mixed. The C200 therefore offers the Company the opportunity to take
advantage of the growing market for combination therapy.
In June 2004, Innovata Biomed entered into an exclusive agreement with a leading
European pharmaceutical company for the marketing and distribution of a
combination of two established respiratory medicines in the C200 device. This
agreement covers Europe and other named countries, with Innovata Biomed
retaining the rights for all remaining territories, including Japan and the US.
Pursuant to this agreement, Innovata Biomed received an access fee of £1.5
million and is entitled to receive further milestone payments of up to £6.0
million. Further, Innovata Biomed will be entitled to receive royalty income
from sales of the product incorporated in this device (with launch planned for
2008/9) and will receive development fees for conducting the development
programme on behalf of the licensee. In addition, Innovata Biomed will supply
the device to the licensee on commercial terms.
Innovata Biomed announced in February 2005 that it had received the grant in the
US of the first of a series of patent applications in relation to the C200
device following earlier grant in Europe. In addition, a second contract is at
an advanced stage of negotiation.
ML Pharmaceuticals
ML Pharmaceuticals is the division of ML Laboratories which concentrates on the
development and commercialisation of specialist pharmaceutical products. The
most significant of these products are Extraneal and Adept.
Extraneal(R)
In the 1990s, ML Laboratories developed a peritoneal dialysis solution
containing icodextrin. In 1996, the Company entered into an agreement with
Baxter for the licensing of this product which Baxter markets under its trade
name, Extraneal. The product has been launched in over 45 countries worldwide
including, in 2003, the major markets of the US and Japan. Baxter is currently
negotiating the reimbursement price for Extraneal with the US authorities. The
Directors believe successful negotiation will result in a significant increase
in sales from the US market. ML Laboratories receives a royalty income from
sales of Extraneal (although royalties for European sales will cease in the
second half of 2006). In the unaudited results for the six months to 31 March
2005, the Group`s income from this source amounted to £1.3 million.
Adept(R)
ML Laboratories has also developed Adept, a solution used during surgery to
prevent post-surgical adhesions. Adhesions are a serious and frequent
complication following gynaecological and other abdominal surgery and are
acknowledged as a major surgical problem. Adhesions are expensive to treat,
often requiring further treatment and hospitalisation.
In October 2001, ML Laboratories granted Shire Pharmaceuticals plc (`Shire`)
pan-European marketing rights to Adept, and Shire subsequently launched the
product in 19 countries. Under the terms of this agreement, ML Laboratories
received an access fee and may receive a further milestone payment. ML
Laboratories continues to receive royalty payments from Shire in respect of
sales of Adept. Negotiations are underway with Shire for the termination of
these distribution arrangements and the Company is in discussions for potential
alternative licence arrangements in Europe.
In addition, the Company is currently in negotiations with potential licensees
for the distribution and marketing of Adept in the US and Japan.
Adept has recently undergone a Phase III US study and the results of this trial
were announced in December 2004. In May 2005, the Company announced that a Pre
Market Approval including the results from this study was formally accepted for
filing by the FDA.
Intellectual Property
ML Laboratories`s extensive portfolio of patents has been fundamental to its
commercialisation success and provides the Board with confidence in the
Company`s ability to support its commercialised products and, furthermore,
commercialise its research and development programmes. The Group maintains six
patent families in support of its commercialised products Extraneal(R), Adept(R)
and Clickhaler(R) with 95 patent grants and 11 grants pending. In addition,
there are three further patent families, two of which have notices of allowances
in Europe and are pending grant in 11 countries. This will increase the level of
protection for the key products. The Group`s respiratory platform technology
C200 is covered by three patent families, with 57 patent grants and 28 grants
pending. This platform will also receive protection from supporting technology
which is the subject of two additional pending patent families.
The territorial focus for each family of patents reflects the major
pharmaceutical markets of Europe, North America and Japan with increasing
emphasis on China to reflect the growing status of this market. Research and
development programmes and technologies involve a further 12 patent families
with 83 patent grants and 48 grants pending including Europe in the case of five
of these families. In addition, 14 patent families are pending grant, each of
which will involve protection in the major pharmaceutical markets. ML
Laboratories maintains a portfolio of registered trademarks across the UK,
Europe, the US and Japan with a number of pending trademarks for products in
development.
Planned divestments
The corporate review undertaken earlier in 2005 identified assets which would be
divested or partnered to reduce research and development costs. These included
Devacade, a drug for enhancing the pain relief produced by morphine, the gene
therapy products CTL 102 and CTL 901, and the UCOE gene expression technology.
Since the decision was taken to discontinue work on Devacade, the proposed
acquisition of Panos (mentioned in the Company`s last annual report) will no
longer take place. The divestiture of the other non-core programmes is underway.
AlpharenTM
AlpharenTM is a phosphate binder for the treatment of hyperphosphataemia, which
occurs when abnormally high and potentially damaging levels of phosphate are
found in the blood, due to the kidneys being unable to rid the body of excess
phosphate absorbed from food. ML Laboratories is currently engaged in
co-developing this novel compound with Ineos Silicas Healthcare Limited `Ineos`.
A Phase I study has shown the compound to have substantial phosphate binding
activity and to cause a significant reduction in the level of phosphate absorbed
from the diet in healthy volunteers. A Phase IIa study is presently underway,
with plans in place for a Phase IIb study.
Discussions with Ineos continue regarding the options for further development
and the commercialisation of the product which, as it is not a core product of
the Group, may include returning some or all of the rights to the product to
Ineos.
Paul Capital financing arrangements
In 2001 and 2002, the Company entered into royalty sharing arrangements with
Paul Capital under which Paul Capital provided funding totalling £22.5 million
in return for which it receives a share of the revenues earned by the Group from
the commercialisation of Extraneal and Adept in the period from commencement of
these arrangements up to 30 September 2010.
Under the operation of this royalty sharing arrangement, monies receivable from
licensees of these products are paid into a `Lock-Box` bank account, out of
which Paul Capital and the Company are paid their respective shares of revenue
by the Lock-Box bank.
In the case of Extraneal, Paul Capital`s entitlement to a share in revenues is
calculated as a percentage of royalties received in respect of that product into
the Lock-Box account. In the case of Adept, Paul Capital`s entitlement to a
share in revenues is calculated as a percentage of total licensee sales of that
product, and this percentage is subject to a ratchet by reference to the extent
to which such sales fall short of the projections made at the time the agreement
was entered into in 2001. The effect of this is that amounts due to Paul Capital
in respect of Adept may exceed royalty payments made by licensees into the
Lock-Box. Any such shortfalls are recoverable by Paul Capital by way of an
increase in its share of the Extraneal royalties paid into the Lock-Box account.
Milestone receipts payable in respect of Extraneal and Adept are paid into a
separate Lock-Box account and can be applied against any outstanding shortfalls
in the payment of Paul Capital`s interest in royalties for the time being.
However, Paul Capital is not otherwise entitled to participate in milestone
receipts.
In respect of the period from 1 October 2001 up to 31 December 2004, the amounts
received into the Lock-Box account in respect of Extraneal and Adept (excluding
milestone payments which have subsequently been received by the Company) have
been shared as to 62 per cent by Paul Capital and as to 38 per cent by the
Company. Taking into account milestone payments, aggregate amounts received
during that period have been shared as to approximately 46 per cent by Paul
Capital and as to approximately 54 per cent by the Company. The proportion of
future revenue sharing is dependent on the level of sales of Adept and the rates
of royalties negotiated with licencees.
In terms of the Company`s accounting treatment of these arrangements, over the
period from commencement of these arrangements up to the financial year ended 30
September 2004, the Company has accounted in full for the £22.5 million received
from Paul Capital in its profit and loss account as other operating income. The
Company includes as turnover within its profit and loss account only its net
share of the royalties received by it from the Lock-Box account. The Company
anticipates continuing to adopt this accounting treatment until the arrangements
come to an end on 30 September 2010.
Directors
Mr Ian Kent (Executive Chairman)
Ian Kent, aged 61, joined ML Laboratories as Executive Chairman in March 2005.
He brings significant experience in the life sciences sector having acted as
chairman and non-executive director of a number of successful public and private
companies. He is currently chairman of three venture capital backed biotech
companies, Argenta Discovery Limited, Intercytex Limited and Piramed Limited. He
is also chairman of LGC, a buy out from the Department of Trade and Industry in
1996 and now the leading analytical science company in the UK. He was founder
and chairman of Ardana Biosciences Limited and is now a non-executive director
of that company. He was founder and chairman of Imutran which was sold to
Novartis in 1997. His previous non-executive appointments include Vernalis plc,
Biofocus plc, Adprotech Limited and Roslin Biomed Limited.
Mr Kieran Murphy, MSc (Chief Executive Officer)
Kieran Murphy, aged 42, joined ML Laboratories as Chief Executive in March 2005
with over 15 years` experience within the life sciences sector. He was
previously chief executive of Adprotech Limited, a privately owned UK biotech
company which was acquired by Inflazyme Pharmaceuticals, Inc. in 2004. Prior to
Adprotech he was chief executive officer of Novartis Animal Vaccines where he
led a merger and acquisitions strategy to build a food animal vaccines business.
He was previously chief executive of Vericore Holdings Limited which he
restructured and sold to Novartis AG in 2000. Before Vericore, he spent six
years at Mallinckrodt where he held a variety of senior management positions and
latterly served as managing director for the UK and Ireland businesses. He
started his career in the sector working in sales and marketing positions at
Janssen UK.
Mr Paul Ballington, BSc (Director of Marketing and Business Development and
Managing Director of Innovata Biomed)
Paul Ballington, aged 50, became a member of the Board on 29 June 2004. He
joined the Group in 1994 from Abbott Laboratories where he held divisional
management and business development roles. Prior to that he has worked in a
commercial capacity for Baxter Healthcare and Schering Ag. Mr Ballington is also
managing director of Innovata Biomed.
Mr Peter Shennan, BA, FCA, MSI (Finance Director)
Peter Shennan, aged 54, became Finance Director on 30 November 1997. He
qualified as a Chartered Accountant in 1977 and is a Member of the Securities
Institute. He joined the Group in June 1997 from Coopers and Lybrand.
Dr Susan Foden, MA, DPhil (Non-executive Director)
Dr Susan Foden, aged 52, joined the Board on 16 May 2005. She holds a number of
non-executive directorships with both public and private companies and public
funding bodies in the biotech and healthcare field. Prior to this Dr Foden held
positions in venture capitalism, technology transfer and UK biotech. From 2000
to 2003, she was an Investor Director with the London-based venture capitalist
firm Merlin Biosciences Limited. From 1987 to 2000 she was chief executive
officer of the technology transfer company, Cancer Research Campaign Technology
Limited, and from 1998 to 2000 also of Cancer Research Ventures. From 1983 to
1987 Dr Foden headed up the academic liaison function at what was then Celltech
Limited, dealing with some of the earliest tech transfer deals in the UK and the
precedents that these set. She studied biochemistry at the University of Oxford
from where she obtained her MA and DPhil degrees.
Dr John Fromson, BSc, PhD (Non-executive Director)
John Fromson, aged 63, joined the Board on 16 May 2005 as a non-executive
director and has 18 years experience in multinational pharmaceutical companies
and was directly involved in the development of three major products. He was
formerly Executive Chairman of Ultrafine Limited which he substantially
restructured and sold to Sigma-Aldrich, Inc. in 2004. He was formerly Chief
Scientific Officer at DevCo Limited and Vice President Pre-Clinical Development
at Vanguard Medica. He has drug development experience from Hoechs
Pharmaceuticals where he worked for 13 years in increasingly senior roles. He
now runs a healthcare consultancy focusing on due diligence and strategic
planning for venture capital and technology transfer companies.
Mr Fred Hallsworth, BAcc, CA (Non-executive Director)
Fred Hallsworth, aged 52, joined the Board on 6 April 2005 and was Senior Client
Service Partner at Deloitte from 2002 until the end of January 2005. Prior to
this, Mr Hallsworth spent 25 years with Andersen where he held a number of
senior management positions, including Managing Partner of the Cambridge office,
and latterly Managing Partner of Scotland. His recent life sciences experience
includes working with Inveresk Research Group Inc on the 1999 management buyout,
the 2001 acquisition of Clintrials Research Inc., the IPO on NASDAQ in 2002, and
the $3.5 billion merger with Charles River Laboratories, Inc in 2004. Mr
Hallsworth is a Non-Executive Director of Scottish Enterprise and has held a
number of other Board positions, including at CBI Scotland, Scottish Institute
for Enterprise and the University of Cambridge Finance Committee.
Proposed Directors
Mr Rajan Uppal, ACA (Non-Executive Director)
Rajan Uppal, aged 42, is a Chartered Accountant with significant corporate
finance and business development experience. After qualifying as a Chartered
Accountant, Mr Uppal joined Price Waterhouse based in the London office before
his first move into industry in 1989 as the CFO of a European printing and
packaging group, Ferry Pickering Group plc, which was quoted on the London Stock
Exchange. Following the successful disposal of this group, Mr Uppal joined the
board of QHL in 1996 which at the time was a small venture capital backed drug
delivery company based in Cambridge. Mr Uppal`s responsibilities as CFO of QHL
included finance, commercial and intellectual property and he was instrumental
in a number of significant commercial transactions and the flotation of QHL on
the official list of the London Stock Exchange prior to its eventual sale to
Elan in 2000. Following the acquisition by Elan, Mr Uppal joined Elan`s Drug
Delivery Division as senior vice president where he carried out a number of
commercial roles prior to leading the management buy out of the Quadrant
business. Mr Uppal is also a non-executive director of Oxford Biomedica plc, a
biopharmaceutical company listed on the London Stock Exchange specialising in
the development of novel gene-based therapeutics.
Dr Colin Dalton, BTech(Hons), PhD (Executive Director)
Dr Colin Dalton, aged 55, was Director of Business Development for five years at
GSK Biologicals, the worldwide vaccine leader, prior to re-joining Quadrant in
January 2005. He managed a group responsible for licensing of new products and
technologies, collaborations and alliances. Previous jobs were in business
development at Quadrant Healthcare, British Sugar plc, a senior consultant in
the Biotechnology Practice of PA Consulting and fermentation scientist at BP Co.
Ltd. He trained as an applied biologist at Brunel University and obtained his
PhD at Leicester University. His technological background is combined with
fifteen years experience in deal making both in large pharma and biotech
companies. He previously spent five years with Quadrant from 1994 to 1999.
Dr Terence Chadwick, BSc, MB, ChB, MRCP, MFPM (Executive Director)
Dr Terence Chadwick, aged 54, is currently Senior Vice President for Research
and Development in Quadrant. He was previously vice president of Elan,
responsible for Research and Development in Elan Drug Delivery-UK, prior to
taking part in the management buy out which led to the formation of Quadrant in
July 2003. He trained as a physician in the UK, obtained honours degrees in
Medical Microbiology and Medicine and is a Member of the Royal College of
Physicians and the Faculty of Pharmaceutical Medicine. Dr Chadwick worked in
hospital-based internal medicine and endocrinology for 7 years before joining
the pharmaceutical industry. He has over 23 years experience in the
pharmaceutical and biotechnology sector and has held senior international posts
in research and development in Novo Nordisk (UK and Copenhagen), Fisons plc and
Rhone-Poulenc Rorer (Paris and Philadelphia). He joined Quadrant Healthcare in
1998 as a main board director with responsibility for Research and Development.
Dr Chadwick has extensive experience of developing products in a variety of
therapeutic areas including diabetes, endocrinology, respiratory, CVS, CNS and
allergy.
Option Proposals
On their appointment to the Board in March 2005, Ian Kent and Kieran Murphy were
granted options under the Company`s 1999 Executive Share Option Scheme over 1
million and 2 million Ordinary Shares respectively. These options are
exercisable three years after grant and only if the performance criteria set out
in the rules of the scheme (which are described in the Prospectus) are achieved.
The remuneration committee of the Board has been considering the level of
incentivisation for these key executives and has concluded that additional
appropriate incentives are required to reflect the challenges that they face
within the Enlarged Group. It is proposed, therefore, that additional options
are granted to Ian Kent over 1 mi
Zitat
Antwort
0
Hallo
So langsam gehts endlich bergauf mit der Aktie.
Ml Labs steigt mit schönem volumen .
http://finance.yahoo.com/q?s=mlb.l
http://www.telegraph.co.uk/money/main.jhtml?xml=/money/2005/…
So langsam gehts endlich bergauf mit der Aktie.
Ml Labs steigt mit schönem volumen .
http://finance.yahoo.com/q?s=mlb.l
http://www.telegraph.co.uk/money/main.jhtml?xml=/money/2005/…
Zitat
Antwort
0
Hi
Deal mit Maxygen
M.L. Laboratories PLC
20 June 2005
ML Laboratories PLC
New Licensing Agreement with Maxygen and Grant of US Patent for Gene Expression Technology
St Albans, UK, 20 June 2005 -- ML Laboratories PLC (LSE: MLB) today announces
that Maxygen Inc has signed a commercial licence agreement for ML`s UCOE
(Ubiquitous Chromatin Opening Element) gene expression technology.
ML also announces that the US Patent and Trademark Office has issued to ML a
second US patent for UCOE.
UCOEs improve the yield, consistency and stability of protein production in
cultured mammalian cells, allowing simpler and quicker generation of proteins at
small scale for drug discovery, as well as quicker and easier isolation of
stable, highly productive cell lines suitable for larger-scale manufacture of
protein therapeutics. Further applications of the technology include gene
therapy, transgenics and generation of cell lines for drug screening.
ML has already licensed UCOEs to a number of pharmaceutical and biotechnology
companies in North America, Europe and Japan.
Licence Agreement with Maxygen
Based in Redwood City, California, Maxygen develops superior versions of
existing protein pharmaceuticals. Maxygen`s technologies combine molecular
biology and protein modification to create novel biotechnology products.
In February 2003, Maxygen signed a research licence to ML`s UCOE technology.
The licence agreement announced today allows Maxygen to use the technology for
the development and commercialization of its portfolio of therapeutic proteins.
The financial terms were not disclosed.
Grant of Second US Patent
The second patent (US6881556) awarded to ML for UCOE covers the use of DNA
elements that enhance the efficiency of protein production in mammalian cells by
prevention of gene silencing. The original broad US patent (US6689606) was
issued in 2004.
Kieran Murphy, Chief Executive Officer of ML Laboratories, commented:
`The agreement with Maxygen and the granting of our second US patent for UCOE
are further validations of the value of this proprietary platform. UCOEs
represents an exciting opportunity and we believe that the developments
announced today will strengthen our offering as we seek to divest non-core
assets as part of the ongoing restructuring process.`
Discussions regarding the divestment of non-core assets are currently
progressing.
Deal mit Maxygen
M.L. Laboratories PLC
20 June 2005
ML Laboratories PLC
New Licensing Agreement with Maxygen and Grant of US Patent for Gene Expression Technology
St Albans, UK, 20 June 2005 -- ML Laboratories PLC (LSE: MLB) today announces
that Maxygen Inc has signed a commercial licence agreement for ML`s UCOE
(Ubiquitous Chromatin Opening Element) gene expression technology.
ML also announces that the US Patent and Trademark Office has issued to ML a
second US patent for UCOE.
UCOEs improve the yield, consistency and stability of protein production in
cultured mammalian cells, allowing simpler and quicker generation of proteins at
small scale for drug discovery, as well as quicker and easier isolation of
stable, highly productive cell lines suitable for larger-scale manufacture of
protein therapeutics. Further applications of the technology include gene
therapy, transgenics and generation of cell lines for drug screening.
ML has already licensed UCOEs to a number of pharmaceutical and biotechnology
companies in North America, Europe and Japan.
Licence Agreement with Maxygen
Based in Redwood City, California, Maxygen develops superior versions of
existing protein pharmaceuticals. Maxygen`s technologies combine molecular
biology and protein modification to create novel biotechnology products.
In February 2003, Maxygen signed a research licence to ML`s UCOE technology.
The licence agreement announced today allows Maxygen to use the technology for
the development and commercialization of its portfolio of therapeutic proteins.
The financial terms were not disclosed.
Grant of Second US Patent
The second patent (US6881556) awarded to ML for UCOE covers the use of DNA
elements that enhance the efficiency of protein production in mammalian cells by
prevention of gene silencing. The original broad US patent (US6689606) was
issued in 2004.
Kieran Murphy, Chief Executive Officer of ML Laboratories, commented:
`The agreement with Maxygen and the granting of our second US patent for UCOE
are further validations of the value of this proprietary platform. UCOEs
represents an exciting opportunity and we believe that the developments
announced today will strengthen our offering as we seek to divest non-core
assets as part of the ongoing restructuring process.`
Discussions regarding the divestment of non-core assets are currently
progressing.
Zitat
Antwort
0
M.L. Laboratories PLC
12 July 2005
NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION IN WHOLE OR IN PART IN OR INTO THE
UNITED STATES, CANADA, THE REPUBLIC OF IRELAND, AUSTRALIA OR JAPAN
ML Laboratories plc
(`ML` or `the Company`)
Result of Placing & Open Offer
St Albans, UK, 12 July 2005: On 16 June 2005, ML Laboratories plc (LSE: MLB)
announced a Placing and Open Offer of 45,741,683 Ordinary Shares and a Vendor
Placing of 91,758,315 Ordinary Shares, each at the Issue Price of 19p, to raise
approximately £23.7 million, net of expenses. The Company also announced the
proposed acquisition of Quadrant Technologies Limited and the proposed
acquisition of a minority shareholding in Innovata Biomed Limited.
The Company today announces that by 3.00 p.m. on 11 July 2005 (being the latest
time and date for receipt of completed Application Forms and payment in full
under the Open Offer), valid applications had been received in respect of
38,645,776 Placing and Open Offer Shares, representing 84.5% per cent of the
Placing and Open Offer Shares available pursuant to the Placing and Open Offer.
The balance of the Placing and Open Offer Shares (being 7,095,907 such shares)
are being subscribed by institutional investors at 19p per Ordinary Share
according to the terms of the Placing Agreement. In accordance with the terms of
the Open Offer, fractional entitlements are not being allotted.
The New Ordinary Shares to be issued pursuant to the Vendor Placing have been
placed firm with institutional investors at 19p per New Ordinary Share.
The Placing and Open Offer and the Vendor Placing each remain conditional, inter
alia, upon the passing by the Company`s shareholders of certain resolutions
which are to be considered at the Company`s Extraordinary General Meeting to be
held on 14 July 2005.
Application has been made for the New Ordinary Shares to be admitted to the
Official List and to trading on the London Stock Exchange`s market for listed
securities. Subject to the passing of the requisite resolutions at the
Extraordinary General Meeting and subject to completion of the Quadrant
Acquisition, it is expected tha Admission will become effective and dealings
will commence at 08.00am on 15 July 2005.
Commenting on today`s announcement, Kieran Murphy, CEO of ML said:
`We are pleased with the support we have received from both existing and new
investors. The funds raised will enable us to deliver on our strategy of
developing new products for respiratory disease and inhaled therapeutics. Our
first priority following shareholder approval will be to integrate Quadrant into
the ML business to create Innovata, and we look forward to implementing this
over the coming months.`
Code Securities Limited (which is regulated in the United Kingdom by the
Financial Services Authority) is acting solely for ML Laboratories plc in
connection with the Placing and Open Offer and is not acting for any person
other than ML Laboratories plc and will not be responsible for any person other
than ML Laboratories plc for providing the protections afforded to clients of
Code Securities Limited or for providing advice to any person other than ML
Laboratories plc for providing advice to any person in connection with the
matters described in this announcement.
Terms defined in the announcement of the Company made on 16 June 2005 bear the
same meaning when used in this announcement.
12 July 2005
NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION IN WHOLE OR IN PART IN OR INTO THE
UNITED STATES, CANADA, THE REPUBLIC OF IRELAND, AUSTRALIA OR JAPAN
ML Laboratories plc
(`ML` or `the Company`)
Result of Placing & Open Offer
St Albans, UK, 12 July 2005: On 16 June 2005, ML Laboratories plc (LSE: MLB)
announced a Placing and Open Offer of 45,741,683 Ordinary Shares and a Vendor
Placing of 91,758,315 Ordinary Shares, each at the Issue Price of 19p, to raise
approximately £23.7 million, net of expenses. The Company also announced the
proposed acquisition of Quadrant Technologies Limited and the proposed
acquisition of a minority shareholding in Innovata Biomed Limited.
The Company today announces that by 3.00 p.m. on 11 July 2005 (being the latest
time and date for receipt of completed Application Forms and payment in full
under the Open Offer), valid applications had been received in respect of
38,645,776 Placing and Open Offer Shares, representing 84.5% per cent of the
Placing and Open Offer Shares available pursuant to the Placing and Open Offer.
The balance of the Placing and Open Offer Shares (being 7,095,907 such shares)
are being subscribed by institutional investors at 19p per Ordinary Share
according to the terms of the Placing Agreement. In accordance with the terms of
the Open Offer, fractional entitlements are not being allotted.
The New Ordinary Shares to be issued pursuant to the Vendor Placing have been
placed firm with institutional investors at 19p per New Ordinary Share.
The Placing and Open Offer and the Vendor Placing each remain conditional, inter
alia, upon the passing by the Company`s shareholders of certain resolutions
which are to be considered at the Company`s Extraordinary General Meeting to be
held on 14 July 2005.
Application has been made for the New Ordinary Shares to be admitted to the
Official List and to trading on the London Stock Exchange`s market for listed
securities. Subject to the passing of the requisite resolutions at the
Extraordinary General Meeting and subject to completion of the Quadrant
Acquisition, it is expected tha Admission will become effective and dealings
will commence at 08.00am on 15 July 2005.
Commenting on today`s announcement, Kieran Murphy, CEO of ML said:
`We are pleased with the support we have received from both existing and new
investors. The funds raised will enable us to deliver on our strategy of
developing new products for respiratory disease and inhaled therapeutics. Our
first priority following shareholder approval will be to integrate Quadrant into
the ML business to create Innovata, and we look forward to implementing this
over the coming months.`
Code Securities Limited (which is regulated in the United Kingdom by the
Financial Services Authority) is acting solely for ML Laboratories plc in
connection with the Placing and Open Offer and is not acting for any person
other than ML Laboratories plc and will not be responsible for any person other
than ML Laboratories plc for providing the protections afforded to clients of
Code Securities Limited or for providing advice to any person other than ML
Laboratories plc for providing advice to any person in connection with the
matters described in this announcement.
Terms defined in the announcement of the Company made on 16 June 2005 bear the
same meaning when used in this announcement.
Zitat
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0
Neuer Name ,neue website und neues Jahreshoch.
ML Laboratories heisst jetzt Innovata Plc
http://www.innovataplc.com
Pipeline:
http://www.innovataplc.com/pipelinehr.html
ML Laboratories heisst jetzt Innovata Plc
http://www.innovataplc.com
Pipeline:
http://www.innovataplc.com/pipelinehr.html
Zitat
Antwort
0
Innovata ist hier in deutschland günstiger zuhaben als an der heimatbörse.
Der kurs liegt akt.bei 25p das entspricht 0,36€ aber in frankfurt notiert die aktie bei 0,28€.
Während Innovata in U.K. sehr gefragt ist findet hier so gut wie kein umsatz statt dabei hat das Unternehmen etliche produkte auf den Markt und ist schon bald profitabel.
News die in kürze erwartet werden:
Alpharen (renal disease treatment - 50-50 venture with Ineos): currently in phase II and expected to enter phase III in H2 05. City Capital suggests massive potential with a licensing deal possibly in H2 05 of £9M to MLB on signing and £18M milestones on approval; with royalties of 10% to MLB. H2 2005
Meptin – IB submitted Meptin for Japanese approval which is expected in H2 05 which will trigger a milestone plus royalties on sales; H2 2005
http://uk.finance.yahoo.com/q?d=t&p=&q=q&s=iov&m=L
Der kurs liegt akt.bei 25p das entspricht 0,36€ aber in frankfurt notiert die aktie bei 0,28€.
Während Innovata in U.K. sehr gefragt ist findet hier so gut wie kein umsatz statt dabei hat das Unternehmen etliche produkte auf den Markt und ist schon bald profitabel.
News die in kürze erwartet werden:
Alpharen (renal disease treatment - 50-50 venture with Ineos): currently in phase II and expected to enter phase III in H2 05. City Capital suggests massive potential with a licensing deal possibly in H2 05 of £9M to MLB on signing and £18M milestones on approval; with royalties of 10% to MLB. H2 2005
Meptin – IB submitted Meptin for Japanese approval which is expected in H2 05 which will trigger a milestone plus royalties on sales; H2 2005
http://uk.finance.yahoo.com/q?d=t&p=&q=q&s=iov&m=L
Zitat
Antwort
0
INNOVATA PLC
OTSUKA LAUNCHES MEPTIN CLICKHALER IN JAPAN
Nottingham, UK, 18 August 2005 - Innovata plc (LSE: IOV), a product development
company focused on respiratory disease and inhaled therapies, announced today
that Otsuka Pharmaceutical Co. Ltd., its Japanese pharmaceutical company
partner, is to launch its bronchodilator drug, Meptin, in the Clickhaler in
Japan on September 2. This marks the successful realisation of a collaborative
development programme first announced in 2002.
Meptin (procaterol) is a successful brand in Japan, generating $66 million in
sales and Otsuka are an important participant in the Japanese asthma market.
Meptin has previously been sold in conventional HFA spray inhalers and now, as a
result of its collaboration with Innovata, it is also available in Clickhaler as
a dry powder inhaler. Meptin Clickhaler was approved by the Japanese regulatory
authorities in March this year.
Kieran Murphy, Chief Executive Officer of Innovata, commented: `Otsuka`s
imminent launch of the Meptin Clickhaler has come as a result of a three year
collaboration between the two companies and is testament to our fast-to-market
approach. Meptin is the third product to be brought to market in our Clickhaler
and we look forward to further product approvals and launches in the coming
months.`
OTSUKA LAUNCHES MEPTIN CLICKHALER IN JAPAN
Nottingham, UK, 18 August 2005 - Innovata plc (LSE: IOV), a product development
company focused on respiratory disease and inhaled therapies, announced today
that Otsuka Pharmaceutical Co. Ltd., its Japanese pharmaceutical company
partner, is to launch its bronchodilator drug, Meptin, in the Clickhaler in
Japan on September 2. This marks the successful realisation of a collaborative
development programme first announced in 2002.
Meptin (procaterol) is a successful brand in Japan, generating $66 million in
sales and Otsuka are an important participant in the Japanese asthma market.
Meptin has previously been sold in conventional HFA spray inhalers and now, as a
result of its collaboration with Innovata, it is also available in Clickhaler as
a dry powder inhaler. Meptin Clickhaler was approved by the Japanese regulatory
authorities in March this year.
Kieran Murphy, Chief Executive Officer of Innovata, commented: `Otsuka`s
imminent launch of the Meptin Clickhaler has come as a result of a three year
collaboration between the two companies and is testament to our fast-to-market
approach. Meptin is the third product to be brought to market in our Clickhaler
and we look forward to further product approvals and launches in the coming
months.`
Zitat
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0
Hallo
Bei Innovata ging am Freitag in der letzten Handelsstunde die post ab ,die Aktie erreicht neues 52W hoch bei höchstem Volumen seit knapp 2jahren.
Da gingen auf ein schlag 10mio aktien über den Tisch.
http://finance.yahoo.com/q?s=iov.l
News Expected for 2005
Alpharen (renal disease treatment - 50-50 venture with Ineos): currently in phase II and expected to enter phase III in H2 05. City Capital suggests massive potential with a licensing deal possibly in H2 05 of £9M to IOV on signing and £18M milestones on approval; with royalties of 10% to IOV. H2 2005
Pipeline:
http://www.innovataplc.com/pipelinehr.html
Innovata hat mich bisher nicht enttäuscht.
Bei Innovata ging am Freitag in der letzten Handelsstunde die post ab ,die Aktie erreicht neues 52W hoch bei höchstem Volumen seit knapp 2jahren.
Da gingen auf ein schlag 10mio aktien über den Tisch.
http://finance.yahoo.com/q?s=iov.l
News Expected for 2005
Alpharen (renal disease treatment - 50-50 venture with Ineos): currently in phase II and expected to enter phase III in H2 05. City Capital suggests massive potential with a licensing deal possibly in H2 05 of £9M to IOV on signing and £18M milestones on approval; with royalties of 10% to IOV. H2 2005
Pipeline:
http://www.innovataplc.com/pipelinehr.html
Innovata hat mich bisher nicht enttäuscht.
Zitat
Antwort
0
Hallo
Diese Nachricht war wohl der auslöser für den kursanstieg am freitag:
Innovata Plc
19 September 2005
Innovata plc
Partner Merck KGaA Establishes International Respiratory Medicines Business
Notts, UK, 19 September 2005 - Innovata plc (LSE: IOV), the product development
company focused on respiratory disease and inhaled therapies, today announces
that its previously undisclosed pharmaceutical partner for Clickhaler(R) in
Europe and some other countries is Merck KGaA.
During the European Respiratory Society`s 15th Annual Congress being held in
Copenhagen from 17-21 September, Merck KGaA announced the establishment of an
international respiratory medicines business unit in order to consolidate its
expertise in this field and better compete in this strategically important
therapeutic area.
Merck KGaA is a global pharmaceutical and chemical company with sales of EUR 5.9
billion in 2004. Its new respiratory business is under the umbrella organisation
of the Merck Generics division, the world`s third-largest generics company with
operations across Europe, the Americas and the Asia/Pacific region.
Merck Respiratory has been working with Innovata to develop respiratory
medicines using Innovata`s patented, dry powder device, Clickhaler(R). Merck
Respiratory has already gained marketing authorisations for the Budesonide
Clickhaler(R) for the treatment of asthma and Formoterol Clickhaler(R), for the
treatment of asthma and COPD, in a number of European markets. Further approvals
in other major European Union markets are anticipated in the coming months.
Under the terms of the agreement with Merck Generics, Innovata has received
milestone payments totalling £6m, and the above announced event triggers a
further milestone payment. Sales of comparable budesonide products in Europe
total £200 million while the European market for comparable formoterol products
is estimated at more than £100 million.
Hank Klakurka, President of Merck Generics, said:
`Merck Respiratory aims to be a leading provider of effective respiratory
medicines, improving the lives of patients with asthma and chronic obstructive
pulmonary disease. We intend to create a full range of respiratory products
underpinned by innovative, affordable and easy-to-use delivery devices.`
Kieran Murphy, Chief Executive Officer of Innovata, added:
`We are delighted to be able to reveal that we are working with one of the
world`s largest generics companies in the respiratory field. With Merck`s new
Respiratory presence, we are confident that our Budesonide and Formoterol
Clickhaler products will gain a significant share of the European markets
following their launches.`
Diese Nachricht war wohl der auslöser für den kursanstieg am freitag:
Innovata Plc
19 September 2005
Innovata plc
Partner Merck KGaA Establishes International Respiratory Medicines Business
Notts, UK, 19 September 2005 - Innovata plc (LSE: IOV), the product development
company focused on respiratory disease and inhaled therapies, today announces
that its previously undisclosed pharmaceutical partner for Clickhaler(R) in
Europe and some other countries is Merck KGaA.
During the European Respiratory Society`s 15th Annual Congress being held in
Copenhagen from 17-21 September, Merck KGaA announced the establishment of an
international respiratory medicines business unit in order to consolidate its
expertise in this field and better compete in this strategically important
therapeutic area.
Merck KGaA is a global pharmaceutical and chemical company with sales of EUR 5.9
billion in 2004. Its new respiratory business is under the umbrella organisation
of the Merck Generics division, the world`s third-largest generics company with
operations across Europe, the Americas and the Asia/Pacific region.
Merck Respiratory has been working with Innovata to develop respiratory
medicines using Innovata`s patented, dry powder device, Clickhaler(R). Merck
Respiratory has already gained marketing authorisations for the Budesonide
Clickhaler(R) for the treatment of asthma and Formoterol Clickhaler(R), for the
treatment of asthma and COPD, in a number of European markets. Further approvals
in other major European Union markets are anticipated in the coming months.
Under the terms of the agreement with Merck Generics, Innovata has received
milestone payments totalling £6m, and the above announced event triggers a
further milestone payment. Sales of comparable budesonide products in Europe
total £200 million while the European market for comparable formoterol products
is estimated at more than £100 million.
Hank Klakurka, President of Merck Generics, said:
`Merck Respiratory aims to be a leading provider of effective respiratory
medicines, improving the lives of patients with asthma and chronic obstructive
pulmonary disease. We intend to create a full range of respiratory products
underpinned by innovative, affordable and easy-to-use delivery devices.`
Kieran Murphy, Chief Executive Officer of Innovata, added:
`We are delighted to be able to reveal that we are working with one of the
world`s largest generics companies in the respiratory field. With Merck`s new
Respiratory presence, we are confident that our Budesonide and Formoterol
Clickhaler products will gain a significant share of the European markets
following their launches.`
Zitat
Antwort
0
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