DGAP-News
Apricus Biosciences Receives European Approval for Vitaros(R) for the Treatment of Erectile Dysfunction
Apricus Biosciences, Inc.
10.06.2013 13:00
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Company to Host Conference Call Today at 9:00 AM ET
SAN DIEGO, 2013-06-10 13:00 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com), today announced that its marketing application for
Vitaros(r), indicated for the treatment of patients with erectile dysfunction
('ED'), has been approved through the European Decentralized Procedure ('DCP').
'The approval of Vitaros(r) in Europe marks a significant milestone for Apricus
Bio as we continue to execute on our core strategy of developing, seeking
regulatory approval, and partnering our sexual health products,' said Richard
Pascoe, Chief Executive Officer of Apricus Bio. 'Vitaros(r) has a unique product
profile that meets the needs of a large number of patients suffering from
erectile dysfunction and who are intolerant to or do not respond to current
treatment options. With its rapid onset of action and unique topical delivery,
we believe that Vitaros(r) will capture a significant share of the approximately
$1 billion PDE-5 inhibitor market in Europe once it is launched by our
commercial partners.'
'Moreover, partnering interest in Vitaros(r) remains strong and we are actively
seeking to secure additional partnerships in the remaining European and global
markets,' continued Pascoe. 'With the completion of a $17.1 million financing,
the divestiture of multiple non-core assets, and streamlining of our global
operations in the second quarter of 2013, Apricus Bio is now well positioned to
advance our lead assets for male and female sexual health, Vitaros(r) and
Femprox(r), in an effort to create long-term shareholder value.'
Under the DCP, Apricus Bio filed its application for marketing approval
designating Netherlands as the Reference Member State ('RMS') on behalf of nine
other European Concerned Member States ('CMS') participating in the procedure.
The CMS include France, Germany, Italy, UK, Ireland, Spain, Sweden, Belgium and
Luxembourg. The Company will continue to work independently as well as with its
commercialization partners, Sandoz, Takeda, and Bracco for the next step of
obtaining national phase approvals in order to make Vitaros(r) ready to launch in
each of the included territories across Europe.
Conference Call Information
The call will take place today, June 10 at 9:00 AM ET and can be accessed in
the U.S. by dialing 877-407-9210 and outside of the U.S. by dialing
Bio as we continue to execute on our core strategy of developing, seeking
regulatory approval, and partnering our sexual health products,' said Richard
Pascoe, Chief Executive Officer of Apricus Bio. 'Vitaros(r) has a unique product
profile that meets the needs of a large number of patients suffering from
erectile dysfunction and who are intolerant to or do not respond to current
treatment options. With its rapid onset of action and unique topical delivery,
we believe that Vitaros(r) will capture a significant share of the approximately
$1 billion PDE-5 inhibitor market in Europe once it is launched by our
commercial partners.'
'Moreover, partnering interest in Vitaros(r) remains strong and we are actively
seeking to secure additional partnerships in the remaining European and global
markets,' continued Pascoe. 'With the completion of a $17.1 million financing,
the divestiture of multiple non-core assets, and streamlining of our global
operations in the second quarter of 2013, Apricus Bio is now well positioned to
advance our lead assets for male and female sexual health, Vitaros(r) and
Femprox(r), in an effort to create long-term shareholder value.'
Under the DCP, Apricus Bio filed its application for marketing approval
designating Netherlands as the Reference Member State ('RMS') on behalf of nine
other European Concerned Member States ('CMS') participating in the procedure.
The CMS include France, Germany, Italy, UK, Ireland, Spain, Sweden, Belgium and
Luxembourg. The Company will continue to work independently as well as with its
commercialization partners, Sandoz, Takeda, and Bracco for the next step of
obtaining national phase approvals in order to make Vitaros(r) ready to launch in
each of the included territories across Europe.
Conference Call Information
The call will take place today, June 10 at 9:00 AM ET and can be accessed in
the U.S. by dialing 877-407-9210 and outside of the U.S. by dialing
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