EQS-News

MS Pharma becomes Partner for the Commercialization of FYB203, Formycon’s Biosimilar Candidate to Eylea (Aflibercept), in the MENA Region

EQS-News: Formycon AG / Key word(s): Agreement MS Pharma becomes Partner for the Commercialization of FYB203, Formycon’s Biosimilar Candidate to Eylea (Aflibercept), in the MENA Region 15.05.2024 / 07:30 CET/CEST The issuer is solely responsible for the content of this announcement. Presse Release // May 15, 2024

MS Pharma becomes Partner for the Commercialization of FYB203, Formycon’s Biosimilar Candidate to Eylea (Aflibercept), in the MENA Region
 

Planegg-Martinsried – Klinge Biopharma GmbH ("Klinge"), licensee and exclusive holder of the worldwide commercialization rights for FYB203, Formycon's biosimilar candidate to Eylea¹ (Aflibercept), has entered into an exclusive licensing and supply agreement with MS Pharma for the commercialization of FYB203 in the Middle East and North Africa (“MENA region”).

MS Pharma is a leading regional pharmaceutical company in the MENA region and specializes in the distribution of biotechnological as well as generic drugs. The company will have exclusive rights to license, commercialize and produce FYB203 locally at its new Biosimilars site in Saudi Arabia for the countries covered by the agreement. Commercialization rights for all other territories remain with Klinge. Formycon is entitled to participate in all Klinge income from the agreement with MS Pharma in the mid-single to low-double-digit-percentage range.

MS Pharma is also marketing Formycon’s ophthalmic Lucentis² biosimilar FYB201 in the MENA region and can therefore leverage on established sales channels and an existing commercial infrastructure in the ophthalmic space.

In June 2023, Formycon announced that the biologics license application (“BLA”) for FYB203, has been submitted to the U.S. Food and Drug Administration (“FDA“). The agency assigned a target action date of June 2024. Moreover, FYB203 has been submitted end of 2023 to the European Medicines Agency (“EMA”), expecting regulatory approval beginning of 2025. MS Pharma plans to submit for regulatory approval in MENA countries at the earliest opportunity.