DGAP-News: MS Pharma becomes Partner for the Commercialization of FYB201, Formycon's Biosimilar Candidate to Lucentis(R)1 (ranibizumab), in the MENA Region

Press Release // December 14, 2021

MS Pharma becomes Partner for the Commercialization of FYB201, Formycon's Biosimilar Candidate to Lucentis(R)1 (ranibizumab), in the MENA Region

Munich - Bioeq AG ("Bioeq"), licensee and exclusive holder of the worldwide commercialization rights for FYB201, Formycon's biosimilar candidate for Lucentis(R) (ranibizumab), has informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) that it has entered into an exclusive partnership with MS Pharma for the commercialization of FYB201 in the Middle East and North Africa (MENA region).

MS Pharma is a leading pharmaceutical company in the MENA region with 2400 employees in 12 countries and specializes in the distribution of biotechnological as well as generic drugs. Under the exclusive agreement, MS Pharma will be responsible for the registration and commercialization of FYB201 in the countries covered by the agreement. The initiation of the approval procedures is expected to start immediately.

By the end of 2019, Bioeq had already entered into a licensing and development agreement with US Biosimilar Specialist Coherus BioSciences, Inc. which will exclusively distribute FYB201 in the United States of America. In August 2021, an exclusive strategic partnership for the commercialization of FYB201 in Europe and a few other markets was also entered into between Bioeq and Teva Pharmaceutical Industries Ltd. Upon successful approval of FYB201, Formycon will participate in the commercialization revenues of FYB201 in all territories.

"MS Pharma is a strong partner for the very dynamically developing Middle East and North Africa region. We are very excited about this additional commercialization partnership, which further increases the economic potential for FYB201. Our partner Bioeq is doing an excellent job in building the global commercialization structure, which also reflects our joint mission to provide access to high quality drugs like our biosimilar candidate for Lucentis(R) to as many patients worldwide as possible," said Dr. Nicolas Combé, CFO of Formycon AG.

¹⁾Lucentis(R) is a registered trademark of Genentech Inc.

About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207.

About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and the Strüngmann Group. Bioeq develops, licenses and commercializes biosimilars. www.bioeq.ch

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection - and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.

Contact:
Sabrina Müller
Senior Manager Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.