Formycon and Bioeq announce File Acceptance for FYB201, a biosimilar candidate to Lucentis(R) (ranibizumab) by the U.S. Food and Drug Administration (FDA)

Formycon AG / Key word(s): Regulatory Admission/Miscellaneous

Formycon and Bioeq announce File Acceptance for FYB201, a biosimilar candidate to Lucentis(R) (ranibizumab) by the U.S. Food and Drug Administration (FDA)

01-Oct-2021 / 20:04 CET/CEST

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Publication of insider information in accordance with Article 17 of the Regulation (EU) No 596/2014 Ad Hoc Announcement // October 1, 2021

Formycon and Bioeq announce File Acceptance for FYB201, a biosimilar candidate to Lucentis(R) (ranibizumab) by the U.S. Food and Drug Administration (FDA)

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) accepted the biologics license application (BLA) for FYB201, a biosimilar candidate to Lucentis(R)1, for review and assigned a target action date for the application for August 2022. Bioeq submitted the BLA to the FDA in August 2021.

Bioeq is a Swiss biopharmaceutical joint venture between the Struengmann Group and the Polpharma Biologics Group which develops, licenses and commercializes biosimilars.

Subject to regulatory approval, FYB201 (also known as BQ201 and CHS-201) will be commercialized in the United States of America by Coherus BioSciences, Inc. (“Coherus”), a US pharmaceutical company with an expertise in biosimilar development and commercialization. Formycon will participate economically in U.S. product sales through its interest in royalties paid by Coherus to Bioeq.

Lucentis(R) is used in the treatment of neovascular (wet) macular degeneration. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. This leads to progressive loss of vision and is one of the major causes of age-related blindness. The total market for ophthalmic drugs in anti-VEGF therapy is over $11 billion per year and, according to analysts, will continue to grow significantly.

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.

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.


01-Oct-2021 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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