Formycon and Bioeq Enroll First Patient in Phase III Study with Aflibercept Biosimilar (FYB203)

DGAP-News: Formycon AG / Key word(s): Study/Miscellaneous
24.08.2020 / 07:00
The issuer is solely responsible for the content of this announcement.

Press Release // August 24, 2020

Formycon and Bioeq Enroll First Patient in Phase III Study with Aflibercept Biosimilar (FYB203)

- The MAGELLAN-AMD study investigates the comparable efficacy, safety and immunogenicity of Formycon's aflibercept biosimilar candidate FYB203 and the reference product Eylea(R)¹ in patients with neovascular age-related macular degeneration (nAMD)

- Global development program highlights leading position of Formycon and Bioeq in the field of ophthalmologic biosimilars

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Bioeq GmbH have today announced the launch of the randomized, double-blind, multi-center phase III study for FYB203, a biosimilar candidate to Eylea(R). The aim of the clinical study is to demonstrate the comparability of FYB203 and the reference product Eylea(R) in terms of efficacy, safety and immunogenicity in patients with neovascular age-related macular degeneration (nAMD). Also known as wet AMD, this is one of the main causes of loss of vision in people over the age of 50 in developed countries. The study design was developed in agreement with the US drug authority (FDA), the European regulatory authority (EMA) and the Japanese regulatory authority (PMDA) and is intended to support the approval process in these regions. Bioeq GmbH, a company of the ATHOS Group, is the sponsor of the phase III study.

The active ingredient aflibercept (Eylea(R)) inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. Eylea(R) is the highest-selling drug in the field of age-related eye disease and in 2019 achieved revenues of around US$ 7.5 billion. In 2015, Formycon AG concluded an exclusive global licensing agreement for FYB203 with Santo Holding (Deutschland) GmbH.

Formycon's COO, Dr. Stefan Glombitza, sees the company's leading position in ophthalmologic biosimilar development being confirmed: "We are delighted that our second project in the field of ophthalmology is now starting the phase III study. Given the extensive experience from the FYB201 project and the successful cooperation with Bioeq GmbH, we are confident that we will also be able to develop a high-quality and cost-effective biosimilar with FYB203. The active ingredient, aflibercept, is an extremely effective and proven treatment for wet macular degeneration and we want to play our part in ensuring that as many patients as possible gain access to this treatment option."

¹ Eylea(R) is a registered trademark of Regeneron Pharmaceuticals 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 antibody-based COVID-19 compounds.

About Bioeq:
Bioeq was founded in 2014 and is a leading service provider in the development of biopharmaceutical follow-on products, known as biosimilars. Working with various partners, Bioeq develops third-wave biosimilars and specializes in ophthalmic agents. The development programs meet the standards for highly regulated markets such as Europe, the USA, Canada, or Japan, and are therefore suitable for global licensing. Bioeq's expertise lies primarily in comprehensive project management, clinical development, the drafting of licensing strategies in dialog with the authorities, the development of application systems for administering the products, the drawing-up of patent strategies, and in license management. Bioeq is currently working on five different biosimilar projects.

Contact:
Sabrina Müller
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.

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