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Teva Pharmaceutical Industries Ltd. becomes strategic partner for the commercialization of FYB201, Formycon's biosimilar candidate to Lucentis(R)1 (ranibizumab) in Europe, Canada, Israel and New Zealand

DGAP-News: Formycon AG / Key word(s): Alliance/Contract
28.06.2021 / 14:30
The issuer is solely responsible for the content of this announcement.

Press Release June 28, 2021

Teva Pharmaceutical Industries Ltd. becomes strategic partner for the commercialization of FYB201, Formycon's biosimilar candidate to Lucentis(R)1 (ranibizumab) in Europe, Canada, Israel and New Zealand

Munich - Bioeq AG ("Bioeq"), the exclusive owner of the global commercialization rights of FYB201, Formycon's biosimilar candidate to Lucentis(R) (ranibizumab), informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), that an exclusive strategic partnership for commercialization of FYB201 in Europe, Canada, Israel and New Zealand has been concluded with Teva Pharmaceutical Industries Ltd. ("Teva").

Teva Pharmaceutical Industries Ltd. is a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Teva maintains an established presence in generics and also conducts significant innovative research to support its growing portfolio of specialty and biopharmaceutical products.

By the end of 2019, Bioeq had already entered into a license and development agreement with the US Biosimilar-specialist Coherus BioSciences, Inc., which will exclusively distribute FYB201 in the United States of America (US). With today's partnership between Bioeq and Teva, FYB201's distribution is now complemented by another strong partner. After successful approval by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Formycon will participate in the marketing revenues.

"With the selection of the two commercialization partners Coherus BioSciences, Inc. and Teva Pharmaceutical Industries Ltd. by Bioeq AG we are optimistically looking forward to the marketing launch of FYB201, which is scheduled for the coming year. We are delighted that two powerful companies will commercialize our product in the territories of the US, Europe, Canada, Israel and New Zealand and are convinced of the quality and potential of our biosimilar candidate to Lucentis(R) (ranibizumab)" says Dr. Carsten Brockmeyer, CEO 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 fusion protein.

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.

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. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.

Sabrina M├╝ller
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 //

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.

28.06.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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Language: English
Company: Formycon AG
Fraunhoferstra├če 15
82152 Planegg-Martinsried
Phone: 089 864667 100
Fax: 089 864667 110
Indices: Scale 30
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1212699

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Last Updated: 28-Jun-2021