Recent press releases

13. October 2016

Formycon Wins Award from Stifterverband for Innovative Strength

Research Seal awarded in recognition of particular dedication to biosimilar development

Munich – The biosimilar company Formycon has been awarded the Research Seal by the Stifterverband in recognition of its innovative research and development work. With this award, the organization is acknowledging the Munich company’s dedication to the development of biopharmaceutical follow-on drugs, known as biosimilars. According to the organization, the “Innovative Through Research” Seal is also intended to highlight the special responsibility that researching companies take on through their work on behalf of the state and society.

The Stifterverband points out that, although there are 3.5 million companies in Germany, less than one percent of them actually carries out research. This is an extremely important group. Only by researching can new things be discovered and innovation and growth created, says the organization.

Formycon is currently working on four biosimilar development projects (FYB201, FYB202, FYB203, FYB205), which are in various stages of pre-clinical and clinical development.

The most advanced development project is FYB201, a biosimilar candidate of the ophthalmic drug Lucentis®* (ranibizumab). It is the world’s only Lucentis® biosimilar to be in a phase III approval study. Formycon is pursuing the goal of marketing FYB201 via its licensing partner Bioeq IP AG as the first Lucentis® biosimilar following the expiry of the drug’s patent in the USA and Europe.

FYB203 is a biosimilar candidate for Eylea®** (aflibercept) which, like Lucentis®, is used to treat neovascular, age-related macular degeneration (nAMD) and other serious eye conditions. The project is licensed to Santo Holding Deutschland (GmbH).

Details of the biosimilar projects FYB202 and FYB205 have not yet been made public.

Dr. Carsten Brockmeyer, CEO of Formycon, is delighted by the award from the Stifterverband: “The award of the Research Seal is a major legitimation for us. It highlights the efforts that the entire Formycon team has been making for years in research and development to develop high-quality biosimilars. We will continue to work hard to ensure that as many patients as possible are able to receive high-quality medicines at affordable prices.”

The Stifterverband, a joint initiative between companies and foundations, is one of Germany’s largest private sponsors of science. Alongside its commitment to academic growth, first-class universities and cutting-edge research, the Stifterverband also regularly examines and evaluates the German research and innovation system on behalf of the German Ministry of Education and Research.

* Lucentis is a registered trademark of Genentech Inc.
** Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.

About Formycon:
Formycon is a leading independent pure play developer of biosimilars and has become a recognized innovator in this field. The company has extensive experience in the development of complex biological molecules. Formycon’s specialist expertise allows the company to develop high-quality biosimilars that meet the strict regulatory requirements of highly regulated markets such as Europe and the United States. Formycon currently has four biosimilars under development, of which two have been licensed out.

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 more than 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. While the global market for biosimilars is currently some USD 3.0 billion, industry experts expect this figure to grow tenfold by the year 2025. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.

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.