Formycon AG / Key word(s): Study 09.03.2015 08:15 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer / publisher is solely responsible for the content of this announcement. --------------------------------------------------------------------------- Munich - Formycon AG, the biosimilar drug development company, has completed a successful GMP (Good Manufacturing Practices) inspection of its site in Munich-Martinsried by the Government of Upper Bavaria. The German GMP certificate confirms that Formycon conducts analytical testing in compliance with EU GMP regulations and underlines Formycon's position as integrated biosimilar development company. This achievement is another important step in Formycon's preparation of the pivotal phase III study of clinical testing for its first biosimilar candidate (FYB201) which already has been licensed out to Santo Holding GmbH back in December 2013. Furthermore, the company has received final advice in December 2014 from the European Medicines Agency (EMA) in London for the non-clinical and clinical development of FYB201. EMA's scientific experts are in consensus with Formycon's approach to move FYB201 directly into phase III clinical testing, which puts Formycon almost one year ahead. Formycon has now submitted the clinical study protocol and other documents to the U.S. Food and Drug Administration (FDA) to obtain also FDA's expert advice before starting the pivotal global phase III study. Background: What are biosimilars? Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of the patents for these biotech drugs will expire - and by the year 2020, medications with revenues of more than USD 100 billion will lose their patent protection. In this way, it will become possible to launch new competing drugs, known as "biosimilars". While the global market for these new-generation drugs is currently some USD 2.5 billion, industry experts expect this figure to grow tenfold by the year 2020. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise. About Formycon: Formycon AG is a leading independent developer of biosimilars for global marketing and has become a recognized innovator in the field. The team of the company which has today become Formycon AG has extensive experience in the development of complex molecules. The company has already successfully licensed two protein-based product portfolios out to major pharmaceutical companies - in 2008 and 2011. Its specialist expertise allows the company to develop high-quality biosimilars that meet the strict requirements of the regulatory authorities in highly regulated countries and regions such as Europe and the USA. Formycon currently has three biosimilar candidates under development, the first of which has already been licensed out to Santo Holding GmbH, with further product development projects in the pipeline. Its aim is to be the first company in the world to present clinical data for each respective product candidate and on this basis to license these products out to major pharmaceutical and generics companies for further development and commercialization. Alternatively, Formycon offers further development of its biosimilars all the way through to marketing authorization, as well as commercial production on behalf of its licensees. Contact: Formycon AG Fraunhoferstr. 15 82152 Martinsried/Planegg Germany phone +49 (0) 89 - 86 46 67 100 fax +49 (0) 89 - 86 46 67 110 [email protected] www.formycon.com Disclaimer: This release may contain forward-looking statements and information which may be identified by formulations using terms such as "expects", "aims", "anticipates", "intends", "plans", "believes", "seeks", "estimates" or "will". Such forward-looking statements are based on our current expectations and certain assumptions which may be subject to variety of risks and uncertainties. The results actually achieved by Formycon AG may substantially differ from these forward-looking statements. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. 09.03.2015 The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: Formycon AG Fraunhoferstraße 145 82152 Planegg-Martinsried Germany Phone: 089 864667 100 Fax: 089 864667 110 E-mail: Internet: www.formycon.com ISIN: DE000A1EWVY8 WKN: A1EWVY Listed: Regulated Unofficial Market in Berlin; Open Market (Entry Standard) in Frankfurt End of Announcement DGAP News-Service ---------------------------------------------------------------------------