Formycon AG / Key word(s): Miscellaneous 28.05.2015 07:02 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. --------------------------------------------------------------------------- - Second biosimilar drug to be out-licensed from Formycon product pipeline - Important milestone strengthens position as world's leading independent biosimilars developer - Formycon to receive success-based payments in the triple-digit millions of euros Munich - Formycon AG has announced the signing of an exclusive, global out-licensing deal for its FYB203 biosimilar drug, with Santo Holding GmbH as licensing partner. The newly signed agreement will ensure that Formycon has project funding in place all the way through to market introduction. Under the agreement, Santo Holding will assume responsibility for, and the costs of, all further development activities, production and marketing of the Formycon biosimilar drug. In return, Santo Holding will receive exclusive worldwide marketing rights for FYB203. Pharmaceutical product development through to regulatory approval will remain in the hands of Formycon, while clinical development will be carried out by Bioeq GmbH, which manages biosimilar product development activities on behalf of Santo Holding. Under the terms of the new agreement, Formycon will receive an immediate payment in the amount of several millions, along with ongoing payment for its product development activities through to regulatory approval. The company will, in addition, participate in sales revenue once the project is brought to market, receiving a percentage share in the low double digits. Based on sales projections, the agreement is thus expected to yield Formycon total cumulative revenue well over the hundred million euro mark. "The signing of this important deal marks a further milestone for our company as well as a major success for our entire team as we work to expand our pipeline of biosimilars for the global market," declared Dr. Carsten Brockmeyer, CEO of Formycon AG. "We are immensely pleased to have found Santo Holding as a strong, ideal partner for our first two projects. Over the past years, we have driven our company forward through our commitment to investment in long-term research - and this is a strategy which we will continue to relentlessly pursue." "With the out-licensing deal for FYB203, we now have financing completely in place for two biosimilar products, all the way through to market launch," said Dr. Nicolas Combé, CFO of Formycon AG, in commenting on the newly signed agreement. "For our shareholders, this means a project financing expected to yield hundreds of millions of euros in revenue - and without shareholder dilution. This is a resounding validation of our strategy and, in particular, the superb work of our staff. The licensing agreement further strengthens our financial flexibility as we work towards our driving goal: to be the world's leading developer for the third wave of biosimilar drugs." "Biosimilar drugs are making an increasingly significant contribution to patient care by making high-quality biopharmaceuticals accessible to them at a fair price," added Nicola Mikulcik on behalf of Bioeq GmbH. "Based on our successful work together on our first joint project, likewise bringing this new product to market in partnership with Formycon is a logical step. We anticipate excellent global market opportunities for both of these products." Formycon currently has three biosimilar drugs under development, with Santo Holding its product partner for FYB201 and now also FYB203. The company plans to develop the third product, FYB202, through to the end of phase I clinical trials using its own resources. 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. 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. 28.05.2015 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 ---------------------------------------------------------------------------