Planegg-Martinsried (pta006/22.12.2017/07:30) - NOT FOR DISTRIBUTION, PUBLICATION OR FORWARDING IN THE UNITED STATES, CANADA, JAPAN AND AUSTRALIA
* Formycon is involved with 24.9 percent of the development costs and potential licensing revenues from the marketing of FYB202
* Development of the biosimilar candidate up to approval planned
The biosimilar company Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Aristo Pharma GmbH, a pharmaceutical company registered in Berlin, have formed a joint company for the continued development of FYB202, Formycon's biosimilar candidate for Stelara®* (ustekinumab). Formycon owns 24.9 percent and Aristo Pharma 75.1 percent of the joint company called FYB202 GmbH & Co. KG. The parties agreed that following a pilot phase the further development costs as well as the existing project investments should be taken into account according to the amount of holding. Similarly, both companies should partake in the licensing revenues to be expected according to their proportion of holding.
The joint venture's aim is to develop the biosimilar candidate until approval, whereby Formycon will take over parts of the continued development work.
Stelara® (ustekinumab) is a human monoclonal antibody directed against the cytokines interleukin-12 and interleukin-23, which is used to treat a variety of serious inflammatory diseases, including moderate to severe psoriasis. In 2016, its indications were extended for the treatment of Crohn's disease, a chronic inflammatory condition of the bowel.
In recent years, Stelara® has achieved growing revenues and in 2016 achieved global sales of around USUSD 3.2 billion. In the first nine months of the current year, sales were already over USD2.9 billion, up approximately 25 percent over the same period last year. Marketing of a biosimilar for Stelara® should become possible towards the end of 2023 in the USA and from the middle of 2024 in Europe once the legal protections expire.
* Stelara is a registered trademark of Johnson & Johnson
Formycon is a leading, independent developer of high-quality follow-on products for biopharmaceutical medicines known as biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire added value chain from technical development to the clinical phase III and 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.
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 more than 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.
Corporate Communications and Investor Relations
phone +49 (0) 89 - 86 46 67 150
fax + 49 (0) 89 - 86 46 67 110
Thorsten.email@example.com // www.formycon.com
This 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.