Publication of insider information in accordance with Article 17 of the Regulation (EU) No 596/2014 Ad-Hoc announcement // December 22, 2017, 07:30 CET

  • 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

Munich – 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 venture 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 US$ 3.2 billion. In the first nine months of the current year, sales were already over $2.9 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