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Agreements

Date: 2017-12-22

Type of information: Joint-venture agreement

Compound: FYB202 - biosimilar version of ustekinumab - biosimilar ustekinumab

Company: Formycon (Germany) Aristo Pharma (Germany) FYB202 GmbH & Co (Germany)

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases - Digestive diseases

Type agreement: joint-venture

Action mechanism:

  • biosimilar/monoclonal antibody. FYB202 is a biosimilar candidate for Stelara® (ustekinumab). This human monoclonal antibody is directed against interleukin-12 and interleukin-23. It is used to treat a variety of serious inflammatory diseases, including moderate to severe psoriasis and Crohn’s disease,.
  • 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.

Disease:

Details:

  • • On December 22, 2017, Formycon and Aristo Pharma 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.
 

Financial terms:

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Is general: Yes