Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara® (ustekinumab), announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”). Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.

Upon conclusion of the agreement Formycon receives an upfront payment as well as milestone payments contingent on the successful achievement of certain regulatory events which are expected to total in the mid double digit million Euro range. Post-commercialization value will be shared approximately equally by both companies. Semi-exclusive commercialization rights for Germany as well as rights for parts of the MENA2 region and Latin America remain with Formycon.

Fresenius Kabi is a global healthcare company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions. In the field of biosimilars, Fresenius Kabi focuses on the development and marketing of biosimilars in the area of autoimmune diseases and oncology.

In August 2022, Formycon published positive interim results for efficacy for FYB202 from the clinical phase III study VESPUCCI. The randomized, double-blind multi-centric phase III study achieved the primary endpoint, demonstrating comparable efficacy of FYB202 and the reference medicine Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

In the extended phase I pharmacokinetics study, the recruitment of study subjects was successfully completed in October 2022. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023.

FYB202 is a proposed biosimilar referencing Johnson & Johnson’s Stelara®, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders. Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis with a global sales volume of more than USD 9.5 billion in 2022.

“We are delighted about the conclusion of the agreement and are looking forward to a successful commercialization of our Ustekinumab biosimilar after approval. The combination of Formycon’s development expertise and Fresenius Kabi’s global commercial competence offers an excellent basis for providing access to our highly efficacious product to many patients,” says Nicola Mikulcik, Chief Business Officer at Formycon AG.

“We welcome the potential of this agreement to build on the strengths of our companies across the value chain from development to commercialization. With the commercialization of the Ustekinumab biosimilar we are expanding our product portfolio with another autoimmune disease treatment option. In line with our Vision 2026, this is yet another key milestone for Fresenius Kabi in delivering on our strategic priority of providing access to biosimilars for patients worldwide,” says Dr. Michael Schönhofen, Fresenius Kabi’s Chief Operating Officer and Member of the Fresenius Kabi Management Board.

 

1) Stelara® is a registered trademark of Johnson & Johnson
2) Middle East and North Africa