Formycon Acquires Assets for Biosimilars Referencing Lucentis, Stelara

Formycon has signed a deal with ATHOS to merge development activities for 2 biosimilars that will reference Lucentis (ranibizumab) and Stelara (ustekinumab) as part of a long-term partnership.

Formycon signed an agreement with ATHOS to establish a long-term strategic partnership that will support the companies' development activities surrounding biosimilars, allowing Formycon to acquire all or some of the rights to 2 biosimilars: FYB202 and FYB201.

FYB202 is a biosimilar candidate referencing Stelara (ustekinumab) and FYB201 references Lucentis (ranibizumab). Ustekinumab is an immunosuppressant that is used to treat plaque psoriasis, psoriatic arthritis, and inflammatory bowel disease and ranibizumab is a blood vessel growth inhibitor used to treat ophthalmic conditions, including neovascular (or wet) age-related macular degeneration, macular edema, and diabetic retinopathy.

“Formycon is one of the few dedicated biosimilar experts worldwide. We have the common objective of providing patients better access to modern and highly effective therapies. We are confident that Formycon will be in a position to fully exploit its potential in the biosimilars’ growth market through this merger,” said Melissa Simon, managing director of ATHOS, in a statement.

Formycon will have full commercialization, development, and approval rights to the ustekinumab biosimilar and a 50% share in the ranibizumab biosimilar. The Munich, Germany–based company integrated FYB201 in 2013 and FYB202 in 2017 into existing partnerships with Bioeq and Aristo Pharma, a company of ATHOS, respectively. FYB202 was developed through a joint venture between ATHOS and Formycon.

Formycon will also acquire the operational development unit of Bioeq; the 50% shareholding that ATHOS has in Bioeq, which was created through a joint venture between ATHOS and Polpharma Biologics; and a 75.1% share of Aristo Pharma, a fully owned subsidiary of ATHOS.

“The measure empowers Formycon to expand its sphere of operation in the strongly growing biosimilar market. This deal demonstrates our ongoing commitment to sustainable growth through the future income of our biosimilar candidates and continuous expansion of our development pipeline,” said Nicolas Combé, PhD, chief financial officer at Formycon.

The acquisition will allow for Formycon to have a significantly higher share in future revenues from the marketing of the biosimilars, which it will invest in the accelerated and expanded development of its other candidates and will enable future biosimilar candidates to be independently developed.

ATHOS will receive approximately €650 million in transaction payments, including funds related to issuance of the new shares and an earn-out component, as of the date of deal’s completion. After the deal is closed, ATHOS will be Formycon’s largest shareholder, with 26.6% stake in the company. Formycon’s shares, in the context of transactions, were valued at €83.41. Another 15.9% of the shares will be distributed to Wendeln & Cie. The full agreement will include over 50% of all total issued shares of Formycon, which will help support the company over a long period of time so that it can grow to become a fully integrated company operating in the biosimilars space.

The transaction is subject to specific regulatory approvals for the biosimilars and is expected to be closed by midyear 2022.

Stefan Glombitza, PhD, chief operating officer at Formycon, commented, “This takes us into the next stage of partnership with ATHOS and consolidates our position as a highly specialized company for biosimilar development. Pooling expertise in the area of research and development combines the complementary capabilities and strengths of Formycon and Bioeq honed over years of collaborative partnership. This will give the expansion of our development pipeline additional dynamic impetus.”