Hansa Biopharma Signs IDEFIRIX Licensing Deal With SERB

Hansa Biopharma AB and SERB S.A. have signed an exclusive licensing agreement for development and commercialization of IDEFIRIX (imlifidase) in the European Union (EU), United Kingdom (UK), Switzerland, Norway, Liechtenstein, Iceland and MENA (Middle East and North Africa) regions.

IDEFIRIX is a first-in-class treatment that specifically targets and cleaves all classes of immunoglobulin G (IgG) antibodies within 2 to 6 hours. It is conditionally authorized by the European Commission for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch test against an available deceased donor.

Under the agreement, Hansa has granted SERB an exclusive EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA license for development and commercialization of IDEFIRIX in transplantation. Hansa will receive an upfront payment of €110 million and a €5 million payment upon acceptance of the filing for full approval of IDEFIRIX by the European Medicines Agency (EMA). Hansa will fully support SERB in the filing and EMA review process following the reporting of the Post-Authorization Efficacy Study (PAES) topline data. SERB will assume responsibility for the long-term PAES follow-up and the ongoing pediatric study upon obtaining Market Authorization Holdership, a process expected to be initiated immediately following the closing of the transaction.

Completion of the transaction is subject to customary conditions, including required foreign direct investment (FDI) regulatory approval, and is expected to be completed within 60 days.

Renée Aguiar-Lucander, CEO of Hansa Biopharma, said, “This agreement is transformative for Hansa Biopharma. It allows patients in the region to benefit from a partner with an established commercial footprint and proven growth track record in Europe. At the same time, it crystallizes the value of the franchise and significantly strengthens our financial position assuring an optimized U.S. launch and a pathway to profitability, subject to a 2026 U.S. approval, as well as the continued pursuit of our R&D pipeline.”

Jeremie Urbain, Chairman of SERB, said, “SERB is designed to address rare and urgent conditions, and will leverage its deep expertise, proven commercial execution and established platform across Europe and MENA to expand the reach and clinical impact of IDEFIRIX.”