Hansa Biopharma and SERB have announced an exclusive licensing agreement for development and commercialisation of IDEFIRIX (imlifidase) in the European Union (EU), United Kingdom (UK), Switzerland, Norway, Liechtenstein, Iceland and Middle East and North Africa (MENA) 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 authorised by the European Commission for the desensitisation treatment of highly sensitised adult kidney transplant patients with a positive crossmatch test against an available deceased donor. IDEFIRIX offers a pioneering breakthrough for patients with a significant unmet medical need.

Renée Aguiar-Lucander, CEO, 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 crystallises the value of the franchise and significantly strengthens our financial position assuring an optimised US launch and a pathway to profitability, subject to a 2026 US approval, as well as the continued pursuit of our R&D pipeline.”

Under the agreement, Hansa has granted SERB an exclusive EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA license for development and commercialisation 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-Authorisation Efficacy Study (PAES) topline data. SERB will assume responsibility for the long-term PAES follow-up and the ongoing pediatric study upon obtaining Market Authorisation Holdership, a process expected to be initiated immediately following the closing of the transaction.

Jeremie Urbain, Chairman, SERB, said, “SERB is committed to expanding access to transplantation for highly sensitised patients who currently have very limited alternatives. 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.”

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.