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.

“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 US launch and a pathway to profitability, subject to a 2026 US approval, as well as the continued pursuit of our R&D pipeline,” says Renée Aguiar-Lucander, CEO of Hansa Biopharma.

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 EUR 110 million and a EUR 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 paediatric study upon obtaining Market Authorization Holdership, a process expected to be initiated immediately following the closing of the transaction.