Hansa Biopharma has completed an exclusive licensing transaction worth up to €115 million with SERB Pharmaceuticals for Idefirix in solid organ transplantation across Europe and the Middle East and North Africa (MENA). Under the agreement, SERB assumes responsibility for commercialization of Idefirix in transplantation in the European Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland and the MENA region. The deal follows receipt of required regulatory approvals and includes an upfront payment of €110 million, plus a €5 million payment upon acceptance of the filing for full approval of Idefirix by the European Medicines Agency.
Idefirix is described as a first‑in‑class treatment that specifically targets and cleaves all classes of immunoglobulin G antibodies within two to six hours. It is conditionally authorized by the European Commission for desensitization treatment in highly sensitized adult kidney transplant patients who have a positive crossmatch test against an available deceased donor, addressing a group with significant unmet medical need.
Hansa said the transaction significantly strengthens its financial position and supports preparations for a potential US launch of imlifidase, subject to regulatory approval, while it continues to advance its broader research and development pipeline. The company plans to apply to the EMA for transfer of the Idefirix marketing authorization to SERB and will support SERB in the filing and review process for conversion to full approval, based on topline data from the Post‑Authorization Efficacy Study reported in May. SERB will take on responsibility for long‑term PAES follow‑up and the ongoing pediatric study once it becomes the marketing authorization holder.
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