Hansa Biopharma licensed exclusive European and MENA rights to IDEFIRIX to SERB in a deal worth up to €115 million, expanding commercialization of the kidney transplant desensitization therapy across key international markets.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Hansa Biopharma and SERB have signed an exclusive licensing agreement for the development and commercialization of IDEFIRIX (imlifidase) across the European Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland, and the Middle East and North Africa (MENA) regions.
The deal grants SERB exclusive rights to commercialize IDEFIRIX in transplantation and includes an upfront payment of €110 million to Hansa, along with an additional €5 million milestone payment tied to the acceptance of a filing for full European Medicines Agency (EMA) approval.
IDEFIRIX is a first-in-class antibody-cleaving therapy designed for highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The therapy works by rapidly cleaving immunoglobulin G (IgG) antibodies within two to six hours, helping reduce immune barriers that can prevent transplantation.
The treatment currently holds conditional approval in the European Union, Norway, Liechtenstein, Iceland, and the United Kingdom. It is also approved in Australia and Switzerland. According to Hansa, the therapy addresses a major unmet need among transplant candidates who are unlikely to receive compatible organs through existing allocation systems.
Hansa CEO Renée Aguiar-Lucander described the agreement as a transformative step for the company, saying the partnership expands patient access through SERB’s established commercial presence in Europe and MENA while strengthening Hansa’s financial position. She added that the transaction supports the company’s planned U.S. launch preparations and continued investment in its research pipeline.
SERB Chairman Jeremie Urbain said the company intends to leverage its rare disease expertise and regional infrastructure to broaden access to transplantation for highly sensitized patients with limited treatment alternatives.
Following the transaction closing, SERB will assume responsibility for ongoing post-authorization commitments, including long-term follow-up of the post-authorization efficacy study (PAES) and an ongoing pediatric study. Hansa will continue to support the regulatory filing and EMA review process related to the transition from conditional to full approval.
The companies expect the transaction to close within approximately 60 days, subject to customary conditions and foreign direct investment regulatory approvals.
Clinical development of imlifidase includes four Phase 2 studies conducted in Europe and the United States, as well as a randomized Phase 3 trial in the U.S. In February 2026, the U.S. Food and Drug Administration accepted Hansa’s biologics license application for imlifidase and assigned a Prescription Drug User Fee Act target action date of December 19, 2026.
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About the Writer
Chikkula Pavan Kumar (LinkedIn), PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.
