SERB Acquires Idefirix Rights in Europe and MENA

SERB Pharmaceuticals and Hansa Biopharma have entered into an agreement under which SERB will acquire exclusive development and commercialization rights to Idefirix (imlifidase) across Europe, the United Kingdom, Switzerland, Norway, Liechtenstein, Iceland and the Middle East and North Africa (MENA) region in a deal valued at €115 million.

The agreement strengthens SERB’s presence in rare disease and transplantation medicine while providing Hansa Biopharma with significant upfront funding as it advances its broader immunology pipeline.

Idefirix is a differentiated therapy designed for desensitization in highly sensitized adult patients awaiting kidney transplantation from deceased donors. These patients possess pre-formed immunoglobulin G (IgG) antibodies that can attack donor tissue, substantially increasing the risk of antibody-mediated rejection and making transplantation significantly more difficult.

Highly sensitized patients often face long waiting periods for a compatible organ, with some remaining on transplant waiting lists indefinitely because of immune compatibility challenges.

According to the companies, approximately 70,000 people in Europe with end-stage renal disease await kidney transplantation each year, with an estimated 10% to 15% classified as highly sensitized. For this subgroup, therapeutic options remain limited, creating demand for interventions capable of improving transplant eligibility and outcomes.

Under the transaction terms, SERB will pay €110 million upfront to Hansa and an additional €5 million payment upon acceptance of a filing for full approval of Idefirix by the European Medicines Agency. The medicine currently holds authorization under conditions requiring further efficacy data, and both companies said ongoing regulatory activities will continue following the agreement.

Hansa Biopharma will continue to support SERB during the filing and review process for full approval after topline results from the post-authorization efficacy study (PAES) become available. Once SERB becomes market authorization holder, it will assume responsibility for long-term PAES follow-up as well as an ongoing pediatric study linked to Idefirix.

The companies said the transfer process is expected to begin immediately following completion of the transaction.

Jeremie Urbain, chairman of SERB Pharmaceuticals, said the acquisition aligns with the company’s focus on addressing rare and urgent medical conditions. He noted that highly sensitized transplant patients currently have few alternatives and said SERB intends to leverage its commercial infrastructure and regional expertise across Europe and MENA to broaden access to Idefirix.

The transaction remains subject to customary closing conditions, including foreign direct investment regulatory approval. The companies expect those approvals to be completed within approximately 60 days.

Advisory firms were also engaged on both sides of the transaction. Rothschild & Co is serving as exclusive financial adviser to SERB, while Freshfields is acting as legal counsel. Hansa Biopharma is being advised by Centerview Partners UK LLP and legal counsel Morgan Lewis.

The agreement highlights continued investment in transplant medicine and rare disease therapies, as companies seek to expand access to specialized treatments addressing unmet clinical needs in highly vulnerable patient populations.