SERB Acquires Idefirix Rights from Hansa Biopharma for €115M

SERB Pharmaceuticals has secured exclusive rights across Europe and the MENA region for Hansa Biopharma's innovative kidney transplant desensitization therapy, Idefirix® (imlifidase). The strategic acquisition, valued at €115 million, significantly expands SERB's rare disease portfolio and its footprint in critical European and North African markets.

This deal positions SERB to address a substantial unmet need within the organ transplantation sector. Idefirix® is designed to enable kidney transplants for highly sensitized adult patients who possess pre-formed IgG antibodies that would otherwise trigger a severe immune response against donor tissue, leading to graft rejection. These patients often face prolonged, or even indefinite, waiting periods for a compatible organ, with an estimated 10-15% of the approximately 70,000 individuals annually awaiting kidney transplants in Europe falling into this highly sensitized category.

Under the terms of the agreement, Hansa Biopharma will receive an initial payment of €110 million, with a further €5 million contingent upon the European Medicines Agency's (EMA) acceptance of the full marketing authorization application for Idefirix®. Hansa Biopharma will provide comprehensive support to SERB Pharmaceuticals throughout the EMA's review process, following the publication of post-authorization efficacy study (PAES) results. SERB Pharmaceuticals will assume responsibility for the long-term follow-up of both the PAES and an ongoing pediatric study once it assumes market authorization holder status.

The transaction, advised by Rothschild & Co for SERB and Centerview Partners UK LLP for Hansa, is subject to customary closing conditions, including regulatory approval for foreign direct investment, anticipated within approximately 60 days. This acquisition underscores SERB's commitment to advancing treatments for rare and urgent pathologies, leveraging its established commercial infrastructure in Europe and the MENA region.

Idefirix®, an enzyme derived from *Streptococcus pyogenes*, functions by cleaving IgG antibodies, thereby neutralizing the immune system's attack on the transplanted organ. Its rapid mechanism of action offers a critical window for transplantation in a patient population with limited therapeutic alternatives. The drug currently holds conditional approval in the EU, UK, Norway, Liechtenstein, and Iceland for highly sensitized adult patients awaiting a kidney transplant from a deceased donor, provided they have a positive crossmatch.

The market for transplant-related therapies is experiencing significant growth, driven by an aging global population and increasing prevalence of end-stage renal disease. Innovations like imlifidase are crucial for improving graft survival rates and expanding access to life-saving transplants. SERB's strategic move into this segment, particularly focusing on the underserved highly sensitized patient group, aligns with broader healthcare trends emphasizing personalized medicine and addressing critical gaps in patient care.