By: IPP Bureau
Last updated : May 21, 2026 9:27 am
SERB has a substantial European commercial presence and a successful track record in critical care and rare disease commercialization
Hansa Biopharma AB and SERB S.A. have entered into an exclusive licensing partnership to advance the development and commercialization of IDEFIRIX (imlifidase) across major European and Middle Eastern territories. Under the terms of the agreement, SERB secures sole rights to the therapy within the European Union, the United Kingdom, Switzerland, Norway, Liechtenstein, Iceland, and the MENA (Middle East and North Africa) region.
IDEFIRIX is a first-of-its-kind therapy that specifically targets and neutralizes all forms of immunoglobulin G (IgG) antibodies in just 2 to 6 hours. The European Commission has granted it conditional approval to help prepare highly sensitized adults for kidney transplants—specifically those who have a positive crossmatch test against an available deceased donor. Ultimately, IDEFIRIX represents a major medical breakthrough for patients who previously had very limited treatment options.
Renée Aguiar-Lucander, CEO of Hansa Biopharma, said "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."
Jeremie Urbain, Chairman of SERB, said "SERB is committed to expanding access to transplantation for highly sensitized patients who currently have very limited alternatives. SERB is designed to address rare and urgent conditions, and will leverage its deep expertise, proven commercial execution and established platform across Europe and MENA to expand the reach and clinical impact of IDEFIRIX."
SERB is a, privately owned, global specialty pharmaceutical company with 25+ years of experience in rare diseases, rare medical emergencies and medical countermeasures. With over 70 products across commercial operations in 18 countries, more than 600 employees and a strong M&A track record, SERB is a fully integrated partner with proven, value-driven growth.
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 €110 million and a €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.