Hansa Biopharma has entered into an exclusive licensing agreement worth up to €115 million with SERB Pharmaceuticals for the development and commercialization of IDEFIRIX (imlifidase) across Europe and the Middle East and North Africa (MENA). The deal covers the European Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland and the MENA region, and is intended to strengthen Hansa’s financial position ahead of a planned U.S. launch of IDEFIRIX, subject to a potential U.S. approval in 2026.
Under the agreement, Hansa grants SERB exclusive rights for IDEFIRIX in transplantation in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA. Hansa will receive an upfront payment of €110 million and an additional €5 million upon acceptance of the filing for full approval of IDEFIRIX by the European Medicines Agency (EMA). Hansa will support SERB in preparing and navigating the EMA review following reporting of topline data from the ongoing Post‑Authorization Efficacy Study (PAES), after which SERB will take over responsibility for long‑term PAES follow‑up and the ongoing pediatric study once it becomes Marketing Authorization Holder.
IDEFIRIX is described as a first‑in‑class treatment that targets and cleaves all classes of immunoglobulin G (IgG) antibodies within two to six hours. It holds a conditional marketing authorization from the European Commission for desensitization treatment of highly sensitized adult kidney transplant candidates who have a positive crossmatch against an available deceased donor, a group with significant unmet medical need.
“This agreement is transformative for Hansa Biopharma,” said Renée Aguiar‑Lucander, CEO of Hansa Biopharma. She said the partnership allows patients in the covered regions to benefit from SERB’s established commercial footprint and growth track record, while “crystallizing” the value of the IDEFIRIX franchise and reinforcing Hansa’s financial footing to support an optimized U.S. launch and a path to profitability, contingent on U.S. approval in 2026, alongside continued investment in the company’s R&D pipeline.
Jeremie Urbain, chairman of SERB, said the company aims to expand access to transplantation for highly sensitized patients with few alternatives and will use its expertise and platform in Europe and MENA to extend the reach and clinical impact of IDEFIRIX. SERB is a privately owned global specialty pharmaceutical company with more than 25 years of experience in rare diseases, rare medical emergencies and medical countermeasures, a portfolio of over 70 products, commercial operations in 18 countries, more than 600 employees and a history of M&A activity that supports what it describes as value‑driven growth.
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