Hansa Biopharma has entered an exclusive licensing agreement with SERB for the development and commercialization of IDEFIRIX (imlifidase) in the EU, UK, Switzerland, Norway, Iceland, Liechtenstein, and MENA. Hansa receives €110 million upfront and €5 million upon EMA filing acceptance.
Hansa Biopharma and SERB have announced an exclusive licensing agreement for the development and commercialization of IDEFIRIX (imlifidase) in the European Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland, and the Middle East and North Africa (MENA) regions, according to official disclosures.
IDEFIRIX is a first-in-class treatment that specifically targets and cleaves all classes of immunoglobulin G (IgG) antibodies within 2 to 6 hours. It is conditionally authorized by the European Commission for desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch test against an available deceased donor.
This development matters because the agreement allows patients in the region to benefit from SERB’s established commercial footprint and proven growth track record in Europe and MENA. Hansa will receive an upfront payment of €110 million and a €5 million payment upon acceptance of the filing for full approval by the European Medicines Agency (EMA).
Hansa will support SERB in the filing and EMA review process following the Post-Authorization Efficacy Study (PAES) topline data. SERB will assume responsibility for long-term PAES follow-up and the ongoing pediatric study upon obtaining Market Authorization Holdership. Completion is subject to foreign direct investment (FDI) regulatory approval and is expected within 60 days.
Industries impacted include rare disease therapeutics, organ transplantation, and specialty pharmaceuticals.
Regional stakeholders include kidney transplant centers, nephrologists, and highly sensitized patients across Europe and MENA.
For investors, the deal crystallizes value for Hansa’s franchise, strengthens its financial position for a potential US launch (subject to 2026 US approval), and supports continued R&D pipeline investment.
Hansa Biopharma is a Swedish biopharmaceutical company listed on Nasdaq Stockholm (HNSA), focused on immunoglobulin G-cleaving enzymes.
SERB is a privately held global specialty pharmaceutical company headquartered in Europe, with 25+ years of experience in rare diseases and rare medical emergencies, operating in 18 countries with over 600 employees.
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