Hansa Biopharma and Serb have entered an exclusive licensing agreement for development and commercialisation of Idefirix (imlifidase) in the European Union (EU), United Kingdom (UK), Switzerland, Norway, Liechtenstein, Iceland and MENA (Middle East and North Africa) regions.
Idefirix is a first-in-class treatment that specifically targets and cleaves all classes of immunoglobulin G (IgG) antibodies within two to six hours. It is conditionally authorized by the European Commission for the desensitisation treatment of highly sensitised adult kidney transplant patients with a positive crossmatch test against an available deceased donor. Idefirix offers a pioneering breakthrough for patients with a significant unmet medical need.
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 commercialisation 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 authorisation holdership, a process expected to be initiated immediately following the closing of the transaction.
