Hansa Biopharma and SERB S.A. has announced required regulatory approvals have been obtained and that the previously announced exclusive licensing transaction with SERB has closed.
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Under the agreement, Hansa has granted SERB an exclusive license for the development and commercialisation of Idefirix in solid organ transplantation in the European Union (EU), United Kingdom (UK), Switzerland, Norway, Liechtenstein, Iceland and the MENA (Middle East and North Africa) region. The total transaction value is €115 million, comprising 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.
Idefirix is a treatment that specifically targets and cleaves all classes of immunoglobulin G (IgG) antibodies within 2 to 6 hours. It is conditionally authorised 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.
Renée Aguiar-Lucander, CEO of Hansa Biopharma, said: “The closing of this transaction marks an important milestone for Hansa. With SERB as our partner in Europe and MENA, we believe Idefirix will benefit from additional expertise, reach and resources to enable access for appropriate highly sensitised kidney transplant patients, addressing a significant unmet medical need. At the same time, the transaction strengthens Hansa’s financial position as we continue to prepare for a potential US launch of imlifidase, subject to US approval, and advance our broader R&D pipeline.”
SERB is a privately owned, 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.
Hansa will apply to the EMA for transfer of the Market Authorisation of Idefirix to SERB and continue to fully support SERB in the filing for conversion to full approval and the EMA review process based on the outcome of the Post-Authorisation Efficacy Study topline data announced 27th May. SERB will assume responsibility for the long-term PAES follow-up and the ongoing paediatric study upon obtaining Market Authorisation Holdership.
Centerview Partners UK LLP acted as exclusive financial advisor and Morgan Lewis acted as legal counsel to Hansa.
Rothschild & Co. acted as exclusive financial advisor and Freshfields acted as legal counsel to SERB.
