SERB Pharmaceuticals (“SERB”) and Hansa Biopharma AB (“Hansa”) (Nasdaq Stockholm: HNSA) announced that they have entered into an agreement under which SERB will acquire the exclusive development and commercialisation rights to Idefirix^® (imlifidase) in the European Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland and the Middle East and North Africa (MENA) region from Hansa for €115 million.

Idefirix^® is a differentiated treatment for the desensitisation of highly sensitised adult patients prior to kidney transplant from a deceased donor. These patients have pre-formed reactive IgG antibodies that can target donor tissue, significantly increasing the risk of antibody-mediated kidney rejection. This makes kidney transplantation in these patients very difficult and may result in patients waiting for transplantation for a lengthy or indefinite period. Of the 70,000 people in Europe with end stage renal diseases awaiting a kidney transplant each year, around 10–15% of these individuals are considered highly sensitised.^{i, ii}

“SERB is committed to expanding access to transplantation for highly sensitised patients who currently have very limited alternatives,” said Jeremie Urbain, Chairman of SERB Pharmaceuticals. “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^®.”

Under the agreement, 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 becoming Market Authorisation Holder, a process expected to be initiated immediately following closing of the transaction.

Completion of the transaction is subject to customary conditions, including required foreign direct investment (FDI) regulatory approval, which is expected to be completed within 60 days.

Rothschild & Co. is acting as exclusive financial advisor and Freshfields is acting as legal counsel to SERB.

Centerview Partners UK LLP is acting as exclusive financial advisor and Morgan Lewis is acting as legal counsel to Hansa.