SERB Pharmaceuticals has signed an agreement to acquire exclusive development and commercialisation rights to Idefirix (imlifidase) from Hansa Biopharma for a total of €115m ($133.6m).
The deal covers the European Union, Iceland, Liechtenstein, Norway, Switzerland, the UK, and the Middle East and North Africa (MENA) region.
Idefirix is used to desensitise adult patients before a kidney transplant from deceased donors, focusing on those with reactive immunoglobulin G (IgG) antibodies that could target donated tissues and increase the risk of rejection.
Under the agreement, Hansa will receive €110m upfront, with a further €5m payable once the European Medicines Agency (EMA) accepts the full approval filing for Idefirix.
Hansa will support SERB through the EMA review process after topline results from the Post-Authorisation Efficacy Study (PAES).
SERB will take responsibility for long-term PAES follow-up and ongoing paediatric research once it becomes a Market Authorisation Holder.
The transaction awaits customary regulatory clearances, including foreign direct investment approval, and completion is expected within 60 days.
Idefirix, an antibody-cleaving enzyme from Streptococcus pyogenes, is conditionally approved in Europe for desensitising highly sensitised adult kidney transplant candidates.
Four Phase II clinical trials supported its approval, and further data will be submitted from follow-up and post-approval studies. The product is under review for US approval, with the Food and Drug Administration (FDA) decision expected by 19 December 2026.
SERB Pharmaceuticals chairman Jeremie Urbain said: “SERB is committed to expanding access to transplantation for highly sensitised patients who currently have very limited alternatives.
“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.”
In August 2024, the FDA accepted the biologics licence application (BLA) of SFJ Pharmaceuticals and SERB Pharmaceuticals’ bentracimab for filing and priority review.
by Salong Debbarma
Source: pharmaceutical-technology.com
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