SERB Pharmaceuticals and Hansa Biopharma AB (HNSA.ST) announced Tuesday their agreement, under which SERB will acquire exclusive rights to develop and sell Hansa's kidney transplant drug Idefirix in Europe and the Middle East and North Africa or MENA region for 115 million euros.
Idefirix, or imlifidase, is used to desensitize highly sensitised adult patients before kidney transplant from a deceased donor.
The treatment targets pre-formed IgG antibodies that increase the risk of organ rejection.
Under the deal, SERB will get rights to Idefirix in the European Union, UK, Switzerland, Norway, Liechtenstein, Iceland and the MENA region.
Hansa Biopharma will receive an upfront payment of 110 million euros and 5 million euros upon acceptance by the European Medicines Agency of the filing for full approval of Idefirix.
Hansa said it will support SERB in the EMA filing and review process.
SERB will take responsibility for the drug's long-term Post-Authorization Efficacy Study and an ongoing paediatric study once it becomes marketing Authorisation Holder. The process will be initiated immediately following closing of the transaction, which is expected within 60 days, pending approvals.
Imlifidase is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename Idefirix for the desensitization treatment.
In the US, the Food and Drug Administration accepted the Biologics License Application for imlifidase in February of 2026. The agency has assigned a Prescription Drug User Fee Act or PDUFA action date of December 19, 2026.
In the transaction, Rothschild & Co. advised SERB in financial terms, with Freshfields acting as legal counsel. Centerview Partners UK LLP advised Hansa, with Morgan Lewis as legal counsel.
On the Nasdaq Stockholm Exchange, shares of Hansa Biopharma closed Monday's trading 2.70 percent lower at 28.84 Swedish kronor.
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