Immunomodulatory therapy company Hansa Biopharma AB (Nasdaq Stockholm: HNSA) announced on Wednesday that it has completed a EUR115m licensing transaction with SERB Pharmaceuticals covering Idefirix in transplantation across the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and the MENA region.
Idefirix specifically targets and cleaves all classes of immunoglobulin G (IgG) antibodies within two to six hours. The treatment 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
Under the agreement, SERB Pharmaceuticals assumes responsibility for the commercialisation of Idefirix in the licensed territories, while Hansa retains involvement in regulatory support and ongoing development activities. The transaction consists of a EUR110m upfront payment and a EUR5m milestone payment linked to regulatory filing acceptance for full European approval.
Hansa said the deal significantly strengthens its financial position and supports preparations for a potential US launch of imlifidase, subject to FDA approval, with a PDUFA action date set for 19 December 2026. SERB will also take responsibility for long-term follow-up studies and paediatric development obligations once marketing authorisation transfer is completed.
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