SERB has completed its €115 million licensing agreement with Hansa Biopharma, taking over European and MENA commercialisation of kidney transplant therapy Idefirix.

Hansa Biopharma has completed its previously announced €115 million licensing transaction with SERB Pharmaceuticals, transferring responsibility for the development and commercialisation of Idefirix for solid organ transplantation across Europe and the Middle East and North Africa (MENA).

The transaction follows the receipt of all required regulatory approvals and includes an upfront payment of €110 million, alongside a further €5 million payment when the European Medicines Agency accepts a filing seeking full approval for Idefirix.

Under the agreement, SERB assumes responsibility for Idefirix in the European Union, UK, Switzerland, Norway, Liechtenstein, Iceland and the MENA region.

Idefirix, the brand name for imlifidase, is conditionally authorised in Europe as a desensitisation treatment for highly sensitised adult kidney transplant patients with a positive crossmatch against an available deceased donor. The enzyme rapidly cleaves immunoglobulin G antibodies, allowing some patients who would otherwise be unable to receive a compatible kidney transplant to undergo transplantation.

The completion of the agreement strengthens Hansa’s financial position as the company continues preparations for a potential US launch of imlifidase, subject to regulatory approval, while advancing its research and development pipeline.

Renée Aguiar-Lucander, chief executive officer 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 sensitized 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.”

Hansa will now apply to the European Medicines Agency to transfer the marketing authorisation for Idefirix to SERB. The company will continue supporting SERB during the application to convert the medicine from conditional to full marketing approval following positive topline data from its post-authorisation efficacy study announced in May.

Once the marketing authorisation transfer is complete, SERB will also assume responsibility for the long-term follow-up of the post-authorisation efficacy study and the ongoing paediatric clinical programme.

SERB is a specialty pharmaceutical company focused on rare diseases, rare medical emergencies and medical countermeasures, with commercial operations in 18 countries.

The completed licensing agreement enables Hansa to focus resources on expanding development of imlifidase while SERB leads commercial activities for Idefirix across Europe and the MENA region.