SERB Pharmaceuticals acquires rights to Idefirix in US$133.6M deal with Hansa Biopharma

SWEDEN—SERB Pharmaceuticals has agreed to acquire exclusive development and commercialization rights to Idefirix (imlifidase) from Hansa Biopharma in a €115 million (US$133.6 million) deal, strengthening its position in the rare disease and transplantation markets.

The agreement covers the European Union, the UK, Switzerland, Norway, Iceland, Liechtenstein, and the Middle East and North Africa (MENA) region.

Through the deal, SERB aims to expand access to the treatment for highly sensitized kidney transplant patients who face limited donor options due to pre-existing antibodies that increase the risk of organ rejection.

Expanding access to kidney transplantation

Idefirix is a first-in-class treatment designed to help highly sensitized adult kidney transplant patients who face difficulties finding compatible donors.

The therapy works by rapidly cleaving immunoglobulin G (IgG) antibodies within two to six hours, reducing the risk that the patient’s immune system will reject a donated organ.

The treatment currently holds conditional approval in Europe for adults awaiting kidney transplantation from deceased donors who test positive in crossmatch assessments.

These patients often have limited transplant options because their antibodies can attack donor tissues and trigger organ rejection.

Four Phase II clinical trials supported the medicine’s approval, while additional evidence continues to emerge through follow-up and post-authorization studies.

Hansa Biopharma stated that the topline results from the Post-Authorisation Efficacy Study (PAES) will play a central role in the EMA review process for full approval.

Following completion of the transaction, SERB will assume responsibility for the long-term PAES follow-up programme and the ongoing paediatric study upon becoming the Market Authorisation Holder.

Hansa strengthens finances ahead of US launch

The transaction still requires customary regulatory approvals, including foreign direct investment clearance, and both companies expect to complete the process within 60 days.

Hansa Biopharma chief executive officer Renée Aguiar-Lucander described the agreement as transformative for the company, saying it would allow patients to benefit from SERB’s established commercial infrastructure and strong growth record across Europe and MENA markets.

She added that the partnership would strengthen Hansa’s financial position ahead of a potential US launch of Idefirix and support the company’s path to profitability, subject to anticipated US regulatory approval in 2026.

Meanwhile, Jeremie Urbain said SERB aims to expand access to transplantation for highly sensitised patients who currently have few treatment alternatives.

He noted that the company plans to leverage its commercial expertise and regional presence to expand Idefirix’s clinical reach.

Idefirix is also under review in the United States, where the US Food and Drug Administration is expected to issue a decision by 19 December 2026.

The development follows another recent regulatory milestone for SERB after the FDA accepted the biologics license application for bentracimab, developed in partnership with SFJ Pharmaceuticals, for priority review in 2024.