SERB Pharmaceuticals

SERB Pharmaceuticals Completes Acquisition of European and MENA Rights to Idefirix® (imlifidase) from Hansa Biopharma

BRUSSELS, July 01, 2026 (GLOBE NEWSWIRE) -- SERB Pharmaceuticals, a global specialty pharmaceutical company designed to address rare and urgent conditions, today announced that it has completed the acquisition of exclusive development and commercialization rights to Idefirix^® (imlifidase) in the European Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland and the Middle East and North Africa (MENA) region from Hansa Biopharma.

“Adding Idefirix to the SERB portfolio reflects SERB’s continued commitment to supplying medicines for rare and urgent conditions, where time and complexity leave no room for failure,” said Jeremie Urbain, Chairman of SERB Pharmaceuticals. “With SERB’s established commercial and medical capabilities and broad international footprint, we are well positioned to expand the availability of Idefirix^® to more patients in Europe and to explore opportunities for expansion into the MENA region, subject to applicable approvals.”

Idefirix is conditionally approved in the European Union, pending completion of a post-authorization efficacy study (PAES) required by the European Medicines Agency (EMA). Results published last month by Hansa Biopharma showed that the study met its primary endpoint, with 90% of patients achieving one-year graft failure-free survival following Idefirix-mediated conversion of a positive crossmatch to enable transplantation. Based on these findings, the post-authorization obligation has now been fulfilled, and a submission to convert to full marketing authorization is planned by the end of 2026.

About Idefirix^® (imlifidase)

Idefirix^® is an antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune response.ⁱ It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration.

Imlifidase is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename Idefirix^® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.

The use of Idefirix^® should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritisation programs for highly sensitised patients^ii. Idefirix^® was reviewed as part of the European Medicines Agency’s (EMA) Priority Medicines (PRIME) program.

Full EU product information can be accessed via the initial Summary of Product Characteristics found here. 

The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG was studied in four Phase 2 open-label, single-arm, six-month clinical trials.^{iii, iv, v, vi} Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one observational follow-up study and one post-approval efficacy study. 

About SERB Pharmaceuticals

SERB is a fast-growing global specialty pharma company designed to address rare and urgent conditions by delivering life-saving medicines when time and complexity leave no room for failure. With a model that combines biotech agility and global pharma reliability, SERB operates end-to-end across 100+ countries, ensuring 70+ essential medicines for rare diseases, rare emergency medicine, and medical countermeasures reach patients and clinicians with urgency, wherever and whenever they are needed. Our growth is driven by selective acquisitions and geographic expansion, powered by teams who go the extra mile to keep critical medicines available worldwide.

Learn more at https://SERB.com.

Contact:

SERB Pharmaceuticals:
Chris Sampson, VP of Communications
chris.sampson@serb.com; Tel: +44 (0)7773 251 178

Media Contact:

LifeSci Communications
Michael Fitzhugh
mfitzhugh@lifescicomms.com

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References:

ⁱ Huang, E., Maldonado, A. Q., Kjellman, C., & Jordan, S. C. (2022). Imlifidase for the treatment of anti-HLA antibody-mediated processes in kidney transplantation. American Journal of Transplantation, 22(3), 691–697. doi 10.1111/ajt.16828

ⁱⁱ European Medicines Agency. Idefirix^® summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf.

ⁱⁱⁱ Heidt S, et al. Highly Sensitized Patients are Well Serves by Receiving a Compatible Organ Offer Based on Acceptable Mismatches. Front Immunol. 2021;12:687254. doi 10.3389/fimmu.2021.687254

^iv Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med. 2017 Aug 3;377(5):442-453. doi: 10.1056/NEJMoa1612567. Erratum in: N Engl J Med. 2017 Oct 26;377(17):1700. doi: 10.1056/NEJMx170015.

^v Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS–A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. PMID: 26177518; PMCID: PMC4503742.

^vi Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733.