BRUSSELS, Might 19, 2026 (GLOBE NEWSWIRE) — SERB Prescribed drugs (“SERB”) and Hansa Biopharma AB (“Hansa”) (Nasdaq Stockholm: HNSA) lately introduced that they have got entered into an settlement underneath which SERB will gain the unique construction and commercialisation rights to Idefirix® (imlifidase) within the Eu Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland and the Center East and North Africa (MENA) area from Hansa for €115 million.
Idefirix® is a differentiated remedy for the desensitisation of extremely sensitised grownup sufferers previous to kidney transplant from a deceased donor. Those sufferers have pre-formed reactive IgG antibodies that may goal donor tissue, considerably expanding the chance of antibody-mediated kidney rejection. This makes kidney transplantation in those sufferers very tricky and would possibly lead to sufferers looking forward to transplantation for a long or indefinite duration. Of the 70,000 other people in Europe with finish degree renal sicknesses anticipating a kidney transplant each and every yr, round 10–15% of those persons are thought to be extremely sensitised.i, ii
“SERB is committed to expanding access to transplantation for highly sensitised patients who currently have very limited alternatives,” stated Jeremie Urbain, Chairman of SERB Prescribed drugs. “SERB is designed to address rare and urgent conditions, and will leverage its deep expertise, proven commercial execution and established platform across Europe and MENA to expand the reach and clinical impact of Idefirix®.”
Beneath the settlement, Hansa will obtain an prematurely fee of €110 million and a €5 million fee upon acceptance of the submitting for complete approval of Idefirix® through the Eu Drugs Company (EMA). Hansa will absolutely toughen SERB within the submitting and EMA assessment procedure following the reporting of the Put up-Authorization Efficacy Find out about (PAES) topline information. SERB will suppose duty for the long-term PAES follow-up and the continuing paediatric find out about upon turning into Marketplace Authorisation Holder, a procedure anticipated to be initiated straight away following last of the transaction.
Final touch of the transaction is matter to standard stipulations, together with required overseas direct funding (FDI) regulatory approval, which is predicted to be finished inside 60 days.
Rothschild & Co. is appearing as unique monetary marketing consultant and Freshfields is appearing as criminal suggest to SERB.
Centerview Companions UK LLP is appearing as unique monetary marketing consultant and Morgan Lewis is appearing as criminal suggest to Hansa.
About extremely sensitised sufferers anticipating kidney transplantation
Extremely sensitised sufferers are a in particular underserved workforce in kidney transplantation, representing an estimated 10–15% of people on transplant ready lists. Those sufferers lift top ranges of pre-formed donor particular antibodies (DSA) with large reactivity in opposition to human leukocyte antigens (HLA), usually as a consequence of earlier transplants, blood transfusions, or pregnancies. Because of this, they face a considerable immunological barrier to transplantation, as DSAs can cause an instantaneous immune reaction in opposition to a donor organ, resulting in tissue injury and most probably graft rejection. Those sufferers are stated to have a ‘positive crossmatch’, which means their immune machine is expected to react in opposition to a possible donor organ, which prevents transplantation and can result in extended and in some instances indefinite ready instances, leaving them depending on long-term dialysis whilst anticipating a viable matched organ.
About Idefirix® (imlifidase)
Idefirix® is an antibody-cleaving enzyme originating from Streptococcus pyogenes that in particular goals and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune reaction.iii It has a speedy onset of motion, cleaving IgG-antibodies and inhibiting their process inside hours after management.
Imlifidase is conditionally authorized within the Eu Union, Norway, Liechtenstein, Iceland and the United Kingdom underneath the tradename Idefirix® for the desensitization remedy of extremely sensitized grownup kidney transplant sufferers with a good crossmatch in opposition to an to be had deceased donor.
Using Idefirix® must be reserved for sufferers who’re not going to be transplanted underneath the to be had kidney allocation machine, together with prioritisation methods for extremely sensitised sufferers.iv Idefirix® used to be reviewed as a part of the Eu Drugs Company’s (EMA) Precedence Drugs (PRIME) program.
Complete EU product news will also be accessed by way of the preliminary Abstract of Product Traits discovered right here.
In the USA, the Meals and Drug Management (FDA) accredited the Biologics License Utility (BLA) for imlifidase in February of 2026 and assigned a Prescription Drug Person Charge Act (PDUFA) motion date of December 19, 2026.
The efficacy and protection of imlifidase as a pre-transplant remedy to cut back donor-specific IgG used to be studied in 4 Section 2 open-label, single-arm, six-month scientific trials.v, vi, vii, viii Hansa is accumulating additional scientific proof and can put up further efficacy and protection information in response to one observational follow-up find out about and one post-approval efficacy find out about.
About SERB Prescribed drugs
SERB is a fast-growing international uniqueness pharma corporate designed to handle uncommon and pressing stipulations through handing over life-saving drugs when time and complexity depart no room for failure. With a fashion that mixes biotech agility and international pharma reliability, SERB operates end-to-end throughout 100+ nations, making sure 70+ very important drugs for uncommon sicknesses, uncommon emergency medication, and clinical countermeasures succeed in sufferers and clinicians with urgency, anywhere and every time they’re wanted. Our expansion is pushed through selective acquisitions and geographic growth, powered through groups who pass the additional mile to stay essential drugs to be had international.
Be informed extra at https://SERB.com.
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________________i International Observatory on Donation and Transplantation (GODT) information, produced through the WHO-ONT collaboration.
ii Sypek, Matthew P. MBBS1,2,3,4; Kausman, Joshua Y. PhD3,5,6; Watson, Narelle MSc7; Wyburn, Kate PhD8; Holt, Stephen G. PhD1,2; Hughes, Peter PhD1,2; Clayton, Philip A. PhD4,9,10. The Advent of cPRA and Its Affect on Get admission to to Deceased Donor Kidney Transplantation for Extremely Sensitized Sufferers in Australia. Transplantation 105(6):p 1317-1325, June 2021. doi: 10.1097/TP.0000000000003410
iii Huang, E., Maldonado, A. Q., Kjellman, C., & Jordan, S. C. (2022). Imlifidase for the remedy of anti‑HLA antibody‑mediated processes in kidney transplantation. American Magazine of Transplantation, 22(3), 691–697. doi 10.1111/ajt.16828
iv Eu Drugs Company. Idefirix® abstract of product traits. To be had at: https://www.ema.europa.european/en/paperwork/product-information/idefirix-epar-product-information_en.pdf.
v Heidt S, et al. Extremely Sensitized Sufferers are Smartly Serves through Receiving a Appropriate Organ Be offering In keeping with Appropriate Mismatches. Entrance Immunol. 2021;12:687254. doi 10.3389/fimmu.2021.687254
vi Jordan SC, et al. IgG Endopeptidase in Extremely Sensitized Sufferers Present process 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.
vii Winstedt L, et al. Whole Removing of Extracellular IgG Antibodies in a Randomized Dose-Escalation Section I Find out about with the Bacterial Enzyme IdeS–A Novel Healing Alternative. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/magazine.pone.0132011. PMID: 26177518; PMCID: PMC4503742.
viii Lorant T, et al. Protection, immunogenicity, pharmacokinetics, and efficacy of deterioration of anti-HLA antibodies through IdeS (imlifidase) in continual kidney illness sufferers. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733.
