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LUND, Sweden and PETACH TIKVA, Israel, Dec. 7, 2021 /PRNewswire/ — Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), a pioneer in enzyme expertise for uncommon immunological circumstances, and Medison Pharma, a world pharma firm targeted on offering entry to extremely revolutionary therapies to sufferers in worldwide markets (“Medison”), at this time announce a multiregional settlement for Medison to commercialize Hansa’s desensitization remedy for kidney transplants in Central Jap Europe and Israel. The commercialization relies on present conditional advertising and marketing authorization for the EU and the UK, and pending advertising and marketing authorization by Israel’s Ministry of Well being. A respective software for advertising and marketing authoritization for desensitization remedy in kidney transplant was filed in Israel earlier this 12 months and, if granted, will make Israel the primary market outdoors of Europe the place imlifidase is commercialized. Hansa and Medison will probably be working collectively to acquire pricing and reimbursement as required relying on the nation.
The partnership covers the next international locations inside the Central Jap European area: Croatia, Hungary, Poland and Slovenia along with Israel.
“This new business partnership with Medison Pharma is a crucial milestone for Hansa because it expands entry to imlifidase for extremely sensitized sufferers awaiting kidney transplants,” says Søren Tulstrup, President & CEO of Hansa. “Sufferers with this uncommon situation at the moment face lengthy wait occasions or are unable to discover a appropriate donor match, resulting from excessive ranges of preformed antibodies elevating the danger of rejection.”
“We’re delighted to accomplice with Hansa Biopharma to speed up the attain of this novel remedy for kidney illness”, says Meir Jakobsohn, Founder and CEO of Medison Pharma. “In our joint dedication to deal with the unmet medical wants of sufferers with uncommon circumstances, we sit up for leveraging our business platform and offering sufferers in worldwide markets with entry to this a lot wanted remedy.”
For extra info:
Klaus Sindahl, Head of Investor Relations
M: +46 (0) 709–298 269
E: [email protected]
Katja Margell, Head of Company Communications
M: +46 (0) 768-198 326
E: [email protected]
Maya Nix, Company Communications Lead
E: [email protected]
Imlifidase is an enzyme derived from the bacterium Streptococcus pyogenes, with the power to particularly goal and cleave (or break) all courses of immunoglobulin G (IgG) antibodies2.
IgG antibodies focused particularly on the transplanted kidney are often known as preformed Human Leukocyte Antigens (HLAs) or donor-specific antibodies (DSAs)3. Extremely sensitized sufferers have excessive ranges of those preformed antibodies that may bind to the donor organ damaging the transplant4. As soon as they’re inactivated with imlifidase, there’s a window of alternative for the transplant to happen. By the point the physique begins renewing the depleted antibodies, the affected person will probably be taking immunosuppressive remedy to proceed to cut back the danger of organ rejection.
The efficacy and security of imlifidase as a pre-transplant remedy to cut back donor-specific IgG was studied in 4 Part 2 open-label, single-arm, six-month scientific trials3,5,6,7.
Hansa is now amassing additional scientific proof and can submit extra efficacy and security knowledge based mostly on one observational follow-up examine and one post-approval efficacy examine. Imlifidase was reviewed as a part of the European Medicines Company’s PRIority MEdicines (PRIME) scheme, which helps medicines that will provide a serious therapeutic benefit over present therapies, or profit sufferers with out remedy choices1.
Imlifidase was granted conditional European Advertising Authorization from the European Drugs’s Company (EMA) in August 2020 for the desensitization remedy of extremely sensitized grownup kidney transplant sufferers with a constructive crossmatch take a look at towards an obtainable deceased donor. The usage of imlifidase needs to be reserved for sufferers unlikely to be transplanted beneath the obtainable kidney allocation system together with prioritization packages for extremely sensitized sufferers1. Conditional approval permits the Company to advocate a drugs for advertising and marketing authorization in instances the place the good thing about a drugs’s quick availability to sufferers, outweighs the danger that not all the info are but obtainable.
About kidney failure
Kidney illness can progress to kidney failure or Finish-Stage Renal Illness (ESRD), recognized when a affected person’s kidney perform is lower than 15%8. ESRD poses a major well being burden, affecting practically 2.5 million sufferers worldwide7. A kidney transplant is the remedy of alternative for appropriate sufferers with ESRD as a result of it affords improved survival and high quality of life advantages in comparison with long-term dialysis. There are roughly 80,000 kidney sufferers on transplant ready lists throughout the European Union9.
About Hansa Biopharma
Hansa Biopharma is a pioneering commercial-stage biopharmaceutical firm on a mission to develop and commercialize revolutionary, lifesaving, and life-altering therapies for sufferers with uncommon immunological circumstances. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme remedy, which has been proven to allow kidney transplantation in extremely sensitized sufferers. Hansa has a wealthy and increasing analysis and growth program, based mostly on the Firm’s proprietary IgG-cleaving enzyme expertise platform, to deal with critical unmet medical wants in transplantation, autoimmune illnesses, gene remedy, and most cancers. Hansa Biopharma relies in Lund, Sweden, and has operations in Europe and the U.S. The Firm is listed on Nasdaq Stockholm beneath the ticker HNSA. Discover out extra at www.hansabiopharma.com.
About Medison Pharma
Medison is a world pharma firm targeted on offering entry to extremely revolutionary therapies to sufferers in worldwide markets. Medison is the primary to create a global commercialization platform for extremely revolutionary therapies, serving to to avoid wasting and enhance lives by making the most effective obtainable novel therapies accessible to sufferers in worldwide markets. Medison has a monitor file of multi-territorial partnerships with main pharmaceutical and biotech corporations searching for to broaden their international attain. Medison can be an lively investor in disruptive healthcare applied sciences and offers its companions with publicity to innovation in biotech and digital well being. To be taught extra go to www.medisonpharma.com and comply with us on LinkedIn.
1 European Medicines Company. Out there at: https://www.ema.europa.eu/en/medicines/human/EPAR/idefirix. Final accessed: October 2021.
2 Hansa. Idefirix® Abstract of Product Traits. August 25 2020.
3 Jordan SC, et al. N Engl J Med 2017; 377(5):442-453.
4 Zhang R. Scientific Journal of the American Society of Nephrology 2018;13(1):182-192.
5 Lorant T, et al. Am J Transplant 2018;18(11):2752-2762.
6 Winstedt L, et al. PLoS One 2015; 10(7): e0132011.
7Jordan SC et al. Transplantation 2021;105(8):1808-1817.
8 NIH (2018). What’s kidney failure? Out there at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure. Final accessed: October 2021.
9 E-newsletter Transplant. EDQM 2020;Vol25:58–60.
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