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  • Hansa Biopharma AB
    Scheelevägen 22 22363 Lund, Sweden
    +46 (0) 461 656 70
    http://www.hansabiopharma.com
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    Hansa Medical lead candidate imlifidase (IdeS) granted orphan drug designation by the FDA for anti-GBM antibody disease

    Hansa Medical today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to imlifidase (IdeS) for the treatment of anti-GBM antibody disease (anti-GBM), also known as Goodpastures disease. More information about the orphan drug designation has been posted on www.fda.govAnti-GBM is a severe kidney disease where the immune system mistakenly develops IgG-antibodies, resulting in an acute immune attack on the kidneys and in some patients also on the lungs. In severe anti-GBM, the disease may progress to renal failure or death. There is no approved

    Completed enrollment in Hansa Medical’s international multi-center Phase II study Highdes

    Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announced today the completion of enrollment for the international multi-center study Highdes.The study aimed to recruit 15-20 patients. A total of 18 patients have been treated with the company’s lead candidate IdeS and subsequently transplanted at five clinics in the US and Europe. All treated and transplanted patients will be followed up for six months. The primary objective of the study - to turn a positive cross-match test into a negative and thereby enable kidney

    The New England Journal of Medicine publishes results from Phase II studies of Hansa Medical’s lead candidate IdeS in highly sensitized patients

    Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company developing novel immunomodulatory enzymes, today announced that combined data from three independent clinical Phase II studies with Hansa Medical’s lead candidate IdeS will appear in The New England Journal of Medicine 2017;377:442-53, August 3, 2017 issue.In the article “IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation”, researchers demonstrated that treatment with IdeS is effective in reducing donor specific antibodies (DSAs) to levels allowing lifesaving kidney transplantation of highly

    Hansa Medical’s application for Orphan Drug Designation for IdeS in the EU receives positive opinion

    LUND, Sweden, December 15, 2016, Hansa Medical AB (publ: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announces that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion on Hansa Medical’s application for Orphan Drug Designation of recombinant IdeS for the prevention of graft rejection following solid organ transplantation. In September 2015, IdeS was granted Orphan Drug Designation for the prevention of antibody mediated organ rejection in solid organ transplant patients by the U.S. Food and

    Hansa Medical proposes a directed share issue

    · The board of directors of Hansa Medical AB (publ) (“Hansa Medical” or the “Company”) proposes a directed share issue of approximately SEK 185 million. · The subscription price for the issue is proposed to be SEK 70 per share. · The issue is directed to selected international specialist investors including HBM Healthcare Investments, Sectoral Asset Management, Sphera Funds Management and Aescap, as well as Swedish institutional and strategic investors including Carnegie Asset Management,AFA Insurance, KK-stiftelsen, Thomas Olausson and Unionen. · Shareholders representing

    Hansa Medical Interim report April – June 2016

    Continued positive development of IdeS in clinical studiesSecond quarter in brief Business highlights›› US Food and Drug Administration (FDA) cleared Hansa Medical’s IND application for a study with IdeS in kidney transplantation ›› All patients are recruited and successfully desensitized in Swedish Phase II study with IdeS in kidney transplantation ›› Successful desensitization with IdeS in all recruited patients in ongoing US Phase II study with kidney transplantation ›› Hansa Medical appointed Henk Doude van Troostwijk as Vice President, Commercial Operations ›› Annual

    Hansa Medical AB (publ) - Year-End Report 2015

    Several significant milestones reached in 2015January – December 2015 in summary – Highlights October – December · Hansa Medical’s shares began trading on Nasdaq Stockholm on November 2, 2015 · Data from the first patient in the ongoing US study with IdeS in highly sensitized patients presented at Hansa Medical’s Capital Markets Day on November 13, 2015, showed that one dose of IdeS effectively inactivates donor specific antibodies · Data published in Journal of Immunology shows that IdeS temporarily can silence B-cells, preventing B-cells from developing into antibody

    Successful Phase 2 Study of IdeS in Highly Sensitized Dialysis Patients awaiting Kidney Transplantation

    Hansa Medical AB today announced preliminary data showing that IdeS has very good efficacy in a phase 2 study with 8 highly sensitized patients on the waiting-list for kidney transplantation. The study shows that IdeS has the capacity to make sensitized patients eligible for transplantation by decreasing HLA antibodies to acceptable levels. IdeS increased the probability of compatible transplantation by reducing the percentage panel reactivity to low levels in all patients.Hansa Medical AB today announced preliminary data showing that IdeS has very good efficacy in a phase 2 study with 8

    The Hansa Medical candidate drug IdeS has enabled successful kidney transplantation

    A successful kidney transplantation of an HLA sensitized patient has been accomplished following desensitization with the candidate drug IdeS at Uppsala University Hospital. The patient is enrolled in the ongoing Phase II study sponsored by Hansa Medical with the primary objective to study IdeS’ capacity to reduce levels of anti-HLA antibodies in sensitized patients.HLA sensitized patients rarely become transplanted due to the immediate risk of transplant rejection caused by donor specific anti-HLA antibodies. However, following treatment with IdeS the now transplanted patient became

    Phase II IdeS-study initiated in Uppsala

    Hansa Medical announces treatment of the first patient in a Phase II study with the drug candidate IdeS. The study is carried out at Uppsala University Hospital targeting IdeS’ safety and efficacy on anti-HLA antibodies in sensitized patients.The drug candidate IdeS is developed as a fast, safe and expedient method to deactivate anti-HLA antibodies in sensitized patients prior to kidney transplantation. The objective is to facilitate kidney transplantation for thousands of sensitized kidney patients within minutes after intravenous treatment with IdeS. In January 2014, a successful Phase I-

    Hansa Medical to present IdeS at the 2014 World Transplant Congress in San Francisco, July 27

    Hansa Medical will present the drug candidate IdeS’s potential as a novel treatment for desensitization prior to kidney transplantation, at the poster session on July 27 at the 2014 World Transplant Congress in San Francisco, USA.The World Transplant Congress gathers international experts on transplantation, attracts prominent keynote speakers as well as pharmaceutical and biotechnology companies committed to the improvement of treatment of transplantation patients. For more information about the World Transplant Congress, please visit: www.wtc2014.org The poster presentation will

    Hansa Medical to present IdeS at the 2014 BIO International Convention in San Diego, USA, on June 26

    Hansa Medical will present the drug candidate IdeS, currently in clinical development, as a method for desensitization prior to kidney transplantation, at 10:15 a.m. in the convention’s venue Mission Beach.The 2014 BIO International Convention (Biotechnology Industry Organization), June 23 through 26, will be held at the San Diego Convention Center in San Diego, California. The convention gathers international and US-based industry leading parties, prominent keynote speakers, and attracts extensive media coverage. For more information about the event, please visit: www.convention.bio.org

    Swedish Medical Products Agency approves Hansa Medical’s clinical Phase II-study application with IdeS

    Hansa Medical announces the Swedish Medical Products Agency’s approval of the application to carry out a clinical Phase II-study with the drug candidate IdeS. The study’s primary objective is to investigate IdeS’ efficacy and safety in sensitised kidney transplantation patients. The Phase II-study will be conducted at Uppsala University Hospital and is scheduled to begin in the second quarter of 2014.The drug candidate IdeS is developed for fast and efficient inactivation of circulating IgG-antibodies in sensitised patients awaiting kidney transplants. The ambition is to enable

    Hansa Medical’s rights issue oversubscribed

    Hansa Medical’s rights issue with preferential rights has been subscribed at 137 percent of which 99 percent was subscribed through preferential rights. The rights issue comprises 3.7 million shares at SEK 10 per share, which brings SEK 37 million to the company before issue expenses. The capital will be used for Phase II-studies with the drug candidate IdeS during 2014 and 2015.An extraordinary general meeting held on March 5, 2014, resolved to carry through a rights issue of at the most 3 704 229 shares with preferential rights at SEK 10 per share. The subscription period for the offer

    Hansa Medical appoints Medical Advisory Board

    Hansa Medical is pleased to announce Professor Kathryn Wood, Professor Christophe Legendre and Professor Gunnar Tufveson as members of Hansa Medical’s Medical Advisory Board. In this capacity, these distinguished experts will bring invaluable medical expertise on kidney transplantation and desensitization to Hansa Medical.Kathryn Wood is Professor of Immunology in the Nuffield Department of Surgical Sciences, University of Oxford where she runs the Transplantation Research Immunology Group. Professor Wood is an internationally renowned medical researcher in transplant tolerance induction,

    Year-end report 2013

    The year in brief · Successfully completed Phase I study with IdeS. The results from the study demonstrate that IdeS is efficacious and well tolerated with a favorable safety profile. · Hansa Medical receives SEK 3.4 million grant from VINNOVA to carry out Phase II study with IdeS · Hansa Medical and Axis-Shield report most promising results from pivotal clinical trial with HBP-analysis · Net sales for the Group amounted to SEK 1.8 (2.6) M · The Group’s results amounted to SEK  -17.6 (-16.5) M · Operating income for the Group amounted to SEK -17.6 (-16.8) M · Earnings

    Succesfully completed Phase I study with IdeS

    The results from the study demonstrate that IdeS is efficacious and well tolerated with a favorable safety profile. IdeS cleaves IgG antibodies efficiently and no intact IgG is detectable in the circulation of healthy subjects within minutes after dosing. The results from the Phase I study are very encouraging and Hansa Medical will file a Phase II study application at the Swedish Medical Products Agency during the first quarter of 2014.”The Phase I trial demonstrates that IdeS is safe, fast and efficacious at the tested dose levels. For a new desensitization protocol, these are exactly the

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