Hansa Biopharma announces decision by Swedish New Therapies Council to recommend use of Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients
· Recommendation to use Idefirix® (imlifidase) as defined in indication approved by the European Medicines Agency (EMA)1,2
· Decision provides highly-sensitized patients in Sweden with the opportunity to receive Idefirix® as desensitization treatment
· Commercial launch activities for Idefirix® in Europe progressing as planned
Lund, Sweden, June 28, 2021. Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), the pioneer in enzyme technology for rare immunological conditions, today announced that its first-in-class treatment Idefirix® (imlifidase) has received recommendation from the Swedish New Theraphies Council (NT-rådet) for use in the desensitization of highly sensitized adult patients prior to kidney transplant.1 This recommendation to the healthcare regions is an important step for transplant clinics across Sweden that would like to introduce Idefirix® as a desensitization treatment to enable highly sensitized patients to qualify for potentially lifesaving and life-altering kidney transplant from a deceased donor. The NT-rådet recommendation follows an earlier health-economic assessment by the Swedish Dental and Pharmaceutical Benefits Agency (TLV), which concluded that Idefirix® treatment would be cost effective or even cost saving in the patient population specified in the Marketing Authorization received from the European Medicines Agency (EMA).2,3
"Idefirix® is the first desensitization treatment to demonstrate positive outcomes in clinical settings. It reduces the risk of hyperacute rejection following transplantation by inactivating the immunoglobulin G in highly sensitized patients," said Associate Professor Bengt von Zur-Mühlen, senior nephrologist at the Department of Transplantation Surgery at Uppsala University Hospital. "I'm pleased to hear today's positive news from the Swedish New Therapies Council. It is a big step forward for highly sensitized kidney patients, who will become more compatible for transplants and have an opportunity for a better quality of life."
Kidney transplant patients are classed as highly sensitized if they have antibodies against many human leukocyte antigens (HLA), which can cause tissue damage and potentially transplant rejection.4 Risk factors for developing HLA antibodies that cause sensitization include previous transplantation, blood transfusion and pregnancy.5 These patients are unlikely to be offered a kidney transplant and spend a longer time on the waiting list with an increased risk of dying while waiting for a suitable donor.6,7
"Kidney patients with high levels of HLA antibodies have previously had very limited access to kidney transplants due to the lack of effective desensitization treatments, and they often have no alternative but to remain on long-term dialysis," said Håkan Hedman, Chairman of the Swedish Kidney Association. "Availability of the novel treatment imlifidase is very encouraging to the kidney disease community because it will provide certain highly sensitized patients with the opportunity to qualify for a transplant."
Long-term dialysis can place a significant burden on patients and on healthcare systems and is associated with a reduction in health-related quality of life and increased risk of mortality and hospitalization.7-9
"At Hansa, our mission is to significantly improve the lives of rare disease patients with serious unmet medical needs, bringing highly innovative medicines from the laboratory to the patients", said Søren Tulstrup, President and CEO, Hansa Biopharma. "Delivering Idefirix® as a new therapy option for highly sensitized patients who are waiting for a potentially life-saving kidney transplant demonstrates our commitment to improving the lives of patients with rare immunological conditions."
Hansa Biopharma's commercial launch activities throughout Europe are underway as planned. Pricing for Idefirix® has been published in the first markets[*] and the first commercial sales were reported in Q1 2021. Agreements around reimbursement and funding access with healthcare providers and payers are expected to be completed in early-launch countries throughout the course of 2021. The recommendation provided by the Swedish New Therapies Council represents the first such national level decision by a European Union Member State.
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For more information:
Klaus Sindahl, Head of Investor Relations
M: +46 (0) 709 298 269
E: klaus.sindahl@hansabiopharma.com
Katja Margell, Head of Corporate Communications
M: +46 (0) 768 198 326
E: katja.margell@hansabiopharma.com
https://investors.hansabiopharma.com/English/press-releases/press-releases-details/2021/Hansa-Biopharma-announces-decision-by-Swedish-New-Therapies-Council-to-recommend-use-of-Idefirix-imlifidase-as-desensitization-treatment-for-highly-sensitized-kidney-transplant-patients/default.aspx
· Recommendation to use Idefirix® (imlifidase) as defined in indication approved by the European Medicines Agency (EMA)1,2
· Decision provides highly-sensitized patients in Sweden with the opportunity to receive Idefirix® as desensitization treatment
· Commercial launch activities for Idefirix® in Europe progressing as planned
Lund, Sweden, June 28, 2021. Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), the pioneer in enzyme technology for rare immunological conditions, today announced that its first-in-class treatment Idefirix® (imlifidase) has received recommendation from the Swedish New Theraphies Council (NT-rådet) for use in the desensitization of highly sensitized adult patients prior to kidney transplant.1 This recommendation to the healthcare regions is an important step for transplant clinics across Sweden that would like to introduce Idefirix® as a desensitization treatment to enable highly sensitized patients to qualify for potentially lifesaving and life-altering kidney transplant from a deceased donor. The NT-rådet recommendation follows an earlier health-economic assessment by the Swedish Dental and Pharmaceutical Benefits Agency (TLV), which concluded that Idefirix® treatment would be cost effective or even cost saving in the patient population specified in the Marketing Authorization received from the European Medicines Agency (EMA).2,3
"Idefirix® is the first desensitization treatment to demonstrate positive outcomes in clinical settings. It reduces the risk of hyperacute rejection following transplantation by inactivating the immunoglobulin G in highly sensitized patients," said Associate Professor Bengt von Zur-Mühlen, senior nephrologist at the Department of Transplantation Surgery at Uppsala University Hospital. "I'm pleased to hear today's positive news from the Swedish New Therapies Council. It is a big step forward for highly sensitized kidney patients, who will become more compatible for transplants and have an opportunity for a better quality of life."
Kidney transplant patients are classed as highly sensitized if they have antibodies against many human leukocyte antigens (HLA), which can cause tissue damage and potentially transplant rejection.4 Risk factors for developing HLA antibodies that cause sensitization include previous transplantation, blood transfusion and pregnancy.5 These patients are unlikely to be offered a kidney transplant and spend a longer time on the waiting list with an increased risk of dying while waiting for a suitable donor.6,7
"Kidney patients with high levels of HLA antibodies have previously had very limited access to kidney transplants due to the lack of effective desensitization treatments, and they often have no alternative but to remain on long-term dialysis," said Håkan Hedman, Chairman of the Swedish Kidney Association. "Availability of the novel treatment imlifidase is very encouraging to the kidney disease community because it will provide certain highly sensitized patients with the opportunity to qualify for a transplant."
Long-term dialysis can place a significant burden on patients and on healthcare systems and is associated with a reduction in health-related quality of life and increased risk of mortality and hospitalization.7-9
"At Hansa, our mission is to significantly improve the lives of rare disease patients with serious unmet medical needs, bringing highly innovative medicines from the laboratory to the patients", said Søren Tulstrup, President and CEO, Hansa Biopharma. "Delivering Idefirix® as a new therapy option for highly sensitized patients who are waiting for a potentially life-saving kidney transplant demonstrates our commitment to improving the lives of patients with rare immunological conditions."
Hansa Biopharma's commercial launch activities throughout Europe are underway as planned. Pricing for Idefirix® has been published in the first markets[*] and the first commercial sales were reported in Q1 2021. Agreements around reimbursement and funding access with healthcare providers and payers are expected to be completed in early-launch countries throughout the course of 2021. The recommendation provided by the Swedish New Therapies Council represents the first such national level decision by a European Union Member State.
--- ENDS ---
For more information:
Klaus Sindahl, Head of Investor Relations
M: +46 (0) 709 298 269
E: klaus.sindahl@hansabiopharma.com
Katja Margell, Head of Corporate Communications
M: +46 (0) 768 198 326
E: katja.margell@hansabiopharma.com
https://investors.hansabiopharma.com/English/press-releases/press-releases-details/2021/Hansa-Biopharma-announces-decision-by-Swedish-New-Therapies-Council-to-recommend-use-of-Idefirix-imlifidase-as-desensitization-treatment-for-highly-sensitized-kidney-transplant-patients/default.aspx
