Imlifidase

Hansa Biopharma provides update on business and key financials ahead of the JP Morgan Healthcare Conference

Retrieved on: 
Saturday, January 6, 2024
Marketing, Repeat, Conference, Partnership, Kidney transplantation, Trial of the century, Sarepta Therapeutics, DMD, Imlifidase, Growth, ANCA, Enzyme, Patient, Duchenne muscular dystrophy, Hansa, Immunoglobulin G, Neutron, Pharmaceutical industry

Søren Tulstrup, President and CEO, Hansa Biopharma said: "Hansa enters 2024 in a strong position to successfully execute on our key priorities.

Key Points: 
  • Søren Tulstrup, President and CEO, Hansa Biopharma said: "Hansa enters 2024 in a strong position to successfully execute on our key priorities.
  • We also continue to expand access to imlifidase for highly sensitized kidney transplant patients through a new commercial partnership with NewBridge in the MENA region.
  • Management will be available for meetings in San Francisco during the J.P. Morgan Conference week, January 8-11, 2024.
  • Susan Noonan is coordinating the schedule on behalf of Hansa Biopharma and can be reached at [email protected] .

Hansa Biopharma provides update on business and key financials ahead of the JP Morgan Healthcare Conference

Retrieved on: 
Saturday, January 6, 2024
Marketing, Repeat, Conference, Partnership, Kidney transplantation, Trial of the century, Sarepta Therapeutics, DMD, Imlifidase, Growth, ANCA, Enzyme, Patient, Duchenne muscular dystrophy, Hansa, Immunoglobulin G, Neutron, Pharmaceutical industry

Søren Tulstrup, President and CEO, Hansa Biopharma said: "Hansa enters 2024 in a strong position to successfully execute on our key priorities.

Key Points: 
  • Søren Tulstrup, President and CEO, Hansa Biopharma said: "Hansa enters 2024 in a strong position to successfully execute on our key priorities.
  • We also continue to expand access to imlifidase for highly sensitized kidney transplant patients through a new commercial partnership with NewBridge in the MENA region.
  • Management will be available for meetings in San Francisco during the J.P. Morgan Conference week, January 8-11, 2024.
  • Susan Noonan is coordinating the schedule on behalf of Hansa Biopharma and can be reached at [email protected] .

Imlifidase met primary endpoint in 16-HMedIdes-12 phase 2 trial in patients with AMR following kidney transplantation

Retrieved on: 
Thursday, December 14, 2023
DSA, Patient, AMR, Hansa, Imlifidase, Vaccine, Medical imaging

LUND, Sweden, Dec. 14, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), today announced full results from the 16-HMedIdeS-12 phase 2 trial in patients with antibody mediated rejection (AMR) episodes following a kidney transplant demonstrating that imlifidase significantly reduced donor-specific antibodies (DSAs) within the first five days of treatment.

Key Points: 
  • In the trial, the primary endpoint was the maximum reduction in DSA level at any time point during the 5 days following the start of treatment.
  • Patients treated with imlifidase demonstrated a statistically significant reduction of DSAs by 94.4% compared to a 35.6% (p-value:
  • The secondary endpoint investigated overall kidney function following treatment.
  • This is an important step in understanding how imlifidase may benefit patients with AMR.

Imlifidase met primary endpoint in 16-HMedIdes-12 phase 2 trial in patients with AMR following kidney transplantation

Retrieved on: 
Thursday, December 14, 2023
DSA, Patient, AMR, Hansa, Imlifidase, Vaccine, Medical imaging

LUND, Sweden, Dec. 14, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), today announced full results from the 16-HMedIdeS-12 phase 2 trial in patients with antibody mediated rejection (AMR) episodes following a kidney transplant demonstrating that imlifidase significantly reduced donor-specific antibodies (DSAs) within the first five days of treatment.

Key Points: 
  • In the trial, the primary endpoint was the maximum reduction in DSA level at any time point during the 5 days following the start of treatment.
  • Patients treated with imlifidase demonstrated a statistically significant reduction of DSAs by 94.4% compared to a 35.6% (p-value:
  • The secondary endpoint investigated overall kidney function following treatment.
  • This is an important step in understanding how imlifidase may benefit patients with AMR.

The Scottish Medicines Consortium (SMC) recommends use of Hansa Biopharma's Idefirix[®] (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients

Retrieved on: 
Monday, September 12, 2022
Adult, Dialysis, Kidney Research UK, SMC, Safety, Healthcare Improvement Scotland, Priority, NHS Scotland, European Medicines Agency, Hansa, Risk, Kidney failure, ESRD, European, Hlas, Antibody, Product, Company, Population, Immunoglobulin G, Kidney disease, Nasdaq Stockholm, Survival, Patient, Program, Transplant, Cancer, Donation, Decision-making, Kidney transplantation, CEO, Chronic kidney disease, European Market Infrastructure Regulation, Quality of life, Degenerative disease, NASDAQ, Human leukocyte antigen, Research, Medicine, NICE, Hospital, State, Kidney, DSA, Veni, vidi, vici, NIH, EMA, Pharmaceutical industry, Dentistry, Medical device, Imlifidase, Agency

Kidney transplant candidates are classified as highly sensitized if they have a broad and intense range of pre-formed antibodies against almost all donororgans.

Key Points: 
  • Kidney transplant candidates are classified as highly sensitized if they have a broad and intense range of pre-formed antibodies against almost all donororgans.
  • It is fantastic to see that the SMC has followed the direction of England and Wales to offer certain highly sensitized patients the opportunity of a life-altering transplant.
  • "We are thrilled that the SMC has recommended Idefirixas the first licensed therapy for highly sensitized kidney patients in Scotland.
  • Hansa has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients.

Hansa Biopharma announces first patient treated in the post-authorization efficacy study (PAES) of Idefirix® (imlifidase) in highly sensitized kidney transplant patients

Retrieved on: 
Monday, July 11, 2022
Safety, Survival, Human leukocyte antigen, Kidney transplantation, World, Kidney, Priority, Quality of life, Veni, vidi, vici, Teaching hospital, Vall d'Hebron University Hospital, Medicine, Kidney disease, European Medicines Agency, Program, Hansa, Kidney failure, Vall, Company, Immunoglobulin G, State, Nasdaq Stockholm, EMA, Nephrology, Risk, Degenerative disease, ESRD, Dialysis, Cancer, Nasdaq, EudraCT, Transplant, DSA, Risk management, Patient, Research, European Market Infrastructure Regulation, Chronic kidney disease, Union, Antibody, NIH, Dentistry, Pharmaceutical industry, Medical device, European, Imlifidase, Agency

We can now happily report that our patient was the first to receive an Idefirix -enabled kidney transplant as part of this important study.

Key Points: 
  • We can now happily report that our patient was the first to receive an Idefirix -enabled kidney transplant as part of this important study.
  • This open-label Phase 3 study will enroll 50 highly sensitized adult kidney transplant patients with positive crossmatch against an available deceased donor to confirm the long-term efficacy and safety of Idefirix.
  • The PAES will enrol patients across multiple countries and centers in Europe and the study will include 50 highly sensitized and crossmatch positive patients to be treated with Idefirix.
  • Hansa has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients.

Hansa Biopharma and German payer head association agree on reimbursement price for Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients

Retrieved on: 
Tuesday, March 15, 2022
Survival, Immunoglobulin G, European Medicines Agency, Mortality, Commercial, Quality of life, Program, Patient, NUB, Nasdaq Stockholm, ESRD, EU, Hansa, AMNOG, State, Nasdaq, National Association, Chronic kidney disease, Risk, Dialysis, Kidney transplantation, EMA, Antibody, Hlas, Safety, Transplant, Degenerative disease, Medicine, Kidney disease, Company, Research, Cancer, CEO, DSA, Kidney failure, European Market Infrastructure Regulation, Priority, Kidney, European, Health insurance, Dentistry, Pharmaceutical industry, Medical device, Agency, Imlifidase

This completes, within the foreseen 12 month timeline, the AMNOG (Medicines Market Reorganization Act) process for Idefirix in Germany.

Key Points: 
  • This completes, within the foreseen 12 month timeline, the AMNOG (Medicines Market Reorganization Act) process for Idefirix in Germany.
  • At Hansa, our commitment is to significantly improve the lives of highly sensitized patients in Germany who are waiting for a potentially life-saving kidney transplant," says Sren Tulstrup, President and CEO, Hansa Biopharma.
  • "Highly sensitized kidney patients 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."
  • Hansa has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients.

Hansa Biopharma announces positive early access decision by French Haute Autorité de Santé to use Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients

Retrieved on: 
Saturday, February 26, 2022
Risk, HAS, Kidney disease, Marketing, Company, Transplant, EU, European Medicines Agency, Nasdaq, Health technology assessment, Survival, Research, Priority, Degenerative disease, Safety, Hansa, Chronic kidney disease, Quality of life, Kidney failure, CEO, Program, National, Committee on National Security Systems, CSP, Population, Kidney transplantation, European, AP1, United Kingdom, Antibody, Kidney, AP2, Dialysis, EMA, HTA, Patient, Nasdaq Stockholm, Hlas, Commercial, European Market Infrastructure Regulation, ESRD, State, Medicine, Adult, Immunoglobulin G, DSA, Cancer, Pharmaceutical industry, Medical device, Dentistry, Agency, Imlifidase

LUND, Sweden, Feb. 26, 2022 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), the pioneer in enzyme technology for rare immunological conditions, today announces that its first-in-class treatment Idefirix® (imlifidase) has been granted early access post marketing authorization (Autorisation d'accès précoce) in France by French HAS (Haute Autorité de Santé) for use in the desensitization of highly sensitized adult patients prior to kidney transplant, in accordance with the patient population specified in the Marketing Authorization received from the European Medicines Agency (EMA).1,2

Key Points: 
  • The authorization has been granted based on Hansa's dossier submitted in December 2021, which rendered a positive opinion of the Transparency Commission.
  • Full details of the early access program can be found at the HAS website .
  • "Delivering Idefirixas a new therapy option for highly sensitized kidney patients in France demonstrates our commitment to improving the lives of patients with rare immunological conditions."
  • Hansa has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients.

Hansa Biopharma announces long term follow-up data demonstrating 3-year graft survival of 84% after imlifidase treatment and transplantation

Retrieved on: 
Friday, July 9, 2021
Health sciences, Branches of biology, Clinical medicine, Antibodies, Imlifidase, Kidney transplantation, Organ transplantation, Immunoglobulin G, Therapy

"We are extremely pleased with these data that support the growing evidence base behind imlifidase", said Christian Kjellman, Chief Scientific Officer at Hansa Biopharma.

Key Points: 
  • "We are extremely pleased with these data that support the growing evidence base behind imlifidase", said Christian Kjellman, Chief Scientific Officer at Hansa Biopharma.
  • "The 3-year outcome results published today demonstrate that imlifidase is a potent option to enable transplantation among patients who have a significant immunologic barrier to successful kidney transplantation".
  • All AMRs were treated with standard therapies and no graft losses were attributed to AMRs.
  • Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients.

Hansa Biopharma publishes Annual Report 2020

Retrieved on: 
Thursday, April 8, 2021
Imlifidase, LZ 13 Hansa

LUND, Sweden, April 8, 2021 /PRNewswire/ -- Hansa Biopharma AB "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced the release of the Annual Report 2020

Key Points: 
  • LUND, Sweden, April 8, 2021 /PRNewswire/ -- Hansa Biopharma AB "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced the release of the Annual Report 2020
    Sren Tulstrup, President and CEO of Hansa Biopharma, comments:
    "2020 was a highly successful and transformative year for Hansa Biopharm - a year where we saw significant progress across all areas important to building a leading biopharmaceutical company: Pipeline development, medical and commercial operations and organizational development.
  • The partnership is progressing as planned, and in the second half of 2020 Sarepta initiated ongoing pre-clinical investigations with imlifidase in the gene therapy setting.
  • We see the gene therapy setting as an important value driver for Hansa and we will continue to build our footprint in this space, including through potential additional partnerships.
  • This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.