LUND, Sweden,– Søren Tulstrup, President and CEO of Hansa Biopharma, comments:
“2019 was an important and overall successful year for Hansa Biopharma – a year with significant progress across our pipeline and platform development activities and a year in which we achieved the landmark milestone of getting our first Marketing Authorization Application (MAA) accepted for review by a regulatory agency. On Feb. 28, 2019 our MAA for imlifidase in kidney transplantation was accepted for review by the European Medicines Agency, EMA. If approved, we will be able to launch the first in a potential series of drug candidates in our internal pipeline addressing rare conditions with high unmet medical need. This will transform Hansa Biopharma into a commercial-stage biopharmaceutical company.
Looking beyond transplantation we are pleased to see the completion of enrollment of patients in the investigator initiated anti-GBM antibody disease study. This marks an important milestone for our expansion outside transplantation. In addition, we have initiated two new Phase 2 programs, one in the acute autoimmune disease Guillain Barré Syndrome (GBS) and one in Antibody Mediated Rejection (AMR) in kidney transplant patients. Both studies are now actively recruiting patients.
A key priority for Hansa Biopharma in 2020 is to ensure a successful launch of imlifidase in kidney transplantation. Our launch strategy involves a sequenced targeting of leading kidney transplantation centers with the potential to become early adopters and centers of reference.
While an exciting and potentially transformative year lies ahead of us, the COVID-19 Corona virus pandemic imposes additional challenges to us as a company. We have taken measures to protect our employees and take social responsibility while attempting to limit negative effects on Hansa’s business. it is still too early to fully understand the potential negative impacts that the pandemic will have on our business – however, the following are key areas we expect a potential impact:
The Annual General Meeting of Hansa Biophamra postponed due to Corona virus outbreak
Due to the recent development in relation to the spreading of COVID-19, the Board of Hansa Biopharma has decided to postpone the Annual General Meeting (AGM) to Tuesday June 23, 2020 (previously Tuesday May 5, 2020). A notice will follow in due time before the AGM.