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Hansa Biopharma publishes Annual Report 2019

2 Apr 2020, 08:00
Regulatory information

Lund April 2, 2020.  Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced the release of the Annual Report 2019

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 regulatory review process by EMA is on track as previously communicated; however, EMA has highlighted a potential risk of staff shortage in the coming period; 
•    The European launch of imlifidase in kidney transplantation may be impacted by limited access to and reduced decision making ability of market access authorities, potentially delaying pricing and reimbursement approval in early launch countries. In addition, pre-launch communication may be impacted negatively by reduced ability to engage with key opinion leaders and clinicians at targeted centers. It remains our aim however to launch imlifidase this year; 
•    The recruitment of patients in the AMR and GBS studies will be delayed by 3-6 months;
•    We aim to commence the recruitment of the randomized controlled phase 3 study for imlifidase in highly sensitized patients in the US in the 4th quarter of 2020. A reprioritization of activities by the FDA and operational challenges may however impact the timeline; 
•    Timing of securing financing from the second half of 2021 onwards."

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.

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. 


For further information, please contact:
Klaus Sindahl, Head of Investor Relations
Hansa Biopharma
Mobile: +46 (0) 709-298 269

About Hansa Biopharma
Hansa Biopharma is leveraging its proprietary immunomodulatory enzyme technology platform to develop treatments for rare immunoglobulin G (IgG)-mediated autoimmune conditions, transplant rejection and cancer. The Company’s lead product candidate, imlifidase, is a unique antibody-cleaving enzyme that potentially may enable kidney transplantation in highly sensitized patients with potential for further development in other solid organ transplantation and acute autoimmune indications. Imlifidase is currently under review for marketing authorization by EMA. Hansa’s research and development program is advancing the next generation of the Company’s technology to develop novel IgG-cleaving enzymes with lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden and also has operations in Europe and US.