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Hansa Medical Receives FDA Fast Track Designation for Imlifidase for Transplantation

Regulatory information
Lund, Sweden, October 17, 2018- Hansa Medical AB (NASDAQ Stockholm: HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the U.S. Food and Drug Administration (FDA) has granted imlifidase Fast Track Designation for the investigation of imlifidase for transplantation.

Imlifidase (IdeS) is an enzyme in late-stage clinical development that specifically cleaves IgG antibodies, thereby inhibiting the IgG-mediated immune response. Hansa Medical is initially developing imlifidase as a proprietary treatment to enable kidney transplantation in sensitized patients previously unable to undergo transplant surgery due to the presence of donor-specific antibodies (DSAs). In addition, imlifidase is being evaluated in a Phase 2 study in anti-GBM antibody disease, a rare and acute autoimmune disorder, and imlifidase has potential applications in other solid organ transplants and in a variety of additional acute autoimmune indications.

“This Fast Track Designation is validation of imlifidase’s potential to address the significant unmet medical need for highly sensitized patients, a patient population for which transplantation is extremely difficult or impossible,” said Søren Tulstrup, President and Chief Executive Officer of Hansa.

“Our two recently reported Phase 2 studies demonstrate imlifidase’s ability to enable kidney transplantation for these patients, who otherwise face high mortality rates associated with long-term dialysis. We continue to actively engage with the regulatory agencies and anticipate submitting a Biologic License Application (BLA), as well as a Marketing Authorisation Application (MAA), in either the fourth quarter of this year or the first quarter of 2019.”

The imlifidase Fast Track Designation is supported by efficacy data reported from four successfully completed Phase 2 studies that demonstrate imlifidase’s ability to rapidly and significantly reduce Donor Specific Antibodies (DSAs), thereby enabling kidney transplantation. The FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs to treat serious or life-threatening conditions that demonstrate the potential to address an unmet medical need. Fast Track designation provides a company more frequent communication with the FDA regarding the investigational drug’s development plan and also provides eligibility for priority review if certain criteria are met.

This is information that Hansa Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CEST on October 17, 2018.