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Hansa Biopharma Announces European Medicines Agency Accepts Marketing Authorization Application for IDEFIRIX™ (imlifidase)

Regulatory information
Lund, Sweden, March 1, 2019 – Hansa Biopharma AB (NASDAQ Stockholm: HNSA), the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, announced today that the European Medicines Agency (EMA) has accepted the Company’s Marketing Authorization Application (MAA) for review of IDEFIRIX™ (INN: imlifidase). Hansa is seeking approval of IDEFIRIX as a treatment to enable kidney transplantation in highly sensitized patients. IDEFIRIX is a novel antibody-degrading enzyme that eliminates immunological barriers. It is administered as a single intravenous infusion immediately prior to transplantation and rapidly inactivates donor specific antibodies (DSAs).

This acceptance follows Hansa’s submission of the MAA on 5 February 2019 and marks the beginning of the regulatory review process for IDEFIRIX in the European Union (EU). IDEFIRIX has both EU Orphan Drug Designation and PRIority MEdicine (PRIME) designation, an EMA program to enhance support for the development of medicines that target an unmet medical need. An opinion of the Committee for Medicinal Products for Human Use (CHMP) is expected within 210 days (plus any clock-stops for the applicant to provide answers to questions which may arise during the review). After the adoption of a CHMP opinion, a final decision regarding the MAA for IDEFIRIX is made by the European Commission.

“The MAA filing represents a significant milestone for Hansa as it is our first regulatory application for marketing authorization and a major step toward making IDEFIRIX available for highly sensitized patients waiting for a kidney transplant. These patients have a significant unmet medical need, often remaining in a debilitating disease state on long-term dialysis treatment. We have demonstrated that our unique enzyme’s rapid and specific cleavage of IgG antibodies successfully enables lifesaving kidney transplantation, for these patients. IDEFIRIX has the potential to significantly improve highly sensitized patients’ access to kidney transplantation,” said Søren Tulstrup, Chief Executive Officer of Hansa.

The MAA for IDEFIRIX is based upon the successful outcomes from five clinical studies demonstrating the efficacy and safety of IDEFIRIX to successfully enable kidney transplantation. In addition, the file includes evidence of the significant medical need for highly sensitized patients who today have extremely limited opportunity for transplantation.

The dialogue with the U.S. Food and Drug Administration (FDA) to determine the path forward for U.S. regulatory approval is ongoing and Hansa will provide updated guidance regarding expected timeline for a Biologic License Application filing in the upcoming months. The FDA has granted IDEFIRIX Orphan Drug Designation and Fast Track Designation in kidney transplantation.

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 CET on March 1, 2019.