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Hansa Medical’s application for Orphan Drug Designation for IdeS in the EU receives positive opinion

Regulatory information
LUND, Sweden, December 15, 2016, Hansa Medical AB (publ: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announces that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion on Hansa Medical’s application for Orphan Drug Designation of recombinant IdeS for the prevention of graft rejection following solid organ transplantation. In September 2015, IdeS was granted Orphan Drug Designation for the prevention of antibody mediated organ rejection in solid organ transplant patients by the U.S. Food and Drug Administration (FDA).

Commenting on today’s announcement, Göran Arvidson, CEO of Hansa Medical, said:
"The positive opinion from the Committee for Orphan Medicinal Products on our Orphan Drug Designation application for IdeS is another important regulatory milestone, following the grant of Orphan Drug Designation from the FDA in 2015. Transplantation is a lifesaving procedure which can significantly improve the quality of life of these very sick patients. Sadly many patients are unable to receive the transplant they need because they are highly sensitized with significant levels of antibodies which can cause organ rejection. We believe IdeS has the potential to revolutionize the transplant process and to become the first therapy to enable these patients to be transplanted. The current preliminary clinical data generated with IdeS in kidney transplantation have been highly encouraging and we look forward to progressing it through the pivotal trial towards registration.”

Based on positive opinion from the Committee for Orphan Medicinal Products (COMP), the European Commission grant Orphan Drug Designation to drugs intended for the treatment of life threatening or chronically debilitating rare diseases where no therapeutic options are either authorised or where the drugs will be of significant benefit to those affected by the condition. Rare diseases are those defined as having a prevalence of no more than five in 10,000 persons in Europe. The designation provides development and commercial incentives, including 10 years of market exclusivity, protocol assistance on the development of the drug, including clinical studies, and certain exemptions from or reductions in regulatory fees.

This information is information that Hansa Medical AB (publ) is obliged to make public pursuant to the Financial Instruments Trading Act. The information was submitted for publication at 08:30am CET on December 15, 2016.