Hansa Biopharma Provides Business Update Ahead of the JP Morgan Global Healthcare Conference

LUND, Sweden, Jan. 13, 2020 /PRNewswire/ --A  Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced a business update for the fourth quarter 2019 and preliminary, unaudited key financials for its financial year 2019.A The company will be participating in the JP Morgan Global Healthcare Conference A in San Francisco from January 13 to 16, 2020.2019 Fourth Quarter Business HighlightsA The European Medicines Agency (EMA) is reviewing a Marketing Authorization Application for imlifidase in Europe. Hansa Biopharma submitted responses to the Day 120 questions on December 22, 2019 and the review process is on track. An opinion from the Committee for Medicinal Products for A Human Use (CHMP) is expected in the second quarter of 2020, followed by a potential decision by the European Commission during the summer 2020.A Hansa Biopharma met with the FDA on November 20th and agreed on a regulatory path forward for imlifidase in kidney transplantation of highly sensitized patients in the United States. Hansa will conduct a randomized, controlled clinical study in a well-defined population of approximately 50 patients with the highest unmet medical need to demonstrate the clinical benefit of imlifidase in the context of the U.S. Kidney Allocation System. It is expected that the outcome of this study will support submission of a A Biologic License Application (BLA) by 2023.
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