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Press Release No. 20
/ March 31, 2015 /
Berlin

Drug candidate based on MDC patent submitted for FDA approval

At the end of last year, Baxter International Inc. announced that the company has submitted a biologics license application to the United States (US) Food and Drug Administration (FDA) for the approval of BAX111, a recombinant von Willebrand factor (rVWF) in development for the treatment of patients with von Willebrand disease, the most common type of inherited bleeding disorder. The candidate received orphan-drug designation from both the European Commission and the FDA.

The drug candidate relates to a US patent that emerged from the work of Prof. Michael Bader and Dr Diego Walter at the Max Delbrück Center for Molecular Medicine Berlin-Buch (MDC). Their research focused on serotonin-modulating pharmaceutical compositions, including VWF, for treating primary haemostasis deficiencies. In 2010, Ascenion mediated a licence agreement between Baxter and the MDC, providing the company with the exclusive right to use the factor for treating coagulation disorders in exchange for milestone and royalty payments. Beyond the license for the pharmaceutical composition patent, MDC does not have a role in the BAX111 development program. ‘Following the approval of Amgen’s anti-cancer drug Blincyto by the FDA, this is the second therapeutic product relating to MDC IP to reach a significant milestone within the last months,’ comments Dr Elisabeth von Weizsäcker, Director Technology Management at Ascenion. ’This impressively demonstrates how MDC research eventually translates into benefits for patients around the world.’

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