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BHR Pharma Investigational Traumatic Brain Injury Treatment Receives European Medicines Agency Orphan Medicinal Product Designation
Date:2/13/2013

HERNDON, Va., Feb. 13, 2013 /PRNewswire/ -- BHR Pharma, LLC announced today the European Medicines Agency (EMA), responsible for evaluating medicines developed for use in the European Union, granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to its proprietary intravenous progesterone infusion agent, BHR-100.  The agent currently is being evaluated as a neuroprotective treatment for severe traumatic brain injury (TBI) in the global, Phase III SyNAPSe® clinical trial.

BHR Pharma is sponsoring SyNAPSe with the intent to bring the first-ever approved TBI treatment to market.  The trial currently has 154 participating sites, including U.S. Level 1 and 2 trauma centers, in 21 countries on four continents. 

"Traumatic brain injury or TBI is a global problem that needs a global solution, and with providing an orphan drug designation for BHR-100 in Europe, the EMA acknowledges the importance of supporting the development of this potential treatment in TBI," said Roland Gerritsen van der Hoop , BHR Pharma Chief Medical Officer and Head of Global R&D. "BHR is committed to bringing this first-of-its-kind treatment to market with the hope of demonstrating progress in a condition with no approved therapies."

To qualify for orphan designation in Europe, a medicine must meet the following criteria:

  • The new medicine must be intended for the treatment, prevention or diagnosis of a disease that is life threatening or chronically debilitating;
  • The prevalence of the disease in the EU most not be more than five of every 10,000 people;
  • The new medicine must be of significant potential benefit to those affected by the disease.

In 2009, the U.S. Food and Drug
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SOURCE BHR Pharma, LLC
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