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

Administration granted BHR-100 an Orphan Drug designation also for treating moderate and severe TBI and placed the drug on Fast Track status designed to accelerate its potential approval.

BHR initiated the SyNAPSe trial in June 2010 with a total enrollment target of 1,180 severe TBI patients. The trial is now more than 75 percent enrolled.  Last month, the SyNAPSe trial's Independent Data and Safety Monitoring Board (DSMB) released its formal interim analysis, concluding no safety issues exist, there was no reason to stop the study for futility and the trial may continue towards its intended completion. Patient enrollment is set to complete in 2013.

About Traumatic Brain Injury (TBI)
TBI is a serious public health problem that affects millions of people worldwide. There are approximately 66,000 deaths attributed annually to TBI in Europe.[1] According to the World Health Organization, traumatic brain injury is the leading cause of death and disability in children and young adults worldwide and is involved in nearly half of all trauma deaths. Despite significant efforts and more than 75 clinical trials over the past 20 years, there is still no approved treatment for TBI.

About BHR Pharma
Founded in January 2008, BHR Pharma, LLC (www.bhr-pharma.com) is a pharmaceutical research and development company located near Washington, DC, USA.  BHR is committed to bringing to market specialty treatments that employ non-oral delivery systems, with an emphasis on unmet and underserved medical needs. The company is a wholly owned subsidiary of Besins Healthcare SA (www.besins-healthcare.com), which markets healthcare products in 93 countries.

[1] Socin et al. JAMA273:22 (1995).


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