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BHR Pharma Files Investigational New Drug Application, Receives Orphan Drug Designation, for Traumatic Brain Injury Treatment
Date:12/8/2009

r biologics that treat a rare disease or condition affecting less than 200,000 Americans. The designation offers a number of incentives to the treatment developer. This includes a seven-year period of U.S. marketing exclusivity if the drug receives marketing authorization by the agency. Funding for clinical studies, study design assistance, waiver of FDA user fees and tax credits are additional potential incentives.

The company plans to request that the treatment be fast tracked during the regulatory approval process.

"Traumatic brain injury is a terrible condition with high rates of mortality and disability, and currently there are no drugs approved for treating these patients," said Tom MacAllister, BHR president and CEO. "We're excited about achieving the IND milestone and believe that the orphan status will help facilitate a development program with the potential to give these patients and their families hope for better quality of life."

About BHR

Founded in January 2008, BHR Pharma, LLC (www.bhr-pharma.com) is a pharmaceutical research and development (R&D) company located near Washington, DC. BHR is committed to bringing to market specialty treatments that employ non-oral delivery systems, with an emphasis on unmet and underserved medical needs.

A wholly owned subsidiary of Besins Healthcare SA (www.besins-healthcare.com), which markets healthcare products in 93 countries, BHR manages all of Besins' global R&D activities. Those activities primarily leverage proprietary parenteral drug formulations, including the Enhanced Hydroalcoholic Gel (EHG(R)) technology pioneered and commercially launched by Besins in 1975.

SOURCE BHR Pharma, LLC


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SOURCE BHR Pharma, LLC
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