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ViroPharma Receives Orphan Drug Designation For Maribavir In Europe
Date:6/11/2013

EXTON, Pa., June 11, 2013 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the European Commission has granted orphan drug designation for maribavir for treatment of cytomegaloviral (CMV) disease in patients with impaired cell mediated immunity.  The "Orphan Medicinal Product Designation" is designed to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases identified as "life-threatening or chronically debilitating" conditions.  ViroPharma has previously received orphan drug designation for maribavir in the United States for treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients.  

Under EMA guidelines, Orphan Medicinal Product Designation provides 10 years of potential market exclusivity if the product candidate is approved for marketing in the European Union and the orphan designation is maintained.  Orphan status also permits EMA assistance in optimizing the candidate's clinical development through participation in designing the clinical protocol and preparing the marketing application.  Additionally, a drug candidate designated by the EMA as an Orphan Medicinal Product may qualify for a reduction in regulatory fees as well as a European Union-funded research grant. Finally, if a Pediatric Investigation Plan is completed, an additional two years of exclusivity could be granted for a product with Orphan Medicinal Product designation.

"We are very pleased to receive orphan designation for maribavir from the European Commission," commented John Watson, ViroPharma's senior director, regulatory affairs, Europe. "This designation recognizes the potential of maribavir to address great unmet medical needs. We commend the
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SOURCE ViroPharma Incorporated
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