Inspire Pharmaceuticals Announces European Orphan Drug Designation For Denufosol Tetrasodium For Treatment Of Cystic Fibrosis

DURHAM, N.C.--(BUSINESS WIRE)--Jan. 10, 2006--Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH) announced today that denufosol tetrasodium has been granted orphan drug designation for the treatment of cystic fibrosis (CF) by the European Medicines Agency (EMEA). According to the EMEA, orphan medicinal products are for diagnosing, preventing or treating life-threatening or very serious conditions that are rare and affect not more than five in 10,000 persons in the European Union (EU). An orphan drug designation provides 10 years of potential market exclusivity if the product candidate is approved for marketing in the EU, regulatory assistance in preparing the marketing application, free protocol assistance to optimize clinical development, reduced regulatory fees associated with applying for marketing approval and direct access to the centralized procedure for Marketing Authorization Application through the EMEA.

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