FDA Grants Orphan Drug Designation for EUR-1073
Tue, 03/10/2009 - 5:15am
Eurand N.V., a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, has announced that the FDA has granted orphan drug designation for EUR-1073 (beclomethasone diproprionate) in pediatric patients. EUR-1073 is a proprietary development product for the treatment of ulcerative colitis. Orphan drug status is granted by the FDA to promote the development of drugs for diseases that affect fewer than 200,000 patients. Products granted orphan drug status are allowed seven years of market exclusivity in the U.S. upon FDA approval. "We are pleased with the FDA's decision, and we believe EUR-1073 has the potential to address key unmet medical needs of pediatric patients with ulcerative colitis," said Gearoid Faherty, Chairman and Chief Executive Officer. "The development of EUR-1073 is part of our strategy to develop a pipeline of gastroenterology products to be marketed by our own sales force, and we believe it would be complementary to EUR-1008, currently under review by the FDA as a treatment for exocrine pancreatic insufficiency, a digestive disease." In April 2008, Eurand acquired from Chiesi Pharmaceutici SpA the exclusive U.S. and Canadian rights to market EUR-1073, an enteric-coated, controlled-release formulation of beclomethasone diproprionate, which Chiesi markets as CLIPPER(TM) in several European countries for use in the treatment of ulcerative colitis.