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Eurand Gets Orphan Designation for EUR-1073

Eurand's EUR-1073 has been granted orphan drug designation for the treatment of ulcerative colitis in pediatric patients. Orphan drug status is granted to promote the development of drugs for diseases that affect fewer than 200,000 patients.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Eurand’s EUR-1073 has been granted orphan drug designation for the treatment of ulcerative colitis in pediatric patients. Orphan drug status is granted to promote the development of drugs for diseases that affect fewer than 200,000 patients. Upon approval, these products have seven years of market exclusivity in the U.S.

“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 Gearóid 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 exclusive U.S. and Canadian rights to market EUR-1073 from Chiesi Pharmaceutici SpA. Chiesi markets the drug as Clipper in several European countries.

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