LAINATE, ITALY (July 19, 2011) Cosmo Pharmaceuticals S.p.A. (SIX: COPN) today announced that Shire plc (LSE: SHP, NASDAQ: SHPGY), announced that the U.S. Food and Drug Administration (FDA) approved Lialda® (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month study demonstrating the safety and effectiveness of Lialda® in maintaining endoscopic remission in adult patients. This approval follows the previous indication of Lialda® approved by the FDA in 2007 for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Cosmo invented the formulation and licensed it out. Shire has the exclusive rights to develop and commercialize LIALDA® in the U.S., Canada, Europe (excluding Italy), Japan and the Pacific Rim.