FDA APPROVES SHIRE'S ULCERATIVE COLITIS DRUG

Shire announced that the FDA has approved Lialda (mesalamine) with MMX technology for the induction of remission in patients with active, mild to moderate ulcerative colitis. Lialda is the first and only FDA-approved once-daily oral formulation of mesalamine. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis, according to Shire.

Shire will launch Lialda in the U.S. sometime this quarter. Once-daily Lialda with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and six to 16 pills a day. A recent study conducted by the Crohn's and Colitis Foundation of America found that 65 percent of patients with ulcerative colitis are poorly compliant with their medication, citing pill burden and inconvenience associated with the medication, according to Shire.

The FDA approval was based on the results of two Phase III clinical studies that found Lialda (2.4 g/day and 4.8 g/day) was effective in inducing remission in patients with active, mild to moderate ulcerative colitis compared with placebo after eight weeks of treatment. Lialda is generally well tolerated and has a similar safety profile to other currently available mesalamines.

Shire has licensed from Giuliani the exclusive rights to develop and commercialize Lialda in the U.S., Canada, Europe (except Italy) and the Pacific Rim. Giuliani retains the development and commercialization rights in Italy.