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GEN News Highlights : Mar 30, 2012

Shire’s Mesalamine MMX Fails Primary Endpoint in Phase III Diverticulitis Study

Second trial in same indication is ongoing, but firm doesn’t foresee applying for approval.

Shire looks set to give up on the idea of filing for approval of its once-daily therapy SPD476 MMX® mesalamine for the treatment of diverticulitis, after the first Phase III trial failed to meet its primary endpoint. SPD476 MMX mesalamine is a delayed release form of the drug that is already approved in the U.S. as Lialda™, and in Europe as Mezavant®/Mezavant XL® for use in the induction and maintenance of remission in patients with active ulcerative colitis.

The reported Phase III Prevent2 study in patients with a history of diverticulitis failed to show that treatment reduced the rate of recurrence over a two-year treatment period. Another Phase III study, Prevent1, is due to report later this year. Shire says that while it will analyze data from both trials, the firm doesn’t foresee pursuing a regulatory filing for the diverticulitis indication. Lialda/Mezavant was Shire’s fifth top-selling drug in calendar 2011, achieving sales of $372.1 million.