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Takeda Initiates Two Phase III Studies with Vedolizumab (MLN0002) in Patients with Inflammatory Bowel Disease
Date:1/21/2009

Simultaneous Studies to Investigate Novel Therapy for Ulcerative Colitis and Crohn's Disease

OSAKA, Japan, Jan. 22 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") announced today that its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc., has initiated two Phase III clinical trials for vedolizumab (MLN0002), an investigational compound for inflammatory bowel disease (IBD). The trials, known as the GEMINI(TM) program, will study vedolizumab for the treatment of ulcerative colitis and Crohn's disease, the two main types of IBD. Developed by Millennium, vedolizumab is a novel alpha4 beta7 integrin antagonist, a highly selective humanized monoclonal antibody.

"Dosing of the first patient in the Phase III development program of vedolizumab is an exciting milestone," said Brian Feagan, M.D., professor of Medicine at the University of Western Ontario, London, Canada and principal investigator of the GEMINI(TM) studies. "This treatment has great potential to improve the lives of patients with Crohn's disease and ulcerative colitis."

Though current IBD treatments have been effective for many patients with mild to moderate disease, a significant unmet need exists for those patients with moderate to severe IBD. Failure of current medical therapy for ulcerative colitis and Crohn's disease frequently leads to surgical removal of the colon in the case of ulcerative colitis, and multiple bowel resections in the case of Crohn's disease.

If approved by the U.S. Food and Drug Administration (FDA), commercialization of vedolizumab will be the responsibility of Takeda Pharmaceuticals North America, Inc., a subsidiary of Takeda Pharmaceutical Company Limited. Takeda has been a leader in gastroenterological therapies, such as Prevacid(R), for more than 10 years and is committed to bringing new therapies to market that may benefit patients.

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SOURCE Takeda Pharmaceutical Company Limited
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