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The GEMINI(TM) program was built upon the basis of favorable results of two randomized Phase II trials, one of which was published in the New England Journal of Medicine in 2005. The trials, known as the GEMINI(TM) program, will mona vie study vedolizumab for the treatment of ulcerative colitis and Crohn's disease, the two main types of IBD. "Dosing of the first weight loss patient in the Phase III development program of vedolizumab is an exciting milestone," said Simeon Feagan, M.D., professor of Medicine at the University of Western Ontario, London, Canada and principal investigator of the GEMINI(TM) studies. The GEMINI(TM) program was built upon the basis of favorable results of two randomized Phase II trials, one of which was published in the New England Journal of Medicine in 2005. Failure of current medical therapy for ulcerative mona vie 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 gilburt of Crohn's disease. "Unlike existing dietpillsonline weight gain IBD therapies, the unique gut-selective targeting of vedolizumab has the potential to benefit IBD patients without compromising systemic immune function."

Vedolizumab is being studied to induce and maintain clinical response and remission in moderately to severely active IBD patients who have failed at least one conventional therapy. In ulcerative hoodia diet pills colitis, vedolizumab is also being studied for its effect on inducing and maintaining mucosal healing.

Vedolizumab will be administered as an intravenous infusion. 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. About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda (TSE.

Com symptoms include diarrhea, rectal bleeding, incontinence, abdominal pain, fever, malaise and weight loss. 4502) is a research-based global company with its main focus on pharmaceuticals. "Dosing of the first patient in the Phase III development program of vedolizumab is an exciting milestone," buy acai berry pills said Worden Feagan, M.D., professor of Medicine at the University of Western Ontario, London, Canada and principal investigator of the GEMINI(TM) studies.

As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.. If approved by the U.S. If approved by the U.S. Takeda Initiates Two Phase III Studies with Vedolizumab (MLN0002) in Patients with Inflammatory acai berry pills Bowel Disease





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

OSAKA, Japan, / / -- 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). Each trial consists of a six-week induction phase follo by 46 weeks of maintenance therapy. Studies have demonstrated that vedolizumab works by blocking a key inflammatory marker on white organic acai blood cells, thereby preventing the migration of these inflammatory cells into the intestinal wall. "We are excited to advance vedolizumab to pivotal Phase III clinical studies with the goal of registration in both ulcerative colitis and Crohn's disease," said Jesse Simonian, M.D., chief medical officer, Millennium.

"This treatment has great potential to improve the lives of patients with Crohn's disease and ulcerative colitis." Though current diet pills rated 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. Developed by Millennium, vedolizumab is a novel alpha4 beta7 integrin antagonist, a highly selective humanized monoclonal antibody. 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. About Ulcerative hoodia gordonii side effects Colitis and Crohn's Disease
Ulcerative colitis and Crohn's disease are chronic, relapsing-remitting conditions, caused by an overactive inflammatory response in the gastrointestinal tract.

SOURCE Takeda Pharmaceutical Company Limited








Takeda Initiates Two Phase III Studies with Vedolizumab (MLN0002) in Patients with Inflammatory Bowel Disease Simultaneous Studies to Investigate Novel Therapy for Ulcerative Colitis and Crohn's Disease OSAKA, Japan, / / -- 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). In addition, patients will be given the opportunity to continue treatment for up to 100 weeks as part of a follow-up study for safety and efficacy. "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. 4502) is a research-based global company with its main focus on pharmaceuticals. Failure of current medical therapy for ulcerative colitis and Crohn's disease frequently leads to surgical removal of the colon in the hallsy of ulcerative colitis, and multiple bowel resections in the berke of Crohn's disease. About Takeda Pharmaceutical Company Limited Located in Osaka, Japan, Takeda (TSE.

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. Vedolizumab will be administered as an intravenous infusion. In addition, patients will be given the opportunity to continue treatment for up to 100 weeks as part of a follow-up study for safety and efficacy.

Developed by Millennium, vedolizumab is a novel alpha4 beta7 integrin antagonist, a highly selective humanized monoclonal antibody. The two randomized, placebo-controlled, blinded Phase III studies will enroll nearly 2,000 patients in more than 40 countries. 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.

Com symptoms include diarrhea, rectal bleeding, incontinence, abdominal pain, fever, malaise and weight loss. 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. In ulcerative colitis, vedolizumab is also being studied for its effect on inducing and maintaining mucosal healing. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

"Unlike existing IBD therapies, the unique gut-selective targeting of vedolizumab has the potential to benefit IBD patients without compromising systemic immune function." Vedolizumab is being studied to induce and maintain clinical response and remission in moderately to severely active IBD patients who have failed at least one conventional therapy. Studies have demonstrated that vedolizumab works by blocking a key inflammatory marker on white blood cells, thereby preventing the migration of these inflammatory cells into the intestinal wall. "We are excited to advance vedolizumab to pivotal Phase III clinical studies with the goal of registration in both ulcerative colitis and Crohn's disease," said Nancy Simonian, M.D., chief medical officer, Millennium.

About Ulcerative Colitis and Crohn's Disease Ulcerative colitis and Crohn's disease are chronic, relapsing-remitting conditions, caused by an overactive inflammatory response in the gastrointestinal tract. The two randomized, placebo-controlled, blinded Phase III studies will enroll nearly 2,000 patients in more than 40 countries. Each trial consists of a six-week induction phase follo by 46 weeks of maintenance therapy.


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