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Takeda Submits Biologics License Application for a New Investigational Drug Vedolizumab, in Moderately to Severely Active Crohn's Disease and Ulcerative Colitis in the United States

DEERFIELD, Ill. and OSAKA, Japan, June 21, 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that a Biologics License Application (BLA) has been submitted to the United States (U.S.) Food and Drug Administration (FDA) for vedolizumab, an investigational humanized monoclonal antibody for the treatment of adults with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC), the two most common types of inflammatory bowel disease (IBD).

"The disease burden of IBD is quite significant in the United States, especially on the many young adults living with Crohn's disease and ulcerative colitis," said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. "This regulatory submission marks a significant step forward for vedolizumab in the U.S., and as a company we are excited about the possibility of providing this community with a new treatment option."

More than four million people worldwide are affected by IBD, with CD affecting as many as 700,000 people and UC affecting as many as 700,000 people in the U.S. Crohn's disease and ulcerative colitis are chronic diseases that cause inflammation of the lining of the digestive tract. Inflammation caused by CD can involve all areas of the digestive tract, while UC typically impacts the colon and rectum. CD and UC can be both painful and debilitating, which may sometimes lead to serious complications. While CD and UC treatment options are available, many patients may not achieve or maintain remission of their disease.  

"CD and UC are chronic diseases that can negatively impact those who live with the associated challenges – and the need to seek new treatment options is well-recognized," said William J. Sandborn, M.D., chief, division of gastroenterology & professor of medicine, University of California San Diego School of Medicine. "In clinical development, vedolizumab has demonstrated the potential to be another possible treatment option for people with moderately to severely active CD and UC."

The BLA submission was supported by the Phase 3 clinical studies, GEMINI I, GEMINI II, GEMINI III and GEMINI LTS (Long-term Safety), which make up the GEMINI Studies™, a four-study clinical program to investigate the efficacy and safety of vedolizumab on clinical response and remission in moderately to severely active CD and UC patients. Enrolled patients had failed at least one conventional therapy, including corticosteroids, immunomodulators and/or a TNF-alpha antagonist. TNF-alpha antagonist failure patients included those with inadequate response (primary nonresponders), loss of response (secondary nonresponders) or those who were intolerant. Vedolizumab has been studied in 2,700 patients in nearly 40 countries, making it the largest Phase 3 clinical trial program conducted to date simultaneously evaluating both CD and UC.

GEMINI I was designed to assess the efficacy and safety of vedolizumab for inducing and maintaining clinical response and remission in patients with moderately to severely active UC in whom one prior therapy had failed. Key primary endpoints included clinical response at week six and clinical remission at week 52.

GEMINI II was designed to assess the efficacy and safety of vedolizumab for inducing and maintaining clinical response and remission in patients with moderately to severely active CD. Primary outcomes included the number of patients in clinical remission and enhanced clinical response at week six, and clinical remission at 52 weeks.

GEMINI III was designed to assess the efficacy and safety of vedolizumab for the induction of clinical response and remission in patients with moderately to severely active CD. The key primary endpoint included the proportion of patients in clinical remission with previous failure of anti-TNFalpha therapy.

GEMINI LTS is an ongoing open-label, long-term safety study of vedolizumab, and was designed to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab administration.

About Crohn's disease and ulcerative colitis
Crohn's disease (CD) and ulcerative colitis (UC) are the two most common forms of inflammatory bowel disease (IBD), which is marked by inflammation in the lining of the GI tract. CD can impact any part of the digestive tract, predominantly the ileum, and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. UC impacts the large intestine only, which includes the colon and the rectum. The most common symptoms of UC include abdominal discomfort and blood or pus in diarrhea. There is no known cause for CD or UC, although many researchers believe that the interaction between genes, the body's immune system, and environmental factors may play a role. The aim of CD and UC treatments is to induce and maintain remission, or achieve extended periods of time when patients do not experience symptoms.

About vedolizumab
Vedolizumab is under development for the treatment of CD and UC, as a humanized monoclonal antibody that specifically antagonizes the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal cell adhesion molecule (MAdCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in CD and UC.

About Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit

About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website,

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

SOURCE Takeda Pharmaceutical Company Limited
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