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Takeda Announces Extension of FDA PDUFA Action Date for Vedolizumab for Ulcerative Colitis

Crohn's disease action date remains unchanged

DEERFIELD, Ill. and OSAKA, Japan, Dec. 24, 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States (U.S.) Food & Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) Priority Review action date for the ulcerative colitis (UC) indication of Takeda's investigational biologic, vedolizumab. At the FDA's request, Takeda submitted a major amendment to its Biologics License Application (BLA) on December 6th which included updated proposed labeling. The FDA has now assigned a PDUFA action date of May 20, 2014 to allow the Agency time for a full review of the submission for the indication of the treatment of adults with moderately to severely active UC.   

Vedolizumab is also under review for the treatment of adults with moderately to severely active Crohn's disease (CD). The action date for the CD indication remains June 18, 2014. The BLA for vedolizumab was submitted in June 2013, and the FDA granted Priority Review status for the proposed indication in UC in September 2013 and standard review for the indication of CD.

"This short delay in the action date allows the FDA sufficient time to complete the review of the vedolizumab file and provide action on the application," said Tom Harris, head, global regulatory affairs, Takeda. "We appreciate the work of the FDA and remain confident in the potential of vedolizumab as an additional important treatment option for patients and the physicians who treat them for these serious conditions."

On December 9th, a joint panel of members from the Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees of the FDA voted to recommend approval of Takeda's vedolizumab for both proposed UC and CD indications. The outcome of the advisory committee meeting is non-binding and will be taken into consideration by the FDA when making its decision on Takeda's BLAs for vedolizumab.

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

About vedolizumab
Vedolizumab, under development for the treatment of UC and CD, is a humanized monoclonal antibody that specifically antagonizes the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 to intestinal mucosal addressin cell adhesion molecule 1 (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 UC and CD. By inhibiting alpha4beta7, vedolizumab may limit the ability of certain lymphocytes to infiltrate gut tissues.

About Takeda Pharmaceuticals U.S.A., Inc.
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.

The company has a commercial presence covering around 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Takeda is ranked 15th globally. Areas of focus include cardiovascular and metabolic, oncology, respiratory and immunology, central nervous system, general medicine, and vaccines.

Through the integration of Millennium Pharmaceuticals and Nycomed, Takeda has been transforming itself, broadening its therapeutic expertise and geographic outreach.

Takeda Pharmaceuticals U.S.A., Inc. is located in Deerfield, Ill., and is the U.S. marketing and sales organization of Takeda Pharmaceutical Company Limited.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Pharmaceuticals U.S.A., Inc. is available through its website, www.takeda.us.

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, www.takeda.com.

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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