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Takeda Resubmits New Drug Applications to the United States Food and Drug Administration for Alogliptin and the Fixed-Dose Combination Alogliptin and Pioglitazone
Date:7/27/2012

DEERFIELD, Ill. and OSAKA, Japan, July 27, 2012 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) announced today that its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., resubmitted New Drug Applications (NDAs) to the United States (U.S.) Food and Drug Administration (FDA) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone. Takeda anticipates that these applications will be reviewed within the next six months. These NDAs were resubmitted in response to the complete response letter Takeda received from the FDA, dated April 25, 2012.

"Takeda was able to respond to the FDA promptly with significant new data from our ongoing clinical trial program and updated postmarketing data from outside the U.S.," said David Recker, M.D., senior vice president, clinical science, Takeda Global Research & Development Center, Inc. "Based on our meeting with the FDA in late June, Takeda believes the information included in the NDA resubmissions for alogliptin and the fixed-dose combination alogliptin and pioglitazone will address the Agency's request for additional data, and these investigational therapies remain a top priority for the company."

This 2012 resubmission includes additional data from three phase 3 clinical trials involving more than 3,275 patients conducted at 1,384 centers worldwide. When combined with previously submitted phase 3 clinical data, which included more than 8,000 patients conducted in more than 1,000 centers worldwide, nearly 10,000 patients have been treated with alogliptin in the clinical development programs to date.

Alogliptin is a selective dipeptidyl peptidase-4 inhibitor (DPP-4i) under investigation in the U.S. for the treatment of type 2 diabetes as an adjunct to diet and exercise. Alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play roles in regulating blood glucose levels. The FDC alogliptin and pioglitazone combines two complementary agents with distinct mechanisms of action and, if approved, will be the first type 2 diabetes treatment option in the U.S. to include both a DPP-4i and the thiazolidinedione (TZD) pioglitazone in a single tablet. Pioglitazone-containing medicines have been available in the U.S. since 1999 for the treatment of type 2 diabetes as an adjunct to diet and exercise.

The most common adverse events (greater than or equal to 5% and greater than placebo) reported in the alogliptin phase 3 program include headache, urinary tract infection, nasopharyngitis, and upper respiratory tract infection. With regard to the co-administration of alogliptin and pioglitazone, common adverse events (greater than or equal to 5%) reported include nasopharyngitis, back pain, urinary tract infection, and influenza.

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. In fact, more than 23 million Americans currently live with the disease. Type 2 diabetes is a progressive and chronic condition and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications in order to help them manage their blood glucose levels. The global health care expenditures for diabetes (both type 1 and 2) were estimated at $376 billion in 2010. By 2030, this number is projected to exceed $490 billion.

About Alogliptin and Alogliptin and Pioglitazone

Alogliptin is a DPP-4i being investigated in the U.S., as an adjunct to diet and exercise, for the treatment of type 2 diabetes. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 and GIP. As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. An NDA for alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name NESINA in this market.

Alogliptin and pioglitazone is an FDC therapy, which combines alogliptin and pioglitazone in a single tablet, in development for the treatment of type 2 diabetes in adults as an adjunct to diet and exercise. Pioglitazone is a TZD that directly addresses insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels, and is approved in adults for the treatment of type 2 diabetes as an adjunct to diet and exercise. An NDA for the alogliptin and pioglitazone FDC was approved in July 2011 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name LIOVEL in this market.

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 www.tpna.com.

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 patients 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.


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SOURCE Takeda Pharmaceutical Company Limited
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