October 10, 2008

Takeda Pharmaceutical Company Limited

FDA Continues Review of Takeda’s New Drug Application for Alogliptin (SYR-322), a DPP- 4 agent for Type 2 Diabetes

OSAKA, Japan, October 10, 2008 - Takeda Pharmaceutical Company Limited (“Takeda”) today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

“In our most recent discussion with the FDA, it indicated that due to internal resource constraints it will not be able to complete the alogliptin review by the PDUFA date,” said Dean Sundberg, senior vice president, regulatory affairs at Takeda Global Research and Development Center, Inc. “Additionally, the FDA did not provide Takeda with any guidance on when a review might be completed nor did it raise any issues with the data in the alogliptin NDA. Takeda remains confident in alogliptin’s potential as a new treatment option for people suffering from type 2 diabetes and we will work with the FDA as they continue this NDA review.”

Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor discovered by Takeda’s wholly owned U.S. subsidiary, Takeda San Diego, Inc. In December, 2007 Takeda submitted its NDA for alogliptin for the treatment of type 2 diabetes. This submission enhances Takeda’s position as a global leader in type 2 diabetes – one of Takeda’s core therapeutic areas.

About DPP-4 Inhibitors

DPP-4 inhibitors inhibit the enzyme dipeptidyl peptidase-4 (DPP-4), which selectively metabolizes the insulin-increasing hormones glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). By maintaining the blood levels of GLP-1 and GIP, DPP-4 inhibitors are a new type of oral anti-diabetic with a novel mechanism of action for lowering blood sugar levels. GLP-1 and GIP are excreted in the digestive tract following food intake, and stimulate the beta-cells in the pancreas—thereby stimulating increased insulin secretion—and it has also been confirmed that they improve the functioning of the beta cells themselves. Furthermore it is known that because GLP-1 suppresses glucagon secretion from the pancreas, the production of sugar in liver cells is also suppressed and appetite is suppressed as well.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda (TSE:4502) 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 striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.

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Contacts:

Matt Kuhn
Takeda Pharmaceuticals North America
+ 1-224-554-5609

Seizo Masuda
Takeda Pharmaceutical Company Limited
+ 1-81-3-3278-2037

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