September 29, 2008

Takeda Pharmaceutical Company Limited

Takeda Submitted a New Drug Application
for Alogliptin in Japan for Treatment of Type 2 Diabetes

Osaka, Japan, September 29, 2008-Takeda Pharmaceutical Company Limited ("Takeda") announced today that it filed a New Drug Application to the Ministry of Health, Labour and Welfare for Alogliptin (development code: SYR-322) for treatment of type 2 diabetes. Alogliptin is a dipeptidyl peptidase-IV (DPP-4) inhibitor taken once a day, and were created by Takeda San Diego, Inc., Takeda's wholly-owned subsidiary located in San Diego, California.

DPP-4 inhibitors are a new class of oral agents for the treatment of type 2 diabetes, which slow the inactivation of the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). The incretins play a major role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function ^[*].

Large-scale clinical studies conducted both in Japan and in the world demonstrated that Alogliptin was effective with statistically significant reductions in hemoglobin A1c,-- which reflects average blood glucose level over the previous one to two months -- and was well-tolerated with no increase in hypoglycemia compared to placebo.

“Following Alogliptin’s NDA submission in the U.S. last December, we are pleased to accomplish Alogliptin’s New Drug Application in Japan,” said Yasuchika Hasegawa, President of Takeda. “We will strive to provide Alogliptin as a new treatment option for type 2 diabetes as early as possible, to patients and healthcare provider in Japan.

^[*] GLP-1 and GIP are produced by the digestive tract in response to food, and regulate glucose balance, primarily by stimulating glucose-dependent insulin secretion. In addition, GLP-1 suppresses pancreatic glucagon secretion and subsequent liver glucose production, enhances glucose disposal, slows gastric emptying, and elicits satiety, a feeling of fullness.

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