October 30, 2008

Takeda Pharmaceutical Company Limited

Takeda Submitted a New Drug Application
for a Fixed Dose Combination Tablet of Actos^® with Metformin in Japan
for the Treatment of Type 2 Diabetes

Osaka, Japan, October 30, 2008 -Takeda Pharmaceutical Company Limited ("Takeda") announced today that it filed a New Drug Application to the Ministry of Health, Labour and Welfare for a fixed dose combination tablet of Actos^® (generic name: pioglitazone HCI) with metformin for the treatment of type 2 diabetes.

Actos, which was discovered by Takeda, is in the thiazolidinedione (TZD) class of oral antidiabetic medications and targets insulin resistance, which is a characteristic symptom associated with type 2 diabetes. It is expected that by combining these two medications, which have differing mechanisms of action, patients will be able to avoid missing a dose due to the greater ease of administration, thereby allowing patients with type 2 diabetes to better control their blood glucose levels.

“The fixed dose combination tablet of Actos with metformin, if approved, will be the first fixed-dose combination treatment for type 2 diabetes in Japan,” said Masaomi Miyamoto, Ph.D., General Manager of Pharmaceutical Development Division of Takeda. “By building on the September NDA submission of Actos^® orally disintegrating tablets in Japan, and by providing this fixed dose combination tablet as a new treatment option, we are striving to meet the needs of a greater number of patients with diabetes.”

A fixed dose combination tablet of Actos  with metformin was approved under the brand name of Actoplus met^® in the U.S. in August 2005 and was approved under the brand name of Competact^® in the E.U. in July 2007.

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