New Drug Application Approval for SONIAS^® HD and SONIAS LD in Japan
- Fixed dose combination tablet of ACTOS^® and sulfonylurea for treatment of type 2 diabetes -

Osaka, Japan January 21 2011 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that a New Drug Application for SONIAS^®, a fixed dose combination tablet of ACTOS^® (generic name: pioglitazone HCl) and sulfonylurea (generic name: glimepiride) for treatment of type 2 diabetes, was approved by the Japanese Ministry of Health, Labour and Welfare.

SONIAS is a tablet taken orally once daily and has two dosage strengths, “SONIAS LD” and “SONIAS HD” which contain 15mg pioglitazone/1mg glimepiride, and 30mg pioglitazone/3mg glimepiride respectively.

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. Sulfonylurea primarily acts on beta cells of the pancreas and increasing the amount of insulin secretion by the pancreas. 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.

“We are very pleased to have received approval for SONIAS, a fixed dose combination tablet of ACTOS and sulfonylurea which has been most often prescribed as a co-administrative regime in Japan for treatment of type 2 diabetes,” said Nancy Joseph-Ridge, M.D., general manager of Takeda’s Pharmaceutical Development Division. “We are pleased to offer a SONIAS as a single treatment option for patients with type 2 diabetes and the health care professionals who treat them.”

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