Takeda Pharmaceutical Company Limited announced that today it submitted an application for an additional indication of ACTOS(R) (pioglitazone HCl) with biguanides to the Ministry of Health, Labour and Welfare.

ACTOS directly targets insulin resistance, a condition where the body does not effectively use the insulin it produces, by improving the sensitivity to insulin mainly in the muscles, fat cells and the liver. Biguanides act primarily by reducing the amount of glucose produced by the liver, and are being used as the standard therapy for type 2 diabetes in Western countries and its use in Japan is now being expanded.

"In Japan, Actos is already approved for monotherapy, and concomitant therapies with sulfonylureas and alpha-glucosidase inhibitors respectively", said Masaomi Miyamoto, Ph.D., General Manager of Pharmaceutical Development Division of Takeda. "Once this concomitant therapy of Actos with biguanides is approved, we can offer a variety of treatment option for patients with type 2 diabetes and also healthcare providers who help them manage their blood glucose levels."

Notes:

1. Currently available biguanides in Japan are metformin and buformin.

2. Approved indications of Actos in Japan: Type 2 diabetes; Monotherapy in patients inadequately controlled by diet and exercise, Concomitant therapy with a sulfonylurea, in patients inadequately controlled by diet and exercise plus the single agent, Concomitant therapy with an alpha-GI, in patients inadequately controlled by diet and exercise plus the single agent.

About Takeda Pharmaceutical

Takeda Pharmaceutical, located in Osaka, Japan, 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, http://www.takeda.com/index-e.html.

Takeda Pharmaceutical
Takeda Pharmaceutical