December 22, 2008

Takeda Pharmaceutical Company Limited

Approval of an Additional Indication of ACTOS^® in Japan;
Concomitant Therapy with Biguanides for Type 2 Diabetes

Osaka, Japan December 22, 2008 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that an additional indication of concomitant therapy with biguanides for ACTOS^® (pioglitazone hydrochloride), medicine for type 2 diabetes, was approved on December 22 by the Ministry of Health, Labour and Welfare.

ACTOS directly targets insulin resistance, a condition characterized in patients with type 2 diabetes, 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.

In a randomized, double-blind, comparative study, in which the clinical usefulness of biguanides monotherapy was compared with that of ACTOS/biguanides concomitant therapy, the latter showed a statistically significant difference in improving HbA_1c –an indicator of glycemic control– without increasing the risk of hypoglycemia. In addition to the currently authorized concomitant therapy with sulfonylurea or alpha-GI, this additional indication for ACTOS of concomitant therapy with biguanides provides a further option to pursue superior glycemic control.

Takeda will continue to earnestly promote development activities that offer a variety of treatment option to patients with type 2 diabetes and also to the healthcare providers.

Notes:

1. The additional indication which was approved in this instance is shown in underline below.

Type 2 diabetes

• (1) Monotherapy in patients inadequately controlled by diet and exercise.
• (2) Concomitant therapy with a sulfonylurea, in patients inadequately controlled by diet and exercise plus the single agent.
• (3) Concomitant therapy with an alpha-GI, in patients inadequately controlled by diet and exercise plus the single agent.
• (4) Concomitant therapy with a biguanide, in patients inadequately controlled by diet and exercise plus the single agent.

• 2. Biguanides which are available for sale in Japan today are metformin hydrochloride and buformin hydrochloride.

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