Healthcare Industry News:  pioglitazone 

Biopharmaceuticals Endocrinology Cardiology

 News Release - July 21, 2006

Takeda Announces Start of Phase 3 Clinical Program in the U.S. of Fixed Dose Combination Product of Actos(R) + TAK-536 for Treatment of Patients with Type 2 Diabetes Associated with Hypertension

Tokyo, Japan, July. 21, 2006 - (HSMN NewsFeed) - Takeda Pharmaceutical Company Limited ("Takeda") announced today that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc., has started the phase 3 clinical program of fixed dose combination product of Actos(R) (generic name: pioglitazone HCl) and Takeda's novel investigational drug TAK-536 in the U.S.

Actos is being marketed in more than 60 countries in the world, including in the U.S. by Takeda Pharmaceuticals North America, Inc., also a wholly owned subsidiary of Takeda. It is indicated for patients with type 2 diabetes with the action of improving insulin resistance, and TAK-536 is a novel angiotensin receptor blocker (ARB) discovered by Takeda currently under development for treatment of hypertension in the U.S. and Europe.

This combined product is expected to provide additional blood glucose-lowering effects compared to Actos alone, while also offering anti-hypertensive action and multi-organ protective action derived from ARBs.

"In the U.S., the prevalence of hypertension among the patients with diabetes is said to be approximately 60%(*), therefore, we believe that this combined product, if successfully developed and launched, can add a beneficial treatment option for type 2 diabetes patients with hypertension." said Masaomi Miyamoto, Ph.D., General Manager of Pharmaceutical Development Division of Takeda. "The development of this combined product and its earliest launch possible represent our commitment to further enhance the U.S. diabetic franchise that has been established with Actos."

(*) Based on information in the website of American Diabetic Association.

About Takeda Pharmaceutical Company, Ltd. Takeda (TSE: 4502; OTC: TKPHF) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the industry's leaders worldwide, Takeda's management mission is "to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products." Takeda is engaged in activities spanning research and development, manufacturing, and sales and marketing on a world-wide level. Under the current management vision to become an R&D oriented world-class pharmaceutical company, Takeda is taking all possible measures to enhance its R&D pipeline through promotion of its own R&D, in-licensing/alliances and life-cycle management of existing products. In addition, Takeda aims to be "a company that grows together with its stakeholders." Takeda is actively engaged in social contribution activities aiming to become a good corporate citizen in the world.


Source: Takeda Pharmaceutical

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