ACTOplus met™ approved by the FDA for type 2 diabetes

08/29/05

New product combines two widely used diabetes medications in a single tablet

LINCOLNSHIRE, Ill., August 29, 2005 – Takeda Pharmaceuticals North America, Inc. (TPNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ACTOplus metTM for the treatment of type 2 diabetes. This is the second Takeda product approved in the U.S. this summer, following the approval of ROZEREMTM (ramelteon) on July 22, 2005.

ACTOplus met combines ACTOS (pioglitazone HCl) and metformin, two widely used diabetes medications, in a single tablet. ACTOS directly targets insulin resistance, a condition where the body does not efficiently use the insulin it produces, and metformin acts primarily by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.

To offer physicians greater flexibility in treating their patient's needs, ACTOplus met will be available in two dosages of pioglitazone/metformin – 15 mg/500 mg and 15 mg/850 mg – both of which are to be given once a day or in divided doses not exceeding the maximum recommended daily doses of pioglitazone 45 mg and metformin 2,550 mg as mentioned in the approved labeling.

"To reach target blood glucose levels, many people with type 2 diabetes will have to take a combination of therapies. In fact, within three years of being prescribed their first medication, approximately 50 percent of patients will need to add additional therapies to manage their condition," said Ralph DeFronzo, M.D., professor of Medicine and chief of the Diabetes Division at the University of Texas Health Science Center at San Antonio. "ACTOplus met may help patients reduce the number of pills they take each day, and offers a new and convenient treatment option."

According to the American Diabetes Association, diabetes affects more than 18 million people, and type 2 diabetes is the most common form of the disease. Both ACTOS and metformin are widely used medications in the treatment of type 2 diabetes and both have a known safety profile. Combining these medications may provide patients with an easier way to take the two drugs, as they are already often prescribed together to help manage the disease.

Takeda Global Research & Development Center, Inc. submitted the ACTOplus met NDA in October 2004. Takeda expects the medication to be available to patients by October 2005.

"Takeda is committed to developing appropriate treatment options for healthcare providers and their patients," said Mark Booth, president of Takeda Pharmaceuticals North America, Inc. "ACTOplus met reflects that commitment by offering a convenient option for people with type 2 diabetes and an important new addition to the ACTOS portfolio."

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