Takeda submits new drug application for extended-release type 2 diabetes medication, AC...( LINCOLNSHIRE Ill. Takeda Global Resea...),Health

LINCOLNSHIRE, Ill. Takeda Global Research & Development Center (TGR&D) today announced that the company has submitted a New Drug Application (NDA) for an extended-release version of the combination medication ACTOplus met ^TM (pioglitazone HCl and metformin HCl) to the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. This new formulation (ACTOplus met XR) would allow for once-daily dosing, while ACTOplus met (immediate release) is already available, being marketed by Takeda Pharmaceuticals North America, Inc.

ACTOplus met is an oral medication that combines ACTOS (pioglitazone HCl), which directly targets insulin resistance a condition in which the body does not efficiently use the insulin it produces with metformin, which 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.

The NDA submission represents yet another milestone for Takeda, following the FDA approval of ROZEREM^TM(ramelteon).

"We are certainly proud of this NDA submission, and the ACTOS portfolio of products," said John Yates, M.D., president of TGR&D. "Not all patients are alike, especially in diabetes, and the addition of this new product would provide patients and their physicians with more options and greater flexibility, while continuing to provide the benefits of treatment with ACTOS." Extended-release metformin, one of the active ingredients in ACTOplus met XR, was developed by Andrx Corporation. Takeda Pharmaceutical Company Limited signed an agreement with Andrx Corporation covering extended-release metformin in December 2003.

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3-Apr-2006

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