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Takeda Submits New Drug Application for Combination Type 2 Diabetes Medication, Actoplus MetTM (pioglitazone HCl and metformin HCl)

October 29, 2004

OSAKA, JAPAN (October 29, 2004) --- Takeda Pharmaceutical Company Limited (“Takeda”) announced today that its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc. (“TPNA”) submitted through Takeda Global Research & Development Center Inc., a new drug application (NDA) for Actoplus MetTM to the U.S. Food and Drug Administration (FDA), for treatment of type 2 diabetes on October 28, 2004.

Takeda is the originator of thiazolidinedione derivatives and Actos® is a member of the thiazolidinedione class of "insulin-sensitizing" agents, and it directly targets insulin resistance. 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.

“We are pleased with the Actoplus MetTM NDA submission, which is expected to provide an additional treatment option for people with type 2 diabetes by combining two medications and support and complement the management of this chronic disease,” said Kiyoshi Kitazawa, Ph.D., member of the board, general manager of Pharmaceutical Development Division of Takeda. “We believe this product will contribute to individual patients with type 2 diabetes according to their clinical conditions, which will lead to realize our management mission of striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.”

TPNA launched Actos® in August 1999, jointly with Eli Lilly and Company (“Lilly”) as a co-promotion partner, for the treatment of type 2 diabetes as monotherapy and in combination with sulfonylureas, insulin or metformin.

Note: Separately from this combination product, Takeda and Andrx Corporation, Fort Lauderdale, FL, are jointly developing a combination product consisting of Actos® and Andrx’s Fortamet® .

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