Takeda Pharmaceutical Co. Ltd. Wins Patent Infringement Litigation Against ANDA Filers For Generic ACTOS(R) (Pioglitazone HCl)

OSAKA, Japan and LINCOLNSHIRE, Ill., Feb. 22 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA") announced today that Takeda's intellectual property rights have been successfully asserted against generic manufacturers seeking to challenge Takeda's patent rights to ACTOS(R) (pioglitazone HCl). A federal judge of the U.S. District Court for the Southern District of New York ruled on February 21, 2006 that a patent covering the active ingredient of ACTOS is valid and enforceable.

Takeda filed patent infringement actions against Mylan Pharmaceuticals(1), Ranbaxy Laboratories(2), and Watson Pharmaceuticals(3), in October 2003, and against Alphapharm Pty(4) in March 2004, in response to the filing of Abbreviated New Drug Applications (ANDAs) with the FDA under provisions of the Hatch-Waxman Act, challenging certain of Takeda's listed patents, including U.S. Patent No. 4,687,777 (the "'777 patent"), which covers the active ingredient of ACTOS, pioglitazone hydrochloride. Alphapharm and Mylan were the only defendants to challenge the '777 patent. Trial of the challenges by Alphapharm and Mylan to the validity and enforceability of the '777 patent took place from January 17, 2006 to January 30, 2006.

The Court's ruling prevents the FDA from approving the ANDAs filed by Alphapharm and Mylan, and thus prevents those generic manufacturers from selling pioglitazone tablets until the '777 patent expires, in 2011. Other U.S. patents covering certain methods of treatment using ACTOS(R) and certain compositions that include ACTOS will expire in 2016.

"Takeda has confidence in its patents," said Mr. Seiji Hakoda, General Manager of Intellectual Property Dept. of Takeda. "Because innovation is critical to our company, we have a profound respect for the protection of intellectual property rights. We are pleased with the ruling."

About Takeda

Takeda, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan, and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, http://www.takeda.com.

About Takeda Pharmaceuticals North America, Inc.

Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes, sleep and cholesterol lowering treatments, and through the Takeda Global Research & Development Center, Inc. the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit http://www.tpna.com.

(1) Mylan Laboratories, Inc., Mylan Pharmaceuticals, Inc., and UDL Laboratories, Inc. (2) Ranbaxy Laboratories, Ltd., and Ranbaxy Pharmaceuticals, Inc. (3) Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., Watson Pharma, Inc. and Danbury Pharmacal, Inc. (4) Alphapharm Pty. Ltd., and Genpharm, Inc.

Takeda Pharmaceutical Company Limited

CONTACT: Seizo Masuda of Takeda Pharmaceutical Company Limited,+81-6-6204-2060; or Matt Kuhn of Takeda Pharmaceuticals North America, Inc.+1-847-383-3454

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