TOPNews Relaese Back numberDecember 25, 2009

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Teijin Pharma Submits New Drug Application for TMX-67, Chronic Management of Hyperuricemia in Patients with Gout in Japan

December 25, 2009

Teijin Pharma Limited

Teijin Pharma Limited announced today that on December 25 it filed a New Drug Application to the Japanese Ministry of Health, Labour and Welfare, for TMX-67 (febuxostat), a self-developed new drug for the treatment of hyperuricemia in patients with gout.

With strong global potential, TMX-67 is one of Teijin Pharma's promising products. Approval was already obtained by Teijin Pharma's respective licensees, in Europe by Ipsen in April 2008, in the U.S. by Takeda Pharmaceuticals North America in February 2009, and in Korea by SK Chemicals in June 2009. Sales are already underway in the United States. In October this year, Ipsen signed an exclusive European sublicense agreement for TMX-67 with Menarini, Italy's largest pharmaceutical company. In addition, Teijin Pharma signed an exclusive distributorship agreement with Astellas Pharma Taiwan, its licensee for the Taiwan market in May this year.

TMX-67, developed by Teijin Pharma after intensive research, is an oral, once-daily, highly potent, non-purine drug that selectively inhibits xanthine oxidase. A novel drug with a structure completely different from that of allopurinol, TMX-67 lowers the level of uric acid in the blood of hyperuricemic patients suffering from gout. Its safety profile does not require dosage adjustments for patients with mild-to-moderate renal or hepatic impairment.

Gout, a chronic disease marked by gouty arthritis associated with severe pain, is mainly treated with medication that inhibits xanthine oxidase, an enzyme directly related to the production of uric acid. The current leading medication, allopurinol, was developed nearly 40 years ago, so a new drug that provides more options for the treatment of gout and hyperuricaemia has long been sought. The estimated number of gout patients in Japan is around 8 million*. Teijin Pharma hopes to contribute to the quality of life in those patients by providing TMX-67 as a new option for the treatment.

* Based on National Livelihood Survey 2004 and the 5th National Survey of Cardiovascular Diseases 2000 (Ministry of Health, Labour and Welfare).

About the Teijin Group

Based in Tokyo and Osaka, Japan, Teijin is a global technology-driven group operating in five main fields: synthetic fibers (polyester fibers, carbon fibers and aramid fibers); films and plastics; pharmaceuticals and home health care; trading and retail; and IT and new products. Teijin Limited, the holding company for the Teijin Group, is listed on the Tokyo and Osaka stock exchanges. The group had consolidated sales of USD 10.5 billion (JPY 943.4 billion, USD 1=JPY 90) in fiscal 2008 and employs 19,453 people worldwide, with 169 companies around the world.

About Teijin Pharma Limited

Teijin Pharma Limited, the core company of Teijin Group's medical and pharmaceuticals business, focuses on three key therapeutic areas: respiratory, bone/joint, and cardiovascular/metabolic diseases. Teijin Pharma has strong marketing positions, particularly in the respiratory and bone/joint areas, with pharmaceutical products as well as a home healthcare business, including home oxygen therapy. Teijin Pharma continues to enhance its presence worldwide through in-house R&D as well as in-licensing and out-licensing activities. For more information, visit www.teijin-pharma.co.jp/english/index.html

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