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May 7, 2008 - Teijin Pharma Limited ("Teijin"; headquarters: Chiyoda-ku, Tokyo; President:Osamu Nishikawa) announced today that on April 21, 2008, its licensee for Europe, Ipsen (stock code Euronext: IPN), an innovation driven international specialty pharmaceutical group ("Ipsen"; headquarters: Paris, France; Chairman and CEO: Jean-Luc Bélingard) was granted a marketing authorization by the European Commission for Adenuric® (febuxostat) for the treatment of chronic hyperuricaemia in gout. Ipsen submitted the Marketing Authorization Application (MAA) for TMX-67 to the European Medicines Agency (EMEA) in August, 2006, and received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMEA. Gout is a chronic disease marked by gouty arthritis associated with severe pain caused by the deposition of monosodium urate crystals in the joints. The underlying cause of gout is hyperuricaemia, a condition characterized by elevated levels of uric acid in the blood. Uncontrolled hyperuricaemia may also lead to tophi and nephrolithiasis, which can ultimately cause nephropathy. Hyperuricaemia can be treated mostly with a xanthine oxidase (an enzyme directly related to the production of uric acid) inhibitor, but currently only one xanthine oxidase inhibitor, allopurinol, is available on the market. Allopurinol is a drug developed nearly 40 years ago, and a novel drug that can provide a new option for the treatment of gout and hyperuricaemia has long been sought. TMX-67, which was discovered by Teijin Pharma after intensive research, is an oral, once-daily, novel highly potent non-purine selective inhibitor of xanthine oxidase having a structure completely different from that of allopurinol. Teijin has positioned TMX-67 as a key product for its strategic expansion of business into overseas markets. Teijin is preparing for resubmission of the New Drug Application (NDA) in Japan, and TAP Pharmaceutical Products Inc. (Head Office: Lake Forest, Illinois) is conducting an additional Phase III study in the US. In Korea, SK Chemicals (Headquarters: Seoul, Korea; CEO and Chairman: Chang Geun Kim) is also conducting clinical studies. Teijin is planning to expand the market for TMX-67 by collaborating with companies in other areas including Asia, to strengthen its basis for overseas business. [Adenuric® approved European Commission]
For further information, please contact: Public Relations & Investor Relations Office Teijin Limited Tel: +81-3-3506-4055 / Fax: +81-3-3506-4150 E-mail: pr@teijin.co.jp |
Information in the press releases is current on the date of the announcement.
It is subject to change without prior notice.
