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February 25, 2008 - Teijin Pharma Limited ("Teijin"; headquarters: Chiyoda-ku, Tokyo; President: Shigeo Ohyagi) announced today that on February 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) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), recommending to grant the marketing authorization for TMX-67 for the treatment of chronic hyperuricaemia in gout. Teijin entered into a licensing agreement with Ipsen for TMX-67 in July 2003* and Ipsen submitted the Marketing Authorization Application (MAA) for TMX-67 to the EMEA in August, 2006. The marketing authorization by the European Commission is expected within 60 to 90 days. (N.B.) At the time of entering the licensing agreement in July 2003, Teijin Pharma was Medical and Pharmaceutical Division of Teijin Limited. 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 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 additional Phase III studies 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. 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 |
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