-Novel Drug for Chronic Management of Hyperuricemia in Gout Patients-
Teijin Pharma Limited announced yesterday the European launch of TMX-67 (febuxostat), a novel drug discovered by Teijin Pharma for the treatment of hyperuricemia in patients with gout. Ipsen, a global biotechnology specialty care group and the TMX-67 licensee in Europe, and its sublicensee the Menarini Group, the first Italian pharmaceutical group in the world, have began marketing the product in Europe under the brand name ADENURIC, starting in France on March 8.
ADENURIC will be further launched by Menarini, which holds the marketing rights in 41 European countries, in the U.K. on March 11, Germany on March 15 and Ireland on March 29. Additional launches in other European countries are expected.
In July 2003, Teijin Pharma signed an exclusive license agreement with Ipsen for the development and marketing of TMX-67 in Europe. Following EMEA approval in April 2008, Ipsen signed in October 2009 an exclusive sublicense agreement with Menarini, which is Italy's largest pharmaceutical company and has the fourth-largest pharmaceutical team for delivering medical information to physicians.
TMX-67, one of Teijin Pharma's most promising products, has strong global potential. Approval was obtained by licensees, Takeda Pharmaceuticals North America in the United States in February 2009 and SK Chemicals in Korea in June 2009. Sales are already underway in the United States. In addition, Teijin Pharma signed in May 2009 an exclusive distributorship agreement with Astellas Pharma Taiwan, its licensee for the Taiwanese market, and resubmitted a New Drug Application (NDA) in Japan in December 2009. Teijin Pharma will continue to pursue collaborative efforts to broaden TMX-67fs global availability. The goal is to reach global annual sales of roughly 100 billion yen, including 40-60 billion yen from Europe in the foreseeable future.
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 hyperuricemia has long been sought.
TMX-67, developed by Teijin Pharma after intensive research, is an oral, once-daily, highly potent, non-purine selective inhibitor of 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. TMX-67 has proven therapeutic superiority to allopurinol and above all is well tolerated by patients suffering from a mild and moderate renal impairment.
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