Teijin Pharma Limited has signed an exclusive distributorship agreement with Astellas Pharma Taiwan, Inc, the Taiwanese sales and marketing arm of Tokyo-based Astellas Pharma Inc, regarding the marketing of TMX-67 (febuxostat) in Taiwan. Developed by Teijin Pharma, TMX-67 is a new drug for treating hyperuricemia in patients with gout and has been positioned as a strategic product for the company's expansion overseas.
Astellas Pharma Taiwan will manage the approval process and handle sales of TMX-67 after its commercial launch, which is targeted at 2013. Teijin Pharma will supply the finished product and receive an upfront licensing fee as well as commercial milestone payments.
Approval of TMX-67 has already been obtained by Teijin Pharma's respective licensees in the European market in April 2008 and the US market in February 2009. A commercial launch in the US followed one month later. In Asia, SK Chemicals is conducting clinical studies in Korea and Teijin Pharma is preparing to resubmit a New Drug Application (NDA) in Japan.
The agreement with Astellas Pharma Taiwan marks an additional milestone for Teijin Pharma's global business. Taiwan has a relatively high prevalence of gout compared to other markets in Asia, so demand is expected to be favorable. Teijin Pharma will continue to strengthen its global operations through collaborations with other companies to expand TMX-67's global availability.
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 hyperuricaemia in patients with gout has long been sought.
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. Clinical data have proven its safety and efficacy, and TMX-67's safety profile does not require dosage adjustments for patients with mild-to-moderate renal or hepatic impairment.
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, with about 1,700 employees.