Teijin Pharma Limited and Astellas Pharma Inc. announced that they have entered into an exclusive distribution agreement for febuxostat (generic name, development code: TMX-67), a novel drug for the treatment of gout and hyperuricemia, in Southeast Asia and India.

Under the agreement, Astellas Pharma will have exclusive rights to sell the product in Thailand, the Philippines, Indonesia, Singapore, Malaysia, Vietnam, and India. Astellas Pharma will apply for marketing approval in each of these countries, with the goal of beginning sales by 2015. Astellas Pharma already has its own sales affiliates in Thailand, the Philippines, Indonesia and India and in Singapore, Malaysia and Vietnam provides its own products through partners. Astellas expects to further expand the business in Asian territories by in-licensing febuxostat.

This new agreement adds to the existing licensing deals between Teijin Pharma and Astellas Pharma covering Taiwan, China and Hong Kong through its subsidiaries. Astellas Pharma Taiwan, Inc. has already obtained marketing approval, while Astellas Pharma China, Inc. and Astellas Pharma Hong Kong Co., Ltd. are currently in the process of development and registration in their respective markets.

Febuxostat is the world's first non-purine selective inhibitor of xanthine oxidase, discovered by Teijin Pharma in 1991. It has a novel chemical structure completely different from that of allopurinol, which has been used for over 40 years as the standard treatment for hyperuricemia and gout. Febuxostat effectively reduces the level of uric acid in the blood of hyperuricemic patients to the recommended level, and is well tolerated without need for dose adjustment in patients suffering from mild to moderate renal impairment.

Teijin Pharma has entered into collaboration on febuxostat in a total of 91 countries, including the above seven countries, to offer new alternative to patients worldwide. The drug is already being sold in 13 countries including the U.S., Canada, Japan, Korea and 9 European countries. Teijin Pharma has positioned the drug as a globally strategic product and expects to achieve annual sales of over 100 billion yen in the foreseeable future.

Both companies look forward to contributing towards raising the quality of life in patients in the territories by offering febuxostat as a new option in the treatment of gout and hyperuricemia.

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