Eisai and FUJI YAKUHIN Conclude License Agreement Concerning the Development and Distribution of Dotinurad, a Treatment for Hyperuricemia and Gout, in China

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and FUJI YAKUHIN CO., LTD. (Headquarters: Saitama, CEO: Masayuki Takayanagi, “FUJI YAKUHIN”) announced today that they have concluded a license agreement concerning dotinurad (generic name), a treatment for hyperuricemia and gout discovered by FUJI YAKUHIN, for development and distribution in China.

Based on this agreement, Eisai will acquire exclusive development and marketing rights for dotinurad in China from FUJI YAKUHIN. FUJI YAKUHIN will retain responsibility for manufacturing the formulation of dotinurad, and supply to Eisai. Eisai will be responsible for a New Drug Application for dotinurad  in China and pay FUJI YAKUHIN upfront payment, development milestone and sales milestone.

Hyperuricemia is the second most common metabolic disease after diabetes mellitus in China. In addition, hyperuricemia is known to be associated with various diseases in the urinary system, endocrine system, metabolic system, cardio-cerebrovascular system etc., including gout. Furthermore, it is estimated that currently in China, the number of patients with hyperuricemia is approximately 190 million and the number of patients with gout is approximately 16 million.1 It is expected that the number of patients will further increase in the near future due to changes in lifestyle and dietary preferences in accordance with socioeconomic development in China.
Dotinurad is a new therapeutic agent for gout and hyperuricemia discovered by FUJI YAKUHIN. Dotinurad suppresses uric acid reabsorption and lowers blood uric acid levels, by selectively inhibiting the urate transporter (URAT1) related to reabsorption of uric acid in the kidney.

Under this agreement, Eisai will proceed with the development of dotinurad in China. Following commercialization, Eisai will aim to contribute to patients with hyperuricemia that is unmet medical needs by utilizing the knowledge and networks that Eisai has cultivated through its China business. FUJI YAKUHIN anticipates maximizing the value of dotinurad in China by leveraging Eisai’s business base as the first step in the global expansion of dotinurad. Through the development and commercialization of dotinurad, Eisai and FUJI YAKUHIN will provide new treatment options for hyperuricemia and gout in China and contribute to improving the quality of life of patients.

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1 For the estimated data regarding the number of patients with hyperuricemia as well as the number of patients with gout:Data of morbidity prevalence rate – Rui Liu et al., Prevalence of Hyperuricemia and Gout in Mainland China from 2000 to 2014: A Systematic Review and Meta-Analysis, BioMed Research International, Volume 2015, Article ID 762820
Estimated data calculated from United Nations World Population Estimates – World Population Prospects, URL:http://www.un.org/en/development/desa/population/