Eisai and Fuji Yakuhin Co., Ltd announced 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 five ASEAN (Association of Southeast Asian Nations) member states: Indonesia, Malaysia, Myanmar, the Philippines, and Thailand. This agreement conclusion will lead to an expansion into Southeast Asia of an agreement regarding dotinurad in China concluded by Eisai and Fuji Yakuhin in February 2020.
Based on this agreement, Eisai will acquire exclusive development and marketing rights for dotinurad in the said five countries from Fuji Yakuhin. Fuji Yakuhin will retain responsibility for manufacturing the formulation of dotinurad, and supply to Eisai. Eisai will be responsible for New Drug Applications for dotinurad in the said five countries and pay Fuji Yakuhin an upfront payment and sales milestones.
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 Southeast Asia, the number of hyperuricemia and gout patients is approximately 2.83 million. 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 Southeast Asia.
Dotinurad is a new therapeutic medicine 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. In Japan, Fuji Yakuhin obtained manufacturing and marketing approval for dotinurad in January 2020 and launched it in May 2020.
Under this agreement, Eisai will proceed with the development and commercialization of dotinurad in the said five countries, and aim to contribute to patients with unmet medical needs in Southeast Asia. Fuji Yakuhin anticipates maximizing the value of dotinurad in Asia by leveraging Eisai's business base.
Through the development and commercialization of dotinurad, Eisai and Fuji Yakuhin will provide new treatment options for hyperuricemia and gout in the said five countries in addition to China, and contribute to improving the quality of life of patients in Asia.