Eisai and Fuji Yakuhin have signed a development and distribution license agreement for dotinurad, a generic treatment for hyperuricemia and gout discovered by Fuji Yakuhin. The agreement covers five ASEAN (Association of Southeast Asian Nations) member states: Indonesia, Malaysia, Myanmar, the Philippines, and Thailand.
Based on the agreement, Eisai will acquire exclusive development and marketing rights for dotinurad in the said five countries. Fuji Yakuhin will retain responsibility for manufacturing the formulation of dotinurad, and supply to Eisai, which will then be responsible for new drug applications for dotinurad in the said five countries. Eisai will compensate Fuji Yakuhin through 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. It’s expected the number of patients for these conditions will further increase in the near future due to changes in lifestyle and dietary preferences in accordance with socioeconomic development in Southeast Asia, the companies say.
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, the company 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 commercialisation of dotinurad in the said five countries, and aim to contribute to patients with unmet medical needs in Southeast Asia.