Eisai and Fuji Yakuhin Enter into Agreement for Dotinurad, a Novel Treatment for Gout and Hyperuricemia, in China

TOKYO, Feb. 25, 2020 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, hereinafter referred to as "Eisai") and Fuji Pharmaceutical Co., Ltd. (Headquarters: Saitama Prefecture, CEO: Masayuki Takayanagi, hereinafter referred to as "Fuji Pharma") announced, alreadyEisai has entered into a licensing agreement with Fuji Pharma for Dotinurad (generic name), a drug developed by Fuji Pharma for the treatment of hyperuricemia and gout. Eisai will be responsible for the development and commercialization of the product in the Chinese market.

Under this agreement, Eisai will obtain the exclusive rights to develop and market Dotinurad in China from Fuji Pharma. Fuji Pharma will retain responsibility for the manufacturing of Dotinurad formulations and supply the drug to Eisai. Eisai will be responsible for filing the New Drug Application for Dotinurad in China and will pay Fuji Pharma an upfront payment, as well as development and sales milestone payments.

In China, hyperuricemia is the second most common metabolic disorder after diabetes mellitus. It is well known to be associated with a variety of diseases in the urinary system, endocrine system, metabolic system, and cardiovascular and cerebrovascular systems, including gout. Furthermore, it is estimated that there are currently approximately 190 million patients with hyperuricemia and about 16 million patients with gout in China.¹. With the socioeconomic development in China, driven by changes in lifestyle and dietary habits, the number of patients is expected to further increase in the near future.

Dotinurad is a novel therapeutic agent for gout and hyperuricemia developed by Fuji Pharma. Dotinurad selectively inhibits urate transporter 1 (URAT1), which is involved in uric acid reabsorption in the kidneys, thereby suppressing uric acid reabsorption and reducing serum uric acid levels.

Under this agreement, Eisai will continue to develop the drug in China and, following its relaunch, leverage the knowledge and network accumulated through Eisai’s operations in China to contribute to meeting the unmet medical needs of patients with hyperuricemia. Fuji Pharma aims to maximize the value of dotinurad in China by utilizing Eisai’s business infrastructure, marking the first step in the drug’s global expansion. Through the development and commercialization of dotinurad, Eisai and Fuji Pharma will provide new treatment options for hyperuricemia and gout in China, thereby helping to improve patients’ quality of life.

Reference

¹ For the estimated data regarding the number of patients with hyperuricemia as well as the number of patients with gout: