has expanded its exclusive license agreement with Fuji Yakuhin Co. Ltd. (“Fuji”) for the development of dotinurad to include the Middle East and North Africa (“MENA”) and Turkey territories. The agreement builds upon the exclusive license agreement between Urica and Fuji previously announced in May of 2021 to develop dotinurad in the United States (“US”), United Kingdom, European Union and Canada.

Under the terms of the agreement, the Company acquired exclusive development and marketing rights in MENA and Turkey from Fuji. Fuji is eligible to receive upfront and royalty payments from the Company. Dotinurad is a potential best-in-class urate transporter (URAT1) inhibitor that is currently in a Urica-sponsored Phase 1 clinical trial in the US and being developed for the treatment of gout.

Dotinurad (URECE® tablet in Japan) was approved and launched in Japan in 2020 as a once-daily oral therapy for gout and hyperuricemia. Dotinurad was efficacious and well-tolerated in more than 1,000 Japanese patients treated for up to 58 weeks in Fuji's clinical program. Urica expects to leverage data from the three completed Phase 3 clinical trials in more than 500 Japanese patients in furthering the development and marketing of dotinurad in the licensed territories.

In May 2021, Fortress announced an exclusive license agreement between its subsidiary, Urica Therapeutics, Inc. (formerly UR-1 Therapeutics, Inc.), and Fuji Yakuhin Co. Ltd. to develop dotinurad in North America and Europe. In November 2022, Urica licensed rights to dotinurad from Fuji for additional territories including MENA and Turkey.

Dotinurad is a potential best-in-class urate transporter (URAT1) inhibitor for gout and possibly other hyperuricemic indications including chronic kidney disease and heart failure. It can lower blood uric acid levels by selectively inhibiting URAT1 and uric acid reabsorption in the kidneys. Dotinurad (URECE® tablet) was approved in Japan in 2020 as a once-daily oral therapy for gout and hyperuricemia.

Dotinurad was efficacious and well-tolerated in more than 500 Japanese patients treated for up to 58 weeks in Phase 3 clinical trials. Its efficacy demonstrated non-inferiority to Febuxostat, which has a black box warning in the US for increased risk of cardiovascular death, and dotinurad was well-tolerated with apparent low safety risk and drug interaction. Over 1,000 Japanese patients have been treated safely with dotinurad in clinical trials.

Also, dotinurad is currently in Phase 3 clinical trials in China. Gout is a serious, progressive and debilitating inflammatory arthritis caused by deposits of uric acid crystal in and around the connective tissue of joints, tendons and the kidneys. There are nearly 20 million diagnosed patients with gout in the US, Europe and Canada as of 2021,4,5,6 and it is estimated that two to three million US patients are unsatisfied with their urate-lowering therapy and their serum uric acid levels remain inadequately controlled.