Business
Fortress Biotech Announces Exclusive License Agreement With Fuji Yakuhin to Develop Dotinurad in North America and Europe
Agreement signed with Fuji Yakuhin to develop Dotinurad, a potential best-in-class urate transporter (URAT1) inhibitor for gout and potentially other
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"Agreement signed with Fuji Yakuhin to develop Dotinurad, a potential best-in-class urate transporter (URAT1) inhibitor for gout and potentially other hyperuricemic indications including chronic kidney disease and heart failure 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 NEW YORK, May 10, 2021 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or the “Company”), an innovative biopharmaceutical company, today announced that it has entered into an exclusive licensing agreement with Fuji Yakuhin Co. Ltd. (“Fuji”) to develop Dotinurad in the United States, United Kingdom, European Union and Canada. Dotinurad is a potential best-in-class urate transporter (URAT1) inhibitor that was approved for the treatment of gout and hyperuricemia in Japan in 2020. Hyperuricemia has also been implicated in the progression of chronic kidney disease and heart failure, and Dotinurad may potentially play a critical role in helping treat these conditions. Under the terms of the agreement, the Company acquired exclusive development and marketing rights in North America and Europe from Fuji. Fuji is eligible to receive upfront, development and commercial milestone and royalty payments from the Company. Fortress expects to leverage data from three completed Phase 3 clinical trials in more than 500 Japanese patients to develop and market Dotinurad. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “We are excited to work with Fuji to develop Dotinurad for the treatment of gout and possibly other indications, and look forward to the opportunity to deliver potential best-in-class medicines to patients in need. With nearly 20 million gout patients in our territory, we believe there is a sizeable market for this opportunity.” About DotinuradDotinurad is a potential best-in-class urate transporter (URAT1) inhibitor which can lower blood uric acid levels by selectively inhibiting URAT1 and uric acid reabsorption in the kidney. Three Japanese Phase 3 trials were completed and more than 500 patients with gout or hyperuricemia were dosed with Dotinurad for up to 58 weeks. Its efficacy was non-inferior to Fe...