Fortress Biotech Announces Exclusive License Agreement With Fuji Yakuhin

Fortress Biotech, Inc. recently announced it has entered into an exclusive licensing agreement with Fuji Yakuhin Co. Ltd. to develop Dotinurad in the US, UK, 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, MD, 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.”

Dotinurad 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 Febuxostat, which has a black box warning for increased risk of cardiovascular death, and it was well-tolerated with low safety risk and drug interaction. Dotinurad was approved in Japan in 2020.

Gout is a serious, progressive and debilitating inflammatory arthritis caused by painful, needle-like uric acid crystal deposits around the connective tissue of the joints and in the kidneys. There are nearly 20 million diagnosed gout patients in the US, Europe, and Canada in 2021, and it is estimated that more than 2 million US patients on urate-lowering therapy may remain inadequately controlled.

Fuji is a pharmaceutical company with integrated manufacturing and sales systems consisting of ethical drug sales, placement drug sales, drugstore business, and the pharmaceutical manufacturing business that supports them. Regarding ethical drugs, Fuji has invented and developed two drugs with different mechanisms of action, Topiroxostat and Dotinurad, for gout and hyperuricemia.

Fortress Biotech, Inc. is an innovative biopharmaceutical company that was ranked in Deloitte’s 2019 and 2020 Technology Fast 500, annual rankings of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentages of fiscal year revenue growth over three-year periods. Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has seven marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children’s Research Hospital and Nationwide Children’s Hospital. For more information, visit www.fortressbiotech.com.