SAN FRANCISCO - FibroGen, Inc. (NASDAQ: NASDAQ:FGEN) announced today the termination of its collaboration agreement with AstraZeneca (NASDAQ:AZN) for the development and commercialization of roxadustat outside of China, excluding South Korea. The agreement, which began on July 30, 2013, is set to transition back to FibroGen, with AstraZeneca providing assistance during the process.
Roxadustat, an oral medication for the treatment of anemia caused by chronic kidney disease (CKD), will continue to be developed and commercialized by AstraZeneca and FibroGen in China, where it leads in brand value share. The drug is approved in China, Europe, Japan, and other countries for both dialysis and non-dialysis CKD patients.
FibroGen's CEO, Thane Wettig, expressed confidence in roxadustat's potential as a therapy in the U.S. and other regions where approval is pending. The company plans to explore licensing opportunities for the drug, particularly after promising data presented at the American Society of Hematology (ASH) 2023 conference.
Roxadustat works by promoting red blood cell production through various biological mechanisms, including increased endogenous production of erythropoietin. Its clinical development also includes potential treatment for chemotherapy-induced anemia, with a Supplemental New Drug Application recently accepted by the China Health Authority.
FibroGen, a biopharmaceutical company, is also developing other first-in-class oncology therapeutics, including pamrevlumab for metastatic and unresectable pancreas cancer, and FG-3246 for metastatic castrate resistant prostate cancer and other CD46-expressing cancers.
The company's collaboration with Astellas Pharma Inc. remains unaffected, continuing the development and commercialization of roxadustat in Japan, Europe, and other territories.
The termination of the U.S./RoW (Rest of World) collaboration agreement with AstraZeneca requires FibroGen to fulfill certain financial obligations should they monetize or commercialize roxadustat in the former territories.
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