SAN FRANCISCO—AstraZeneca and FibroGen have begun astrategic collaboration for the development and commercialization of FG-4592, alate-stage, first-in-class oral compound for the treatment of anemia associatedwith chronic kidney disease (CKD) and end-stage renal disease (ESRD), and maybe extended to include other anemia indications. The collaboration willencompass the United States, China and all major markets except for Japan,Europe, the Commonwealth of Independent States, the Middle East and SouthAfrica, which are already covered by an agreement between FibroGen and AstellasPharma Inc.
Per the terms of the agreement, AstraZeneca will payFibroGen $350 million in upfront and subsequent non-contingent payments, withthe potential for an additional $465 million in development-related milestones.FibroGen will also be eligible for future sales-related milestone payments aswell as tiered royalty payments in the low 20-percent range on future sales ofFG-4592. If any additional indications are pursued, further developmentmilestones will be payable in those indications as well. AstraZeneca willassume responsibility for commercialization of the compound in the UnitedStates, and FibroGen will be responsible for specified promotional activitiesin the ESRD segment of the market. Both companies will co-commercialize inChina, where FibroGen will be responsible for clinical trials, regulatoryconcerns, manufacturing and medical affairs, while AstraZeneca will overseepromotional activities and commercial distribution.
"Our collaboration with FibroGen on FG-4592 is an importantaddition to AstraZeneca's growing late-stage portfolio in cardiovascular andmetabolic disease, one of our core therapy areas," Pascal Soriot, CEO ofAstraZeneca, said in a press release. "We know from our research intocomplications of renal disease that anemia continues to be a challenge forpatients with chronic kidney disease, due in part to the inconvenience andcomplexity of existing injectable and intravenous therapies and the safetyconcerns associated with them. The science behind this compound is compelling.Through our collaboration with FibroGen we aim to offer a first-in-class,convenient treatment option for doctors and patients."
FG-4592 is a small-molecule inhibitor of hypoxia-induciblefactor (HIF), a protein that handles the body's needs for oxygen by inducingerythropoiesis, the process by which red blood cells are created. The compoundworks with the body's system to help produce red blood cells. FG-4592 stands toprovide a treatment for anemia with the convenience of oral administration andan improved safety profile compared to the current standards of care. In PhaseII clinical studies, the compound met its primary objective of demonstratinganemia correction in treatment-naïve CKD patients who were not on dialysis, aswell as maintenance of hemoglobin levels and anemia correction in dialysis patients.FG-4592 has also shown an acceptable safety profile in clinical trials.
"FG-4592 has the potential to offer anemia patients an oraltherapy that provides coordinated erythropoiesis, that increases naturalerythropoietin within the normal physiological range, and that is effectivewithout intravenous iron supplementation and without an increased risk forhypertension," Thomas B. Neff, CEO for FibroGen, commented in a statement. "Weare especially pleased that AstraZeneca will share our commitment to makingChina the first-to-launch country for FG-4592 and join our effort to bringimportant innovation in anemia therapy to CKD and ESRD patients in the U.S. andother countries. This agreement secures proper development andcommercialization resources for FG-4592, and ensures U.S. clinical trialefforts are fully funded."
AstraZeneca and FibroGen intend to begin a Phase IIIdevelopment program for the compound in the United States, and to begin PhaseIII trials in China, with the hope of regulatory filings for China in 2015 andthe United States in 2017.
SOURCE: FibroGen press release