FibroGen, Astellas advance FG-4592 to phase 2b development for treatment of anemia in chronic kidney disease

FibroGen, Inc., today announced that FibroGen and partner Astellas Pharma Inc. ("Astellas") advanced FG-4592 (Astellas designation ASP1517), an investigational anemia therapy, to phase 2b development for treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The advancement decision resulted in a payment of $40 million from Astellas to FibroGen in the fourth quarter of 2010 under Astellas' license to rights for the European Union and certain other territories. FG-4592 is a novel, first-in-class hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI) that works through stabilization of HIF, a mechanism distinct from that of current anemia therapy using erythropoiesis-stimulating agents (ESAs).

“When the total cost associated with use of ESAs is considered, it appears that FG-4592 therapy, if proven safe and effective, can be both more convenient and substantially more cost effective”

"We are pleased to report progress in the clinical development program for FG-4592 for the treatment of anemia in CKD patients on dialysis and not on dialysis," said Thomas B. Neff, FibroGen's chief executive officer. "We continue to see signs of potential therapeutic advantages of FG-4592 compared to ESAs, such as clinical evidence that FG-4592 is potentially superior by certain efficacy measures such as median time to achieve hemoglobin correction."