Astellas Pharma Inc. (Tokyo:4503) (Astellas) and FibroGen, Inc. (FibroGen) announced today the initiation of a Phase 2 clinical study in Japan of ASP1517/FG-4592 for treatment of anemia associated with chronic kidney disease (CKD) in patients on dialysis. ASP1517/FG-4592, an orally administered small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PHI), is the most clinically advanced candidate in this new class of potential anemia therapeutic agents.
Astellas plans to conduct an additional Phase 2 clinical study in Japan of ASP1517/FG-4592 in non-dialysis patients in late 2013.
FibroGen has received a $12.5 million milestone payment from Astellas for the initiation of the Phase 2 Japan study. Astellas is responsible for the development cost of ASP1517/FG-4592 in Japan as part of the terms and conditions of the exclusive license agreement with FibroGen for Japan.
In December 2012, Astellas and FibroGen announced the initiation of the first clinical study in the Phase 3 development of ASP1517/FG-4592 to support approval in the U.S. and Europe.
Astellas has licensed from FibroGen certain rights to ASP1517/FG-4592 in Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. As part of these agreements, FibroGen and Astellas equally share development costs for ASP1517/FG-4592 in the U.S. and in Europe. Astellas makes milestone payments to FibroGen upon clinical advancement and approvals in Europe and in Japan, as well as for other subsequent events. FibroGen retains the rights to its anemia therapies in North America and South America, remaining parts of Africa, and all of Asia Pacific outside of Japan. FibroGen has also completed Phase 2 studies for ASP1517/FG-4592 for the treatment of CKD anemia in the People's Republic of China.
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