Astellas Pharma Inc.,a pharmaceutical company dedicated to improving health of people around the globe, and FibroGen, Inc.,a privately-held biotechnology company, have initiated a phase II clinical study in Japan of ASP1517/FG-4592 for treatment of anaemia 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 anaemia therapeutic agents.

Astellas plans to conduct an additional phase II 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 II 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 III development of ASP1517/FG-4592 to support approval in the US 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 US 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 anaemia therapies in North America and South America, remaining parts of Africa, and all of Asia Pacific outside of Japan. FibroGen has also completed phase II studies for ASP1517/FG-4592 for the treatment of CKD anaemia in the People’s Republic of China.

Astellas and FibroGen are developing ASP1517/FG-4592, a novel oral small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity, for the treatment of anaemia in patients with chronic kidney disease (CKD). ASP1517/FG-4592 has been shown to correct and maintain hemoglobin levels without the need for supplementation with intravenous iron in CKD patients not yet receiving dialysis and in end-stage renal disease patients receiving dialysis. An Independent Data Monitoring Committee has found no signals or trends to date to suggest that treatment with ASP1517/FG-4592 is associated with increased risk of cardiovascular events, thrombosis, or increases in blood pressure requiring initiation or intensification of anti-hypertensive medications.