Astellas Pharma, Inc. (ALPMY) and FibroGen Inc., a privately-held biotechnology company, recently commenced a phase II study in Japan on ASP1517/FG-4592.
ASP1517/FG-4592 is being studied for the treatment of anemia associated with chronic kidney disease (:CKD) in patients on dialysis. On the initiation of the study, FibroGen received a $12.5 million milestone payment from Astellas.
In late 2013, Astellas will conduct an additional phase II study in Japan on the candidate in non-dialysis patients.
Astellas had licensed certain rights to ASP1517/FG-4592 from FibroGen in Japan, Europe, the Commonwealth of Independent States (CIS), the Middle East, and South Africa. Under this deal, both the companies will equally share development costs for the candidate in the U.S. and Europe. Astellas will solely bear the development costs in Japan. Milestone payments will be made on the achievement of clinical milestones and approvals in Japan and Europe.
The first phase III study on ASP1517/FG-4592 commenced in Dec 2012. Data from the study is expected to support approval of the candidate in the U.S. and Europe.
As per information provided by Astellas, CKD is a global healthcare problem affecting more than 10% of the global population. The incidence of the disease is on the rise.
We note that the market for the treatment of anemia associated with CKD includes drugs such as AMAG Pharmaceuticals, Inc.’s (AMAG) Feraheme.
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