Astellas Pharma, Inc.
) and FibroGen Inc., a privately-held biotechnology company,
recently commenced a phase II study in Japan on
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
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.
Astellas carries a Zacks Rank #3 (Hold). Currently, companies
Questcor Pharmaceuticals Inc
Anika Therapeutics Inc.
) look well-positioned with a Zacks Rank #1 (Strong
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