SAN FRANCISCO--(BUSINESS WIRE)--May 7, 2015--
FibroGen, Inc. (Nasdaq:FGEN) announced today that it has received a $15
million milestone payment from AstraZeneca AB (“AstraZeneca”), triggered
by the completion of roxadustat non-clinical carcinogenicity studies. In
two separate two-year carcinogenicity studies, in rats and in mice,
there was no evidence of a roxadustat-related effect on mortality or
carcinogenicity.
Non-clinical carcinogenicity data are a standard component of novel
small molecule drug development and are typically required by the U.S.
Food and Drug Administration and other regulatory agencies as part of
the drug approval process.
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor
(HIF-PHI) that acts by stimulating the body’s natural pathway of red
blood cell production, or erythropoiesis. Roxadustat is the first
HIF-PHI to enter Phase 3 clinical development and represents a novel
approach to the treatment of anemia in patients with chronic kidney
disease (CKD), with the potential to address the considerable unmet
medical need for an effective treatment for anemia that offers the
convenience of oral administration and an improved safety profile as
compared to current standards of care.
Roxadustat is currently in Phase 3 global development for the treatment
of anemia in patients with chronic kidney disease (CKD) on dialysis and
not on dialysis. The global development program is being conducted by
FibroGen and its partners, AstraZeneca and Astellas Pharma Inc.
Approximately 8,000 CKD patients will be enrolled in 10 clinical trials.
Regulatory filings are expected to be submitted in 2016 for China and in
2018 for the US.
About FibroGen
FibroGen is a research-based biopharmaceutical company focused on the
discovery, development and commercialization of novel therapeutics to
treat serious unmet medical needs. The company utilizes its extensive
experience in fibrosis and hypoxia-inducible factor (HIF) biology to
generate multiple programs targeting various therapeutic areas. Its most
advanced product candidate, roxadustat, or FG-4592, is an oral small
molecule inhibitor of HIF prolyl hydroxylases, or HIF-PHs, in Phase 3
clinical development for the treatment of anemia in CKD. A second
product candidate, FG-3019, is a monoclonal antibody in Phase 2 clinical
development for the treatment of idiopathic pulmonary fibrosis (IPF),
pancreatic cancer and liver fibrosis.
Forward Looking Statements
This release contains forward-looking statements, including statements
regarding the potential for continued safety of roxadustat and our
expectations regarding the timing for regulatory filings in China and
the US. Our actual results may differ materially from those indicated in
these forward-looking statements due to risks and uncertainties,
including the continued progress and timing of the Phase 3 clinical
trials for roxadustat; the potential to achieve and receive remaining
milestones from our collaborators; the continued progress of our plans
and programs in China; and other matters that are described in our
Annual Report on Form 10-K filed with the Securities and Exchange
Commission, including the risk factors set forth therein. Investors are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this release and we
undertake no obligation to update any forward-looking statement in this
press release, except as required by law.
Source: FibroGen, Inc.
FibroGen, Inc.
Greg Mann, 415-978-1433
gmann@fibrogen.com
