Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa,
Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Thomas B.
Neff, “FibroGen”) today announced that Astellas submitted a New
Drug Application (NDA) for marketing approval in Japan of
roxadustat (generic name, development code: ASP1517/FG-4592) for
the treatment of anemia associated with Chronic Kidney Disease
(CKD) in patients on dialysis. The results obtained from four Phase
3 studies conducted in CKD patients on dialysis in Japan support
this NDA submission.
“We are pleased to report the submission of the
Japan NDA for roxadustat as a treatment of anemia associated with
CKD in patients on dialysis,” said Bernhardt G. Zeiher, M.D., Chief
Medical Officer, Astellas. “We believe roxadustat offers a
potential new oral therapeutic option for a condition which can
have a debilitating impact on patients with renal disease.”
“We are excited about this critical advancement
as we work together to bring this new therapy to patients with
anemia associated with CKD in Japan,” said K. Peony Yu, M.D., Chief
Medical Officer, FibroGen. “We appreciate the joint team’s
dedicated effort and commitment to addressing important unmet
medical needs of these patients and their physicians.”
Anemia is a common complication of CKD and is
associated with significant morbidity and mortality in dialysis and
non-dialysis populations. Anemia is a serious medical condition in
which patients have insufficient red blood cells and low levels of
hemoglobin (Hb), a protein in red blood cells that carries oxygen
to cells throughout the body. Anemia is associated with increased
risk of hospitalization, cardiovascular complications, need for
blood transfusion, exacerbation of other serious medical
conditions, and death. In addition, anemia frequently causes
significant fatigue, cognitive dysfunction, and decreased quality
of life. The more severe the anemia, as measured by lower Hb
levels, the greater the health impact on patients. Treatment for
anemia in CKD patients is a critical worldwide healthcare issue
that represents a large and growing unmet medical need.
About Chronic Kidney Disease (CKD) and
Anemia CKD is estimated affect more than 200 million
people worldwide*1 and specifically in Japan, the prevalence of CKD
has increased significantly over time.*2 Although CKD can occur at
any age, it becomes more common in aging populations, and the
prevalence is increasing. Anemia is a common complication of CKD
and is associated with significant morbidity and mortality in
dialysis and non-dialysis populations. In addition, CKD can be both
a cause and a consequence of cardiovascular disease and is now a
critical worldwide healthcare issue that represents a large and
growing unmet medical need.
About Roxadustat Roxadustat, discovered and
developed by FibroGen, is a compound currently in Phase 3
development on a global basis as a potential therapy for anemia
associated with CKD in both patients on dialysis and not on
dialysis. Roxadustat is an orally administered small molecule
inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase
activity. HIF is a protein transcription factor that induces the
natural physiological response to conditions of low oxygen,
"turning on" erythropoiesis (the process by which red blood cells
are produced).
Astellas and FibroGen are collaborating on the development of
roxadustat for the potential treatment of anemia in patients with
CKD and myelodysplastic syndromes in territories including Japan,
Europe, the Commonwealth of Independent States, the Middle East,
and South Africa. FibroGen and AstraZeneca are collaborating on the
development and commercialization of roxadustat for the potential
treatment of anemia in patients with CKD in the U.S., China, and
other markets. For information about roxadustat studies, please
visit clinicaltrials.gov at this link:
https://clinicaltrials.gov/ct2/results?term=roxadustat&Search=Search.
About AstellasAstellas Pharma
Inc., based in Tokyo, Japan, is a company dedicated to improving
the health of people around the world through the provision of
innovative and reliable pharmaceutical products. For more
information, please visit our website at
https://www.astellas.com/en
About FibroGen FibroGen, Inc., headquartered in
San Francisco, with subsidiary offices in Beijing and Shanghai, is
a leading biopharmaceutical company discovering and developing a
pipeline of first-in-class therapeutics. The company applies
its pioneering expertise in hypoxia-inducible factor (HIF),
connective tissue growth factor (CTGF) biology, and clinical
development to advance innovative medicines for the treatment of
anemia, fibrotic disease, and cancer. Roxadustat, the company’s
most advanced product candidate, is an oral small molecule
inhibitor of HIF prolyl hydroxylase activity, completing worldwide
Phase 3 clinical development for the treatment of anemia in chronic
kidney disease (CKD), with a New Drug Application (NDA) currently
under review by the State Drug Administration (SDA). Roxadustat is
in Phase 3 clinical development in the U.S. and Europe and in Phase
2/3 development in China for anemia associated with myelodysplastic
syndromes (MDS). Pamrevlumab, an anti-CTGF human monoclonal
antibody, is advancing towards Phase 3 clinical development for the
treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic
cancer, and is currently in a Phase 2 trial for Duchenne
muscular dystrophy (DMD). FibroGen is also developing a
biosynthetic cornea in China. For more information, please visit
www.fibrogen.com.
Astellas Cautionary
NotesIn this press release, statements made with respect
to current plans, estimates, strategies and beliefs and other
statements that are not historical facts are forward-looking
statements about the future performance of Astellas. These
statements are based on management’s current assumptions and
beliefs in light of the information currently available to it and
involve known and unknown risks and uncertainties. A number of
factors could cause actual results to differ materially from those
discussed in the forward-looking statements. Such factors include,
but are not limited to: (i) changes in general economic conditions
and in laws and regulations, relating to pharmaceutical markets,
(ii) currency exchange rate fluctuations, (iii) delays in new
product launches, (iv) the inability of Astellas to market existing
and new products effectively, (v) the inability of Astellas to
continue to effectively research and develop products accepted by
customers in highly competitive markets, and (vi) infringements of
Astellas’ intellectual property rights by third parties.
Information about pharmaceutical products
(including products currently in development) which is included in
this press release is not intended to constitute an advertisement
or medical advice.
FibroGen Forward-looking
Statements This release contains forward-looking
statements regarding FibroGen strategy, future plans, and
prospects, including statements regarding the development of the
company’s product candidates pamrevlumab and roxadustat, the
potential safety and efficacy profile of our product candidates,
and our clinical, regulatory, and commercial plans, and those of
our partners. These forward-looking statements include, but are not
limited to, statements about our plans, objectives, representations
and contentions and are not historical facts and typically are
identified by use of terms such as “may,” “will”, “should,” “on
track,” “could,” “expect,” “plan,” “anticipate,” “believe,”
“estimate,” “predict,” “potential,” “continue” and similar words,
although some forward-looking statements are expressed differently.
Our actual results may differ materially from those indicated in
these forward-looking statements due to risks and uncertainties
related to the continued progress and timing of our various
programs, including the enrollment and results from ongoing and
potential future clinical trials, and other matters that are
described in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2017, and our Quarterly Report on Form 10-Q for
the fiscal quarter ended June 30, 2018, filed with the Securities
and Exchange Commission (SEC), 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.
Contacts for inquiries or additional
information:Astellas Pharma Inc. Corporate Communications
TEL: +81-3-3244-3201 FAX: +81-3-5201-7473
FibroGen, Inc. Karen L. Bergman Vice President, Investor
Relations and Corporate Communications 1 (415) 978-1433
kbergman@fibrogen.com
_______________________________
1 Ojo, A. Addressing the Global Burden of Chronic Kidney Disease
Through Clinical and Translational Research. Transactions of the
American Clinical and Climatological Association. 2014, No. 125, p.
229-246.
2 Nagata M, Ninomiya T, Doi Y, Yonemoto K, Kubo M, Hata J,
Tsuruya K, Iida M, Kiyohara Y. Nephrol Dial Transplant. 2010, Aug,
vol. 25, no.8, 2557-2564.
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