FibroGen Reports UK Court Ruling
April 20 2020 - 7:00AM
FibroGen, Inc. (NASDAQ: FGEN) today announced that the United
Kingdom’s High Court of Justice has held certain patents1 relating
to methods of using hypoxia-inducible factor prolyl hydroxylase
inhibitors (HIF-PHIs) to be invalid. This decision does not affect
the validity of these patents across the rest of Europe.
While FibroGen is disappointed with the court’s
decision, this UK ruling does not affect development or
commercialization timelines for roxadustat, FibroGen’s HIF-PHI for
treatment of anemia in chronic kidney disease, including in the UK
or elsewhere in Europe.
Roxadustat is a first-in-class small molecule
HIF-PH inhibitor approved in China for the treatment of anemia in
chronic kidney disease (CKD) patients on dialysis and not on
dialysis, and approved in Japan for the treatment of anemia in CKD
patients on dialysis, with a supplemental NDA for the non-dialysis
indication submitted this past January. The U.S. NDA for roxadustat
for the treatment of anemia in CKD patients on dialysis and not on
dialysis was accepted with a Prescription Drug Use Fee (PDUFA) date
of December 20, 2020. In Europe, the Marketing Authorization
Application filing for roxadustat for the treatment of anemia in
both dialysis- and non-dialysis-dependent patients with CKD is
expected in the second quarter of 2020.
About Roxadustat
Roxadustat is a first-in-class, orally
administered small molecule HIF-PH inhibitor that promotes
erythropoiesis through increasing endogenous production of
erythropoietin, improving iron regulation, and overcoming the
negative impact of inflammation on hemoglobin synthesis and red
blood cell production by downregulating hepcidin. Administration of
roxadustat has been shown to induce coordinated erythropoiesis,
increasing red blood cell count while maintaining plasma
erythropoietin levels within or near normal physiologic range in
multiple subpopulations of chronic kidney disease (CKD) patients,
including in the presence of inflammation and without a need for
supplemental intravenous iron. Roxadustat is currently approved in
China for the treatment of anemia in CKD patients on dialysis and
patients not on dialysis and approved in Japan for the treatment of
anemia in CKD patients on dialysis. The NDA filing for roxadustat
for the treatment of CKD anemia was accepted by the U.S. Food and
Drug Administration in February 2020 with a Prescription Drug User
Fee Act date of December 20, 2020. Our partner Astellas expects the
Marketing Authorization Application filing for roxadustat for the
treatment of anemia in both dialysis- and non-dialysis-dependent
patients with CKD to the European Medicines Agency in the second
quarter of 2020. 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), and in a
Phase 2 U.S. trial for treatment of chemotherapy-induced
anemia.
Astellas and FibroGen are collaborating on the
development and commercialization of roxadustat for the treatment
of anemia in territories including Japan, Europe, the Commonwealth
of Independent States, the Middle East, and South Africa.
AstraZeneca and FibroGen are collaborating on the development and
commercialization of roxadustat for the treatment of anemia in the
U.S., China, and other markets in the Americas and in Australia/New
Zealand, as well as Southeast Asia.
1 * UK designations of European patents
EP(UK)1,463,823, EP(UK)2,298,301, EP(UK)1,633,333, EP(UK)2,322,153,
and EP(UK)2,322,155
About FibroGen FibroGen, Inc.,
headquartered in San Francisco, California, with subsidiary offices
in Beijing and Shanghai, People’s Republic of China, is a
biopharmaceutical company discovering, developing, and
commercializing a pipeline of first-in-class therapeutics. The
company applies its pioneering expertise in hypoxia-inducible
factor (HIF) and 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, an oral small molecule inhibitor
of HIF prolyl hydroxylase activity, is approved by the National
Medical Products Administration in China for CKD patients on
dialysis and not on dialysis and by the Ministry of Health, Labour
and Welfare in Japan for CKD patients on dialysis. The NDA filing
for roxadustat for the treatment of CKD anemia was accepted by the
U.S. Food and Drug Administration in February 2020. Our partner
Astellas expects the Marketing Authorization Application filing for
roxadustat for the treatment of anemia in both dialysis- and
non-dialysis-dependent patients with CKD to the European Medicines
Agency in the second quarter of 2020. 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), and in a Phase 2 U.S. trial for treatment of
chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human
monoclonal antibody, is in Phase 3 clinical development for the
treatment of idiopathic pulmonary fibrosis (IPF) and locally
advanced unresectable pancreatic cancer, and is currently in a
Phase 2 trial for Duchenne muscular dystrophy (DMD). For more
information, please visit www.fibrogen.com.
Forward-Looking Statements This
release contains forward-looking statements regarding our strategy,
future plans and prospects, including statements regarding the
development and commercialization of the company’s product
candidates, our clinical programs and regulatory events, 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, 2019 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.
Contact:FibroGen, Inc.
Media Inquiries: Sara Iacovino
1.703.474.4452sara.iacovino@gcihealth.com
Investors: Michael Tung, M.D.Corporate Strategy
/ Investor Relations1.415.978.1433mtung@fibrogen.com
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