SAN FRANCISCO, March 01, 2018 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, today
announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF antibody,
pamrevlumab, for the treatment of patients with locally advanced unresectable pancreatic cancer. This follows review of the Phase 2
clinical trial evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel and represents recognition by the FDA that
pamrevlumab has the potential to address an unmet medical need for this disease.
“There are no approved treatment options for patients with locally advanced pancreatic cancer, who face a short life expectancy. We
are encouraged by our Phase 2 study results, where the combination of pamrevlumab with chemotherapy changed eligibility for
surgical resection in a majority of treated patients who were previously not candidates for surgery,” said Peony Yu, M.D.,
FibroGen’s Chief Medical Officer. “This designation is an important milestone for our pamrevlumab program and has the potential to
speed our ability to advance pamrevlumab to patients.”FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company,
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF
antibody, pamrevlumab, for the treatment of patients with locally advanced unresectable pancreatic cancer. This follows review of
the Phase 2 clinical trial evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel and represents recognition by
the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.
About Fast Track Designation
Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill
an unmet medical need. Fast Track designation enables the company to have more frequent interactions with the FDA throughout
the drug development process, so that an approved product can reach the market expeditiously.
About Locally Advanced Pancreatic Cancer
In locally advanced pancreatic cancer (LAPC), the patient’s tumor typically involves structures, particularly blood vessels that
are closely associated with the pancreas such as the superior mesenteric artery and superior mesenteric vein. Involvement of the cancer around these
blood vessels precludes surgical removal of the tumor. Patients with unresectable LAPC have a median survival of six to 10 months,
only slightly better than patients with metastatic pancreatic cancer, and only 20 percent of newly diagnosed patients are
classified as having resectable disease. Patients who have their tumor surgically removed have a much better prognosis with median
survival of approximately 23 months with some patients being cured.
About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a
common factor in fibrotic and proliferative disorders. Fibrosis is characterized by persistent and excessive scarring that can lead
to organ dysfunction and failure. In desmoplastic, or fibrotic cancers, such as pancreatic cancer, fibrous tissue promotes abnormal
proliferation of tumor cells and associated stromal cells. Pamrevlumab 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). In Phase 2 clinical studies conducted to date, pamrevlumab has demonstrated a good safety and tolerability
profile. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
About FibroGen
FibroGen, Inc., headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of
China, is a leading science-based biopharmaceutical company discovering and developing 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 candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase
activity in worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD); in China, our New
Drug Application is currently under review by the CFDA for regulatory approval. Roxadustat is in Phase 3 clinical development in
the U.S. and Europe, and expected to shortly enter Phase 2/3 development in China, for anemia associated with myelodysplastic
syndromes (MDS). Pamrevlumab, a fully-human monoclonal anti-CTGF 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.
Forward-Looking Statements
This release contains forward-looking statements regarding our 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 the potential advantages of having Fast Track designation in pancreatic
cancer. 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,” “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, 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.
Investor and Media Contact
Karen L. Bergman
Vice President, Investor Relations and
Corporate Communications
FibroGen, Inc.
kbergman@fibrogen.com
(415) 978-1433