-GENFIT partnership expands Terns’ portfolio,
adding a Phase 3 product with a complementary mechanism of action
well-suited to combinations with Terns’ NASH assets-
Terns Pharmaceuticals, Inc. today announced an exclusive
licensing and collaboration agreement with GENFIT (GNFT), a
late-stage biopharmaceutical company dedicated to the discovery and
development of innovative therapeutic and diagnostic solutions in
metabolic and liver-related diseases. Under the terms of the
agreement, Terns acquires the exclusive right to develop, register,
and market elafibranor for the treatment of non-alcoholic
steatohepatitis (NASH) and primary biliary cholangitis (PBC) in
Greater China (mainland China, Hong Kong, Macau, and Taiwan).
GENFIT will receive a $35 million upfront payment and will be
eligible to receive up to $193 million in subsequent payments,
based on achieving clinical, regulatory, and commercial milestones.
The two companies will also collaborate on research and development
moving forward in NASH and PBC. These research and development
efforts include potential combinations of elafibranor, a dual
peroxisome proliferator-activated alpha/delta (PPAR α/δ ) agonist,
with Terns’ development candidates, including TERN-101, a farnesoid
X receptor (FXR) agonist, TERN-201, a semicarbazide-sensitive amine
oxidase (SSAO) inhibitor, and their thyroid hormone receptor (THR)
β-selective agonist and apoptosis signal-regulating kinase 1 (ASK1)
inhibitor programs.
“Terns is committed to bringing new, innovative therapies for
the treatment of liver disease to China and other global markets.
Our partnership with GENFIT is a natural next step for us as a
company,” said Weidong Zhong, Ph.D., Chief Executive Officer of
Terns. “We believe combination therapy will rapidly become the
standard of care for NASH treatment, and our strategy is based on
this conviction. Elafibranor is a late-stage compound with a
mechanism of action synergistic with those in our own pipeline,
making it a perfect fit for our strategy to advance combination
therapies for chronic liver disease. We’re excited to add
elafibranor to our portfolio, to expand our focus on liver disease
to include PBC, and to gain a strong partner in GENFIT, a company
that shares our focus on developing innovative treatments for liver
disease.”
“The team at Terns has an extensive track record in drug
development combined with the infrastructure to successfully
develop, register and commercialize new therapies in Asia,” said
Pascal Prigent, Executive Vice President of Marketing and
Commercial Development at GENFIT. “We have great confidence in the
company and its management team as we work to bring elafibranor to
patients in Greater China and to collaborate on future R&D
efforts and combination strategies.”
The licensing and collaboration agreement with GENFIT follows
the 2018 announcement that Terns acquired the global, exclusive
rights to develop and commercialize three NASH assets from Eli
Lilly and Company. Collectively, these agreements demonstrate
Terns' commitment to enhancing its pipeline through partnerships
with regional and global companies, in addition to internal
discovery efforts, to accelerate effective combination therapies
for patients living with chronic liver disease.
About elafibranor
Elafibranor is GENFIT’s lead pipeline product candidate.
Elafibranor is an oral, once-daily, first-in-class drug acting via
dual peroxisome proliferator-activated alpha/delta pathways
developed to treat, in particular, nonalcoholic steatohepatitis
(NASH), for which it has been granted Fast Track Designation.
GENFIT believes, based on clinical results to date, that
elafibranor has the potential to address multiple facets of NASH,
including inflammation, insulin sensitivity, lipid/metabolic
profile, and liver markers. Results from a Phase 3 study in
patients with NASH is expected in the fourth quarter 2019. Phase 2
clinical trial results have also shown that elafibranor may be an
effective treatment for PBC, a severe liver disease. Elafibranor
was granted a Breakthrough Therapy Designation for this
indication.
About NASH
Non-alcoholic steatohepatitis (NASH) is a severe form of
non-alcoholic fatty liver disease (NAFLD), which is caused by the
accumulation of excess fat in the liver. NASH is associated with
chronic liver inflammation and liver cell injury, and it can lead
to fibrosis, cirrhosis, and eventually liver cancer or liver
failure. Global rates of NAFLD and NASH are increasing rapidly, in
tandem with rising rates of obesity. There is currently no approved
medication for the treatment of NASH.
About PBC
PBC is a chronic disease in which damage to bile ducts can
inhibit the liver’s ability to rid the body of toxins and can lead
to scarring of liver tissue known as cirrhosis.
About Terns Pharmaceuticals
Terns Pharmaceuticals, Inc. is a clinical-stage pharmaceutical
company that is focused on the discovery and development of
medicines for chronic liver disease and cancer. Based in China and
the United States, the company is advancing a pipeline of drug
candidates for the treatment of non-alcoholic steatohepatitis
(NASH) and cancer, across multiple modalities. Terns leverages
world class expertise in disease biology, medicinal chemistry, and
clinical development in order to bring promising new therapies to
patients in China and other global markets.
For more information, visit www.ternspharma.com and
www.ternspharma.com.cn
About GENFIT
GENFIT is a late-stage biopharmaceutical company dedicated to
the discovery and development of innovative therapeutic and
diagnostic solutions in metabolic and liver related diseases where
there are considerable unmet medical needs, corresponding to a lack
of approved treatments. GENFIT is a leader in the field of nuclear
receptor-based drug discovery with a rich history and strong
scientific heritage spanning almost two decades. Its most advanced
drug candidate, elafibranor, is currently being evaluated in a
pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential
treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical
trial in PBC later this year following its positive Phase 2
results. As part of GENFIT’s comprehensive approach to clinical
management of NASH patients, the company is also developing a new,
non-invasive and easy-to-access blood-based in vitro diagnostic
test to identify patients with NASH who may be appropriate
candidates for drug therapy. With facilities in Lille and Paris,
France, and Cambridge, MA, USA, the Company has approximately 160
employees. GENFIT is a public company listed on the Nasdaq Global
Select Market and in compartment B of Euronext’s regulated market
in Paris (Nasdaq and Euronext: GNFT). www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain forward-looking statements,
including those within the meaning of the Private Securities
Litigation Reform Act of 1995, with respect to GENFIT, including
the potential to and success of commercialization of elafibranor in
Greater China and the effect of new regulations in China to
accelerate and facilitate drug approvals. The use of certain words,
including “believe,” “potential,” “expect” and “will” and similar
expressions, is intended to identify forward-looking statements.
Although the Company believes its expectations are based on the
current expectations and reasonable assumptions of the Company’s
management, these forward-looking statements are subject to
numerous known and unknown risks and uncertainties, which could
cause actual results to differ materially from those expressed in,
or implied or projected by, the forward-looking statements. These
risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including
related to safety, biomarkers, progression of, and results from,
its ongoing and planned clinical trials, review and approvals by
regulatory authorities of its drug and diagnostic candidates and
the Company’s continued ability to raise capital to fund its
development, as well as those risks and uncertainties discussed or
identified in the Company’s public filings with the French Autorité
des marchés financiers (“AMF”), including those listed in Section 4
“Main Risks and Uncertainties” of the Company’s 2018 Registration
Document filed with the AMF on February 27, 2019 under n°
D.19-0078, which is available on GENFIT’s website (www.genfit.com)
and on the website of the AMF (www.amf-france.org) and public
filings and reports filed with the U.S. Securities and Exchange
Commission (“SEC”), including the Company’s final prospectus dated
March 26, 2019, and subsequent filings and reports filed with the
AMF or SEC, or otherwise made public, by the Company. In addition,
even if the Company’s results, performance, financial condition and
liquidity, and the development of the industry in which it operates
are consistent with such forward-looking statements, they may not
be predictive of results or developments in future periods. These
forward-looking statements speak only as of the date of publication
of this document. Other than as required by applicable law, the
Company does not undertake any obligation to update or revise any
forward-looking information or statements, whether as a result of
new information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20190624005672/en/
Terns Pharmaceuticals, Inc.
US Media Contact: Margaret Robinson
mrobinson@ternspharma.com +1 (415) 690 0084 China Media
Contact: Yan Wan ywan@ternspharma.com +86 186 1196 5371
GENFIT Investors Naomi
EICHENBAUM – Investor Relations | Tel: +1 (617) 714 5252 |
investors@genfit.com Media Hélène LAVIN – Press Relations |
Tel: +333 2016 4000 | helene.lavin@genfit.com
Genfit (EU:GNFT)
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