Multi-Biomarker Test Will Provide the Clinical
Research Community with a Non-Invasive Tool to Identify and Monitor
Patients with NASH and Significant Fibrosis
LabCorp® (NYSE: LH), a leading global life sciences company, and
GENFIT (Euronext: GNFT), a biopharmaceutical company focused on
discovering and developing drug candidates and diagnostic solutions
targeting liver diseases, have announced the signing of a licensing
agreement between GENFIT and Covance, LabCorp’s drug development
business. The agreement will expand access to an innovative
non-alcoholic steatohepatitis (NASH) liver diagnostic test for the
clinical research market.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20190102005679/en/
NASH is a silent, asymptomatic disease that often progresses to
more serious and life-threatening stages before a clinical
diagnosis is made. Liver biopsy, a highly invasive procedure, is
currently the clinical standard to formally diagnose NASH and stage
fibrosis. Furthermore, there are currently no extensively validated
non-invasive diagnostic tests in NASH to address evolving disease
and therapeutic implications, providing clinical and market
opportunities for new product innovations.
To address this pressing need, GENFIT has developed a novel,
non-invasive test created specifically for NASH. This
multi-parametric blood-based biomarker test, named NIS4, leveraged
a rich biobank of samples from roughly 700 well-characterized
patients to establish a novel combination of biomarkers to identify
and monitor patients with NASH and significant fibrosis. The
primary focus of the licensing agreement will be to deploy NIS4 in
the clinical research space through Covance’s central laboratories
to further validate the test’s use for better identification and
characterization of patients, and to generate new biological
insights on NASH disease pathogenesis.
“We are very enthusiastic to announce this agreement, which
represents a major step in GENFIT’s commercial strategy in NASH.
The expertise that LabCorp and Covance have in this field will add
tremendous value to GENFIT’s pioneering work in developing this
innovative technology. I’m excited to see collaborations like this,
which will help move the test toward the goal of being an in vitro
diagnostic (IVD) to identify NASH patients who should be considered
for therapeutic intervention,” said Jean-François Mouney, chairman
& CEO of GENFIT.
“LabCorp and Covance will be able to leverage our experience in
clinical trial biomarkers and diagnostics development to validate
the NIS4 algorithm,” said Marcia Eisenberg, Ph.D., chief scientific
officer of LabCorp Diagnostics. “We are well-positioned to expand
access to NIS4 to the global clinical research community through
this agreement. Forward-thinking collaborations like this one
enable early and efficient validation of diagnostics that have the
potential to significantly impact patients with serious,
life-changing unmet medical needs, including NASH.”
GENFIT is a pioneer in NASH therapeutics and diagnostics
development. Both LabCorp Diagnostics and Covance have been
involved in the development of drugs and diagnostics for more than
20 years, and Covance is a recognized global leader in NASH
clinical trials.
Financial terms for this agreement have not been disclosed.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global
life sciences company that is deeply integrated in guiding patient
care, providing comprehensive clinical laboratory and end-to-end
drug development services. With a mission to improve health and
improve lives, LabCorp delivers world-class diagnostic solutions,
brings innovative medicines to patients faster, and uses technology
to improve the delivery of care. LabCorp reported net revenues of
more than $10 billion for 2017. To learn more about LabCorp, visit
www.LabCorp.com, and to learn more about Covance Drug Development,
visit www.Covance.com.
LabCorp Forward-Looking Statements
This press release contains forward-looking statements including
but not limited to statements with respect to customer
relationships and agreements, the impact of various factors on
operating and financial results, expected savings and synergies
(including from the LaunchPad initiative and from acquisitions),
and the opportunities for future growth. Each of the
forward-looking statements is subject to change based on various
important factors, including without limitation, competitive
actions and other unforeseen changes and general uncertainties in
the marketplace, changes in government regulations, including
healthcare reform, customer purchasing decisions, including changes
in payer regulations or policies, other adverse actions of
governmental and third-party payers, changes in testing guidelines
or recommendations, adverse results in material litigation matters,
the impact of changes in tax laws and regulations, failure to
maintain or develop customer relationships, our ability to develop
or acquire new products and adapt to technological changes, failure
in information technology, systems or data security, employee
relations, and the effect of exchange rate fluctuations. Actual
results could differ materially from those suggested by these
forward-looking statements. The Company has no obligation to
provide any updates to these forward-looking statements even if its
expectations change. Further information on potential factors,
risks and uncertainties that could affect operating and financial
results is included in the Company’s Form 10-K for the year ended
December 31, 2017, and subsequent Forms 10-Q, including in each
case under the heading risk factors, and in the Company’s other
filings with the SEC. The information in this press release should
be read in conjunction with a review of the Company’s filings with
the SEC including the information in the Company’s Form 10-K for
the year ended December 31, 2017, and subsequent Forms 10-Q, under
the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS.
About GENFIT
GENFIT is a biopharmaceutical company focused on discovering and
developing drug candidates and diagnostic solutions targeting liver
diseases, in particular those of metabolic origin, and
hepatobiliary diseases. GENFIT concentrates its R&D efforts in
areas of high unmet medical needs corresponding to a lack of
approved treatments. GENFIT’s lead proprietary compound,
elafibranor, is a drug candidate currently being evaluated in one
of the most advanced Phase 3 studies worldwide (“RESOLVE-IT”) in
nonalcoholic steatohepatitis (NASH), considered by regulatory
authorities as a medical emergency because it is silent, with
potentially severe consequences, and with a prevalence on the rise.
Elafibranor has also obtained positive results in a Phase 2
clinical trial in Primary Biliary Cholangitis (PBC), a chronic
liver disease. As part of its comprehensive approach to clinical
management of NASH patients, GENFIT is conducting an ambitious
discovery and development program aimed at providing patients and
physicians with a blood-based test for the diagnosis of NASH, i.e.
non-invasive and easy-to-access. With facilities in Lille and
Paris, France, and Cambridge, MA (USA), the Company has
approximately 150 employees. GENFIT is a public company listed in
compartment B of Euronext’s regulated market in Paris (Euronext:
GNFT - ISIN: FR0004163111). www.genfit.com
GENFIT Forward-Looking Statements
This press release contains certain forward-looking statements.
Although the Company believes its expectations are based on
reasonable assumptions, these forward-looking statements are
subject to numerous 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, including its RESOLVE-IT
Phase 3 trial, review and approvals by regulatory authorities, such
as the FDA or the EMA, of its drug and diagnostic candidates, the
success of any in-licensing strategies, the Company’s continued
ability to raise capital to fund its development, as well as those
discussed or identified in the Company’s public filings with the
AMF, including those listed in Section 4 “Main Risks and
Uncertainties” of the Company’s 2017 Registration Document
registered with the French Autorité des marchés financiers on April
27, 2018 under n° R.18-032, which is available on GENFIT’s website
(www.genfit.com) and on the website of the AMF (www.amf-france.org)
and as updated by the 2018 Half Year Business and Financial Report
and available on the Investors page of GENFIT’s website. Other than
as required by applicable law, the Company does not undertake any
obligation to update or revise any forward-looking information or
statements. This press release and the information contained herein
do not constitute an offer to sell or a solicitation of an offer to
buy or subscribe to shares in GENFIT in any country. This press
release has been prepared in both French and English. In the event
of any differences between the two texts, the French language
version shall supersede.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190102005679/en/
LabCorp Contacts:Scott Frommer (investors):
+1 336-436-5076Investor@labcorp.comSue Maynard (media): +1
336-436-8263Media@labcorp.comGenfit
Contacts:Naomi Eichenbaum (investors): +1
617-714-5252investors@genfit.comHélène Lavin (media): +333
2016-4000helene.lavin@genfit.com
Genfit (EU:GNFT)
Graphique Historique de l'Action
De Mar 2024 à Avr 2024
Genfit (EU:GNFT)
Graphique Historique de l'Action
De Avr 2023 à Avr 2024