GENFIT AND LABCORP
SIGN A LICENSING AGREEMENT TO EXPAND ACCESS TO AN INNOVATIVE
DIAGNOSTIC ASSAY FOR NON-ALCOHOLIC STEATOHEPATITIS (NASH)
Multi-Biomarker Test
Will Provide the Clinical Research Community with a Non-Invasive
Tool
to Identify and Monitor Patients with NASH and Significant
Fibrosis
LILLE, FRANCE;
CAMBRIDGE, MASS.; AND BURLINGTON, N.C. - January 3, 2019 -
LabCorp® (NYSE: LH), a leading global life sciences company, and
GENFIT (Euronext: GNFT), a late-stage biopharmaceutical company
dedicated to the discovery and development of innovative
therapeutic and diagnostic solutions in metabolic and liver related
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.
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.
Jean-François
Mouney, chairman & CEO of GENFIT, commented: "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."
Marcia Eisenberg,
Ph.D, chief scientific officer, LabCorp Diagnostics, added:
"LabCorp and Covance will be able to leverage our
experience in clinical trial biomarkers and diagnostics development
to validate the NIS4 algorithm. 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 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 STATEMENT/DISCLAIMER
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.
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.
genfit
CONTACT
Naomi EICHENBAUM - Investor Relations
| Tel: +1 (617) 714 5252 | investors@genfit.com
Hélène LAVIN - Media & Press
Relations | Tel: +333 2016 4000 | helene.lavin@genfit.com
LABCORP
CONTACT
Scott FROMMER - Investors | Tel: +1
(336) 436 5076 | investor@labcorp.com
Sue MAYNARD - Media | Tel: +1 (336)
43 6 8263 | media@labcorp.com
GENFIT | 885
Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 |
www.genfit.com
2019.03.01 - PR
GENFIT-LabCorp
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: GENFIT via Globenewswire
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