GENFIT and LabCorp Sign Exclusive Agreement to Commercialize a
Novel Diagnostic Test for Liver Disease
- Innovative multi-biomarker blood test based on GENFIT’S
NIS4™ technology is specifically designed to identify patients with
at-risk non-alcoholic steatohepatitis (NASH)
- LabCorp to commercialize the test for clinical care use
in U.S. and Canada to help identify the approximately 10 million
individuals at risk of progressing to late stage complications due
to NASH among the tens of millions of people with metabolic risk
factors and suspected disease
- The test is expected to be available from LabCorp by
early 2021
Lille, France; Cambridge, MA; [AND
Burlington, N.C.,] September 28, 2020 GENFIT
(Nasdaq and Euronext: GNFT), a late-stage
biopharmaceutical company dedicated to improving the lives of
patients with metabolic and liver diseases, and
LabCorp® (NYSE:LH), a leading global life sciences
company that is focused on advancing health and guiding patient
care decisions, have agreed to a five-year exclusive licensing
agreement for GENFIT’s NIS4™ technology to help identify patients
with at-risk non-alcoholic steatohepatitis (NASH). As part of the
agreement, LabCorp will develop and commercialize a blood-based
molecular diagnostic test powered by NIS4™ technology throughout
the U.S. and Canada enabling widespread access to healthcare
providers.
NASH remains a highly underdiagnosed disease due
to its asymptomatic nature and the limitations of existing
diagnostic approaches. Liver biopsy, a highly invasive procedure,
is the current clinical standard to formally diagnose NASH and to
determine the stage of fibrosis. NIS4™ technology, as recently
published in The Lancet Gastroenterology & Hepatology
(available here), is a novel, multi-biomarker-based algorithm
specifically developed to identify at-risk NASH, defined as the
presence of NASH based on a non-alcoholic fatty liver disease
(NAFLD) Activity Score (NAS) ≥4 and significant to advanced
fibrosis (F≥2).
Patients with at-risk NASH have an advanced form
of the disease and face a greater likelihood of progression to
severe complications including liver cancer, cirrhosis and the need
for liver transplant, if left untreated. A single test score
generated from the integration of four independent biomarkers –
miR-34a-5p, alpha-2-macroglobulin, YKL-40, and HbA1c – can be used
by a healthcare provider to help inform the best course of
intervention.
This agreement with LabCorp will provide broad
clinical availability of the test to specialty and primary care
physicians across the U.S. and Canada. LabCorp will leverage its
deep experience in commercializing innovative diagnostics to
educate providers on NASH and the importance of non-invasive
testing. The collaboration between the organizations began in early
2019, when LabCorp began offering NIS4™ technology to
biopharmaceutical customers for use in clinical studies through
Covance, its drug development business.
Marcia Eisenberg, Ph.D., Chief
Scientific Officer of LabCorp Diagnostics, stated:
“LabCorp is committed to developing and distributing novel
diagnostics to support the diagnosis of patients with NASH, which
is one of the fastest growing serious medical conditions in the
U.S. GENFIT’s NIS4™ is a non-invasive technology specifically
designed to identify patients with both NASH and significant to
advanced fibrosis, and is an important advance in the ability to
identify patients with NASH. We have gained valuable experience
with this test since we began performing it in 2019 for clinical
studies with biopharmaceutical clients, which will provide insights
as we develop and prepare to make it available for use in patient
care.”
Suneil Hosmane, Ph.D., Head of Global
Diagnostics at GENFIT added: “We are
pleased to expand our collaboration with LabCorp and are very
enthusiastic about the potential impact of this agreement. We
strongly believe that this test will help healthcare providers
identify the approximately 10 million patients with at-risk NASH
and higher risk of progression among the tens of millions with
metabolic risk factors, such as type 2 diabetes and obesity, and
suspected disease.”
Pascal Prigent, CEO of
GENFIT, continued, “This partnership
supports GENFIT’s pioneering research efforts in the field of NASH
diagnostics that were recently recognized by experts in our most
recent Lancet publication. The commercialization of NIS4™
technology by LabCorp is a defining opportunity whereby millions of
NASH patients can become aware of, and then begin to take control
of their disease.”
GENFIT is a pioneer in NASH diagnostics and is
committed to the development of additional diagnostics and
therapeutics in chronic liver disease. LabCorp has been involved in
the development of drugs and diagnostics for more than 50 years and
is a recognized global leader in NASH clinical trials.
Specific financial terms for this agreement have
not been disclosed.
ABOUT NIS4™
NIS4™ is GENFIT’s non-invasive, blood-based
diagnostic technology, which was developed to identify patients
with non-alcoholic steatohepatitis (NASH) and significant to
advanced fibrosis (F>2), also referred to as at-risk NASH. In
January 2019, GENFIT signed a licensing agreement with LabCorp® to
make NIS4™ technology available for use in clinical research
through their drug development subsidiary, Covance. GENFIT also
continues to explore opportunities to obtain formal marketing
authorization of an in vitro diagnostic (IVD) version of NIS4™ in
both the U.S. and European markets. For more information, please
visit: https://nis4.com.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with metabolic and
liver diseases. GENFIT is a pioneer in the field of nuclear
receptor-based drug discovery, with a rich history and strong
scientific heritage spanning more than two decades. GENFIT
initiated a Phase 3 clinical trial of elafibranor in patients with
primary biliary cholangitis (PBC). As part of GENFIT’s
comprehensive approach to clinical management of patients with
liver disease, the Company is also developing NIS4™, a new,
non-invasive blood-based diagnostic technology which, if approved,
could enable easier identification of patients with at-risk NASH.
With facilities in Lille and Paris, France, and Cambridge, MA, USA,
the Company has approximately 200 employees. GENFIT is a publicly
traded company listed on the Nasdaq Global Select Market and on
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 statements about NIS4™’s performance in
identifying patients with at-risk NASH, the performance of NIS4™
relative to other technologies, the potential for diagnostic tests
powered by NIS4™ technology to play a critical role in the
diagnosis and management of patients with NASH, the potential for
non-invasive testing to gain importance, its capability to identify
patients who may require medical intervention, the development
plans for NIS4™ in the U.S. and in Europe and timing of such
development plans, and the potential to obtain formal marketing
authorization of an IVD version of NIS4™ in the U.S. and/or
European markets. 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 2.1 “Main Risks and Uncertainties” of the
Company’s 2019 Universal Registration Document filed with the AMF
on May 27, 2020 under n° D.20-0503, 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 20-F dated May 27, 2020. 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.
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 diagnostics
solutions, brings innovative medicines to patients faster, and uses
technology to improve the delivery of care. LabCorp reported
revenue of more than $11.5 billion in 2019.
To learn more about LabCorp, visit
www.LabCorp.com, and to learn more about LabCorp’s Covance Drug
Development business, visit www.Covance.com.
LABCORP FORWARD-LOOKING STATEMENTS
This press release contains forward-looking
statements, including but not limited to statements with respect to
clinical laboratory testing, including a testing in development
based on GENFIT’s NIS4™ technology, the impact of various factors
on operating and financial results, and the opportunities for
future growth. Each of the forward-looking statements is subject to
change based on various important factors, many of which are beyond
the Company’s control, 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, the Company’s satisfaction of
regulatory and other requirements, patient safety issues, changes
in testing guidelines or recommendations, adverse results in
material litigation matters, 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, and employee relations. These
factors, in some cases, have affected and in the future (together
with other factors) could affect the Company’s ability to implement
the Company’s business strategy and actual results could differ
materially from those suggested by these forward-looking
statements. As a result, readers are cautioned not to place undue
reliance on any of our forward-looking statements. The Company has
no obligation to provide any updates to these forward-looking
statements even if its expectations change. All forward-looking
statements are expressly qualified in their entirety by this
cautionary statement. Further information on potential factors,
risks and uncertainties that could affect operating and financial
results is included in the Company’s most recent Annual Report on
Form 10-K and subsequent Forms 10-Q, including in each case under
the heading RISK FACTORS, and in the Company’s other filings with
the SEC.
GENFIT CONTACT
GENFIT | Investors
Naomi EICHENBAUM – Investor Relations | Tel: +1
(617) 714 5252 | investors@genfit.com
PRESS RELATIONS | Media
Hélène LAVIN – Press Relations | Tel: +3 33 2016
4000 | Helene.lavin@genfit.com
LABCORP CONTACTS
Clarissa Willett – Investors | Tel: +1 (336) 436 5076 |
Investor@LabCorp.com
Donald Von Hagen – Media | Tel: +1 (336) 436 8263 |
Media@LabCorp.com
GENFIT | 885 Avenue Eugène Avinée, 59120
Loos - FRANCE | +333 2016 4000 |
www.genfit.com
- GENFIT and LabCorp Sign Exclusive Agreement to Commercialize a
Novel Diagnostic Test for Liver Disease