Pfizer Announces Clinical Development Agreement with Novartis to Advance the Treatment of NASH
29 Octobre 2018 - 7:15AM
Business Wire
Joint studies will evaluate one or more of
Pfizer’s investigational NASH therapies in combination with
Novartis’s FXR agonist for the treatment of the progressive liver
disease
Pfizer Inc. (NYSE:PFE) announced today that it has entered into
a non-exclusive clinical development agreement with Novartis (NYSE:
NVS) to investigate one or more combination therapies for the
treatment of non-alcoholic steatohepatitis (NASH). The companies
will conduct both non-clinical and Phase 1 clinical studies of
Pfizer’s investigational therapies, including an Acetyl
CoA-Carboxylase (ACC) Inhibitor (PF-05221304, currently in Phase
2), a Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor
(PF-06865571, Phase 1) and a Ketohexokinase (KHK) Inhibitor
(PF-06835919, Phase 2), together with Novartis’s tropifexor, a
non-bile acid, Farnesoid X receptor (FXR) agonist.
With three assets in development, and several first-in-class
pre-clinical candidates under investigation, Pfizer is building a
robust NASH program, which was entirely developed in-house and
targets NASH through multiple, diverse pathways of the disease. The
collaboration with Novartis helps Pfizer to explore combination
approaches at an early stage.
“This is an exciting collaboration with Novartis that furthers
our approach to this complex disease by exploring
different and potentially complementary mechanisms of action,” said
Morris Birnbaum, MD, PhD, Senior Vice President and Chief
Scientific Officer, Pfizer Internal Medicine. “Our research in NASH
dates back more than a decade and stems directly from how we have
developed medicines to address conditions that put patients at risk
for NASH, including Type 2 diabetes and cardiovascular disease. We
are confident that by drawing from our history and deep
understanding of the close interplay between metabolic,
inflammatory and cardiovascular conditions, we can potentially
uncover treatments that truly meet patient needs.”
About NASH
Non-alcoholic steatohepatitis (NASH) is a serious, progressive
form of non-alcoholic fatty liver disease caused by a buildup of
fat in the liver accompanied by inflammation, liver cell scarring
and damage. Due to its lack of symptoms, NASH is often unrecognized
and underdiagnosed, but it is believed to affect at least three to
five percent of the global adult population. With no currently
available treatments, NASH is expected to be the leading cause of
liver transplants within the next decade. Pfizer is committed to
researching multiple pathways to treat NASH at different stages of
its progression with monotherapies, or combinations of medicines,
to address different aspects of the disease.
Pfizer Inc: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best‐known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
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addition, to learn more, please visit us on www.pfizer.com and
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DISCLOSURE NOTICE: The information contained in this
release is as of October 29, 2018. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s
investigational programs in non-alcoholic steatohepatitis (NASH)
and a non-exclusive clinical development agreement with Novartis to
investigate one or more combination therapies for the treatment of
NASH, including their potential benefits, that involves substantial
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical trial commencement and
completion dates and regulatory submission dates, as well as the
possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing
data; the risk that clinical trial data are subject to differing
interpretations, and, even when we view data as sufficient to
support the safety and/or effectiveness of a product candidate,
regulatory authorities may not share our views and may require
additional data or may deny approval altogether; whether regulatory
authorities will be satisfied with the design of and results from
our clinical studies; whether and when drug applications may be
filed in any jurisdictions for any investigational therapies for
the treatment of NASH; whether and when any such applications may
be approved by regulatory authorities, which will depend on the
assessment by such regulatory authorities of the benefit-risk
profile suggested by the totality of the efficacy and safety
information submitted, and, if approved, whether any such
investigational therapies will be commercially successful;
decisions by regulatory authorities regarding labeling and other
matters that could affect the availability or commercial potential
of any investigational therapies for NASH; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2017 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
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For Pfizer Inc.European Media:Andy Widger, +44 1737
330909Andrew.Widger@pfizer.comorUS Media:Neha Wadhwa,
212-733-2835neha.wadhwa@pfizer.comorInvestors:Ryan Crowe,
212-733-8160ryan.crowe@pfizer.com
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