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Pfizer Announces Clinical Development Agreement with Novartis to Advance the Treatment of NASH

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

Monday, October 29, 2018 - 2:15am

NEW YORK--(BUSINESS WIRE)--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

“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™

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to people that extend and significantly improve their lives. We strive
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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




For Pfizer Inc.
European Media:
Andy Widger, +44 1737 330909
[email protected]
US Media:
Neha Wadhwa, 212-733-2835
[email protected]
Ryan Crowe, 212-733-8160
[email protected]