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Novartis International AG: Novartis announces investment in FortiHFy clinical program of Entresto® and heart failure

Novartis International AG / Novartis announces investment in FortiHFy clinical
program of Entresto® andheart failure . Processed and transmitted by NASDAQ
OMX Corporate Solutions.The issuer is solely responsible for the content of
this announcement.
* Forti fyingH eartF ailure clinical evidence and patient quality of life
(FortiHFy) is an umbrella clinical program comprising over 40 active or
planned trials
* The global clinical program will generate additional data on symptom
reduction, efficacy, safety, quality of life benefits and real world
evidence with Entresto
* Investigators and patients from over 50 countries to participate over 5

Basel, May 19, 2016
- Novartis today announced the establishment of FortiHFy, the largest global
clinical program in the heart failure disease area across the pharma industry
to date, comprising over 40 active or planned clinical studies designed to
generate an array of additional data on symptom reduction, efficacy, quality
of life benefits and real world evidence with its novel heart failure
medicine Entresto®(sacubitril/valsartan), and extend understanding of heart

"The FortiHFy program reinforces our long term commitment to improving heart
failure treatment for as many people as possible," said Vas Narasimhan Global
Head, Drug Development and Chief Medical Officer. "The outcomes of these
trials will increase our understanding of heart failure, the patient
population who may benefit from Entresto, and could potentially support
applications to regulatory authorities".

Major trials in the FortiHFy program include:

* PARAGON-HF examining the efficacy and safety of Entresto in heart failure
patients with with preserved ejection fraction (compared to valsartan),
expected study completion in 2019
* PARADISE-MI testing the hypothesis that Entresto can reduce cardiovascular
death, heart failure hospitalizations and new onset heart failure in
patients at high risk for heart failure after a myocardial infarction,
expected study completion in 2020
* TRANSITION comparing in-hospital initiation of Entresto to initiation after
hospital discharge in heart failure patients with reduced ejection fraction
(HFrEF) who have recently been hospitalized for acute decompensation,
expected study completion in 2018
* PIONEER investigating the effect of in-hospital initiation of Entresto on
changes in NT-proBNP (compared to enalapril) in patients with HFrEF
following an acute decompensation, expected study completion in 2018

FortiHFy trials that are already active are posted on and
are currently enrolling patients in more than 50 countries worldwide.
Entresto is approved in 57 countries to date for the treatment of heart
failure with reduced ejection fraction (HFrEF), based on data from the
PARADIGM-HF study which reported results in 2014[1].

About Heart Failure

Heart failure is a debilitating and life-threatening condition, which impacts
over 60 million people worldwide[2]. It is the leading cause of
hospitalization in people over the age of 65[3],[4]. About half of people
with heart failure have HFrEF[5]. Reduced ejection fraction means the heart
does not contract with enough force, so less blood is pumped out[6]. Heart
failure presents a major and growing health-economic burden that currently
costs the world economy $108 billion every year[3],[7].

About Entresto

Entresto is a twice-a-day medicine that reduces the strain on the failing
heart. It does this by enhancing the protective neurohormonal systems of the
heart (NP system) while simultaneously suppressing the harmful effects of the
overactive renin-angiotensin-aldosterone system (RAAS)[8]. Other heart
failure medicines only block the harmful effects of the overactive RAAS[9].
Entresto contains the neprilysin inhibitor sacubitril, which is a new
molecular entity, and the angiotensin receptor blocker (ARB) valsartan[8].

In Europe, Entresto is indicated in adult patients for treatment of
symptomatic chronic heart failure with reduced ejection fraction. In the U.S.
Entresto is indicated for the treatment of heart failure (NYHA class II-IV)
in patients with systolic dysfunction[8]. It has been shown to reduce the
rate of cardiovascular death and heart failure hospitalization compared to
enalapril, and also to reduce the rate of all-cause mortality compared to
enalapril. Entresto is usually administered in conjunction with other heart
failure therapies, in place of an ACE inhibitor or other angiotensin receptor
blocker (ARB). Approved indications may vary depending upon the individual


The foregoing release contains forward-looking statements that can be
identified by words such as "planned," "will," "to participate," "designed
to," "long term," "commitment," "may," "potential," "could," "potentially,"
or similar terms, or by express or implied discussions regarding the
commencement or completion of additional clinical trials of Entresto, or
regarding potential new indications or labeling for Entresto, or regarding
potential future revenues from Entresto. You should not place undue reliance
on these statements. Such forward-looking statements are based on the current
beliefs and expectations of management regarding future events, and are
subject to significant known and unknown risks and uncertainties. Should one
or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those
set forth in the forward-looking statements. There can be no guarantee that
any or all of the clinical trials discussed in this release will be commenced
or completed, or that they will be commenced or completed in the manner or
time described or implied in this release. Neither can there be any
guarantee that Entresto will be submitted or approved for any additional
indications or labeling in any market, or at any particular time. Nor can
there be any guarantee that Entresto will be commercially successful in the
future. In particular, management's expectations regarding Entresto could be
affected by, among other things, the uncertainties inherent in research and
development, including unexpected clinical trial results and additional
analysis of existing clinical data; unexpected regulatory actions or delays
or government regulation generally; unexpected resistance to Entresto by
payors or prescribers; the company's ability to obtain or maintain
proprietary intellectual property protection; general economic and industry
conditions; competition in general; global trends toward health care cost
containment, including ongoing pricing pressures; unexpected safety,
manufacturing or quality issues, and other risks and factors referred to in
Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new information,
future events or otherwise.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland,
Novartis offers a diversified portfolio to best meet these needs: innovative
medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the
only global company with leading positions in these areas. In 2015, the Group
achieved net sales of USD 49.4 billion, while R&D throughout the Group
amounted to approximately USD 8.9 billion (USD 8.7 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 118,000 full-time-equivalent associates. Novartis products are
available in more than 180 countries around the world. For more information,
please visit

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[1] McMurray JJV et al. Angiotensin-Neprilysin Inhibition versus Enalapril in
Heart Failure,N Engl J Med

[2] Global Burden of Disease Study 2013 Collaborators. Global, regional, and
national incidence, prevalence, and years lived with disability for 301 acute
and chronic diseases and injuries in 188 countries, 1990-2013: a systematic
analysis for the Global Burden of Disease Study 2013,Lancet

[3] Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke
Statistics-2016 Update: A report from the American Heart Association.
Circulation. 2015; 132:000-000. doi: 10.1161/CIR.0000000000000350.
[4] Wier LM, Pfuntner A, Maeda J, et al. HCUP facts and figures: statistics on
hospital-based care in the United States, 2009. Rockville, MD: Agency for
Healthcare Research and Quality, 2011.
[5] Owan TE, Hodge DO, Herges RM, et al. Trends in prevalence and outcome of
heart failure with preserved ejection fraction. N Engl J Med.
[6] Ejection Fraction Heart Failure Measurement. American Heart Association
Published March 24, 2015. Accessed March 10, 2016.

[7] Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the impact of
heart failure in the United States: a policy statement from the American
Heart Association. Circ Heart Fail. 2013;6:606-619.
[8] Entresto Prescribing Information.
[9] Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the
management of heart failure: A report of the American College of Cardiology
Foundation/American Heart Association task force on practice guidelines.
Circulation. 2013;128:e240-e327.

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