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Press Release: Novartis PARAGON-HF trial suggests -2-

1995. Forward-looking statements can generally be identified by words

such as "potential," "can," "will," "plan," "expect," "anticipate,"

"look forward," "believe," "committed," "investigational," "next steps,"

"to date," "could," "investigating," "ongoing," "emerging," "suggests,"

"may," or similar terms, or by express or implied discussions regarding

potential marketing approvals, 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 our current beliefs and expectations 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 Entresto will be submitted or

approved for sale or 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,

our expectations regarding Entresto could be affected by, among other

things, the uncertainties inherent in research and development,

including clinical trial results and additional analysis of existing

clinical data; regulatory actions or delays or government regulation

generally; global trends toward health care cost containment, including

government, payor and general public pricing and reimbursement pressures

and requirements for increased pricing transparency; our ability to

obtain or maintain proprietary intellectual property protection; the

particular prescribing preferences of physicians and patients; general

political and economic conditions; safety, quality or manufacturing

issues; potential or actual data security and data privacy breaches, or

disruptions of our information technology systems, 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 is reimagining medicine to improve and extend people's lives.

As a leading global medicines company, we use innovative science and

digital technologies to create transformative treatments in areas of

great medical need. In our quest to find new medicines, we consistently

rank among the world's top companies investing in research and

development. Novartis products reach more than 750 million people

globally and we are finding innovative ways to expand access to our

latest treatments. About 108,000 people of more than 140 nationalities

work at Novartis around the world. Find out more at www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at

http://twitter.com/novartis or follow @NovartisNews for the latest News

& Media Updates at https://twitter.com/novartisnews

For Novartis multimedia content, please visit

www.novartis.com/news/media-library

For questions about the site or required registration, please contact

media.relations@novartis.com

References

[1] Solomon S, McMurray J, et al. Angiotensin-Neprilysin in Heart

Failure with Preserved Ejection Fraction. N Engl J Med. 2019; doi:

10.1056/NEJMoa1908655

[2] Ponikowski P, Voors A, et al. 2016 ESC Guidelines for the diagnosis

and treatment of acute and chronic heart failure. Eur Heart J.

2016;37:2129--2200. doi:10.1093/eurheartj/ehw128.

[3] Treatment for Heart Failure: Endpoints for Drug Development

Guidance for Industry. U.S. Department of Health and Human Services,

Food and Drug Administration, Center for Drug Evaluation and Research

(CDER) and Center for Biologics Evaluation and Research (CBER). June

2019. Available at: https://www.fda.gov/media/128372/download. Accessed

July 17, 2019.

[4] McMurray J, Packer M, Desai A, et al. Angiotensin-neprilysin

inhibition versus enalapril in heart failure. N Engl J Med.

2014;371:993-1004. doi: 10.1056/NEJMoa1409077.

[5] Seferovic P, Ponikowski P, Anker S, et al. Clinical practice update

on heart failure 2019: pharmacotherapy, procedures, devices and patient

management. An expert consensus meeting report of The Heart Failure

Association of the European Society of Cardiology. Eur J Heart Fail.

2019. doi: 10.1002/ejhf.1531.

[6] Velazquez E, Morrow D, DeVore, A, et al., Angiotensin-Neprilysin

Inhibition in Acute Decompensated Heart Failure. N Engl J Med. 2018.

doi: 10.1056/NEJMoa1812851.

[7] Chandra A, Lewis E, Claggertt B, et al. The Effects of

Sacubitril/Valsartan on Physical and Social Activity Limitations in

Heart Failure Patients: The PARADIGM-HF Trial. JAMA Cardiol.

2018;3(6):498-505. doi: 10.1001/jamacardio.2018.0398.

[8] EMA. Entresto (sacubitril/valsartan). Summary of product

characteristics. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004062/WC500197536.pdf.

Accessed July 2019.

[9] Yancy C, Jessup M, et al. 2017 ACC/AHA/HFSA Focused Update of the

2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of

the American College of Cardiology/American Heart Association Task Force

on Clinical Practice Guidelines and the Heart Failure Society of

America. Circulation. 2017;136:e137-161. doi:

10.1161/CIR.0000000000000509.

[10] Solomon S, Rizkala A, et al. Angiotensin Receptor Neprilysin

Inhibition in Heart Failure with Preserved Ejection Fraction: Rationale

and Design of the PARAGON-HF Trial. JACC Heart Fail. 2017;5(7):471-482.

doi: 10.1016/j.jchf.2017.04.013.

[11] Solomon S, Zile M, et al. The angiotensin receptor neprilysin

inhibitor LCZ696 in heart failure with preserved ejection fraction: a

phase 2 double-blind randomised controlled trial. Lancet.

2012;380(9851):1387-1395. doi: 10.1016/S0140-6736(12)61227-6.

[12] Ndumele C, Matsushita K, et al. NT-proBNP and Heart Failure Risk

Among Individuals With and Without Obesity: The ARIC Study. Circulation.

2016;133:631-638. doi: 10.1161/CIRCULATIONAHA.115.017298.

[13] What is Heart Failure? American Heart Association. Website.

http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/What-is-Heart-Failure_UCM_002044_Article.jsp#.WvB9T6iPKyJ.

Updated March 7, 2018. Accessed July 20, 2019.

[14] Savarese G, Lund L. Global Public Health Burden of Heart Failure.

Card Fail Rev. 2017;3(1):7-11. doi: 10.15420/cfr.2016:25:2.

[15] Borlaug B, Redfield M. Distolic and systolic heart failure are

distinct phenotypes within the heart failure spectrum. Circulation.

2011;123(18):2006-214. doi: 10.1161/CIRCULATIONAHA.110.954388.

[16] Ejection Fraction Heart Failure Measurement. American Heart

Association. Website.

https://www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-failure-measurement.

Published March 24, 2015. Accessed July 17, 2019.

[17] Dunlay S, Roger V, et al. Epidemiology of heart failure with

preserved ejection fraction. Nature Reviews Cardiology.

2017;14:591--602. doi: 10.1038/nrcardio.2017.65.

[18] Oktay A, Rich J, et al. The Emerging Epidemic of Heart Failure

with Preserved Ejection Fraction. Curr Heart Fail Rep.

2013;10(4):401-410. doi:10.1007/s11897-013-0155-7.

[19] Yancy C, Jessup M, et al. 2013 ACCF/AHA Guideline for the

Management of Heart Failure. J Am Coll Cardiol. 2013;62(16):e147-e239.

doi: 10.1016/j.jacc.2013.05.019.

[20] Owan T, Hodge D, et al. Trends in prevalence and outcome of heart

failure with preserved ejection fraction. N Engl J Med.

2006;355:251-259. doi: 10.1056/NEJMoa052256.

[21] Yancy C, Jessup M, et al. 2017 ACC/AHA/HFSA Focused Update of the

2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of

the American College of Cardiology/American Heart Association Task Force

on Clinical Practice Guidelines and the Heart Failure Society of

America. Circulation. 2017;136:e137-161. doi:

10.1161/CIR.0000000000000509.

[22] Langenickel T, Dole W. Angiotensin receptor-neprilysin inhibition

with LCZ696: a novel approach for the treatment of heart failure. Drug

Discov Today. 2012;9(4):e131-139. doi: 10.1016/j.ddstr.2013.11.002.

[23] ENTRESTO [prescribing information]. East Hanover, NJ: Novartis

Pharmaceuticals Corp; November 2018.

[24] Desai A, Claggett B, et al. Influence of Sacubitril/Valsartan

(LCZ696) on 30-Day Readmission After Heart Failure Hospitalization.

JACC. 2016;68(3):241-248. doi: 10.1016/j.jacc.2016.04.047.

# # #

Novartis Global External Communications

E-mail: media.relations@novartis.com

Peter Züst Eva Mispelbaum

Novartis Global External Communications Novartis Global Pharma Communications

+41 61 324 6383 (direct) +49 911 273 13 051 (direct)

peter.zuest@novartis.com +49 172 686 62 30 (mobile)

Eric Althoff eva.mispelbaum@novartis.com

Novartis US External Communications

+1 646 438 4335

eric.althoff@novartis.com

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@novartis.com

Central North America

Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052

Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 862 778 3258

Thomas Hungerbuehler +41 61 324 8425

Isabella Zinck +41 61 324 7188

(END) Dow Jones Newswires

September 01, 2019 08:30 ET (12:30 GMT)

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