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17.11.2019 16:44:57

Press Release: Novartis PARAGON-HF analyses -2-

-- Overall incidence of confirmed angioedema events was low in the two

treatment arms, with 14 events in the Entresto arm (0.6%) and 4 events in

the valsartan arm (0.2%); no angioedema events resulted in airway


-- Entresto resulted in lower rates of worsening renal function (1.4% versus

(Anzeige)Passende neue Barrier Reverse Convertibles

2.7% compared to valsartan); and serious adverse events of hyperkalemia

compared to valsartan (0.8% versus 1.8%)4.

PARAGON-HF follows PARAMOUNT-HF, the Phase II trial in HFpEF. Additional

studies investigating Entresto on other relevant endpoints in HFpEF are


About Entresto for heart failure with reduced ejection fraction

Entresto is a twice-a-day medicine that reduces the strain on the

failing heart(12). It does this by enhancing the protective

neurohormonal systems (natriuretic peptide system) while simultaneously

inhibiting the harmful effects of the overactive

renin-angiotensin-aldosterone system (RAAS) (12,15). Other common heart

failure medicines, called angiotensin converting enzyme (ACE) inhibitors

and angiotensin II receptor blockers (ARBs), only block the harmful

effects of the overactive RAAS. Entresto contains the neprilysin

inhibitor sacubitril and the ARB valsartan(12,16).

In Europe, Entresto is indicated in adult patients for the treatment of

symptomatic chronic heart failure with reduced ejection fraction(12).

In the United States, Entresto is indicated for the treatment of heart

failure (New York Heart Association class II-IV) in patients with

systolic dysfunction(16). It has been shown to reduce the rate of

cardiovascular death, heart failure hospitalization and 30-day hospital

readmission compared to enalapril, to reduce the rate of all-cause

mortality compared to enalapril, and to improve aspects of

health-related quality of life (including physical and social

activities) compared to enalapril(5,11,17). Entresto is usually

administered in conjunction with other heart failure therapies, in place

of an ACE inhibitor or other ARB(12). Approved indications may vary

depending upon the individual country.


This press release contains forward-looking statements within the

meaning of the United States Private Securities Litigation Reform Act of

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

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

"look forward," "believe," "committed," "investigational," "pipeline,"

"launch," or similar terms, or by express or implied discussions

regarding potential marketing approvals, new indications or labeling for

the investigational or approved products described in this press release,

or regarding potential future revenues from such products. 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 the investigational or

approved products described in this press release 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

such products will be commercially successful in the future. In

particular, our expectations regarding such products 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 109,000 people of more than 140 nationalities

work at Novartis around the world. Find out more at


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1. Solomon S, Packer M, Rouleau J, et al. Effect Of Sacubitril/Valsartan

Across The Spectrum Of Ejection Fraction In Heart Failure. Data presented

at: AHA Scientific Sessions 2019, Nov 16-18; Philadelphia, USA.

2. McMurray J, Lam C, McGrath M, et al. Effects Of Sacubitril/Valsartan In

Women Compared To Men With Heart Failure And Preserved Ejection Fraction.

Circulation. 2019.

3. Vaduganathan M, Claggett B, Desai A, et al. Prior Heart Failure

Hospitalization, Clinical Outcomes, and Response to Sacubitril/Valsartan

Compared with Valsartan in HFpEF. JACC 2019. doi:


4. Solomon S, McMurray J, Anand I, et al. Angiotensin-Neprilysin in Heart

Failure with Preserved Ejection Fraction. N Engl J Med.

2019;381:1609-1620. doi: 10.1056/NEJMoa1908655.

5. 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:


6. Yancy C, Jessup M, Bozkurt B, 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.

7. Ponikowski P, Voors A, Anker SD, 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.

8. 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.

9. 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;21(10);1169-1186. doi: 10.1002/ejhf.1531.

10. Velazquez E, Morrow D, DeVore, A, et al. Angiotensin-Neprilysin

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

2019;380:539-548. doi: 10.1056/NEJMoa1812851.

11. 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.

12. EMA. Entresto (sacubitril/valsartan). Summary of product characteristics.

Available at:


Accessed July 2019.

13. Yancy C, Jessup M, Bozkurt B, 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:


14. Solomon S, Rizkala A, Gong J, 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.

15. 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.

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

Pharmaceuticals Corp; October 2019.

17. Desai A, Claggett B, Packer M, 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 Media Relations

E-mail: media.relations@novartis.com

Peter Züst Meghan O'Donnell

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