Timely use of Novartis' Entresto could prevent or postpone over 28,000 US deaths per year among HFrEF patients, according to an expert analysis in JAMA Cardiology

• Findings are first to quantify magnitude of potential survival benefits if Entresto were prescribed to all eligible US HFrEF patients (as defined by authors) [1]
   
• Cardiology experts highlight risk of delaying broad adoption of Entresto in patients with HFrEF and call for efforts to accelerate treatment uptake [1]
   
• Report reinforces independently released HF Treatment Guideline update by leading US cardiology societies that gave Entresto a strong Class 1 recommendation for the management of HFrEF [1,2]
   
• Separate analysis in JAMA Cardiology shows Entresto to be cost effective compared to ACE inhibitor treatment, and consistent with other high-value cardiovascular interventions [3]

Basel, June 22, 2016 - A new analysis published today in JAMA Cardiology has found that timely and broad adoption of Entresto® (sacubitril/valsartan) by all eligible heart failure patients with reduced ejection fraction (HFrEF) could prevent or postpone more than 28,000 deaths each year in the US alone. [1] This analysis, based on an application of the results of PARADIGM-HF to published heart failure statistics, is the first to quantify the possible impact of Entresto's potential benefit in reducing death. [1]

Heart failure is a chronic condition that contributes to more than 300,000 deaths in the US every year. [4] About half of people with heart failure have HFrEF. [5] This new analysis estimates that as many as 28,484 deaths in HFrEF patients annually could be prevented or postponed with optimal use of Entresto (with sensitivity analyses demonstrating a range of 18,230 to 41,017)^. [1]

Further, the study suggests that delaying routine use of Entresto in clinical practice could have a substantial negative effect on patients, given the expected risk-benefit profile, as it could result in failure to prevent tens of thousands of deaths. [1] These findings demonstrate the significant survival benefits Entresto could offer to those living with HFrEF, if patients in the group defined by the authors were given access to treatment. [1] The study authors stated that nearly 84% of HFrEF patients - 2.2 million people - may be candidates for treatment with Entresto. [1]

Heart failure is a life-threatening condition and despite available medicines, about half of patients diagnosed with heart failure die within 5 years. [4,6,7] According to the study authors, these findings may substantially impact the national health of the HFrEF population, offering significant clinical benefit in preventing or postponing death when applied in clinical practice. [1]

"This analysis demonstrates that Entresto can save the lives of thousands of patients every year if used in all eligible heart failure patients with reduced ejection fraction (HFrEF)," said Vas Narasimhan, Global Head of Development and Chief Medical Officer for Novartis. "Entresto has now independently received a class I recommendation in clinical guidelines and was shown in multiple analysis to be cost effective so physicians and health care systems should feel confident in ensuring rapid and broad use of this breakthrough medicine."

In a separate analysis published in the same issue of JAMA Cardiology, researchers used data from the PARADIGM-HF trial to model the health consequences and cost-effectiveness of Entresto over a 30-year time period. [3] They compared Entresto to the ACE-inhibitor enalapril and found Entresto was associated with more than a year longer average survival time, and that it was cost-effective compared to enalapril when these medications were used with other standard of care therapies. [3]  For every 1,000 patients treated with Entresto vs. enalapril, potentially 59.7 HF hospital admissions could be averted per each year alive in the model. [3] In addition, Entresto increased life expectancy at an incremental cost-effectiveness ratio consistent with other high-value widely accepted cardiovascular interventions such as implantable cardioverter defibrillators (ICDs) and cholesterol-lowering statins before they became generic. [3]

About Heart Failure

Heart failure is a debilitating and life-threatening condition, which impacts over 60 million people worldwide [6]. It is the leading cause of hospitalization in people over the age of 65 [4,8]. 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 [8]. Heart failure presents a major and growing health-economic burden that currently costs the world economy $108 billion every year [4,10], which accounts for both direct and indirect costs.

Novartis has established the largest global clinical program in the heart failure disease area across the pharma industry to date, FortiHFy, 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 Entresto, as well as to extend understanding of heart failure.

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) [11]. Other heart failure medicines only block the harmful effects of the overactive RAAS. [12] Entresto contains the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan [11].

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 [11]. 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 country.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "could," "potential," "call for," "accelerate," "possible," "suggests," "expected," "may," "can," or similar terms, or by express or implied discussions 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 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; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety, quality or manufacturing 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 http://www.novartis.com.

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References

[1] Fonarow GC, Hernandez AF, Solomon SD, et al. Potential Mortality Reduction with Optimal Implementation of Angiotensin Receptor Neprilysin Inhibitor Therapy in Heart Failure. JAMA Cardiol. 2016;1(6):1-4. doi:10.1001/jamacardio.2016.1724
[2] Yancy CW, Jessup M, Bozkurt B, Butler J, Casey Jr DE, Colvin MM, Drazner, MH, Filippatos G, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride, PE, Peterson PN, Stevenson LW, Westlake C, 2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure, Journal of the American College of Cardiology (2016), doi: 10.1016/j.jacc.2016.05.011.
[3] Gaziano TA, Fonarow GC, et al. Cost-Effectiveness Analysis of Sacubitril/Valsartan versus Enalapril in Heart Failure Patients with Reduced Ejection Fraction in the United States. JAMA Cardiol. 2016; http://cardiology.jamanetwork.com/journal.aspx
[4] Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics-2016 Update: A report from the American Heart Association. Circulation. 2015;133;e38-e360. doi: 10.1161/CIR.0000000000000350
[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. 2006;355:251-259
[6] Roger VL, Weston SA, Redfield MM, et al. Trends in heart failure incidence and survival community-based population. JAMA. 2004;292:344-350
[7] Levy D, Kenchaiah S, Larson MG, et al. Long term trends in the incidence and survival with heart failure. N Engl J Med. 2002;347(18):1397-1422.
[8] Weir 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.
[9] Ejection Fraction Heart Failure Measurement. American Heart Association Website.http://www.heart.org/HEARTORG/Conditions/HeartFailure/SymptomsDiagnosisofHeartFailure/Ejection-Fraction-Heart-Failure-Measurement_UCM_306339_Article.jsp. Published March 24, 2015. Accessed March 10, 2016.
[10] 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.
[11] Entresto Prescribing Information
[12] 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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