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

• Fortifying Heart Failure 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 years

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 failure.

"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 clinicaltrials.gov 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 country.

Disclaimer
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 http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
For Novartis multimedia content, please visit www.novartis.com/news/media-library. For questions about the site or required registration, please contact: [email protected]  

# # #

References
[1] McMurray JJV et al. Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure, N Engl J Med 2014.
[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 2015.
[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. 2006;355:251-259.
[6] 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.
[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.

Novartis Media Relations

e-mail: [email protected]

Novartis Investor Relations