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Novartis announces new analysis demonstrating Entresto helped preserve kidney function in patients with chronic heart failure, especially those with diabetes

Novartis International AG /
Novartis announces new analysis demonstrating Entresto helped preserve kidney
function in patients with chronic heart failure, especially those with diabetes
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.

* Heart failure (HF) patients with reduced ejection fraction treated with
Entresto experienced significantly less reduction in kidney function
compared to patients treated with standard of care ACE inhibitor
enalapril[1]

* Magnitude of benefit was twice as high in a sub group of patients with HF
and diabetes[1]

* Up to 40% of HF patients have diabetes, which is associated with greater
risk of developing chronic kidney disease leading to poorer cardiovascular
outcomes[2],[3],[4]

* In addition to the established benefits on mortality and HF
hospitalizations, Entresto treatment also helps to preserve kidney function,
especially in diabetic patients

Basel, April 16, 2018 - Novartis today announced a new post hoc analysis of the
pivotal Phase III heart failure study, PARADIGM-HF, demonstrating that treatment
with Entresto(®) (sacubitril/valsartan) helped to preserve kidney function, as
assessed by estimated glomerular filtration rate (eGFR), in patients with heart
failure with reduced ejection fraction (HFrEF).[1] HFrEF patients treated with
Entresto had a slower rate of decline in eGFR than those treated with ACE
inhibitor enalapril.[1] In a sub group of patients who had both HFrEF and
diabetes, the magnitude of benefit was twice as high.[1] The findings of the
analysis are published today in The Lancet Diabetes & Endocrinology.

"These results suggest that in addition to the established benefits on heart
failure, Entresto treatment also helps to preserve kidney function. This is
important because impaired kidney function is associated with poorer outcomes in
patients with heart failure," said Shreeram Aradhye, Chief Medical Officer and
Global Head, Medical Affairs, Novartis Pharmaceuticals. "The benefit is
particularly significant for people with chronic heart failure who also have
diabetes, which is an independent risk factor for kidney damage."

Non-diabetic HFrEF patients in the PARADIGM-HF study were shown to lose kidney
function twice as fast as the general population.[1] This was further
accelerated in HFrEF patients with diabetes, who experienced a decline in kidney
function that was twice as fast as the non-diabetic patients.[1] When compared
with enalapril, treatment with Entresto significantly slowed this decline in all
HFrEF patients (-1.3 vs -1.8 ml/min/1.73m[2] per year).[1] In HFrEF patients who
also had diabetes, the benefit of treatment with Entresto was doubled vs. those
without diabetes (+0.6 (0.4, 0.8) vs. +0.3 (0.2, 0.5) ml/min/1.73m[2] per
year).[1]

Heart failure is associated with both diabetes and kidney disease, which lead to
poorer outcomes for patients, including increased risk of morbidity and
mortality.[2],[3],[4] More than half of all heart failure patients are expected
to experience moderate to severe chronic kidney disease (CKD), and up to 40% of
heart failure patients will have a diagnosis of diabetes.[2],[4] Diabetes
significantly increases an individual's risk for CKD. Added to this, many anti-
diabetic medications are known to increase the risk of heart failure
hospitalization or mortality.[2],[5]

Primary data from PARADIGM-HF, the largest clinical trial ever conducted in
heart failure, showed that treatment with Entresto reduced the risk of dying
from a cardiovascular cause by 20%, reduced heart failure hospitalizations by
21% and reduced the risk of dying from any cause by 16% as compared to
enalapril.[6] This new analysis adds to the growing evidence that Entresto has
important clinical benefits for heart failure patients beyond improving their
cardiovascular outcomes, and validates findings from a further post hoc analysis
of PARADIGM-HF, published online in the Journal of the American College of
Cardiology: Heart failure (JACC-HF) on 12 April 2018, which found that Entresto
helped slow the rate of renal function decline, even in heart failure patients
with chronic kidney disease, as compared to enalapril.[7] Entresto is indicated
for the treatment of chronic heart failure (NYHA II-IV) with reduced ejection
fraction.[8] It is not indicated to treat diabetes.

About Heart Failure
Heart failure is a debilitating and life-threatening condition, which impacts
over 60 million people worldwide.[9] It is the leading cause of hospitalization
in people over the age of 65.[10],[11] About half of people with heart failure
have heart failure with reduced ejection fraction (HFrEF).[12] Reduced ejection
fraction means the heart does not contract with enough force, so less blood is
pumped out.[13] Heart failure presents a major and growing health-economic
burden that currently costs the world economy $108 billion every year, which
accounts for both direct and indirect costs.[10],[14]

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(® )(sacubitril/valsartan)
Entresto is a twice-a-day medicine that reduces the strain on the failing heart.
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).[8],[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.[16] Entresto contains the neprilysin inhibitor sacubitril
and the angiotensin receptor blocker (ARB) valsartan.[8]

In Europe, Entresto is indicated in adult patients for the treatment of
symptomatic chronic heart failure with reduced ejection fraction. 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.[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.[6] Entresto is usually administered in
conjunction with other heart failure therapies, in place of an ACE inhibitor or
other angiotensin receptor blocker (ARB).[8] Approved indications may vary
depending upon the individual country.

Disclaimer
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; 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 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,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2017, the Group achieved
net sales of USD 49.1 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
122,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 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
media.relations@novartis.com

References

[1]   Packer Milton, Claggett Brian L, Lefkowitz Martin P., et al. Effect of
neprilysin inhibition on renal function in patients with type 2 diabetes and
chronic heart failure. The Lancet Diabetes & Endocrinology. 2018
[2]   Mentz RJ, Kelly JP, von Lueder TG, et al. Noncardiac comorbidities in
heart failure with reduced versus preserved ejection fraction. J Am Coll
Cardiol. 2014; 64(21):2281-2293.
[3]   Arise GS Galil, Hélady S Pinheiro, et al. Chronic kidney disease increases
cardiovascular unfavorable outcomes in outpatients with heart failure. BMC
Nephrol. 2009; 10(31)
[4]   Ahmed A, Campbell RC. Epidemiology of Chronic Kidney Disease in Heart
Failure. Heart failure clinics. 2008;4(4):387-399.
[5]   Rosano GM, Vitale C, Seferovic P. Heart Failure in Patients with Diabetes
Mellitus. Cardiac Failure Review. 2017;3(1):52-55.
[6]   McMurray JJV, Packer M, Desai AS, et al. Angiotensin-Neprilysin Inhibition
versus Enalapril in Heart Failure. N Engl J Med. 2014; 371:993-1004. doi:
10.1056/NEJMoa1409077.
[7]   Damman, K. et al. Renal effects and associated outcomes during
angiotensin-neprilysin inhibition in heart failure. JACC: Heart Failure. 2018.
https://doi.org/10.1016/j.jchf.2018.02.004
[8]   Entresto Prescribing Information.
[9]   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; 386(9995):743-800.
[10] 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.
[11] 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.
[12] 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.
[13] American Heart Association. Ejection Fraction Heart Failure Measurement.
Available at:
http://www.heart.org/HEARTORG/Conditions/HeartFailure/SymptomsDiagnosisofHeartFa
ilure/Ejection-Fraction-Heart-Failure-Measurement_UCM_306339_Article.jsp. Last
accessed: March 2017.
[14] 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.
[15] Langenickel T, Dole W. Angiotensin receptor-neprilysin inhibition with
LCZ696: a novel approach for the treatment of heart failure. Drug Disc Today.
2012; 4:131-139.
[16] 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
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com

Eric Althoff Agnes Estes
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 61 324 1896 (direct)
+41 79 593 4202 (mobile) +41 79 644 1062 (mobile)
eric.althoff@novartis.com agnes.estes@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 Richard Pulik +1 212 830 2448

Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 212 830 2417

Thomas Hungerbuehler +41 61 324 8425

Isabella Zinck +41 61 324 7188



Media release (PDF):
http://hugin.info/134323/R/2184339/843941.pdf



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Novartis International AG via GlobeNewswire



 
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