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New Novartis Entresto® real world evidence data shows beneficial impact on quality of life in people living with heart failure

Novartis International AG /
New Novartis Entresto® real world evidence data shows beneficial impact on
quality of life in people living with heart failure
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.

*  Entresto reversed trend of worsening New York Heart Association
(NYHA) class - a key measure of the severity of a patient's heart failure
symptoms - improving common physical activity such as exercise and other
daily activities at 90 and 180 days after treatment initiation in a
retrospective database study in patients with heart failure with reduced
ejection fraction (HFrEF) in Germany[1]

* Entresto significantly reduced levels of NT-proBNP, a key blood marker
associated with cardiovascular risk in patients with heart failure; the
magnitude of the decrease was similar to that observed in the PARADIGM-HF
study[1]

* Results are consistent with other real world data published in 2017 which
showed Entresto improves NYHA class[2] as well as exercise capacity[2]

* Majority of patients in this cohort started and stayed on the lowest dose of
Entresto, highlighting the potential to further improve patient outcomes by
increasing treatment to recommended target maintenance dose

* Data were shared today at the American Heart Association's Scientific
Sessions 2017, building on existing evidence that Entresto has beneficial
effects on the quality of life in addition to reducing cardiovascular death
and heart failure hospitalization

Basel, November 12, 2017 - Novartis today announced new results from a real-
world database study of patients in Germany prescribed Entresto(®)
(sacubitril/valsartan) for heart failure with reduced ejection fraction (HFrEF).
The findings further substantiate the beneficial effect of Entresto on heart
failure symptoms and patients' quality of life observed in the PARADIGM-HF study
and in other real-world cohorts. Results were presented today as a poster at the
American Heart Association's Scientific Sessions 2017.

"People living with heart failure experience symptoms that severely limit their
physical activities and quality of life," said Shreeram Aradhye, Chief Medical
Officer and Global Head, Medical Affairs, Novartis Pharmaceuticals. "We are
excited to see the growing body of evidence showing that Entresto has a
beneficial effect on the quality of life in heart failure, in addition to
reducing cardiovascular death and heart failure hospitalization."

The non-interventional, retrospective database study examined changes in
clinical characteristics of 1,643 patients in Germany on Entresto in the 12
months after their first dose. All patients with available data were analyzed
and the results included:
* The majority of patients had a stable New York Heart Association (NYHA)
class over time. Before Entresto more patients had a trend of worsening NYHA
class. The trend of worsening NYHA was reversed after switching to Entresto
at Day 90 (n=121) and 180 (n=81)[1]. NYHA classification is used to grade
the severity of a patient's heart failure symptoms, with physicians
determining class based on specific criteria (e.g., the level of discomfort
associated with physical activity)
* There was an approximately 30% mean decrease (-503pg/mg; p<0.001; n=119) in
NT-proBNP, a blood marker used to diagnose heart failure and to determine
prognosis[1]. Levels of NT-proBNP are typically higher in patients with
worse outcomes[3]
* The majority of patients had a documented first dose of Entresto at the
lowest level (24/26mg twice daily). Of these patients, 36% from the primary
care practices and 41% from the cardiology practices had their dose up-
titrated during follow-up; however, <11% received the target dose (97/103mg
twice daily) at the last recorded prescription

These results are consistent with other real world data published in 2017, which
show that Entresto has a beneficial impact on quality of life:
* Canada (n=276): 45% of patients switched to Entresto report feeling better
after four weeks, 56% after 12 weeks[4]
* France (n=200): in patients treated with Entresto improvement in NYHA class
and exercise capacity was observed[2]

These data results were also consistent with post-hoc analyses of the landmark
PARADIGM-HF clinical trial published between 2015 and 2017, which show that:
* In surviving patients, treatment with Entresto improved patients' quality of
life, including heart failure symptoms and physical limitations as compared
with enalapril, as measured by KCCQ[5]; this effect is sustained over 36
months
* Entresto improved seven out of 10 activities when compared with enalapril,
with the most significant changes in household chores and intimate/sexual
relationships[6]
* Among patients who had been hospitalized for heart failure, Entresto has
been shown to slow the further decline in health-related quality of life in
approximately half of patients compared to enalapril, as measured by KCCQ[7]
* Patients were less likely to have NYHA functional class deterioration on
Entresto compared with enalapril[8]

KCCQ is a self-administered health-related quality of life (HRQL) measure for HF
patients, with higher scores indicating fewer symptoms and physical limitations
associated with HF[5]. The questionnaire quantifies physical function, symptoms
(recent change, frequency and burden), social function, self-efficacy and
knowledge, and quality of life. Scores are transformed to a range of 0-100, in
which higher scores reflect better health status.

About the German Disease Analyzer Study
This non-interventional, retrospective database study, 'Dosing patterns and
evolution of clinical parameters in patients prescribed sacubitril/valsartan in
Germany,' was initiated to assess dosing patterns and the evolution of clinical
parameters in patients who were prescribed Entresto(® )(sacubitril/valsartan) in
the primary care or cardiology setting in Germany. Patients aged 18 and above
were identified via electronic medical records from the German IMS(® )Disease
Analyzer database, which contained data from 1,095 primary care practices and
43 cardiology practices at the time of the study. The study period was January
1, 2016 to December 31, 2016, with a maximum look-back period to January
1, 2015.

The study population included 1,643 patients with a subset of patients having
available data for analysis (n=119 evaluated for impact on NT-proBNP and n=121
evaluated for impact on NYHA classification trend).

About the PARASAIL study
The PARASAIL study, 'Patient reported outcomes from the Canadian real world
experience use of sacubitril/valsartan in patients with heart failure and
reduced ejection fraction (HFrEF),' is an ongoing, multi-center, open-label,
prospective, post-approval (Phase IV) study being conducted in 302 patients with
HFrEF at 32 study sites across Canada. It aims to characterize the tolerability,
safety and therapeutic effectiveness of Entresto(®) (sacubitril/valsartan)
97/103mg twice daily in Canadian patients with HFrEF.

In addition to primary and secondary efficacy and safety endpoints, the study
included pre-specified exploratory endpoints to evaluate heart failure symptoms
and quality of life (QoL): changes in Patient Global Assessment (PGA - a seven-
point patient self-evaluation scale that determines how a patient feels at
subsequent visits compared with baseline), Minnesota Living with Heart Failure
Questionnaire (MLHFQ - a validated questionnaire representative on how heart
failure is impacting key dimensions of QoL) and EuroQoL questionnaire (EQ-5D -
an instrument consisting of five domains [morbidity, self-care, usual activity,
pain, and anxiety and depression among patients] and a visual analogue scale to
assess the current health status of patients) from baseline to weeks four, 12
and 24.

The interim analysis of this study evaluated these pre-specified exploratory
endpoints in the first 276 patients who completed their initial 12 weeks of
Entresto treatment. Results showed early signs of improvement in two of the
three validated QoL questionnaires: nearly half of the patients reported feeling
better (using PGA questionnaire) and there was a significant improvement in
MLHFQ scores. No changes were detected based on the EQ-5D score.

These results were published in the September 2017 supplement of the European
Journal of Heart Failure. 2017;19: p34.

About the France Study
The study 'Results of a single center experience on 200 consecutive patients
treated with Entresto(®) (sacubitril/valsartan),' evaluates results from a
monocentric cohort of 200 consecutive heart failure with reduced ejection
fraction (HFrEF) patients treated with Entresto. Between October 2015 and
September 2016, 200 patients received Entresto; 180 were evaluated one month
after introduction, 157 three months after, and 99 after six months of follow
up.

Entresto was initiated at half dosage or less depending on the fragility of the
patient (78% at 49mg/51 mg twice daily and 22% at 24/26mg twice daily). Patients
attended a first follow-up appointment after one month of treatment, and if
tolerance was good, the dosage was increased. At three months, 82% of patients
received the target dose of 97/103mg. After one month of treatment, functional
class improved significantly with 4.5% New York Heart Association (NYHA) 1, 81%
NYHA 2, and 14.5% NYHA 3 (p= <0.001), as the 6-minute walk distance (511 vs
461m, p <0.0001). These improvements occurred from the first month of treatment
with the half dosage of Entresto and were still significantly present after six
months of follow up.

These results were published in the September 2017 supplement of the European
Journal of Heart Failure. 2017;19: p296.

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

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. 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
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; our ability to obtain or maintain
proprietary intellectual property protection; the particular prescribing
preferences of physicians and patients; global trends toward health care cost
containment, including government, payor and general public pricing and
reimbursement pressures; general economic and industry conditions, including the
effects of the persistently weak economic and financial environment in many
countries; 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,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
121,000 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] Wachter R, et al. Dosing Patterns and Evolution of Clinical Parameters in
Patients Prescribed Sacubitril/Valsartan in Germany. Poster presentation at:
American Heart Association Scientific Sessions 2017. Nov 11-15, Anaheim, CA.
[2] Canu A, et al. Results of a single center experience on 200 consecutive
patients treated with Entresto (sacubitril/valsartan). Eur J Heart Fail.
2017; 19:413-414.
[3] Ndumele C, et al. NT-proBNP and Heart Failure Risk Among Individuals With
and Without Obesity: The ARIC Study. Circulation. 2016; 133:631-638.
[4] Haddad H, et al. The PARASAIL study - Patient reported outcomes from the
Canadian real-world experience use of sacubitril/valsartan in patients with
heart failure and reduced ejection fraction. Eur J Heart Fail. 2017; 19(Suppl.
S1):34.
[5] Lewis EF, et al. Health-Related Quality of Life Outcomes in PARADIGM-HF.
Circ Heart Fail. 2017; 10:e003430.
[6] Chandra A, et al. The Effects of Sacubitril/Valsartan on Physical and Social
Activity Limitations in patients with Heart Failure: The PARADIGM-HF. Oral
presentation presented at: Heart Failure Society of America 21st Annual
Scientific Meeting. 2017; Sep 16-19, Dallas, TX.
[7] Lewis EF, et al. Sacubitril/Valsartan Associated with Lower Declines in
Health-Related Quality of Life Compared with Enalapril in Patients with Heart
Failure Hospitalization. J Card Fail. 2016; 22(8):S24.
[8] Packer M, et al. Angiotensin receptor neprilysin inhibition compared with
enalapril on the risk of clinical progression in surviving patients with heart
failure. Circulation. 2015; 131:54-61.

# # #

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/2149070/824684.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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