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Novartis canakinumab (ACZ885) reduced cardiovascular risk by 25% in subgroup of CANTOS Phase III trial participants

Novartis International AG /
Novartis canakinumab (ACZ885) reduced cardiovascular risk by 25% in subgroup of
CANTOS Phase III trial participants
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.

* Subgroup of patients had a 25% reduction in major adverse cardiovascular
events when treated with canakinumab in a new analysis of Phase III CANTOS
trial presented at the American Heart Association Scientific Sessions

* The analysis showed a 31% reduction in cardiovascular death and a 31%
reduction in all-cause mortality in patients whose inflammation - as
measured by hsCRP - decreased below 2mg/L three months after initiating

* hsCRP (high-sensitivity C-reactive protein) is a simple, inexpensive and
widely available biomarker test for residual inflammatory risk[2]

* Results suggest that in the future, physicians may be able to identify
patients who can achieve the greatest cardiovascular benefit from long-term
canakinumab treatment

* Analysis showed that the estimated number of patients needed to treat (NNT)
for the subgroup was 16; the NNT for the CANTOS cohort as a whole was 24[1]

The digital press release with multimedia content can be accessed here:
Basel, November 13, 2017 - Novartis today announced results from a new analysis
of the Phase III CANTOS study presented by Dr. Paul Ridker at the American Heart
Association (AHA) Scientific Sessions 2017 and published simultaneously in The
Lancet[1]. The pre-planned secondary analysis of an exploratory endpoint showed
that people with a prior heart attack who achieved hsCRP levels below 2mg/L at
three months after the first dose of canakinumab had a 25% reduction in major
adverse cardiovascular events (MACE) versus placebo (HR(adj)=0.75, 95% CI
0.66-0.85, p<0.0001)[1]. These patients also had a significant reduction of 31%
in the rate of cardiovascular (CV) death (HR(adj)=0.69, 95% CI 0.56-0.85,
p=0.0004) and all-cause death (HR(adj)=0.69, 95% CI 0.58-0.81, p<0.0001)[1].
There was no significant reduction in these endpoints observed among those
treated with canakinumab who achieved hsCRP levels equal to or above 2mg/L[1].
This analysis indicates that on-treatment hsCRP testing may offer a quick and
reliable way to identify the patients most likely to achieve the greatest
benefits from long-term canakinumab treatment[1],[2]. It also demonstrates that
treating inflammation in addition to lowering cholesterol may significantly
reduce the risk of recurrent CV events[1].

"This CANTOS analysis suggests that the initial biologic response to canakinumab
may provide a simple method to identify which patients are most likely to obtain
long-term benefits," said Dr. Paul Ridker, MD, CANTOS Study Chairman and
Director of the Center for Cardiovascular Disease Prevention at Brigham and
Women's Hospital. "Importantly, these data also support the value of targeting
inflammation when treating patients who have had a heart attack in the past,
reinforcing that 'lower is better' when it comes to levels of inflammation."

"This outcome is an exciting new development in the field of personalized
cardiovascular medicine," said Vas Narasimhan, Global Head, Drug Development and
Chief Medical Officer, Novartis. "In addition to offering targeted
cardiovascular benefits for patients, personalized treatment approaches can also
be more cost-efficient for the overall healthcare system. We hope we can bring
this innovative treatment to patients in the near future."

The analysis also evaluated the number of patients needed to treat (NNT). NNT is
an epidemiological measure used to communicate the effectiveness of a health-
care intervention in which the lower the NNT, the more effective the
intervention. The estimated NNT of the subgroup of patients was 16, indicating
that 16 patients treated with canakinumab whose hsCRP values dropped below
2mg/L would need to be treated for five years to prevent one death, heart
attack, stroke or coronary revascularization[1]. The NNT for the CANTOS cohort
as a whole was 24[1].

Canakinumab has been shown to have major effects on inflammation, which is
associated with atherothrombosis, the main cause of acute coronary syndromes and
CV death[1],[3]. People with elevated inflammatory biomarkers, such as hsCRP
(high-sensitivity C-reactive protein), are at an increased risk of CV events[3].
The hsCRP test is a simple, inexpensive and widely available blood biomarker
test that may also be used for residual inflammatory risk[2]. This subgroup
analysis by Dr. Paul Ridker included patients whose level of hsCRP at three
months was 2mg/L or greater, as well as those whose level was less than 2mg/L,
which is a commonly used clinical cut point for hsCRP measuring residual
inflammatory risk[1],[4]. The analysis supports that patients who achieve an
hsCRP level of less than 2mg/L by the third month on treatment may receive the
greatest benefit from long-term treatment with canakinumab[1]. The safety
profile of canakinumab in the subgroup of patients whose hsCRP levels dropped
below 2mg/L was consistent with the overall study population. The overall rates
of adverse events (AEs), serious AEs, and discontinuations due to AEs in CANTOS
were similar to placebo across all canakinumab doses. There was no relationship
between on-treatment hsCRP levels and adverse events[1].

With more than 10,000 patients enrolled in the study over six years, CANTOS was
one of the largest and longest-running clinical trials in Novartis history. As
previously announced, initial data from the CANTOS study showed that quarterly
treatment with 150mg canakinumab resulted in a statistically significant 15%
reduction in MACE - a composite of CV death, non-fatal myocardial infarction,
and stroke - in people with a prior heart attack and inflammatory

Pending final regulatory discussions, Novartis plans to file CANTOS CV data for
regulatory approval in Q4 2017.

About CANTOS (NCT01327846)
The Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS)
(NCT01327846) is a randomized, double-blind, placebo-controlled, event-driven
Phase III study designed to evaluate the efficacy, safety and tolerability of
quarterly subcutaneous injections of canakinumab (also known as ACZ885) in
combination with standard of care in the prevention of recurrent cardiovascular
(CV) events among 10,061 people with a prior myocardial infarction (MI) and with
a high-sensitivity C-reactive protein (hsCRP) level of >=2mg/L. The study
evaluated three different doses of canakinumab vs placebo. The primary endpoint
of the study was time to first occurrence of major adverse CV events (MACE), a
composite of CV death, non-fatal MI, and non-fatal stroke. Initial results
showed that canakinumab met the primary endpoint and led to a statistically
significant 15% reduction in the risk of MACE, compared to placebo (p-value
0.021)[5]. This benefit was sustained throughout the duration of the study
(median follow up 3.7 years) and was largely consistent across key pre-specified
baseline subgroups[5]. Secondary endpoints included time to first occurrence of
the composite CV endpoint consisting of CV death, non-fatal MI, non-fatal stroke
and hospitalization for unstable angina requiring unplanned revascularization;
time to new onset type 2 diabetes among people with pre-diabetes at
randomization; time to occurrence of non-fatal MI, non-fatal stroke or all-cause
mortality; and time to all-cause mortality. The study ran for approximately six
years. The overall rates of adverse events (AEs), serious AEs, and
discontinuations due to AEs were similar to placebo across all canakinumab
doses. During the average follow-up time of 3.7 years, serious infections were
reported in 11.3% vs 10.2% and malignancies were reported in 6.4% vs 7.1% of
participants (canakinumab 150mg vs placebo, respectively)[5]. Fatal infections
were rare and occurred in about one per 1,000 patients on placebo[5].

In a pre-specified secondary analysis designed to address the relationship of
hsCRP reduction to event reduction in CANTOS the researchers evaluated the
effects of canakinumab on rates of MACE, CV mortality, and all-cause mortality
according to on-treatment levels of hsCRP. The researchers used multivariable
modeling to adjust for baseline factors associated with achieved hsCRP and
multiple sensitivity analyses to address the magnitude of residual confounding.

About heart attack and inflammatory atherosclerosis
Heart attack occurs in about 580,000 people every year in the five largest
European Union countries and 750,000 people in the United States alone[6],[7].
Despite optimal standard treatment, patients who have had a prior heart attack
live with a higher ongoing risk of secondary major adverse cardiovascular events
(MACE), a composite of cardiovascular (CV) death, non-fatal myocardial
infarction, and non-fatal stroke[7]. It has been shown that in about four in 10
people, this risk is directly related to the increased inflammation associated
with inflammatory atherosclerosis as measured by a high-sensitivity C-reactive
protein (hsCRP) biomarker level of >=2mg/L[8]. The recurrent MACE in people with
inflammatory atherosclerosis are associated with increased morbidity, mortality
and reduced quality of life and currently represent a major economic burden on
patients and healthcare systems around the world.

About ACZ885 (canakinumab)
Canakinumab (ACZ885) is a selective, high-affinity, fully human monoclonal
antibody that inhibits IL-1ß, a key cytokine in the inflammatory pathway known
to drive the continued progression of inflammatory atherosclerosis[9]-[13].
Canakinumab works by blocking the action of IL-1ß for a sustained period of
time, therefore inhibiting inflammation that is caused by its over-
production[14],[15]. Canakinumab is the first and only investigational treatment
which has shown that selectively targeting inflammation significantly reduces
cardiovascular risk.

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

Novartis is on Twitter. Sign up to follow @Novartis at
For Novartis multimedia content, please visit www.novartis.com/news/media-
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    [1]    Ridker PM, et al. Relationships of C-Reactive Protein Reduction to
Cardiovascular Event Reduction Following Treatment with Canakinumab:  Analyses
from the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS). The
Lancet. 2017.
    [2]    WebMD. Heart Disease and C_Reactive Protein (CRP) Testing. Available
at: http://www.webmd.com/heart-disease/guide/heart-disease-c-reactive-protein-
crp-testing#1. Last accessed: November 2017.
    [3]    Ridker PM. Testing the inflammatory hypothesis of atherothrombosis:
scientific rationale for the cardiovascular inflammation reduction trial (CIRT).
J Throm Haemost. 2009; 7(Suppl.1):332-9.
    [4]    Goff DC Jr, et al. ACC/AHA guideline on the assessment of
cardiovascular risk: a report of the American College of Cardiology/American
Heart Association Task Force on Practice Guidelines. Circulation. 2014; 129:S49-
    [5]    Ridker PM, et al. Anti-inflammatory Therapy with Canakinumab for
Atherosclerotic Disease. N Engl J Med. 2017. 377:119-1131.
    [6]    EU5 MI trend. Based on Eurostat discharge data. Novartis data on
    [7]    Benjamin E, et al. Heart Disease and Stroke Statistics-2017 Update: A
Report From the American Heart Association. Circulation. 2017; 135:e146-e603.
    [8]    Ridker PM. How Common Is Residual Inflammatory Risk? Circ Res.
2017; 120:617-619.
    [9]    Fearon WF, Fearon DT. Inflammation and cardiovascular disease: role
of the interleukin-1 receptor antagonist. Circulation. 2008; 117:2577-2579.
    [10]  Duewell P, et al. NLRP3 inflammasomes are required for atherogenesis
and activated by cholesterol crystals. Nature. 2010; 464(7293):1357-61.
    [11]  Rajamaki K, et al. Cholesterol Crystals Activate the NLRP3
Inflammasome in Human Macrophages: A Novel Link between Cholesterol Metabolism
and Inflammation. PLoS One. 2010; 5(7):e11765.
    [12]  Ridker PM, Luscher TF. Anti-inflammatory therapies for cardiovascular
disease. Eur Heart J. 2014; 35(27):1782-91.
    [13]  Ridker PM. From C-Reactive Protein to Interleukin-6 to Interleukin-1.
Circ Res. 2016; 118:145-156.
    [14]  Ridker PM, et al. Interleukin-1ß inhibition and the prevention of
recurrent cardiovascular events: rationale and design of the Canakinumab Anti-
inflammatory Thrombosis Outcomes Study (CANTOS). Am Heart J.
2011; 162(4):597-605.
    [15]  Ridker PM, et al. Effects of Interleukin-1ß Inhibition with
Canakinumab on Hemoglobin A1c, C-Reactive Protein, Interleukin-6 and Fibrinogen.
Circulation. 2012; 126(23):2739-48.

# # #

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):

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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