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Breadth of data at ECTRIMS underpins Novartis' relentless commitment to decoding the science of multiple sclerosis (MS) and decreasing the patient burden

Novartis International AG /
Breadth of data at ECTRIMS underpins Novartis' relentless commitment to decoding
the science of multiple sclerosis (MS) and decreasing the patient burden
. Processed and transmitted by West Corporation.
The issuer is solely responsible for the content of this announcement.

* 33 abstracts from the leading MS portfolio include data for Gilenya®
(fingolimod), and investigational drugs siponimod (BAF312) and ofatumumab
(OMB157)

* New research will be presented on neurofilaments, a biomarker for MS that
can be detected in the blood and could reimagine the way treatments are
assessed in clinical trials

* MS portfolio underlines the company's drive to identify the right approach
for each patient, across all age groups and types of MS

Basel, October 10, 2018 - Novartis announced today it will present 33 scientific
abstracts at the 34th Congress of the European Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS) being held October 10-12, 2018 in
Berlin, Germany. The presentations highlight the company's efforts to advance
the understanding of MS and showcase its broad portfolio which addresses
different types of MS across patients of all ages.

The abstracts presented at ECTRIMS include studies on Gilenya® (fingolimod), a
leading oral disease modifying therapy and the only relapsing MS treatment
approved in the US for children 10 years of age through to adulthood. There will
also be data for the investigational treatment siponimod (BAF312), the first and
only oral drug to meaningfully delay disability progression in typical secondary
progressive MS (SPMS) patients; and ofatumumab (OMB157), the first self-
administered subcutaneous B-cell therapy for relapsing MS (RMS), which is
currently in Phase III development.

Novartis will also present new data on neurofilaments, protein fragments that
are found in the blood at elevated levels in MS patients when damage to neurons
occurs. Today, it is possible to measure neurofilaments in the blood and there
is growing evidence that demonstrates a strong correlation between their levels
and key measures of MS disease activity. Utilizing blood neurofilaments as an
easy-to-use biomarker for MS could transform clinical trials in the future and
allow for disease monitoring in real time in routine clinical practice. Novartis
is leading the field with 12 data analyses presented so far.

"At Novartis, we are working to ensure there is an effective treatment for every
MS patient, regardless of their age or level of disability progression," said
Danny Bar-Zohar, Global Head, Neuroscience Development for Novartis. "We are
committed to transform the lives of people living with MS and reimagining care
by relentlessly confronting the disease from all angles."

Highlights of the Novartis data include:
* New research shows neurofilaments are good predictors of long-term clinical
outcomes in MS: One study showed neurofilaments were effective in predicting
long-term disability progression in patients with RRMS.[1] In another, blood
neurofilament light chain predicted brain atrophy in patients with PPMS and
SPMS in placebo-controlled Phase III trials of fingolimod (INFORMS) and
siponimod (EXPAND) respectively.[2] A third study investigated the
predictive value of neurofilaments for disease activity and drug response in
pediatric MS patients, and the data suggest that they may be useful
biomarkers in this population.[3]

* Long-term safety of siponimod in SPMS: New data showed that longer-term
follow up treatment (up to six years) with siponimod 2 mg did not reveal any
increase in incidence rates of adverse events or new safety findings. These
results demonstrated siponimod could be a safe and effective treatment
option for typical SPMS patients.[4]

* Baseline characteristics of patients in the fully enrolled ASCLEPIOS program
with ofatumumab: Studies provide additional data on patients treated with
ofatumumab, the first fully human anti-CD20 monoclonal antibody with a
monthly self-administered subcutaneous dosing regimen tailored for MS. Two
parallel Phase III trials are currently being conducted to evaluate its
efficacy and safety versus teriflunomide in patients with relapsing multiple
sclerosis (RMS).

About Multiple Sclerosis
Multiple sclerosis (MS) affects approximately 2.3 million people worldwide. MS
is a chronic disorder of the central nervous system (CNS) that disrupts the
normal functioning of the brain, optic nerves and spinal cord through
inflammation and tissue loss.

The evolution of MS results in an increasing loss of both physical (e.g.
walking) and cognitive (e.g. memory) function. In adults, there are three types
of MS: relapsing-remitting MS, secondary progressive MS and primary progressive
MS. Approximately 85 percent of people with MS have relapsing-remitting MS,
where the immune system attacks healthy tissue. In children, RRMS accounts for
nearly all cases (approximately 98 percent).

About Novartis in Multiple Sclerosis
The Novartis multiple sclerosis portfolio includes Gilenya(®) (fingolimod, an
S1P modulator), which is indicated for relapsing forms of MS. In the United
States, Gilenya is the first disease-modifying therapy approved for the
treatment of children and adolescents 10 to less than 18 years of age with
relapsing forms of multiple sclerosis (RMS). In September 2018, the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) recommended approval of Gilenya for the treatment of children and
adolescents 10 to 17 years of age with relapsing remitting forms of multiple
sclerosis (RRMS). The European Commission will review the CHMP opinion and is
expected to deliver its final decision within three months.

Investigational compounds include siponimod (BAF312). Siponimod is an
investigational, selective modulator of specific subtypes of the sphingosine-1-
phosphate (S1P) receptor, and has the potential to delay progression and expand
possibilities for patients with typical SPMS. Novartis initiated the submission
of siponimod for US approval in SPMS in the first half of 2018, which was
followed by filing with the EMA in September 2018 for EU approval. The file has
been accepted by both agencies.

Our other investigational compound is ofatumumab (OMB157), a fully human
monoclonal antibody in development for relapsing MS. Ofatumumab targets CD20,
and is currently being investigated in two Phase III pivotal studies.

Extavia(®) (interferon beta-1b for subcutaneous injection) is approved in the US
for the treatment of relapsing forms of MS. In Europe, Extavia is approved to
treat people with relapsing-remitting MS, secondary progressive MS (SPMS) with
active disease and people who have had a single clinical event suggestive of
MS.

In the US, the Sandoz Division of Novartis markets Glatopa(®) (glatiramer
acetate injection) 20 mg/mL and 40 mg/mL, generic versions of Teva's
Copaxone(®).

*Copaxone(®) is a registered trademark of Teva Pharmaceutical Industries Ltd.

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 is reimagining medicine to improve and extend people's lives. As a
leading global medicines company, we use innovative science and digital
technologies to create transformative treatments in areas of great medical need.
In our quest to find new medicines, we consistently rank among the world's top
companies investing in research and development. Novartis products reach nearly
1 billion people globally and we are finding innovative ways to expand access to
our latest treatments. About 125,000 people of more than 140 nationalities work
at Novartis around the world. Find out more at 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] An Integral Measure of Serial Neurofilament Light Chain Assessments in Blood
is a Predictor of Long-Term Disability Progression in Relapsing-Remitting
Multiple Sclerosis. J. Kuhle et. al.
[2] Neurofilament Light Levels in the Blood of Patients with Secondary
Progressive MS are higher than in Primary Progressive MS and may Predict Brain
Atrophy in both MS Subtypes. J. Kuhle, et. al.
[3] Neurofilament Light Chain is a Useful Biomarker in Paediatric Multiple
Sclerosis. M. C. Reinert, et. al.
[4] Longer-Term Safety with Siponimod Treatment in Multiple Sclerosis: Pooled
Analysis of Data from the BOLD and EXPAND Trials and their Extensions, L.
Kappos, et. al

# # #

Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com

Eric Althoff Angela Fiorin
Novartis Global Media Relations Novartis Global Pharma Communications
+41 61 324 7999 (direct) +41 61 324 8631 (direct)
+41 79 593 4202 (mobile) +41 79 752 6955 (mobile)
eric.althoff@novartis.com angela.fiorin@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/2219903/868464.pdf



This announcement is distributed by West Corporation on behalf of West Corporation 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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