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2014-04-23

Novartis International AG: New data at AAN to confirm efficacy of Novartis' Gilenya® across four key measures of MS disease activity, including brain volume l

Novartis International AG / New data at AAN to confirm efficacy of Novartis'
Gilenya® across four keymeasures of MS disease activity, including brain
volume loss . Processed and transmitted by NASDAQ OMX Corporate Solutions.The
issuer is solely responsible for the content of this announcement.
* Gilenya reduced relapse rates, new MRI lesion counts, brain volume loss and
disability progression in previously-treated MS patients with high disease
activity

* Data at AAN showed significantly more Gilenya-treated patients (vs.
patients on placebo) had brain volume loss rates comparable to people
without MS

* Generation of scientifically meaningful data, highlighted by 38 abstracts
at AAN, is central to Novartis' commitment to address the unmet needs of MS
community

Basel, April 23, 2014
-
New analyses of pooled data from the FREEDOMS and FREEDOMS II trials will be
presented at the 66thAmerican Academy of Neurology (AAN) Annual Meeting in
Philadelphia, Pennsylvania[1], and will show the consistent efficacy of
Gilenya®(fingolimod) on four key measures of multiple sclerosis (MS) disease
activity - reducing relapses, new MRI lesion counts, brain volume loss and
disability progression.

Demonstrating benefit on these four measures is important in order to improve
the course of MS and ultimately address the loss of function (e.g. problems
walking or difficulty with mental tasks) experienced by patients with MS. An
additional analysis of FREEDOMS and FREEDOMS II will show that significantly
more Gilenya-treated patients (vs. patients on placebo) had brain volume loss
rates comparable to people without MS[2]. Given that brain volume loss,
measured by Magnetic Resonance Imaging (MRI), starts early in the disease
course and is correlated with long-term disability (both physical and
cognitive)[3]-[8], a treatment benefit on this measure will be important for
patients with MS.

"These new analyses provide further evidence of how Gilenya impacts four key
measures of MS disease activity," said David Epstein, Division Head, Novartis
Pharmaceuticals. "Additionally, new data reinforcing Gilenya's positive
effect on brain volume loss are of significant interest to the MS community.
People with MS lose brain volume up to three to five times faster than people
without MS and these data will highlight the importance of a treatment that
can minimize brain volume loss in patients."

Novartis is also presenting trial design information on PARADIGMS, the first
controlled clinical trial investigating a disease-modifying therapy (DMT) in
pediatric MS patients[9]. In collaboration with regulatory agencies and
international leaders in pediatric MS, Novartis has developed the PARADIGMS
study to evaluate the efficacy and safety of fingolimod versus an injectable
interferon beta 1-a treatment in pediatric patients treated for 24 months[9].
Pediatric MS is uncommon, given that only 3-5% of all MS cases start in this
age range[10]-[14]. There are currently no approved treatments for pediatric
MS, and no controlled studies of MS therapies have been conducted in this
population.

Novartis MS portfolio highlights at AAN include:

Gilenya®(fingolimod) in relapsing-remitting MS

* Proportion of patients with brain volume loss comparable to healthy adults
in fingolimod phase 3 multiple sclerosis studies - Platform presentation
S13.006, De Stefano: April 29, 14:15 EST
* Efficacy of fingolimod in pre-treated patients with disease activity:
pooled analyses of FREEDOMS and FREEDOMS II - Poster P3.174, Bergvall:
April 29, 15:00 EST
* Consistent reduction in the annualized rate of brain volume loss across
phase 3 core and extension trials of fingolimod in relapsing multiple
sclerosis - Poster P3.180, Radue: April 29, 15:00 EST
* Efficacy benefits of fingolimod 0.5 mg once daily in patients previously
treated with glatiramer acetate: pooled analysis of the phase 3,
placebo-controlled FREEDOMS and FREEDOMS II studies in relapsing multiple
sclerosis - Poster P3.193, Jeffrey: April 29, 15:00 EST
* Four-year Expanded Disability Status Scale (EDSS) outcomes in patients
treated with fingolimod in the phase 3 and extension trial program - Poster
P3.185, Cree: April 29, 15:00 EST
* Long-term safety of fingolimod: interim evaluation of data from the
LONGTERMS trial - Poster P2.210, Cohen: April 29, 07:30 EST
* Relapse rates among patients with multiple sclerosis who switch from
interferon therapy to fingolimod or glatiramer acetate: a retrospective US
claims database analysis - Poster P7.211, Lahoz: May 1, 15:00 EST

Fingolimod in pediatric MS

* Fingolimod in pediatric MS: design of a double-blind study versus
interferon beta-1a IM (PARADIGMS) - Poster P2.238, Chitnis: April 29, 07:30
EST

BAF312 (siponimod) in relapsing-remitting MS

* Safety and efficacy of siponimod (BAF312) in patients with
relapsing-remitting multiple sclerosis: Results from dose-blinded extension
phase of BOLD study - Poster P3.151, Kappos: April 29, 15:00 EST

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic disorder of the central nervous system
(CNS) that disrupts the normal functioning of the brain, optic nerve and
spinal cord[15]. The evolution of MS results in an increasing loss of both
physical (e.g. difficulty with walking) and cognitive (e.g. problems with
mental tasks or memory) function[16]. This has a substantial negative impact
on the approximately 2.3 million people worldwide affected by MS[17], a
disease that begins in early adulthood, most often between the ages of 20 and
40[18].

The loss of physical and cognitive function is driven by two main types of
damage that both contribute to widespread loss of neurons (nerve cells in the
brain and spinal cord that transmit impulses): discrete inflammatory lesions,
focal damage, in the brain that can clinically manifest as relapses; and
ongoing, more diffuse damage that starts early in the disease and causes the
progressive loss of brain tissue, including neurons, and over time is
associated with both physical and cognitive problems[19]-[21].

About Gilenya
Gilenya is the only oral disease modifying therapy (DMT) that works on four
key measures of multiple sclerosis (MS) disease activity - relapses, MRI
lesions, brain volume loss and disability progression[22]-[26].

Gilenya reduces both the distinct inflammatory lesions in the brain (focal
damage) that can clinically manifest as relapses, and the ongoing, underlying
damage in the brain (diffuse damage) that starts early in the
disease[19]-[21],[27]-[29]. Diffuse damage often goes unnoticed, causes the
loss of neurons and over time is associated with both physical and cognitive
problems[19]-[21]. Gilenya's reduction of both focal damage and diffuse
damage is due to its impact on the inflammatory process (peripheral action)
and its ability to enter the CNS and impact from within the CNS (central
action)[27]-[29]. It is by addressing both focal and diffuse damage that the
course of MS can be effectively impacted, helping to preserve a patient's
physical (e.g. difficulty with walking) and cognitive (e.g. problems with
mental tasks or memory) function.

To date, more than 91,500 patients worldwide have been treated with Gilenya in
both clinical trial and post-marketing settings[29].

About Novartis in Multiple Sclerosis
Novartis is committed to the research and development of new treatment options
to offer the right treatment to the right patient at the right time, to meet
patients' needs at every stage of disease with innovative and targeted drugs.

In addition to its ongoing development program for Gilenya in primary
progressive MS (PPMS), pediatric MS and chronic inflammatory demyelinating
polyneuropathy (CIPD), the Novartis MS portfolio includes Extavia®(interferon
beta-1b for subcutaneous injection). Investigational compounds include BAF312
(siponimod), currently in Phase III clinical development and being developed
as the first oral therapy for secondary progressive MS (SPMS), and VAY736, an
anti-B-cell compound for MS that is currently being investigated in proof of
concept studies. Novartis is also exploring the IL-17 pathway in MS.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "to confirm," "will," "commitment," "can," "is
also presenting," "committed," "ongoing," "investigational," "being
developed," "being investigated," "exploring," or similar terms, or by
express or implied discussions regarding potential future indications or
labeling for Gilenya, potential future marketing submissions or approvals for
the other investigational compounds in the Novartis MS portfolio, or
regarding potential future revenues from any or all of the products and
investigational compounds in the Novartis MS portfolio, including Gilenya.
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 Gilenya 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 any of the investigational compounds in
the Novartis MS portfolio will be submitted or approved for sale in any
market, or at any particular time. Neither can there be any guarantee that
any of the products and investigational compounds in the Novartis MS
portfolio will be commercially successful in the future. In particular,
management's expectations regarding these products 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; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry conditions;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected 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 ...

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