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Novartis announces new data from the first direct head-to-head trial to demonstrate superior efficacy of Gilenya® over Copaxone® in patients with relapsing remitting multiple sclerosis

Novartis International AG /
Novartis announces new data from the first direct head-to-head trial to
demonstrate superior efficacy of Gilenya® over Copaxone® in patients with
relapsing remitting multiple sclerosis
. Processed and transmitted by West Corporation.
The issuer is solely responsible for the content of this announcement.

* Topline findings from ASSESS show adult relapsing remitting multiple
sclerosis (RRMS) patients taking Gilenya (fingolimod) 0.5mg experienced
significantly fewer relapses than patients on Copaxone (glatiramer acetate)
20mg

* Gilenya 0.5mg is the first and only disease modifying therapy to show
superiority in reducing relapses vs Copaxone in a controlled, head-to-head
trial

* Treatment discontinuations were overall more common in the Copaxone group
due to adverse events and unsatisfactory therapeutic effects

Basel, October 10, 2018 - Novartis announced today topline results from the
Phase IIIb ASSESS study, which evaluated the efficacy and safety of oral, once
daily Gilenya (fingolimod) 0.5mg and 0.25mg versus once daily subcutaneous
injections of Copaxone (glatiramer acetate) 20mg in patients with relapsing
remitting multiple sclerosis (RRMS). The data show that Gilenya 0.5mg met its
primary endpoint of significantly reducing the annualized relapse rate (ARR)
compared to Copaxone[1]. Treatment with Gilenya 0.5mg resulted in a 40.7%
relative reduction in the rate of relapses over a period of one year, compared
to Copaxone (ARR estimates of 0.153 vs. 0.258, respectively, p= 0.0138)[1].
Further initial findings showed adults taking Gilenya 0.25mg achieved a
numerical risk reduction in relapses compared to the comparator, but did not
reach statistical significance. The safety of Gilenya observed in ASSESS across
both doses was consistent with the known safety profile of the drug, with
overall more discontinuations due to adverse events and unsatisfactory treatment
effects reported in the Copaxone group[1].

"ASSESS is the first controlled head-to-head study of a MS disease modifying
therapy versus Copaxone to show superior efficacy in reducing relapses, a key
measure of disease activity and a significant burden for patients," said Bruce
Cree, MD, PhD, MAS, George A. Zimmermann Endowed Professor in Multiple
Sclerosis at the University of California San Francisco, and ASSESS Principal
Study Investigator. "Head-to-head trials, such as ASSESS, are extremely
important to help clinicians better understand the relative efficacy and safety
of MS therapies, thereby making better-informed treatment decisions."

"Gilenya reimagined MS care as the first oral treatment and is a testament to
Novartis' quest to stop MS," said Danny Bar-Zohar, Global Head of Neuroscience
Development, Novartis Pharmaceuticals. "The ASSESS data add to the robust body
of evidence which show that Gilenya is a highly efficacious, cornerstone therapy
in relapsing MS."

Gilenya 0.5mg is a leading oral disease-modifying therapy, that has demonstrated
high efficacy across multiple measures of disease activity in patients 10 years
of age and through to adulthood. To date, Gilenya 0.5mg has been used to treat
more than 255,000 patients worldwide[1]. Long-term experience has shown Gilenya
treatment to be convenient for people to incorporate into everyday life, leading
to high treatment satisfaction, long-term persistence, and ultimately, improved
long-term outcomes[2],[3]. Gilenya 0.25mg is not approved for adults with RRMS.

Novartis will complete full analyses of the ASSESS data and intends to submit
the full results to upcoming medical meetings and for peer-reviewed publication.

About the ASSESS Study
The ASSESS study (NCT01633112) is a Phase IIIb randomized, rater- and dose-
blinded study to compare the safety and efficacy of Gilenya (fingolimod) 0.25mg
and 0.5mg administered orally once-daily, with Copaxone (glatiramer acetate)
20mg administered via subcutaneous injections once-daily, in patients with RRMS
over the course of one year.

Novartis initiated the ASSESS study in 2012 as part of a post-approval
commitment to the US FDA. In agreement with the FDA, a total of 1,064 patients
were enrolled into ASSESS, with 352, 370 and 342 patients randomized in Gilenya
0.5mg, Gilenya 0.25mg and Copaxone 20mg arms respectively.

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 nerves and spinal
cord through inflammation and tissue loss[4]. In adults, there are three main
types of MS: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and
primary progressive MS (PPMS)[5]. Approximately 85% of people with MS have
relapsing-remitting MS, where the immune system attacks healthy tissue[6]. In
children, RRMS account for nearly all cases (approximately 98%)[7].

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]  Novartis Data on File
[2]  Warrender-Sparkes M et al. The effect of oral immunomodulatory therapy on
treatment uptake and persistence in multiple sclerosis. Mult Scler.
2016;22(4):520-532.
[3]  Khatri B et al. Comparison of fingolimod with interferon beta-1a in
relapsing-remitting multiple sclerosis: a randomised extension of the TRANSFORMS
study. Lancet Neurol. 2011;10(6):520-529.
[4]  PubMed Health. Multiple sclerosis
(MS). https://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0024311/. Accessed October
2018.
[5]  Multiple sclerosis international federation. Types of
MS. https://www.msif.org/about-ms/types-of-ms/. Accessed October 2018.
[6]  Multiple sclerosis international federation. Atlas of MS
2013. http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf. Accessed
October 2018.
[7]  Waldman A et al. Pediatric multiple sclerosis. Neurology. 2016;87 (9):74-
81.

# # #

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/2220124/868583.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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