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MEDIA RELEASE COMMUNIQUE AUX MEDIAS MEDIENMITTEILUNG

Novartis confirms growing Gilenya

clinical and real-world experience

as number of patients treated increases to over 63,000

Growing global evidence base reinforces consistent and sustained efficacy of first
once-daily oral multiple sclerosis treatment

Up to seven years of clinical trial experience (Phase II and III) and over two years of
real-world use

Gilenya is the only approved MS treatment shown to consistently decrease brain
volume loss across studies with a significant effect seen as early as six months

Low rate of brain volume loss with Gilenya sustained for up to four years in Phase III
studies and for up to seven years in patients after completing a Phase II study

Basel, March 26, 2013 Latest global patient-use data show that Gilenya

(fingolimod)
has been used to treat more than 63,000 patients in clinical trials and the post-marketing
setting
1
.

"As the first once-daily oral MS therapy, we are pleased Gilenya has played such an
important role in addressing unmet medical need in the MS community in the two years
following initial approvals, said David Epstein, Head of the Pharmaceuticals Division of
Novartis Pharma AG. Our growing experience reinforces Gilenyas high efficacy and
very good tolerability profile and Novartis remains committed to ensuring eligible patients
have access to Gilenya.

Gilenya is the only approved treatment shown to consistently decrease brain volume
loss
2,3
. Brain volume loss is the best magnetic resonance imaging (MRI) correlate of
long-term disability. New data presented at the recent 65th Annual Meeting American
Academy of Neurology (AAN), showed that Gilenya reduced the rate of brain volume loss
by about one-third compared to interferon beta-1a IM or placebo in studies with over
3,600 patients with relapsing MS.
4
Patients from a Phase II study who remained on
treatment for up to seven years experienced consistently low rates of brain volume loss
5
.

Data has also shown significant efficacy with Gilenya in reducing relapses and slowing of
six-month disability progression sustained at four years
6
. Nearly half of Gilenya patients
were disease-free after one year of treatment
7,8
and in the pivotal FREEDOMS study,
eight out of ten patients on the approved dose remained on treatment at two years
2
.

In clinical trials Gilenya exhibited a well-characterized safety profile and very good
tolerability profile
2,3
.

Gilenya was approved based on the largest phase III clinical trial program in MS at the
time of submission, which included a head-to-head study versus Avonex (interferon
beta-1a IM), a commonly prescribed treatment. Gilenya is now approved in 70 countries,
and there is approximately 73,000 patient years of exposure
1
.


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Up to 2.5 million people worldwide are affected with MS
9
, a neurodegenerative condition
that often begins in early adulthood
10
. Around 70% of newly diagnosed patients with MS
are in the prime of their lives - between 20 and 40 years of age - so most people are
employed at the time of diagnosis. This can have a significant impact on careers, quality
of life and families
11,12
.

About Gilenya
Gilenya is the first oral therapy approved to treat relapsing forms of MS and the first in a
new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators.
Gilenya is thought to act on inflammatory processes implicated in the MS disease
process
13,14
.

Gilenya has demonstrated superior efficacy compared to Avonex (interferon beta-1a
IM), a commonly prescribed treatment, showing a 52% relative reduction in annualized
relapse rate (primary endpoint) at one year in a pivotal head-to-head trial in patients with
relapsing-remitting multiple sclerosis
3
. In a post hoc sub-group analysis, Gilenya showed
a 61% relative reduction in annualized relapse rate compared to interferon-beta-1a IM at
one year in subgroups of patients with highly active relapsing-remitting MS not
responding to interferon treatment
15
.

In clinical trials Gilenya exhibited a well-characterized safety profile and very good
tolerability profile
2,3
. The most common side effects were headache, liver enzyme
elevations, influenza, diarrhea, back pain, and cough. Other Gilenya-related side effects
included transient, generally asymptomatic, heart rate reduction and atrioventricular
block upon treatment initiation, mild blood pressure increase, macular edema, and mild
bronchoconstriction
2,3
. The rates of infections overall, including serious infections, were
comparable among treatment groups, although a slight increase in lower respiratory tract
infections (primarily bronchitis) was seen in patients treated with Gilenya. The number of
malignancies reported across the clinical trial program was small, with comparable rates
between the Gilenya and control groups
2,3
.

Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by
terminology such as "committed," or similar expressions, or by express or implied
discussions regarding potential new indications or labeling for Gilenya or regarding
potential future revenues from Gilenya. You should not place undue reliance on these
statements. Such forward-looking statements reflect the current views of management
regarding future events, and involve known and unknown risks, uncertainties and other
factors that may cause actual results with Gilenya to be materially different from any
future results, performance or achievements expressed or implied by such 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 Gilenya will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Gilenya could be affected by, among
other things, unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; competition in general, including
potential competition from additional newly-approved oral multiple sclerosis treatments;
unexpected regulatory actions or delays or government regulation generally;
government, industry and general public pricing pressures; unexpected manufacturing
issues; the company's ability to obtain or maintain patent or other proprietary intellectual
property protection; the impact that the foregoing factors could have on the values
attributed to the Novartis Group's assets and liabilities as recorded in the Group's
consolidated balance sheet, and other risks and factors referred to in Novartis AG's
current Form 20-F on file with the US Securities and Exchange Commission. Should one
or more of these risks or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those anticipated, believed,

3/4
estimated or expected. 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, eye care, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal
health products. Novartis is the only global company with leading positions in these
areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout
the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding
impairment and amortization charges). Novartis Group companies employ approximately
128,000 full-time-equivalent associates and operate in more than 140 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.

References:
1. Data on file. Novartis Pharma AG.
2. Kappos L. et al; for FREEDOMS Study Group. A placebocontrolled trial of oral fingolimod in relapsing
multiple sclerosis. N Engl J Med. 2010;362(5):387401.
3. Cohen JA, Barkhof F, Comi G, et al; for TRANSFORMS Study Group. Oral fingolimod or intramuscular
interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):402415
4. Cohen J. et al. Fingolimod-effect on brain atrophy and clinical/MRI correlations in Three Phase 3 studies
TRANSFORMS, FREEDOMS and FREEDOMS II. Abstract Presented at AAN, San Diego, March
2013.
5. Chin PS, Calabresi PA, Zhang Y, von Rosenstiel P, Kappos L. Early effect of fingolimod on clinical and
MRI related outcomes in relapsing multiple sclerosis. Poster presented at: 28th Congress of the
European Committee for Treatment and Research in Multiple Sclerosis; October 10-13, 2012: Lyon,
France. Abstract P459
6. Kappos L. et al. Phase 3 FREEDOMS study extension: fingolimod (FTY720) efficacy in patients with
relapsingremitting multiple sclerosis receiving continuous or placebofingolimod switched therapy for up
to 4 years. Poster presented at: 28th Congress of the European Committee for Treatment and Research
in Multiple Sclerosis; October 1013, 2012: Lyon, France. Poster P979.
7. Khatri B. et al. Fingolimod treatment increases the proportion of patients who are free from disease
activity in multiple sclerosis compared to interferon beta1a: results from a phase 3 activecontrolled
study (TRANSFORMS). Abstract presented at: 64th AAN Annual Meeting; April 2128, 2012; New
Orleans, LA. Abstract PD5:006.
8. Khatri B. et al. Fingolimod treatment increases the proportion of patients who are free from disease
activity in multiple sclerosis compared to interferon beta1a: results from a phase 3 activecontrolled
study (TRANSFORMS). Poster presented at: 64th AAN Annual Meeting; April 2128, 2012; New
Orleans, LA. Poster PD5:006.
9. Multiple Sclerosis International Federation. Atlas of MS [online]. Available at: www.atlasofms.org.
Accessed January 2013.
10. Declaration of the European Parliament of 13 September 2012 on tackling multiple sclerosis in Europe
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2012-
0357&format=XML&language=EN. Accessed January 2013.
11. European Multiple Sclerosis Platform, MS fact sheet 2011 http://www.ms-in-europe.org/multiple-
sclerosis/index.php?kategorie=whatisms&cnr=6&anr=127. Accessed January 2013.
12. Multiple Sclerosis Factsheet http://www.emsp.org/ms-need/content/factsheet.pdf Accessed January
2013.
13. Brinkmann V. FTY720 (fingolimod) in multiple sclerosis: therapeutic effects in the immune and the
central nervous system. Br J Pharmacol 2009;158(5):1173-1182.
14. Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in Multiple Sclerosis. Clin
Neuropharmacol. 2010 Mar-Apr;33(2):91-101.
15. Havrdov E. et al. Clinical outcomes in subgroups of patients with highly action relapsing-remitting
multiple sclerosis treated with Fingolimod (FTY720): Results from the FREEDOMS and TRANSFORMS
phase III studies. Poster presented at ECTRIMS, Amsterdam, October 2011.

Avonex is a registered trademark of Biogen Idec.

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