New analysis shows Novartis drug Gilenya® significantly reduced rate of brain volume loss across three large Phase III studies

New analysis shows Novartis drug Gilenya® significantly reduced rate of brain
               volume loss across three large Phase III studies

-- Data show reductions in 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 MS1

-- Gilenya is the first oral disease modifying treatment to show consistent
effect on brain volume loss, an important indicator of disease progression

-- Analysis of FREEDOMS II, a Phase III study, confirms Gilenya consistently
reduces annualized relapse rates across disease activity, gender, age and
prior treatment2

-- Safety profile of Gilenya reinforced in patients treated up to four years3;
more than 56,000 patients treated with Gilenya worldwide

PR Newswire

EAST HANOVER, N.J., March 21, 2013

EAST HANOVER, N.J., March 21, 2013 /PRNewswire/ -- New data presented at the
65th annual meeting of the American Academy of Neurology (AAN) show Gilenya^®
(fingolimod), the first oral disease modifying therapy approved to treat
relapsing forms of multiple sclerosis (MS), significantly and consistently
reduced the rate of brain volume loss. Results also showed that Gilenya
reduced annualized relapse rates across important subgroups; and additional
data reinforce Gilenya's safety profile in patients treated up to four years.

"Loss of brain volume is a consequence of multiple sclerosis and is a key MRI
correlate of disease progression," said Dr. Timothy Wright, Global Head
Development, Novartis Pharmaceuticals AG. "The findings reported show the
effect of Gilenya across a variety of important disease measures and support
evidence for initiating early use of this highly effective treatment in
patients with relapsing MS."

Data shows consistent reduction in rate of brain volume loss
In a new analysis of over 3,600 patients from three large Phase III studies
(TRANSFORMS, FREEDOMS, and FREEDOMS II) Gilenya showed a significant reduction
in the rate of brain volume loss vs. a comparator – consistent with previously
reported results.^1 In the TRANSFORMS study over one year, Gilenya reduced the
rate of brain volume loss by 32 percent (p<0.001) compared to Avonex^®
(interferon beta-1a IM), a commonly prescribed injectable treatment.^1 Over
two years, Gilenya reduced the rate of brain volume loss compared to placebo
by 35 percent (p<0.001) in the FREEDOMS study, and by 33 percent (p<0.001) in
the FREEDOMS II study, respectively.^1

The data also showed that brain volume, at baseline, consistently correlated
with the level of disease severity and disability.^1 Lower brain volume was
linked with more severe disease and disability, while higher brain volume
correlated with less severe levels. In addition, traditional markers of
disease activity (such as MRI lesion counts) at baseline were predictive of
the rate of brain volume loss over two years.^1

New results highlight consistent efficacy and long-term safety profile
Separately, a recent subgroup analysis (n=1083) of FREEDOMS II, the third
large Phase III Gilenya study, supports the known efficacy of Gilenya
treatment. Specifically, results show Gilenya consistently reduced annualized
relapse rates (ARR) compared to placebo in patients with relapsing-remitting
MS, across gender, age, prior treatment, and baseline disease activity.^2

New extension data from FREEDOMS II (n=632) reinforce the known safety profile
of Gilenya in patients treated up to four years.^3 More than eight out of ten
patients (83 percent) completed the extension study, which identified no
unexpected safety concerns.^3

Gilenya was approved based on the largest Phase III program in
relapsing-remitting MS at the time of submission. With up to seven years of
clinical trial experience (Phase II and III) and over two years of real-world
use, there is increasing experience of Gilenya's long-term effectiveness and
safety profile in more than 56,000 patients treated worldwide; this includes
clinical trial use and patients prescribed Gilenya.^4

About Gilenya
Gilenya is the first oral disease modifying therapy (DMT) approved to treat
relapsing forms of MS and the first in a class of compounds called sphingosine
1-phosphate receptor (S1PR) modulators. Gilenya is thought to act on
inflammatory processes implicated in the MS disease process although the exact
mechanism in MS is unknown.^5,6 In targeting the S1P receptor, initiation of
treatment with Gilenya is known to be associated with bradycardia (slowing of
the heart rate) and atrioventricular (AV) block (a problem with electrical
impulse conduction in the heart).^6

Gilenya is the only oral DMT for relapsing forms of MS with proven and
consistent efficacy across two pivotal trials, including a head-to-head study
(interferon beta-1a IM).^7,8 In a two-year study, Gilenya reduced annualized
relapses by 54 percent (p<0.001) when compared to placebo.^8 In addition,
Gilenya showed a 30 percent reduction in the risk of 3-month confirmed
disability progression (p=0.02, key secondary endpoint) compared to placebo.^8
However, in a separate one-year study, there was no significant risk reduction
of disability progression between Gilenya and Interferon beta-1a IM. Gilenya
reduced annualized relapse rate by 52 percent (p<0.001) compared to interferon
beta-1a IM in a one-year study. A two-year pivotal clinical trial has shown
that the majority of patients who start on Gilenya stay on therapy compared to
placebo (81.2 percent vs. 72.5 percent).^8 Gilenya is licensed from Mitsubishi
Tanabe Pharma Corporation.

Gilenya is a prescription medicine used to treat relapsing forms of multiple
sclerosis (MS) in adults. Gilenya can decrease the number of MS flare-ups
(relapses). Gilenya does not cure MS, but it can help slow down the physical
problems that MS causes.

Important Safety Information
You should not take Gilenya if in the last 6 months you experienced heart
attack, unstable angina, stroke or warning stroke, or certain types of heart
failure. Do not take Gilenya if you have an irregular or abnormal heartbeat
(arrhythmia) or if you take medicines that change your heart rhythm.

Gilenya may cause serious side effects such as:

  oSlow heart rate, especially after your first dose. A test to check the
    electrical activity of your heart (ECG) will be performed before and six
    hours after your first dose. Your pulse and blood pressure should be
    checked every hour while you stay in a medical facility during this time.
    If your heart rate slows down too much, you might feel dizzy or tired, or
    feel like your heart is beating slowly or skipping beats. Symptoms can
    happen up to 24 hours after your first dose. After 6 hours, if your ECG
    shows any heart problems or if your heart rate is still too low or
    continues to decrease, you will continue to be watched by a health care
    professional. If you have any serious side effects after your first dose,
    especially those that require treatment with other drugs, you will stay in
    a medical facility to be watched overnight and for at least 6 hours after
    your second dose of Gilenya the next day. If you experience slow heart
    rate, it will usually return to normal within 1 month. Call your doctor or
    go to the nearest emergency room right away if you have any symptoms of a
    slow heart rate. If you stop taking Gilenya for more than 14 days, you
    will need to repeat this observation.
  oIncreased risk of serious infections. Gilenya lowers the number of white
    blood cells (lymphocytes) in your blood. This will usually go back to
    normal within 2 months of stopping Gilenya. Your doctor may do a blood
    test before you start Gilenya. Increased risk of infection was seen with
    doses higher than the approved dose (0.5 mg). Two patients died who took
    higher-dose Gilenya (1.25 mg) combined with high-dose steroids. Call your
    doctor right away if you have fever, tiredness, body aches, chills,
    nausea, or vomiting.
  oMacular edema, a vision problem that can cause some of the same vision
    symptoms as an MS attack (optic neuritis), or no symptoms. Macular edema
    usually starts in the first 3 to 4 months after starting Gilenya. Your
    doctor should test your vision before you start Gilenya; 3 to 4 months
    after you start Gilenya; and any time you notice vision changes. Vision
    problems may continue after macular edema has gone away. Your risk of
    macular edema may be higher if you have diabetes or have had an
    inflammation of your eye (uveitis). Call your doctor right away if you
    have blurriness, shadows, or a blind spot in the center of your vision;
    sensitivity to light; or unusually colored vision.
  oBreathing problems. Some patients have shortness of breath. Call your
    doctor right away if you have trouble breathing.
  oLiver problems. Your doctor should do blood tests to check your liver
    before you start Gilenya. Call your doctor right away if you have nausea,
    vomiting, stomach pain, loss of appetite, tiredness, dark urine, or if
    your skin or the whites of your eyes turn yellow.
  oIncreases in blood pressure (BP). BP should be monitored during treatment.

Gilenya may harm your unborn baby. Talk to your doctor if you are pregnant or
planning to become pregnant. Women who can become pregnant should use
effective birth control while on Gilenya, and for at least 2 months after
stopping. If you become pregnant while taking Gilenya, or within 2 months
after stopping, tell your doctor right away. Women who take Gilenya should not
breastfeed, as it is not known if Gilenya passes into breast milk. A pregnancy
registry is available for women who become pregnant during Gilenya treatment.
Call 1-877-598-7237 or visit for more

Tell your doctor about all your medical conditions, including if you had or
now have an irregular or abnormal heartbeat; history of stroke or warning
stroke; heart problems; a history of fainting; a fever or infection, or if you
are unable to fight infections; eye problems; diabetes; breathing or liver
problems; or high blood pressure. Also tell your doctor if you have had
chicken pox or have received the vaccine for chicken pox. Your doctor may do a
test for the chicken pox virus, and you may need to get the vaccine for
chicken pox and wait 1 month before starting Gilenya.

Tell your doctor about all the medicines you take, including medicines for
heart problems or high blood pressure or other medicines that may lower your
heart rate or change your heart rhythm; medicines that could increase your
chance of infections, such as medicines to treat cancer or control your immune
system; or ketoconazole (an antifungal) by mouth. If taken with Gilenya,
serious side effects may occur. You should not get certain vaccines while
taking Gilenya, and for at least 2 months after stopping.

The most common side effects with Gilenya were headache, flu, diarrhea, back
pain, abnormal liver tests, and cough.

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit, or call 1-800-FDA-1088.

Please see full Prescribing Information for Gilenya:

The foregoing release contains forward-looking statements that can be
identified 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; unexpected
regulatory actions or delays or government regulation generally; competition
in general; 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, 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 Pharmaceuticals Corporation researches, develops, manufactures and
markets innovative prescription drugs used to treat a number of diseases and
conditions, including cardiovascular, dermatological, central nervous system,
bone disease, cancer, organ transplantation, psychiatry, infectious disease
and respiratory. The company's mission is to improve people's lives by
pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is
an affiliate of Novartis AG, which 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

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1.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.
2.Goodin D. et al. Fingolimod reduces annualized relapse rates in patients
    with relapsing-remitting multiple sclerosis: FREEDOMS II study subgroup
    analysis. Abstract Presented at AAN, San Diego, March 2013.
3.Vollmer T. et al. Long-term safety of fingolimod in patients with
    relapsing-remitting multiple sclerosis: Results from phase 3 FREEDOMS
    extension study. Abstract Presented at AAN, San Diego, March 2013.
4.Data on file. Novartis Pharmaceuticals Corporation East Hanover, NJ.
5.Brinkmann V. FTY720 (fingolimod) in multiple sclerosis: therapeutic
    effects in the immune and the central nervous system. Br J Pharmacol
6.Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in
    Multiple Sclerosis. Clin Neuropharmacol.
7.Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon in Relapsing
    Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010;362:402-415.
8.Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in Relapsing
    Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010; 362:387-401.

Avonex^® is a registered trademark of Biogen Idec.

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