Novartis International AG : New analysis shows Novartis drug Gilenya® significantly reduced rate of brain volume loss across

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

Novartis International AG / New analysis shows Novartis drug Gilenya®
significantly reduced rate of brain volume loss across three large Phase III
studies . Processed and transmitted by Thomson Reuters ONE. The issuer is
solely responsible for the content of this announcement.

  *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 MS
  *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 treatment
  *Safety profile of Gilenya reinforced in patients treated up to four years;
    overall more than 56,000 patients treated with Gilenya worldwide

Basel, March 21,2013 - 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%  (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% (p<0.001) in the FREEDOMS study,  and by 33% (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. 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.

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%) 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 worldwide[4].

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 
modulators[5],[6].  Gilenya  is  thought  to  act  on  inflammatory  processes 
implicated in the MS disease process[5],[6].

Data has  shown significant  efficacy with  Gilenya in  reducing relapses  and 
significant slowing  of six-month  disability  progression sustained  at  four 
years[7]. Nearly half of Gilenya patients were disease-free after one year  of 
treatment[8] and  in the  pivotal FREEDOMS  study eight  out of  ten  patients 
remained on treatment at two years[9]. Gilenya is the only treatment shown  to 
consistently decrease  brain  volume  loss, the  best  characterized  magnetic 
resonance imaging (MRI) predictor of long-term disability.

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[10]. 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[11].

In clinical trials,  Gilenya was  generally well-tolerated  with a  manageable 
safety profile.  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[9],[10].  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[9],[10].

Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.


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 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

Novartis is on Twitter. Sign up to follow @Novartis at

[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] Novartis data on file.
[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. 2010 March-April;33(2):91-101.
[7] Kappos L. et al. Phase 3 FREEDOMS study extension: fingolimod (FTY720)
efficacy in patients with relapsing-remitting multiple sclerosis receiving
continuous or placebo-fingolimod switched therapy for up to 4 years. Poster
presented at: 28th Congress of the European Committee for Treatment and
Research in Multiple Sclerosis; October 10-13, 2012: Lyon, France. Poster
[8] Khatri B. et al. Fingolimod treatment increases the proportion of patients
who are free from disease activity in multiple sclerosis compared to
interferon beta-1a: results from a phase 3 active controlled study
(TRANSFORMS). Abstract presented at: 64th AAN Annual Meeting; April 21-28,
2012; New Orleans, LA. Abstract PD5:006.
[9] Kappos L. et al; for FREEDOMS Study Group. A placebo-controlled trial of
oral fingolimod in relapsing multiple sclerosis. N Engl J Med.
[10] 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):402-415.
[11] Havrdová E, et al. Clinical outcomes in subgroups of patients with highly
active 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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