New Data Presented at American Academy of Neurology (AAN) Annual Meeting Show Additional Patient Benefits for Daily Multiple Sclerosis Pill Fingolimod

By Novartis Uk Ltd., PRNE
Monday, April 12, 2010

FRIMLEY, England, April 13, 2010 - Developed for UK consumer and medical journalists

Not intended for media in Republic of Ireland

New Data Presented at the AAN Show That Treatment With Fingolimod:

    - Improves Self-Reported Ability to Perform Daily Activities for People
      With Multiple Sclerosis (MS)

    - Reduces Severity of Relapses, as Compared to Interferon Beta -1a, With
      Significantly Less Need for Steroid Intervention and Hospitalisation

    - Benefits Patients Switched From Interferon Beta -1a to Fingolimod, With
      Significantly Reduced Relapse Rates and Improved Brain Lesion Measures

    - Reduces Relapses by 62% in Newly Treated Patients

The recent publication of two pivotal studies (FREEDOMS and
TRANSFORMS) in the New England Journal of Medicine (NEJM) confirmed that
daily multiple sclerosis pill, fingolimod, was twice as effective as a
commonly used injection (interferon Beta -1a) and placebo for the treatment
of relapsing-remitting multiple sclerosis (RRMS) - the most common form of
the disease.(1,2,3) New data presented this week at the 62nd annual meeting
of the American Academy of Neurology (AAN) adds to the growing body of
evidence to support fingolimod, showing additional benefits for patients.

New data from a sub-analyses of the TRANSFORMS study demonstrated that
patients treated with fingolimod for 12 months experienced significantly less
deterioration in their ability to perform daily activities compared with
patients taking interferon Beta -1a, thus helping to maintain the
independence of people with MS.(4) At month 12, 17.5 - 19.6% of
fingolimod-treated patients experienced improvements in PRIMUS-Activities
scores from baseline vs. 14.1% of interferon Beta -1a-treated patients.(4)
The PRIMUS-Activities Scale, a patient-reported outcome measure of activity
limitation, was used to detect changes in the daily functioning of
patients.(4)

A further sub-analyses from the TRANSFORMS study showed that patients
taking fingolimod 0.5 mg had a 71% reduction in relapses resulting in
hospitalisation and a 52% reduction in relapses requiring steroid treatment
compared with patients taking interferon Beta -1a, suggesting a better
outcome for patients and a reduced burden on hospital resources.(5)

Data presented from the one year extension study for TRANSFORMS confirmed
the efficacy of fingolimod in reducing relapses and MRI brain lesions.(6) Of
the 1,153 patients who participated in the original one-year study, 1,027
(89%) elected to enter the one-year extension study.(6) Patients who received
fingolimod in the original study remained on their original dose (0.5 mg or
1.25 mg) and patients who had received interferon Beta -1a were randomised to
receive fingolimod 0.5 mg or 1.25 mg.(6) Patients who received fingolimod 0.5
mg for the full two years of the study experienced a consistently low
annualised relapse rate (ARR) in year one (0.16) and year two (0.18).(6)

In the subset of 167 patients who received interferon Beta -1a during the
first year and fingolimod 0.5 mg during the second year, the annualised
relapse rate was reduced by 31%.(6) The number of new or newly enlarged T2
lesions in the brain, a marker of disease activity, was reduced by 67% after
switching to fingolimod.(6) In addition, the percentage of patients free from
lesions was significantly higher after switching to fingolimod.(6)

These findings on efficacy are consistent with those of the original
one-year core TRANSFORMS study, in which fingolimod significantly reduced
annualised relapse rates by 52% (0.5 mg dose) vs. interferon Beta -1a.(1)

In addition, data presented from a sub analyses of the two-year FREEDOMS
study showed that fingolimod 0.5 mg reduced the annualised relapse rate (ARR)
by 62% for newly treated patients compared to placebo.(7) For patients who
had previously received other treatments, the annual relapse rates were
reduced by 44%. This new data confirms the effectiveness of fingolimod
regardless of treatment history.(7)

In addition to the data presented at the AAN for fingolimod, Novartis is
investing in the research and development of an innovative pipeline of MS
products:

    -	BAF312 - a second generation S1-P modulator currently in Phase II
      clinical trials
    -	PI-2301 - a second generation peptide copolymer from a similar compound
      class as Copaxone(R)
    -	KRP203 - an S1-P modulator with a differentiated S1-P receptor profile.

Notes to editors: Fingolimod safety information Fingolimod has a
well-studied safety profile, with over 5,300 patient years of exposure.(8)
The fingolimod MS study programme includes more than 4,000 patient years of
exposure, with some patients in the sixth year of therapy, making it the
largest Phase III clinical trial programme ever conducted in MS.(8) This
robust clinical trial programme strengthens the potential for fingolimod to
be the first approved product in a new therapeutic class called S1P receptor
modulators.(9)

In TRANSFORMS and FREEDOMS overall, the most commonly reported adverse
events for both fingolimod and control groups were nasopharyngitis, headache
and fatigue.(1,2)Fingolimod-related adverse events included dose-related,
transient, generally asymptomatic heart rate reduction, infrequent transient
AV conduction block, mild (1-3 mm Hg) blood pressure increase, macular edema
(more common with 1.25 mg than the 0.5 mg target dose), and asymptomatic,
reversible elevation of liver enzymes.(1,2)

The rates of infections overall, including serious infections, were
comparable between treatment groups, although a slight increase in lung
infections (primarily bronchitis) was seen in patients treated with
fingolimod.(1,2) The number of malignancies reported in the two studies was
small with comparable rates between the fingolimod and control groups;
malignancies were reported more frequently with fingolimod than the control
group in the one-year TRANSFORMS study but the opposite pattern was seen in
the two-year FREEDOMS study.(1,2)

Extensive clinical trial efficacy and safety data provide evidence of a
positive benefit-risk profile for the 0.5 mg dose of fingolimod.(4)
Fingolimod was submitted for marketing approval in Europe at the end of 2009.

Novartis in MS: Novartis has been highly active in neuroscience for more
than 50 years, having developed treatments for conditions including epilepsy,
ADHD, Alzheimer's disease and schizophrenia. Novartis continues to be active
in the research and development of new compounds, is committed to addressing
unmet medical needs and to supporting patients and their families affected by
MS.

Disclaimer: The foregoing release contains forward-looking statements
that can be identified by terminology such as "planned," "future," "to focus
on," "will," "potential," "potentially," or similar expressions, or by
express or implied discussions regarding potential future regulatory
submissions or approvals for fingolimod or regarding potential future
revenues from fingolimod. 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 fingolimod
to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that fingolimod will be submitted or approved for sale in any
market. Nor can there be any guarantee that fingolimod will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding fingolimod 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; the company's ability to obtain or maintain patent or other
proprietary intellectual property protection; government, industry and
general public pricing pressures; 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 materialise, 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 healthcare solutions that address the
evolving needs of patients and societies. Focused solely on healthcare,
Novartis offers a diversified portfolio to best meet these needs: innovative
medicines, cost-saving generic pharmaceuticals, preventive vaccines,
diagnostic tools and consumer health products. Novartis is the only company
with leading positions in these areas. In 2009, the Group's continuing
operations achieved net sales of USD 44.3 billion, while approximately USD
7.5 billion
was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 100,000 full-time-equivalent associates and operate in more
than 140 countries around the world. For more information, please visit
www.novartis.com.

Please note that fingolimod (FTY720) is an investigational drug and has
not been approved or licensed anywhere in the world (April 2010)

References Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon
in Relapsing Multiple Sclerosis. N Eng J Med 2010, 362 (5) 402-415. Kappos L,
et al. Placebo-Controlled Study of Oral Fingolimod in Relapsing Multiple
Sclerosis. N Eng J Med 2010, 362 (5) 387-401.
www.mstrust.org.uk/information/aboutms/types.jsp. Last accessed 9
April 2010
. Cohen J et al. Oral Fingolimod (FTY720) Treatment Improves the
Performance of Daily Activities Compared with Intramuscular Interferon -1a:
Patient-Reported Indices for Multiple Sclerosis (PRIMUS ) - Activities
Results from a Phase III Study (TRANSFORMS). Poster presented at AAN,
Toronto, April 2010. Khatri B et al. Oral Fingolimod (FTY720) Reduces the
Rate of Relapses that Require Steroid Intervention or Hospitalization
Compared with Intramuscular Interferon β-1a: Results from a Phase III study
(TRANSFORMS) in Multiple Sclerosis. Poster presented at AAN, Toronto, April
2010
. Khatri B. et al. 24-Month Efficacy and Safety Outcomes from the
TRANSFORMS Extension Study of Oral Fingolimod (FTY720) in Patients with
Relapsing-Remitting Multiple Sclerosis. Poster presented at AAN, Toronto,
April 2010. Kappos L. et al. Oral Fingolimod (FTY720) vs. Placebo in
Relapsing-Remitting Multiple Sclerosis: 24-month Clinical Efficacy Results
from a Randomized, Double-Blind, Multicenter Phase III Study (FREEDOMS).
Slide deck associated with Oral Presentation at the American Academy of
Neurology (AAN) Annual Meeting 2010 in Toronto. Novartis. Data on file.
Foster CA et al. Brain penetration of the oral immunomodulatory drug FTY720
and its phosphorylation in the central nervous system during experimental
autoimmune encephalomyelitis: consequences for mode of action in multiple
sclerosis. J Pharmacol Exp Ther 2007, 323 (2) 469-76.

Media contacts Claire Eldridge / Aaron Pond, Aurora Healthcare Communications, Tel: +44-207-424-7940 Mobile: +44-7736-277-196 / +44-7872-812-405, Email: FTYteam at auroracomms.com; Novartis Communications UK Tel: +44-1276-698-691 (Press Office), Email: pressoffice-uk.phgbfr at novartis.com

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