Novartis International AG: Novartis announces Russian regulatory approval for Gilenya®, a once-daily oral multiple sclerosis therapy and first in a new class

Novartis International AG / Novartis announces Russian regulatory approval for Gilenya,
a once-daily oral multiple sclerosis therapy and first in a new class processed and
transmitted by Hugin AS. The issuer is solely responsible for the content of this
announcement.

* Russia is first country to approve Gilenya for the treatment of relapsing remitting
MS, the most common form of the disease

* Gilenya is the first disease-modifying treatment in a new drug class and offers
significant efficacy with a well-characterized safety tolerability profile

* Action from the US Food and Drug Administration (FDA) on Gilenya is expected in
September 2010; other submissions under review worldwide

Basel, September 10, 2010- The Russian health authority, the Federal Service on
Surveillance in Healthcare and Social Development, has granted approval for Gilenya
(fingolimod) 0.5 mg once-daily oral therapy for the treatment of relapsing remitting
multiple sclerosis (MS). Approximately 85% of patients with MS are estimated to have the
relapsing remitting form at the onset of disease[1]. Russia is the first country to
approve Gilenya, providing a new treatment option offering significant efficacy for
patients in the convenience of an oral capsule. Novartis expects to launch Gilenya in
Russia in early 2011.

In June, an advisory committee of the US Food and Drug Administration (FDA) unanimously
recommended approval of Gilenya and action from the FDA is expected in September 2010.
Gilenya is also under review by the European Medicines Agency (EMA) as well as other
health authorities worldwide.

Data from one of the largest-ever Phase III clinical trial programs conducted in MS were
submitted to support the regulatory submissions. These studies provided evidence of the
efficacy of Gilenya in reducing relapses, disability progression and brain lesions in
patients with relapsing remitting MS as well as safety data. Gilenya is the first in a
new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators.
Gilenya provides selective and reversible retention of lymphocytes in lymph nodes,
preserving key immune functions and flexibility in patient management.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by
terminology such as "expected," "under review," "expects," "recommended," or similar
expressions, or by express or implied discussions regarding potential marketing
approvals for Gilenya, or the timing of such approvals, 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 approved for sale 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 regulatory actions or delays or
government regulation generally; unexpected clinical trial results, including unexpected
new clinical data and unexpected additional analysis of existing clinical data; the
company's ability to obtain or maintain patent or other proprietary intellectual
property protection; competition in general; 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 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 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 102,000 full-time-equivalent associates and operate
in more than 140 countries around the world. For more information, please visit
http://www.novartis.com http://www.novartis.com/ .

References
[1] National Multiple Sclerosis Society website.
http://www.nationalmssociety.org/about-multiple-sclerosis/relapsing-ms/index.aspx
http://www.nationalmssociety.org/about-multiple-sclerosis/relapsing-ms/index.aspx .
Accessed September, 2010.

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HUG#1443688

Media release (PDF) http://hugin.info/134323/R/1443688/387659.pdf

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