NOVARTIS N : Afinitor® Phase II trial results positive in patients with advanced gastric cancer after failure of one or more prior treatments

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  * After eight weeks of treatment Afinitor halted tumor growth in
    55% of advanced gastric cancer patients previously treated with
    chemotherapy

  * Based on these promising data, Novartis will initiate a Phase III
    trial of Afinitor for advanced gastric cancer patients

  * Gastric cancer is the second leading cause of cancer death
    worldwide, with the majority of new cases occurring in East Asia


Basel, January 13, 2009  - Data released  today show Afinitor®  (also
known as RAD001, everolimus) halted  tumor growth in 55% of  patients
with advanced gastric cancer, a condition for which there are limited
treatment  options.  In  addition,  45%  of  patients  in  the  study
demonstrated some tumor shrinkage[1].

The data  will  be presented  at  the American  Society  of  Clinical
Oncology's 2009 Gastrointestinal Cancers Symposium on January 15.

The open  label,  single  arm,  multi-center Phase  II  study  of  54
patients conducted in Japan, is  designed to assess the efficacy  and
safety of Afinitor  in patients  with advanced  gastric cancer  whose
disease progressed despite prior treatment. Patients enrolled in  the
trial were  heavily pre-treated.  All  trial participants  were  from
Japan and of Asian descent[1].

"There are very limited treatment options for patients who progressed
despite the  standard treatment  for  this aggressive  cancer,"  said
Atsushi Ohtsu,  MD, PhD,  Director,  Research Center  for  Innovative
Oncology, National Cancer  Center Hospital East,  Chiba, Japan.  "The
results from this study demonstrate  that Afinitor has the  potential
to provide an effective new option for these patients."

A global Phase III  clinical trial program  to evaluate the  efficacy
and safety  of Afinitor  monotherapy  in approximately  500  advanced
gastric cancer patients will begin enrollment this year.

"Most advanced gastric cancer patients eventually stop responding  to
current  therapies,  demonstrating  a   considerable  need  for   new
treatment  options,"  said  Alessandro   Riva,  MD,  Executive   Vice
President &  Global Head  of Development,  Novartis Oncology.  "Early
data show  Afinitor  may  benefit these  patients  and  provides  the
rationale for additional  studies. Novartis is  committed to  further
exploring the potential of Afinitor for this hard-to-treat cancer, as
well as studying its role in treating other tumor types."

Gastric  cancer,  commonly   referred  to  as   stomach  cancer,   is
responsible for more  than 865,000  deaths each year,  making it  the
second leading  cause of  cancer  death worldwide[2].This  cancer  is
highly prevalent among people of  Asian descent, with more than  half
of all new cases occurring in  East Asia[3]. It is believed that  the
incidence is high among this  population due in part to  Helicobacter
pylori infection  and  a  diet  high in  smoked,  salted  or  pickled
foods[4].

Study details
The proof-of-concept,  Phase  II  study is  designed  to  assess  the
efficacy and safety of Afinitor 10 mg daily in patients with advanced
gastric cancer (inoperable, recurrent  or metastatic gastric  cancer)
whose  disease  progressed  despite  prior  treatment.  The   primary
endpoint of  the  study is  to  assess disease  control  rate  (DCR).
Secondary endpoints included  assessment of  objective response  rate
(ORR), progression-free survival (PFS) and overall survival (OS), and
to describe the safety profile of Afinitor.

The average  duration  of  therapy  was 57  days.  There  was  a  DCR
(complete response/partial response/stable disease)  of 55% at  eight
weeks (95% Confidence  Interval: 40.4  - 68.4%). Of  the 53  patients
evaluated for the  study's primary  endpoint, 29  patients (55%)  had
stable disease, 22 (41%)  had progressive disease and  2 (4%) had  an
unknown response. The ORR was zero.  The median PFS was 83 days  (95%
Confidence Interval: 50 - 91 days), with 29.6% of patients  estimated
to still be progression-free at four months. Median overall  survival
was not attained at the time of evaluation.

The most commonly reported adverse events (all grades; >10% patients)
in the study  included stomatitis, anorexia,  fatigue, rash,  nausea,
edema  peripheral,  thrombocytopenia,  diarrhea,  pruritus,   anemia,
dysgeusia, vomiting, pyrexia, pneumonitis, constipation and insomnia.
Serious adverse  events (grade  3  or 4;  >3% of  patients)  included
anemia, hyponatremia,  raised  liver function,  fatigue,  stomatitis,
anorexia, hyperglycemia, hypophosphatemia, ileus and lymphopenia.

About Afinitor
Afinitor, an oral once-daily inhibitor of mTOR, is an investigational
drug being studied in multiple tumor types. In cancer cells, Afinitor
provides daily inhibition of mTOR, a  protein that acts as a  central
regulator of tumor  cell division, cell  metabolism and blood  vessel
growth.

Afinitor is being studied in multiple cancer types including advanced
kidney, breast and  neuroendocrine tumors and  lymphoma.   Currently,
Afinitor is under  regulatory review  in the  US and  Europe for  the
treatment of advanced renal cell carcinoma.

The safety  and  efficacy  profile  of  Afinitor  has  not  yet  been
established in oncology  and there is no guarantee that Afinitor will
become commercially available  for oncology  indications. The  active
ingredient in Afinitor is everolimus, which is available in different
dosage strengths under the trade name Certican® for the prevention of
organ rejection in heart  and kidney transplant recipients.  Certican
was first approved in the EU in 2003.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "promising," "will," "potential,"
"may," "committed," "exploring," "believed," "estimated,"
"anticipated," or similar expressions, or by express or implied
discussions regarding potential regulatory filings or marketing
approvals for Afinitor or regarding potential future revenues from
Afinitor. 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 Afinitor to be materially different from any future results,
performance or achievements expressed or implied by such statements.
There can be no guarantee that Afinitor will be approved for sale for
any oncology indication in any market. Nor can there be any guarantee
that Afinitor will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding Afinitor a
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 AG 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 2007,  the
Group's  continuing  operations   (excluding  divestments  in   2007)
achieved net sales  of USD  38.1 billion and  net income  of USD  6.5
billion. Approximately USD 6.4 billion was invested in R&D activities
throughout the Group. Headquartered  in Basel, Switzerland,  Novartis
Group companies employ approximately 97,000 full-time associates  and
operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.

References
[1] Ohtsu, A et al. Multicenter phase II study of RAD001 for
previously treated metastatic gastric cancer. Presented at the
American Society of Clinical Oncology's 2009 Gastrointestinal Cancers
Symposium, January 15, 2008.
[2] World Health Organization. Cancer.
http://www.who.int/mediacentre/factsheets/fs297/en/.  Accessed on
December 23, 2008.
[3] Ohtsu, A. Chemotherapy for metastatic gastric cancer: past,
present, and future. J Gastroenterol 2008; 43:256-264.
[4] American Cancer Society. Overview: Stomach Cancer. Available at:
http://www.cancer.org/docroot/CRI/content/CRI_2_2_2X_What_causes_stomach_cancer_40.asp?sitearea=.
Accessed on December 23, 2008.
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