Glivec receives FDA priority review as first therapy to reduce recurrence of gastrointestinal stromal tumors after surgery

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* Clinical data showing unprecedented 89% reduction in risk of GIST
relapse with use of Glivec after surgery are basis for FDA, EMEA,
Swissmedic filings

* Historically, one in two patients experienced recurrence of
GIST
after surgery

* Regulatory submissions reflect continued commitment to bringing

new therapeutic approaches to patients with rare diseases

* Clinical data showing unprecedented 89% reduction in risk of GIST
relapse with use of Glivec after surgery are basis for FDA, EMEA,
Swissmedic filings

* Historically, one in two patients experienced recurrence of GIST
after surgery

* Regulatory submissions reflect continued commitment to bringing
new therapeutic approaches to patients with rare diseases

Basel, August 27 2008 - Novartis announced today that Glivec®
(imatinib)* has been granted priority review status by the US Food
and Drug Administration (FDA) as the first therapy to be reviewed for
use after surgery in kit-positive gastrointestinal stromal tumors
(GIST). FDA priority review status is granted to therapies that could
potentially fill a currently unmet medical need and accelerates the
standard review timing from ten to six months[1]. Similar regulatory
submissions have been filed in the European Union and Switzerland and
will be filed in other countries shortly.

The Glivec submissions are based on data from a Phase III,
double-blind, randomized, multicenter, international study of more
than 700 GIST patients who had surgery to remove their tumors. The
results showed a dramatic 89% reduction in risk of GIST returning
after surgery (adjuvant setting) in patients treated with Glivec
versus placebo[2].

In early 2007, the study met its primary efficacy endpoint, showing
an advantage for Glivec in recurrence-free survival. At that time,
following the recommendation of the independent study data monitoring
committee to stop the trial accrual early, the study investigators
made public the interim results and offered Glivec to patients
receiving placebo[3].

Approximately half of all patients with newly diagnosed GIST are
considered candidates for surgical resection, or removal of their
tumors. Of those who have the surgery, about half will suffer a
recurrence[4]. If approved for this indication, Glivec will be the
first treatment option available to GIST patients after surgery to
reduce the risk of disease recurrence or to possibly prevent the
disease from returning.

"FDA priority review status acknowledges the potential for Glivec to
become the first post-surgery treatment available to GIST patients
and may soon create a fundamental shift in the treatment of this
disease," said Herve Hoppenot, Executive Vice President, Chief
Commercial Officer, Novartis Oncology.

Glivec is currently indicated in both the US and EU for the
first-line treatment of metastatic or unresectable (inoperable)
kit-positive GIST. If approved, the use of Glivec for the treatment
of GIST in the adjuvant setting would add to its eight current
indications, which include Philadelphia chromosome-positive chronic
myelogenous leukemia (Ph+ CML) and five other rare diseases.
Novartis also has a therapy for the treatment for carcinoid tumors
and acromegaly and multiple treatments in the pipeline targeting rare
diseases.

Filing data
The study on which the regulatory filing is based compared the
recurrence-free survival of GIST patients taking Glivec 400 mg/day
versus placebo for one year immediately following surgery. The
results showed that 98% of patients receiving Glivec remained
recurrence free at one year following surgery compared to
approximately 82% of those receiving placebo[3]. This shows that as a
result of adjuvant therapy with Glivec, there was an 89% reduction in
risk of GIST returning[2].

The study, known as ACOSOG Z90001, was conducted at multiple cancer
centers throughout the US and Canada, under a Cooperative Research
and Development Agreement between Novartis and the National Cancer
Institute (NCI). The study was led by the American College of
Surgeons Oncology Group (ACOSOG).

The investigators reported that Glivec therapy was well tolerated by
most patients, with side effects similar to those observed in
previous clinical trials with Glivec. These include nausea, diarrhea
and swelling (edema)[3].

About gastrointestinal stromal tumors (GIST)
Gastrointestinal stromal tumors (GIST) belong to a group of cancers
known as soft tissue sarcomas. They are the most common sarcomas and
can be found most often in the stomach and small intestine. The
incidence of GIST is estimated to be 4,500 - 6,000 new cases per year
in the US (15-20 cases per million population)[5], of which more than
90% are Kit-positive[6]. Kit - also known as CD117 - is a protein
that, when mutated, has been identified as one of the major causes of
GIST.

About Glivec
Glivec is approved in more than 90 countries, including the US, EU
and Japan, for the treatment of all phases of Ph+ CML. Glivec is also
approved in the EU, US and other countries for the treatment of
patients with Kit (CD117)-positive gastrointestinal tumors (GIST),
which cannot be surgically removed and/or have already spread to
other parts of the body (metastasized). In Japan, Glivec is approved
for the treatment of patients with Kit (CD117)-positive GIST. In the
EU, Glivec is also approved for the treatment of adult patients with
newly diagnosed Ph+ acute lymphoblastic leukemia (Ph+ ALL) in
combination with chemotherapy and as a single agent for patients with
relapsed or refractory Ph+ ALL. Glivec is also approved for the
treatment of adult patients with unresectable, recurrent and/or
metastatic dermatofibrosarcoma protuberans (DFSP) who are not
eligible for surgery. Glivec is also approved for the treatment of
patients with myelodysplastic/myeloproliferative diseases (MDS/MPD).
Glivec is also approved for hypereosinophilic syndrome and/or chronic
eosinophilic leukemia (HES/CEL).

The effectiveness of Glivec is based on overall hematologic and
cytogenetic response rates and progression-free survival in CML, on
hematological and cytogenetic response rates in Ph+ ALL, and on
objective response rates in GIST and DFSP. There are no controlled
trials demonstrating increased survival.

Not all indications are available in every country.

Glivec contraindications, warnings and adverse events
The majority of patients treated with Glivec in clinical trials
experienced adverse events at some time. Most events were of mild to
moderate grade and treatment discontinuation was not necessary in the
majority of cases.

The safety profile of Glivec was similar in all indications. The most
common side effects included nausea, superficial edema, muscle
cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia,
arthralgia, hemorrhage, fatigue, headache, joint pain, cough,
dizziness, dyspepsia and dyspnea, dermatitis, eczema, fluid
retention, as well as neutropenia, thrombocytopenia and anemia.
Glivec was generally well-tolerated in all of the studies that were
performed, either as monotherapy or in combination with chemotherapy,
with the exception of a transient liver toxicity in the form of
transaminase elevation and hyperbilirubinemia observed when Glivec
was combined with high dose chemotherapy.

Rare/serious adverse reactions include: sepsis, pneumonia,
depression, convulsions, cardiac failure, thrombosis/embolism, ileus,
pancreatitis, hepatic failure, exfoliative dermatitis, angioedema,
Stevens-Johnson syndrome, renal failure, fluid retention, edema
(including brain, eye, pericardium, abdomen and lung), hemorrhage
(including brain, eye, kidney and gastrointestinal tract),
diverticulitis, gastrointestinal perforation, tumor hemorrhage/
necrosis, hip osteonecrosis/avascular necrosis.

Patients with cardiac disease or risk factors for cardiac failure
should be monitored carefully and any patient with signs or symptoms
consistent with cardiac failure should be evaluated and treated.
Cardiac screening should be considered in patients with HES/CEL, and
patients with MDS/MPD with high level of eosinophils (echocardiogram,
serum troponin level).

Glivec is contraindicated in patients with known hypersensitivity to
imatinib or any of its excipients. Women of childbearing potential
should be advised to avoid becoming pregnant while taking Glivec.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "priority review", "risk",
"commitment", "potentially", "will", "if approved", "possibly",
"potential", "may", or similar expressions, or by express or implied
discussions regarding potential new indications or labelling for
Glivec, regarding potential future revenues from Glivec, or regarding
the long-term impact of a patient's use of Glivec. Such
forward-looking statements reflect the current views of the Company
regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with
Glivec to be materially different from any future results,
performance or achievements expressed or implied by such statements.
There can be no guarantee that Glivec will be approved for any
additional indications or labelling in any market. Nor can there be
any guarantee that Glivec will achieve any particular levels of
revenue in the future. Neither can there be any guarantee regarding
the long-term impact of a patient's use of Glivec. In particular,
management's expectations regarding Glivec 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, 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 growth areas in
healthcare, Novartis offers a diversified portfolio to best meet
these needs: innovative medicines, cost-saving generic
pharmaceuticals, preventive vaccines and 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 98,000 full-time associates and operate in over 140
countries around the world. For more information, please visit
http://www.novartis.com.

References
[1.] Fast Track, Priority Review and Accelerated Approval. U.S. Food
and Drug Administration - Center for Drug Evaluation and Research.
http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm
Accessed 31 July 2008.
[2.] Internal data.
[3.] Z9001: A Phase III Randomized Double-blind Study of Adjuvant
STI571 (Gleevec®) Versus Placebo in Patients Following the Resection
of Primary Gastrointestinal Stromal Tumor (GIST).
http://www.cancer.gov/clinicaltrials/ACOSOG-Z9001. Accessed June
2008.
[4.] Van den Abbeele A., Benjamin R., Blanke C, et al. Clinical
Management of GIST. Recurrence patterns and prognostic factors for
survival. 2003;1-24.
[5.] American Cancer Society. Cancer Reference Information. Detailed
Guide for Gastrointestinal Stromal Tumors. Key Statistics.
http://www.cancer.org/docroot/CRI/content/
CRI_2_4_1x_What_Are_the_Key_Statistics_About_Gastrointestinal_Stromal_Tumors.asp?rnav=cri.
Accessed 22 February 2008.
[6.] US Department of Health and Human Services. Agency for
Healthcare Research and Quality (AHRQ). Technology Assessment: Report
on the Relative Efficacy of Oral Cancer Therapy for Medicare
Beneficiaries Versus Currently Covered Therapy, Part 2. Imatinib for
Gastrointestinal Stromal Tumors (GISTs). Available at:
http://www.ahrq.gov/clinic/ta/gist/gist1.htm

* Known as Gleevec® (imatinib mesylate) tablets in the US, Canada and
Israel.

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