Asia PR News

BASEL, Dec. 28 /PRNewswire-AsiaNet/ –

- BIG 1-98 data published in latest New England Journal of Medicine

- Femara reduced risk of cancer coming back by an additional 21% over the
reduction offered by tamoxifen

- Femara also reduced risk of cancer spreading to distant parts of the
body (metastases) by 27%, compared with tamoxifen

Novartis announced today the US regulatory approval of Femara(R)
(letrozole) in a new indication as a treatment for use after surgery in
postmenopausal women with hormone-sensitive early breast cancer (adjuvant
setting).

The US approval was based on results of the BIG 1-98 study, which were
published for the first time in the December 29 issue of The New England
Journal of Medicine (NEJM). BIG 1-98 compared the effectiveness and
tolerability of Femara versus tamoxifen when used as initial therapy after
surgery (adjuvant setting) in postmenopausal women with hormone-sensitive
early breast cancer.

Femara reduced the risk of breast cancer returning by an additional 21%
(p=0.002)(1) over the reduction offered by tamoxifen. Further, patients taking
Femara showed a 27% (p=0.0012) reduction in the risk of the cancer spreading
to distant parts of the body. Women whose disease does spread to other sites
(metastases) may be at greater risk of dying from their disease.

In addition to the overall findings, Femara demonstrated its greatest
benefit in two groups of women at increased risk of recurrence. Femara reduced
this risk by 29% in women whose breast cancer had already spread to the lymph
nodes at the time of diagnosis and by 30% in women who had undergone
chemotherapy. The data also showed that in these high-risk subgroups, Femara
reduced the risk of cancer spreading to distant parts of the body by 33% and
31%, respectively.

"Femara has consistently demonstrated superiority against tamoxifen as
first-line therapy in women with locally advanced or metastatic breast cancer,
as well as in the adjuvant setting. In addition, Femara provides a notable
benefit to patients who are at especially high risk of having their breast
cancer return," said Diane Young, MD, vice president and global head of
Clinical Development at Novartis Oncology.

Femara is now the only medicine in its class approved by the US Food and
Drug Administration (FDA) for use as an initial treatment immediately after
surgery in patients with this form of breast cancer, as well as following
completion of five years of tamoxifen therapy (extended adjuvant setting).
Additional data released earlier this month at the San Antonio Breast Cancer
Symposium demonstrated that women experienced dramatic improvements in overall
survival, disease-free survival and distant disease-free survival, even if
they started taking Femara years after completing post-surgery tamoxifen
therapy.

"One of the greatest fears confronted by women who have been treated for
early breast cancer is that their cancer will come back. With Femara, we now
have an option that can help address that fear early on, even in the patients
who we know face the greatest risk of recurrence. Femara has proven to be a
very important option in the treatment paradigm for postmenopausal women with
hormone-sensitive early breast cancer," said Matthew Ellis, MD, PhD, FRCP,
director of the Breast Cancer Program at Washington University and associate
professor and section head of the Medical Oncology Division in the Department
of Medicine at Washington University in St. Louis.

The approval of Femara for adjuvant use in the US was based on a six-month
priority review. The FDA grants priority review to products that could
potentially offer a significant improvement compared to marketed products in
the diagnosis, treatment or prevention of disease, increased compliance or
demonstrated efficacy in subgroups. Novartis recently received approval for
this indication in the UK. Femara has also been submitted in the EU, Japan and
other countries. Additional approvals in other countries are expected in 2006.

About BIG 1-98
The BIG 1-98 study was a Phase III, randomized, double blind study that
compared the safety and efficacy of Femara versus tamoxifen, when used as
adjuvant therapy in postmenopausal women with hormone receptor-positive early
breast cancer.

BIG 1-98 is the only clinical trial designed to incorporate both a head-
to-head comparison of Femara with tamoxifen during the first five years
following breast cancer surgery and a sequencing of both agents to determine
the most effective approach to minimizing the risk of recurrence. BIG 1-98 was
conducted by the International Breast Cancer Study Group (IBCSG) with many
independent centers and was supported by Novartis.

About Femara
Femara is a leading once-a-day oral aromatase inhibitor currently
available in more than 90 countries worldwide. Femara is approved for extended
adjuvant treatment of early breast cancer in postmenopausal women who have
completed standard adjuvant tamoxifen therapy in 57 countries worldwide,
including Europe as well as the United States. In addition, it is indicated
for first-line treatment of postmenopausal women with hormone receptor-
positive or hormone receptor-unknown locally advanced or metastatic breast
cancer and for the treatment of advanced breast cancer in postmenopausal women
with disease progression following anti-estrogen therapy, and as neo-adjuvant
(pre-operative) therapy. Not all of these indications are available in every
country.

Contraindications, warnings and adverse events
Patients should talk to their doctor if they are allergic to Femara or any
of its ingredients. Femara should not be taken by women who are pregnant as it
may cause fetal harm. Femara should be taken only by women who are
postmenopausal. Some women have reported fatigue and dizziness with Femara.
Patients should use caution before driving or operating heavy machinery until
they know how Femara affects them. In the extended adjuvant setting, longer
follow-up is needed to determine the risk of bone fracture associated with
long-term use of Femara.

In the adjuvant setting, commonly reported side effects are generally mild
to moderate. Side effects seen in Femara versus tamoxifen included: hot
flashes (33.7% vs. 38%), joint pain (21.2% vs. 13.5%), night sweats (14.1% vs.
13.5%), and weight gain (10.7% vs. 12.9%). Other side effects seen were bone
fractures and osteoporosis.

In the extended adjuvant setting, commonly reported side effects are
generally mild to moderate. Those seen more often with Femara versus placebo
were hot flashes (50% vs. 43%), joint pain (22% vs. 18%) and muscle pain (7%
vs. 5%). Other side effects, which were comparable to placebo, include fatigue
(34% vs. 32%), swelling due to fluid retention (18% vs. 16%), headache (20%
vs. 20%), increase in sweating (24% vs. 22%) and increase in cholesterol (16%
vs. 16%). The percentage of patients on Femara versus placebo reporting a
fracture was 5.9% vs. 5.5%. The percentage of patients reporting osteoporosis
was 6.9% vs. 5.5%. Bisphosphonates, which are drugs used to increase bone
strength, were given to 21.1% of Femara patients and 18.7% of placebo
patients.

The foregoing release contains forward-looking statements that can be
identified by terminology such as "may be," "notable benefit," "significantly
reduce," or similar expressions, or by express or implied discussions
regarding potential new indications, marketing approvals, or future sales of
Femara. Such forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results with Femara to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that Femara
will be approved for any additional indications in any market, nor that it
will reach any particular sales levels. In particular, management’s
expectations regarding commercialization of Femara could be affected by, among
other things, additional analysis of Femara clinical data; new clinical data;
unexpected clinical trial results; unexpected regulatory actions or delays or
government regulation generally; the Company’s ability to obtain or maintain
patent or other proprietary intellectual property protection; competition in
general; increased government, industry, and general public pricing pressures;
and other risks and factors referred to in the Company’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.

For more information
Additional information regarding Femara or Novartis Oncology can be found
on the websites http://www.femarainfo.com or http://www.novartisoncology.com.

About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer
health. In 2004, the Group’s businesses achieved net sales of USD 28.2 billion
and pro forma net income of USD 5.6 billion. The Group invested approximately
USD 4.1 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group
companies employ about 91,700 people and operate in over 140 countries around
the world.

For further information please consult http://www.novartis.com.

(1) 19% (p=0.003) in European filing due to slightly different definition
of disease-free survival by FDA and European health authorities.

Contacts
Kim Fox
Novartis Oncology
+1-862-778-7692 (direct)
+1-973-960-7532 (mobile)
kim.fox@novartis.com

Corinne Hoff
Novartis Global Media Relations
+41 61 324 9577 (direct)
+41 79 248 5717 (mobile)
corinne.hoff@novartis.com

SOURCE: Novartis

CONTACT: Kim Fox of Novartis Oncology,
+1-862-778-7692 (direct),
+1-973-960-7532 (mobile),
kim.fox@novartis.com, or

Corinne Hoff of Novartis Global Media Relations,
+41-61-324-9577 (direct),
+41-79-248-5717 (mobile),
corinne.hoff@novartis.com

Web site: http://www.novartis.com
http://www.femarainfo.com
http://www.novartisoncology.com

(NVS)