27.10.2004 – 07:36

Novartis International AG

Novartis Receives European Marketing Authorization for Emselex(R)

Basel, Switzerland (ots/PRNewswire)

- New M3 selective receptor antagonist treatment for overactive
bladder

Novartis Pharma AG announced today that Emselex(R) (darifenacin
hydrobromide), 7.5 mg and 15 mg, has been granted Marketing
Authorization by  the European Commission for the treatment of
overactive bladder (OAB) in all  25 European member states as well as
Norway and Iceland.

"The approval of Emselex will provide many people in Europe who
experience OAB symptoms a safe and effective new treatment option,"
said Jorg Reinhardt, Global Head of Development, Novartis Pharma AG.
"Emselex has an excellent efficacy as well as central nervous system
and cardiovascular safety profile, offering physicians a new choice
for treating people with overactive bladder."

Emselex is a once-daily M3 selective receptive antagonist (M3 SRA)
oral  treatment that works by selectively inhibiting the detrusor
muscle that  controls bladder contraction while sparing the M1 and M2
receptors believed  to be involved in central nervous system (CNS)
and cardiovascular (CV)  function, respectively.(1) Emselex has been
shown to reduce the number of weekly incontinence episodes by up to
77%(2) versus placebo. Additional clinical trials have shown that
Emselex works without impairing cognitive function(3) and without
cardiovascular safety concerns(2).

To date, 97 clinical trials with Emselex have been carried out
involving more than 10,500 subjects and patients, of whom 7,146 were
treated with darifenacin. Across a range of pivotal endpoints,
Emselex has been shown to significantly improve all other key
symptoms of OAB, including the number of times patients had to visit
the bathroom each day, bladder capacity, frequency of urgency,
severity of urgency and number of incontinence episodes leading to a
change in clothing or pads.(1)

About OAB

Symptoms of overactive bladder include urinary urgency (a sudden
and compelling desire to pass urine, which is difficult to defer)
with or without urge incontinence (involuntary leakage accompanied by
urgency), urinary frequency (voiding the bladder too often), and
nocturia (waking at night one or more times to void the bladder).

Disclaimer

This release contains certain forward-looking statements that can
be identified by the use of forward-looking terminology, such as
"will provide", or similar expressions, or by express or implied
discussions regarding potential additional marketing approvals or
future sales of Emselex. 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 the actual results with Emselex to be materially different from
any future results, performance, or achievements expressed or implied
by such statements. There can be no guarantee that Emselex will
receive any additional marketing approvals in any other countries, or
that it will reach any particular sales levels. Any such results can
be affected by, among other things, uncertainties relating to
clinical trials, regulatory actions or delays or government
regulation generally, the ability to obtain or maintain patent or
other proprietary intellectual property protection, competition in
general, government, industry, and general public pricing pressures,
as well as factors discussed in the Company's Form 20-F filed 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 described herein as 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 (NYSE: NVS) is a world leader in pharmaceuticals and
consumer health. In 2003, the Group's businesses achieved sales of
USD 24.9 billion and a net income of USD 5.0 billion. The Group
invested approximately USD 3.8 billion in R&D. Headquartered in
Basel, Switzerland, Novartis Group companies employ about 80,000
people and operate in over 140 countries around the world. For
further information please consult http://www.novartis.com.

    References
    1. Haab F et al. Darifenacin, an M3 Selective Receptor Antagonist, is an
       Effective and Well-Tolerated Once-Daily Treatment for Overactive
       Bladder. European Urology. 2004; 45: 420-429.
    2. Chapple C. Darifenacin is effective in improving the major symptoms of
       overactive bladder: A pooled analysis of phase III studies. Eur Urol
       Suppl 2004;3(2):A512
    3. Wesnes K, Lipton R, Kolodner K, Edgar C. Darifenacin, an M3 selective
       receptor antagonist for the treatment of overactive bladder, does not
       affect cognitive function in elderly volunteers. Eur Urol Suppl 2004;3
       (2):A513

Contact:

Contacts: Eric Althoff, Novartis Global Pharma Communications, Tel:
+41-61-324-6392, Mobile: +41-79-593-4202; John Gilardi, Novartis
Global Media Relations, Tel: +41-61-324-3018, Or : +41-61-324-2222