BASEL, Oct. 27 --PRNewswire-AsiaNet/InfoQuest
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
SOURCE: Novartis International AG
CONTACT: Eric Althoff, Novartis Global Pharma Communications
+41-61-324-6392 or Mobile +41-79-593-4202
John Gilardi, Novartis Global Media Relations
+41-61-324-3018 or +41-61-324-2222
Web site: http://www.novartis.com
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