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New darifenacin data released at the American Urological Association (AUA)

SAN FRANCISCO, CA May 9, 2004 Results of two separate Phase III studies involving EnablexTM (darifenacin hydrobromide), an M3 selective receptor antagonist (M3 SRA) being developed for the treatment of overactive bladder (OAB), demonstrated a statistically significant reduction in the frequency of weekly incontinence episodes (up to 77 percent) with Enablex treatment versus placebo. Results from one of the studies (Abstract #5167) also indicate that Enablex reduces the number of weekly nocturnal awakenings due to OAB by 23 percent versus 3.6 percent with placebo. Both were presented today in a plenary session at the Annual Meeting of the American Urological Association (AUA).

"In our study, Enablex-treated patients had a significant reduction in the number of weekly incontinence episodes and the number of times they awoke each night to urinate," said Vik Khullar, MD, Consultant Uro-gynecologist, St. Mary's National Health Service Trust, Imperial College London, UK. "Since nocturia associated with OAB can influence sleep parameters and daytime functioning, Enablex may be an important new treatment option for OAB."

In a second study (Abstract #1528), in addition to reducing the number of incontinence episodes, Enablex improved all efficacy parameters associated with OAB, without central nervous system (CNS) or cardiovascular (CV) safety concerns as compared with placebo.

"Due to its M3 receptor selectivity, Enablex has the potential to provide an effective treatment option with minimal effects on the central nervous and cardiovascular systems," said Christopher Chapple, Consultant Urologist, Royal Hallamshire Hospital, Sheffield, UK. "Furthermore, our results indicate that Enablex significantly reduces the major symptoms of OAB, including incontinence, urination frequency, urge frequency and severity, and bladder capacity."

Acquired by Novartis in 2003, Enablex is an M3 selective receptor antagonist (M3 SRA), which
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Contact: Eric Althoff
eric.althoff@pharma.novartis.com
41-61-324-6392
Ketchum
10-May-2004


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