Darifenacin increases 'warning time' for OAB sufferers

October 13, 2003

Florence, Italy, 10th October 2003 -- Darifenacin, a new oral treatment for overactive bladder (OAB), has the potential to prolong "warning time" - the period between the first sensation of urgency and micturition - in patients experiencing OAB syndrome. This is according to data presented at the International Continence Society's 33rd Annual Congress in Florence, Italy1. Darifenacin is a new treatment option and the first M3 selective receptor antagonist (M3 SRA) currently awaiting regulatory approval in the US and Europe.

As presented by Linda Cardozo, Professor in Urogynaecology at Kings College Hospital London, urgency was reported as being one of the most distressing symptoms for patients with overactive bladder syndrome. It was suggested that, as a result, people who suffer symptoms of an overactive bladder often have a very limited social and personal life with increased psychological problems. Any help in prolonging the warning time between urgency and the embarrassment of incontinence helps the sufferer to lead a more normal life.

The multicentre, randomised, double-blind, placebo controlled study, evaluated the change in warning time of 72 patients either receiving darifenacin 30mg daily or placebo. After two weeks of treatment, patients using darifenacin showed a significant improvement in median warning time of 4.3 minutes compared with patients in the placebo group. This change represented a 22.5% increase in mean warning time for patients taking darifenacin1.

Overactive bladder is a very common condition, estimated to affect 16.5% of the worldwide adult population. Symptoms of OAB affect both sexes and increase with age - as many as 30 to 50 % of women over the age of 50 are estimated to suffer from the symptoms. In many patients, a specific cause cannot be identified. Many do not seek medical help (50-75%) and of those, who have sought medical help, 80% do not receive treatment.
This release contains certain forward-looking statements relating to Novartis Pharma AG's business, which can be identified by the use of forward-looking terminology, such as "new", "first" and "may" or similar expressions, or by discussions of strategy, plans or intentions. Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Commercialisation can be affected by, amongst other things, uncertainties relating to regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78 200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

1. "Can Medication Prolong Warning Time?" Cardozo L, Prescott K, Serdarevic D, Skillern L, poster presented at the International Continence Society, 33rd Annual Meeting, Florence, Italy, 5-9th October 2003

Notes to editors

Regulatory applications for Enablex/Emselex (darifenacin hydrobromide) have been submitted to the US and European authorities for the once daily treatment of overactive bladder in doses of 7.5mg and 15mg. On 3 October 2003, the company received an approvable letter from the US Food and Drug administration. Novartis expects to launch Enablex/Emselex globally in 2004.

Ketchum UK

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