UCB Pharma announces granting of European marketing authorisation for innovative transdermal therapy for symptomatic treatment of urge incontinence

Brussels, 21st June 2004 – UCB Pharma, one of Europe's leading specialist pharmaceutical companies, today announced that the European Commission has granted marketing authorisation for an innovative product for the symptomatic treatment of urge incontinence, a condition often called ‘overactive bladder' which affects nearly 17% of Europeans aged 40 and above.¹

The marketing authorisation, for a novel oxybutynin transdermal product for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency in patients with unstable bladder, was granted to the European subsidiary of Watson Pharmaceuticals Inc of Corona, California. In September 2003, UCB Pharma and Watson announced that they had entered into a marketing and supply agreement for the marketing of the product in Europe by UCB Pharma.

Approval of this application supports UCB Pharma's stated intention of developing a specialist pharmaceutical business providing innovative new therapies focussing on areas of unmet medical need.

In clinical studies, the transdermal patch has been shown to significantly reduce the number of incontinence episodes and the average daily urinary frequency, with a significant proportion of patients achieving total continence.^2,3 Whereas dry mouth is the commonest side-effect of traditional oral oxybutynin treatment, its incidence with transdermal oxybutynin was shown to be similar to placebo.³ No patient has discontinued treatment due to constipation or dizziness in clinical studies.^2,3 Central nervous system and cardio-vascular undesirable effects known to be associated with traditional oral therapy were not observed in clinical trials with transdermal oxybutynin.⁴

Commenting on the granting of the marketing authorisation, Francois Meurgey, Director of Global Marketing at UCB Pharma said, “The approval of this novel oxybutynin transdermal patch is further evidence of UCB Pharma's determination to become the preferred partner for patients and physicians seeking innovative new therapies to treat unmet needs.”

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References:

1. Milson I, Abrams P, Cardozo L, Roberts RG, Thüroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population based prevalence study. Br J Urol Int. 2001; 87: 760-766.
2. Dmochowski RR et al. Efficacy and Safety of Transdermal Oxybutynin in Patients with Urge and Mixed Urinary Incontinence. The Journal of Urology 2002;168: 580-586.
3. Dmochowski RR et al. Comparative Efficacy and Safety of Transdermal Oxybutynin and Oral Tolterodine versus Placebo in Previously Treated Patients with Urge and Mixed Urinary Incontinence. Urology 2003; 62: 237-242.
4. European Summary of Product Characteristics.

*UCB Pharma is part of the pharmaceutical division of the UCB group of companies. OxytrolTM is a trademark of Watson Pharmaceuticals Inc.