Press Release

Brussels, 1 December 2004 – UCB Pharma, one of Europe’s leading specialist biopharmaceutical companies, today confirmed that the novel oxybutynin transdermal patch for overactive bladder (OAB) has been granted approval to be marketed under the brand name Kentera(TM) by the European Medicines Agency (EMEA).

Francois Meurgey, Director of Global Product Strategy at UCB Pharma commented “We are delighted with the EMEA’s decision and we are now looking forward to the early launch of Kentera(TM) across Europe. This novel product will provide both patients and physicians with a valuable new therapy option in the treatment of overactive bladder and is further evidence of UCB Pharma’s continuing dedication in seeking innovative therapies to treat unmet medical needs.” 

Kentera(TM) will be the first patch for OAB and has been shown in clinical trials to reduce significantly the number of incontinence episodes and average daily urinary frequency in patients.^1,2 Dry mouth, the most common side-effect associated with traditional oral therapies, was found to have an incidence similar to placebo with Kentera^(TM).¹  Furthermore, in clinical studies, less than 1% of patients have discontinued treatment due to constipation, dizziness or any other anticholinergic side-effect^1,2 and undesirable side-effects of the central nervous and cardio-vascular system (such as tachycardia, arrhythmia) known to be associated with traditional oral therapy were not observed at all.³ 

Kentera(TM)’s efficacy combined with a low incidence of anticholinergic side effects is due to the patch technology that continuously delivers the drug through the skin over a three to four day period and thereby avoids the presystemic gastrointestinal and hepatic metabolism that occurs with oral administration.  This results in lower plasma concentrations of the active metabolite that causes the anticholinergic side effects.⁴  In addition, patients viewed the patch favourably, with significant improvements in quality of life being recorded in phase three clinical trials^1,2, and the majority of patients (65%) indicating they would prefer to use a patch for future treatment of OAB.⁵

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References:

1. 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.

2. 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.

3. European Product Information.

4. Bang LM et al. Transdermal Oxybutynin For Overactive Bladder. Drugs Aging 2003: 20 (11); 857-864.

5. Newman DK. Poster at 34th SUNA, 2003, USA. 

About the UCB Group:

UCB (www.ucb-group.com) is a global pharmaceutical and specialty chemical leader with headquarters in Brussels, Belgium. UCB is focused on innovative solutions for human healthcare through its UCB Pharma division, as well as technically innovative products for surface applications through its Surface Specialities division, and employs 12,000 people around the world. UCB Pharma’s research activities are focused in the fields of neurology, allergy and respiratory disease, inflammation and oncology. UCB Pharma’s main products include Keppra (antiepileptic), Xyzal and Zyrtec (antiallergics), Nootropil (cerebral function regulator) and Tussionex (antitussive). UCB is listed on Euronext Brussels, and achieved sales of E3 billion and a net profit of E340 million in 2003.

About UCB Pharma:

UCB Pharma is part of the UCB Group, a global pharmaceutical and specialty chemical company with headquarters in Brussels, Belgium.  UCB Pharma is a leading biopharmaceutical company, specialising in the fields of allergy and respiratory disease, immune and inflammatory disorders, central nervous system disorders, and oncology. UCB Pharma’s key products are Keppra(R) (antiepileptic), Nootropil(R) (cerebral function regulator), Xyzal(R) and Zyrtec^(R) (antiallergics), and Tussionex(R) (antitussive). UCB Pharma employs over 8,000 people operating in over 100 countries, and in 2003 achieved sales of E1.5 billion.

About Watson Pharmaceuticals Inc:

Watson currently markets transdermal oxybutynin in the United States under the brand name OXYTROL(TM).

Watson Pharmaceuticals Inc, headquartered in Corona CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes branded and generic pharmaceutical products.  Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.  

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