UCB accelerates transition to become patient-centric global biopharmaceutical leader with decision to exit the primary care market in the U.S.
Brussels, Belgium, 29 January 2010 - 18.15 CET - Press Release, Regulated information - UCB announced today that it plans to accelerate its U.S. transition to a purely specialty-focused biopharmaceutical company and will exit the primary care market in the U.S., effective 1 March 2010. This strategic decision impacts the reported 2009 net profit with one-time restructuring charges, while freeing more resources for core products. This transition is part of the company's long-term strategy to become the patient-centric global biopharmaceutical leader focused on immunology and neurology.
"Following the successful U.S. launches of our core products Cimzia® (certolizumab pegol) and Vimpat® (lacosamide) and awaiting FDA approval for the U.S. launch of Neupro® (rotigotine transdermal patch), we are focusing the resources of the total U.S. organisation and strengthening the foundation for the company's focus on immunology and neurology. After the exit of the primary care market in most of Western Europe 18 months ago, UCB will now exit the U.S. primary care market, and focus its resources on providing solutions to patients who suffer from severe diseases with Cimzia®, Vimpat® as well as prepare for Neupro®," said Roch Doliveux, UCB's Chief Executive Officer.
UCB has plans in place to ensure the continued commercialisation of all primary care products. Effective 1 March 2010, sanofi-aventis U.S. will assume all of the commercialisation responsibility for allergy drug Xyzal (levocetirizine dihydrochloride) in the U.S. UCB will continue to receive a percentage of Xyzal profits. Also effective 1 March 2010, the co-promotion agreement for ProAir HFA (albuterol sulfate) with Teva's respiratory division will end and Teva will assume full commercialisation responsibility for ProAir.
UCB will continue to support its cough medication, Tussionex® (hydrocodone polistirex), which has significant brand recognition in the U.S. market, through direct-to-physician and trade promotional activities that do not require sales force support. UCB remains fully committed to the commercialisation of venlafaxine extended-release tablets (VERT) through its subsidiary, Upstate Pharma.
"UCB is extremely grateful to our entire U.S. primary care team. Their hard work and dedication for more than a decade laid a strong foundation for UCB's future success in the U.S.," said Greg Duncan, UCB's President for North America. "Additionally, through many partnerships in the pharmaceutical industry, we have identified continued employment opportunities for some of our colleagues affected by this organisational change."
This transition, the organisational changes in Europe and the debt re-financing trigger non-recurring (one-time) charges to be accounted for in 2009. These non-recurring charges are expected to reach approx. €70m (after tax), lowering UCB's 2009 expected net profit as reported. However, UCB's 2009 total revenue and underlying profitability (recurring earnings before interests, taxes, depreciation and amortization, "recurring EBITDA") are not impacted by these one-time, non-recurring charges. Further information will be available with the publication of the company's full year results on 2 March 2010.
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Antje Witte, Investor Relations UCB
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Xyzal® (levocetirizine dihydrochloride) is indicated for the relief of symptoms associated with perennial allergic rhinitis and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older, and for relief of symptoms of seasonal allergic rhinitis in adults and children 2 years of age and older.
The use of Xyzal® is contraindicated in: patients with a known hypersensitivity to levocetirizine or any of the ingredients of Xyzal®or to cetirizine (observed reactions range from urticaria to anaphylaxis); patients with end-stage renal disease with a creatinine clearance less than 10 mL/min or patients undergoing hemodialysis; and pediatric patients aged 6 months to 11 years with renal impairment.
Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking Xyzal®. Concurrent use of Xyzal®with alcohol or other central nervous system (CNS) depressants should be avoided. In clinical trials, the most common adverse reactions in ≥2% of adult and adolescent patients (12 years of age and older) taking Xyzal® 2.5 mg or Xyzal® 5 mg once daily or placebo were somnolence (5%, 6%, 2%), nasopharyngitis (6%, 4%, 3%), fatigue (1%, 4%, 2%), dry mouth (3%, 2%, 1%), and pharyngitis (2%, 1%, 1%), respectively.
In clinical trials, the most common adverse reactions in ≥2% of pediatric patients 6 to 12 years of age taking Xyzal® 5 mg once daily or placebo were pyrexia (4%, 2%), cough (3%, <1%), somnolence (3%, <1%), and epistaxis (2%, <1%), respectively. The most common adverse reactions in ≥2% of pediatric patients 1 to 5 years of age taking Xyzal® 1.25 mg twice daily or placebo were pyrexia (4%, 2%), diarrhea (4%, 3%), vomiting (4%, 3%), and otitis media (3%, 0%), respectively. The most common adverse reactions in pediatric patients 6 to 11 months of age taking Xyzal® 1.25 mg once daily or placebo were diarrhea (13%, 4%) and constipation (7%, 4%), respectively. Visit www.xyzal.com for full prescribing information.
Tussionex® (hydrocodone polistirex) is indicated for the relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older. Each 5 ml of Tussionex® contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate.
Tussionex® is contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression, and in the presence of known allergy or sensitivity to hydrocodone or chlorpheniramine. The most common adverse reactions associated with Tussionex® are sedation, drowsiness, and mental clouding, which may impair the mental and/or physical abilities required for potentially hazardous tasks such as driving or operating machinery. Tussionex® should not be taken with alcohol or other CNS depressants. Tussionex® is dosed at 5 mL every 12 hours in patients 12 years of age and older, and at 2.5 mL every 12 hours in patients 6-11 years of age. Overdose with Tussionex® has been associated with fatal respiratory depression. Patients should be advised to measure Tussionex® with an accurate measuring device. A household teaspoon is not an accurate measuring device. As with any other drugs in this class, the possibility of tolerance and/or dependence, particularly in patients with a history of drug dependence, should be considered. Visit www.tussionex.com for full prescribing information.
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing approximately 10 000 people in over 40 countries, UCB generated revenue of EUR 3.6 billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB).
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
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