UCB accelerates transition to become patient-centric global biopharmaceutical leader with decision t
(Thomson Reuters ONE) - Decision maximises U.S. focus and resources on core productsBrussels, Belgium, 29 January 2010 - 18.15 CET - Press Release, Regulatedinformation - UCB announced today that it plans to accelerate its U.S.transition to a purely specialty-focused biopharmaceutical company and will exitthe primary care market in the U.S., effective 1 March 2010. This strategicdecision impacts the reported 2009 net profit with one-time restructuringcharges, while freeing more resources for core products. This transition is partof the company's long-term strategy to become the patient-centric globalbiopharmaceutical 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 theU.S. launch of Neupro® (rotigotine transdermal patch), we are focusing theresources of the total U.S. organisation and strengthening the foundation forthe company's focus on immunology and neurology. After the exit of the primarycare 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 patientswho suffer from severe diseases with Cimzia®, Vimpat® as well as prepare forNeupro®," said Roch Doliveux, UCB's Chief Executive Officer.UCB has plans in place to ensure the continued commercialisation of all primarycare products. Effective 1 March 2010, sanofi-aventis U.S. will assume all ofthe commercialisation responsibility for allergy drug Xyzal? (levocetirizinedihydrochloride) 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 willassume full commercialisation responsibility for ProAir?.UCB will continue to support its cough medication, Tussionex® (hydrocodonepolistirex), which has significant brand recognition in the U.S. market, throughdirect-to-physician and trade promotional activities that do not require salesforce support. UCB remains fully committed to the commercialisation ofvenlafaxine extended-release tablets (VERT) through its subsidiary, UpstatePharma."UCB is extremely grateful to our entire U.S. primary care team. Their hard workand dedication for more than a decade laid a strong foundation for UCB's futuresuccess in the U.S.," said Greg Duncan, UCB's President for North America. "Additionally, through many partnerships in the pharmaceutical industry, wehave identified continued employment opportunities for some of our colleaguesaffected by this organisational change."This transition, the organisational changes in Europe and the debt re-financingtrigger non-recurring (one-time) charges to be accounted for in 2009. Thesenon-recurring charges are expected to reach approx. EUR70m (after tax), loweringUCB's 2009 expected net profit as reported. However, UCB's 2009 total revenueand underlying profitability (recurring earnings before interests, taxes,depreciation and amortization, "recurring EBITDA") are not impacted by theseone-time, non-recurring charges. Further information will be available with thepublication of the company's full year results on 2 March 2010.For further informationPatty Fritz, U.S. Policy and CommunicationsT+1.770.970.8585,patty.fritz(at)ucb.com Antje Witte, Investor Relations UCBT +32.2.559.9414,antje.witte(at)ucb.com Richard Simpson, Investor Relations, UCBT+32.2.559.9494,richard.simpson(at)ucb.com About Xyzal®Xyzal® (levocetirizine dihydrochloride) is indicated for the relief of symptomsassociated with perennial allergic rhinitis and the treatment of uncomplicatedskin manifestations of chronic idiopathic urticaria in adults and children 6months of age and older, and for relief of symptoms of seasonal allergicrhinitis in adults and children 2 years of age and older.The use of Xyzal® is contraindicated in: patients with a known hypersensitivityto levocetirizine or any of the ingredients of Xyzal®or to cetirizine (observedreactions range from urticaria to anaphylaxis); patients with end-stage renaldisease with a creatinine clearance less than 10 mL/min or patients undergoinghemodialysis; and pediatric patients aged 6 months to 11 years with renalimpairment.Patients should be cautioned against engaging in hazardous occupations requiringcomplete mental alertness such as driving or operating machinery when takingXyzal®. Concurrent use of Xyzal®with alcohol or other central nervous system(CNS) depressants should be avoided. In clinical trials, the most common adversereactions 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 pediatricpatients 6 to 12 years of age taking Xyzal® 5 mg once daily or placebo werepyrexia (4%, 2%), cough (3%, <1%), somnolence (3%, <1%), and epistaxis (2%,<1%), respectively. The most common adverse reactions in ?2% of pediatricpatients 1 to 5 years of age taking Xyzal® 1.25 mg twice daily or placebo werepyrexia (4%, 2%), diarrhea (4%, 3%), vomiting (4%, 3%), and otitis media (3%,0%), respectively. The most common adverse reactions in pediatric patients 6 to11 months of age taking Xyzal® 1.25 mg once daily or placebo were diarrhea (13%,4%) and constipation (7%, 4%), respectively. Visitwww.xyzal.com for full prescribing information.About Tussionex®Tussionex® (hydrocodone polistirex) is indicated for the relief of cough andupper respiratory symptoms associated with allergy or a cold in adults andchildren 6 years of age and older. Each 5 ml of Tussionex® contains hydrocodonepolistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniraminepolistirex equivalent to 8 mg chlorpheniramine maleate.Tussionex® is contraindicated in children less than 6 years of age due to therisk of fatal respiratory depression, and in the presence of known allergy orsensitivity to hydrocodone or chlorpheniramine. The most common adversereactions associated with Tussionex® are sedation, drowsiness, and mentalclouding, which may impair the mental and/or physical abilities required forpotentially hazardous tasks such as driving or operating machinery. Tussionex®should not be taken with alcohol or other CNS depressants. Tussionex® is dosedat 5 mL every 12 hours in patients 12 years of age and older, and at 2.5 mLevery 12 hours in patients 6-11 years of age. Overdose with Tussionex® has beenassociated with fatal respiratory depression. Patients should be advised tomeasure Tussionex® with an accurate measuring device. A household teaspoon isnot an accurate measuring device. As with any other drugs in this class, thepossibility of tolerance and/or dependence, particularly in patients with ahistory of drug dependence, should be considered. Visitwww.tussionex.com for full prescribing information.About UCBUCB, Brussels, Belgium (www.ucb.com ) is abiopharmaceutical company dedicated to the research, development andcommercialization of innovative medicines with a focus on the fields of centralnervous system and immunology disorders. Employing approximately 10 000 peoplein over 40 countries, UCB generated revenue of EUR 3.6 billion in 2008. UCB islisted on Euronext Brussels (symbol: UCB).Forward-looking statementThis press release contains forward-looking statements based on current plans,estimates and beliefs of management. Such statements are subject to risks anduncertainties that may cause actual results to be materially different fromthose that may be implied by such forward-looking statements contained in thispress release. Important factors that could result in such differences include:changes in general economic, business and competitive conditions, effects offuture judicial decisions, changes in regulation, exchange rate fluctuations andhiring and retention of its employees.[HUG#1378822] Press Release (PDF): http://hugin.info/133973/R/1378822/339173.pdf
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Datum: 29.01.2010 - 12:16 Uhr
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