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29-01-2010 18:16:00

UCB accelerates transition to become patient-centric global biopharmaceutical leader with decision to exit the primary care market in the U.S.

Relateret indhold

Decision maximises U.S. focus and resources on core products

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. EUR70m (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.

For further information

Patty Fritz, U.S. Policy and Communications

T+1.770.970.8585,patty.fritz@ucb.com

Antje Witte, Investor Relations UCB

T +32.2.559.9414,antje.witte@ucb.com

Richard Simpson, Investor Relations, UCB

T+32.2.559.9494,richard.simpson@ucb.com

About Xyzal®

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. Visitwww.xyzal.com

for full prescribing information.

About Tussionex®

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. Visitwww.tussionex.com

for full prescribing information.

About UCB

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).

Forward-looking statement

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.

[HUG#1378822]

Press Release (PDF): http://hugin.info/133973/R/1378822/339173.pdf

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