UCB to divest Equasym®
Brussels (Belgium), February 20, 2009 at 8 am CET - press release, regulated information - UCB has agreed the sale of Equasym® IR and Equasym® XL (methylphenidate HCl) for the treatment of attention deficit hyperactivity disorder (ADHD) to Shire, a specialty biopharmaceutical company.
With the exception of the U.S., Canada and Barbados, world-wide product rights and relevant staff for Equasym® IR/XL are being acquired by Shire. UCB will receive an up-front payment totalling EUR 55 million and additional undisclosed milestone payments if Shire meets certain pre-defined sales targets. Equasym® IR/XL sales in 2008 were approximately EUR 17 million.
The transaction is expected to close in the second quarter 2009 and is subject to standard closing conditions. In the U.S., UCB will continue to market Metadate® CD (methylphenidate HCl) extended release tablet for the treatment of ADHD. Further details of the transaction are not disclosed.
"ADHD is a behavioural disorder mainly treated by paediatric psychiatrists and paediatricians. With this agreement, UCB further underlines its SHAPE programme and focuses its CNS franchise on our core products bringing new innovative medicines to people living with severe neurological conditions," said Troy Cox, President CNS Operations UCB.
Notes to Editors:
In August 2008, UCB launched "SHAPE", a major global project designed to drive its transformation into a specialist company focused on the therapy areas of the central nervous system (CNS) and immunology while strengthening its presence in core strategic markets, including the U.S., Europe, Japan, major emerging and international markets.
With SHAPE, the company increases its focus on core assets, re-deploys its resources, advances research and development, and simplifies its organization, while bringing new medicines to patients. In early January 2009, UCB announced a strategic alliance with the German oncology specialist Wilex to develop UCB's preclinical oncology portfolio. Later in January this year, UCB announced the divestiture of smaller selected markets to GSK for a cash consideration of EUR 515 million. Consistent with the principles of the SHAPE strategy this enables UCB to further focus on its core areas. With the ongoing execution of the SHAPE strategy UCB confirms its 2009 financial guidance of a recurring EBITDA* of at least EUR 650 million.
UCB is actively pursuing its transformation into a leading biopharmaceutical company by continuing to invest in its late stage pipeline and innovative breakthrough research, while preparing launches of several new products in its core areas of CNS and immunology. With the recent approvals of Cimzia® for Crohn's disease in the U.S. and of Vimpat® for epilepsy in Europe and in the U.S., UCB has reached the right point in time to transform into a specialist company.
*(Earnings before interests, taxes, depreciation and amortisation)
ADHD is a common neurobehavioural disorder. Symptoms of ADHD may include chronic history of short attention span, distractability, emotional lability, impulsivity and moderate to severe hyperactivity. Learning may or may not be impaired.
Equasym® is indicated as part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder (ADHD) in children over six years of age when remedial measures alone prove insufficient.
Important safety information about Equasym® in Europe
Equasym® is contraindicated in patients known to be hypersensitive to methylphenidate or to any of its excipients and in patients with: marked anxiety, agitation or tension, glaucoma, hyperthyroidism, thyrotoxicosis, severe angina pectoris, cardiac arrhythmia, severe hypertension, heart failure, myocardial infarction, severe depression, psychotic symptoms, psychopathological personality structure, history of aggression or suicidal tendency, known drug dependence or alcoholism, diagnosis of motor tics, tics in siblings, or a family history or diagnosis of Tourette's syndrome. Equasym® is contraindicated during pregnancy. Equasym® is contraindicated in concomitant use or use within two weeks following discontinuation of non-selective, irreversible monoamine oxidase inhibitors. The most commonly reported adverse events in pivotal studies were insomnia and nervousness. Other common adverse events included decreased appetite, reduced weight gain during prolonged use in children, headache, drowsiness, dizziness, dyskinesia, hyperactivity, abnormal behaviour, aggression, agitation, anorexia, anxiety, depression, irritability, arrhythmia, palpitations, tachycardia, abdominal pain, nausea, vomiting, dry mouth, changes in blood pressure and heart rate (usually an increase), arthralgia, alopecia, pruritus, rash and urticaria.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company dedicated to the research, development and commercialisation of innovative medicines focused on central nervous system and immunology disorders. Employing more than 10 000 people in over 40 countries, UCB aims to reach revenues of at least EUR 3.3 billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB).
Richard Simpson, Investor Relations, UCB
T +32.2.559.9494, Richard.firstname.lastname@example.org
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 employees.
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