BRUSSELS, BELGIUM -- (MARKET WIRE) -- 06/26/08 -- Press release: regulatedinformation UCB announced today that the Committee for MedicinalProducts for Human Use (CHMP) of the European Medicines Agency (EMEA)has issued a positive opinion recommending that the EuropeanCommission grants a marketing authorisation for lacosamide, proposedtrade name Vimpat(TM), for the adjunctive treatment of partial onsetseizures with or without secondary generalisation in patients withepilepsy, aged 16 years and older.The recommendation has been granted for the oral tablet, oral syrupand intravenous formulations.
"The European positive opinion for approval of Vimpat(TM) marks amajor achievement for patients with epilepsy whose seizures are notwell controlled by current antiepileptic drugs, and for UCB,strengthening our leadership in treatments for this severe disease,"said Roch Doliveux, CEO, UCB. "Today also represents anothersignificant step forward for UCB in our strategic execution withanother innovative medicine to be approved."
The CHMP decision is supported by data from three multicentre, doubleblind, placebo controlled clinical trials that evaluated theefficacy, safety and tolerability of lacosamide (200, 400 and 600mg/day given in two divided doses) in a total of over 1,300 adultswith uncontrolled partial onset seizures. Patients in these trialswere taking at least one to three antiepileptic drugs (AEDs) and manyof the patients had previously tried at least seven AEDs.
Across these studies significantly greater than 50% responder ratesand reductions in median seizure frequency were seen versus placebo.Lacosamide was also generally well tolerated with the most commonadverse events of lacosamide ( > =10% and greater than placebo)reported in these trials including dizziness, nausea, diplopia andheadache.
"With as many as 30 per cent of epilepsy patients continuing to haveseizures despite treatment with antiepileptic drugs, there is a needfor new, efficacious and well tolerated treatment options," saidProfessor Elinor Ben-Menachem, Department of Clinical Neuroscience,Goteborg University, Sweden. "These clinical studies suggest thatadjunctive lacosamide may be a useful pharmacological treatmentoption for patients with partial onset seizures."
Regulatory filings for Vimpat(TM) oral tablet, oral solution andintravenous formulation are currently also under review by the USFood and Drug Administration (FDA) for use as adjunctive therapy inthe treatment of partial onset seizures in adults with epilepsy.Vimpat(TM), oral tablet, is currently under review by the EMEA andthe US FDA for the treatment of diabetic neuropathic pain.About Epilepsy: Epilepsy is a chronic neurological disorderaffecting 50 million people worldwide. It is caused by abnormal,excessive electrical discharges of the nerve cells or neurons in thebrain. Epilepsy is characterised by a tendency to have recurrentseizures and defined by two or more unprovoked seizures. There aremany different seizure types and epileptic syndromes and effectiveclassification guides treatment and prognosis. Between 70-80% ofindividuals are successfully treated with one of the more than 20antiepileptic drugs now available. However, 20-30% of patients haveeither intractable or uncontrolled seizures or significant adverseside effects secondary to medication highlighting the ongoing needfor the development of new antiepileptic drugs.
About lacosamide: Lacosamide has a dual mode of action and is thefirst agent of its kind to be clinically studied for the treatment ofepilepsy. It selectively enhances slow inactivation of sodiumchannels and interacts with the neuroplasticity-relevant target -collapsin-response mediator protein-2 (CRMP-2).
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in thebiopharmaceutical industry dedicated to the research, development andcommercialisation of innovative pharmaceutical and biotechnologyproducts in the fields of central nervous system disorders,allergy/respiratory diseases, immune and inflammatory disorders andoncology. UCB focuses on securing a leading position in severedisease categories. Employing around 12,000 people in over 40countries, UCB achieved revenue of EUR 3.6 billion in 2007. UCB S.A.is listed on the Euronext Brussels Exchange.
Forward looking statement
This press release contains forward-looking statements based oncurrent plans, estimates and beliefs of management. Such statementsare subject to risks and uncertainties that may cause actual resultsto be materially different from those that may be implied by suchforward-looking statements contained in this press release. Importantfactors that could result in such differences include: changes ingeneral economic, business and competitive conditions, effects offuture judicial decisions, changes in regulation, exchange ratefluctuations and hiring and retention of its employees.
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Antje Witte
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UCB Group
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Antje.witte@ucb-group.com