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US FDA Grants Pediatric Exclusivity for UCB's Keppra(R)
Date:6/6/2008

43.1% of levetiracetam-treated patients experiencing at least a 50% reduction in seizure frequency during the evaluation period (five days) compared with 19.6% of placebo-treated patients (p=0.013). Levetiracetam was generally well-tolerated in this pediatric population. The most commonly reported adverse events that occurred more frequently in the treatment group were somnolence (13.3% vs. 1.8% for placebo) and irritability (11.7% vs. 0 for placebo). The incidence of other adverse events was similar in both groups.

In October 2007, UCB announced that it had reached an agreement to settle pending patent infringement lawsuits in the US. Under the terms of the settlement agreement with Mylan, and subject to its receiving FDA approval, Mylan will be allowed to sell its generic levetiracetam tablets effective November 1, 2008, in advance of the expiry of UCB's market exclusivity on January 14, 2009.

About Epilepsy: Epilepsy is a chronic neurological disorder affecting 40 million people worldwide including 2.5 million people in the US. It is caused by abnormal, excessive electrical discharges of the nerve cells or neurons in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are many different seizure types and epileptic syndromes and effective classification guides treatment and prognosis. Between 70-80% of individuals are successfully treated with one of the more than 20 antiepileptic drugs now available. However, 20-30% of patients have either intractable or uncontrolled seizures or significant adverse side effects secondary to medication highlighting the ongoing need for the development of new antiepileptic drugs.

About Keppra(R) in the US: Keppra(R) (levetiracetam) tablets were first approved by the FDA in 1999 as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since 1999, Keppra(R) has received several supplemental indications
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