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Japan's Eisai gains EU approval to sell epilepsy drug

Eisai Co., Japan's fourth-largest drugmaker, said it received European approval to sell its Inovelon epilepsy tablets, adding a new competitor for GlaxoSmithKline Plc's top-seller, Lamictal

Inovelon is designed to treat epilepsy in adults and Lennox-Gastaut syndrome, a severe childhood form of the neurological disorder. The European Commission approved the anticonvulsant drug for sale in the European Union after a study found it reduced the frequency of seizures associated with the syndrome, Tokyo-based Eisai said in a faxed statement today. Eisai, which makes Aricept to treat Alzheimer's disease, is targeting specialized medicines for neurological disorders that face less competition than the company's drugs for stomach ulcers and osteoporosis. Inovelon, which has the generic name refinamide, may be an alternative to Lamictal and to Novartis AG's Trileptal.

„We expect this European sales approval to help us expand our product line” in the region, Eisai said in the statement. The EU approval came almost two years after Eisai filed an application with the European Medicines Agency in March 2005. Shares of Eisai rose 80 yen, or 1.2%, to end trading at 6,550 yen on the Tokyo Stock Exchange. Refinamide, which was developed by Basel, Switzerland-based Novartis, is designed to be used in combination with other treatments for Lennox-Gastaut syndrome, or childhood epilepsy.

The Epilepsy Foundation estimates there are 2.7 million people of all ages who suffer epilepsy and seizures in the US, resulting in direct and indirect costs of $12.5 billion annually. Causes of Lennox-Gastaut syndrome include severe head injury, congenital brain defect, infection of the central nervous system and oxygen deprivation during birth. No specific cause is found in about 35% of cases, according to the US National Institute of Neurological Disorders and Stroke. Symptoms include continuous involuntary muscular contraction and loss of consciousness. Onset is typically in children aged 4 and under. No single medication is currently available to control the syndrome, and complete recovery is „very unusual,” according to the neurological institute said on its Web site. (Bloomberg)