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Eisai Submits New Drug Application to the FDA for Anti-epileptic Drug Rufinamide


Rufinamide Designated by the FDA as Orphan Drug for Lennox-Gastaut Syndrome

RIDGEFIELD PARK, N.J., September 13, 2005 -- Eisai Medical Research Inc. (Headquarters: Ridgefield Park, President Mindell Seidlin, M.D.) has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the anti-epileptic drug (AED) rufinamide. Eisai is seeking approval for two indications for rufinamide, as adjunctive therapy for Lennox-Gastaut syndrome (LGS) in children ages four and over and as adjunctive therapy for partial-onset seizures with and without secondary generalization in adults and adolescents (12 years of age and over).

Rufinamide is a triazole derivative, a compound structurally distinct from currently approved AEDs. In a multicenter, double-blind, placebo-controlled clinical trial, rufinamide was shown to have clinical benefit in the treatment of seizures associated with LGS, a severe form of epilepsy that develops in early childhood, and was designated as an orphan drug for this indication by the FDA in October 2004. Based on key findings of two double-blind, placebo- controlled trials, rufinamide will also be filed with the FDA as adjunctive therapy in adults and adolescents, 12 years of age and over, with partial- onset seizures with and without secondary generalization.

"Rufinamide may be an important breakthrough for Lennox-Gastaut syndrome," said Santiago Arroyo, MD, PhD, Medical Director CNS, Eisai Medical Research Inc. "LGS is a serious condition that is difficult to manage with currently approved treatments, and the epilepsy community needs new options."

Lennox-Gastaut syndrome is a severe form of epilepsy. Seizures usually begin before four years of age, and children with LGS often suffer from several types of seizures. An estimated 1,400 to 4,500 new cases of LGS are diagnosed each year in the U.S., and complete recovery, including freedom from seizures and normal development, is very unusual. There is no known cure for the disorder.

Rufinamide also was shown to have clinical benefit as adjunctive therapy in treating adults and adolescents (12 years of age and over) with partial- onset seizures with or without secondary generalization. Partial seizures affect only one area of the brain and are the most common type of seizure experienced by people with epilepsy.

Eisai acquired exclusive North American and European manufacturing and marketing rights to rufinamide from Novartis Pharma AG in 2004. With the filing of rufinamide, Eisai plans to strengthen its neurology franchise and continue to fulfill its human health care (hhc) mission to satisfy unmet medical needs and increase benefits to patients and their families.

In double-blind studies, the most commonly observed adverse experiences seen in association with rufinamide and at a higher frequency (greater than or equal to 10%) than in placebo-treated patients were headache, dizziness, fatigue, somnolence and nausea.

Source: Eisai Medical Research Inc.

Posted: September 2005

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