New drug to treat epileptic seizures

Eisai Medical ResearchInc. (Headquarters: Ridgefield Park, President Mindell Seidlin, M.D.) hassubmitted a new drug application (NDA) to the U.S. Food and DrugAdministration (FDA) for the anti-epileptic drug (AED) rufinamide. Eisai isseeking approval for two indications for rufinamide, as adjunctive therapy forLennox-Gastaut syndrome (LGS) in children ages four and over and as adjunctivetherapy for partial-onset seizures with and without secondary generalizationin adults and adolescents (12 years of age and over).

Rufinamide is a triazole derivative, a compound structurally distinct fromcurrently approved AEDs. In a multicenter, double-blind, placebo-controlledclinical trial, rufinamide was shown to have clinical benefit in the treatmentof seizures associated with LGS, a severe form of epilepsy that develops inearly childhood, and was designated as an orphan drug for this indication bythe FDA in October 2004.

Based on key findings of two double-blind, placebo-controlled trials, rufinamide will also be filed with the FDA as adjunctivetherapy 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 ResearchInc. "LGS is a serious condition that is difficult to manage with currentlyapproved treatments, and the epilepsy community needs new options."

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

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

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

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

About Eisai Medical Research Inc. Eisai Medical Research Inc. is a U.S. pharmaceutical subsidiary of EisaiCo., Ltd. Eisai Medical Research Inc. was established to focus solely onclinical research and to expedite clinical drug development of new chemicalentities and of new indications for marketed products.