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News Release

September 13, 2005

Eisai Submits New Drug Application for the Anti-epileptic Agent Rufinamide in the United States

Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced that on September 8, 2005 (US Eastern Time), its U.S. subsidiary, Eisai Medical Research Inc. (Headquarters: New Jersey, President: Mindell Seidlin, M.D.), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the anti-epileptic agent rufinamide as adjunctive treatment of partial-onset seizures in adult and adolescent patients (12 years and older) and adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in children (4 years and older).

Rufinamide, a structurally novel compound unrelated to currently marketed anti-epileptic drugs, is a broad-spectrum anticonvulsant discovered and developed by Novartis. Eisai signed an in-licensing agreement for rufinamide with Novartis Pharma AG in February 2004. In Europe, a Marketing Authorization Application was submitted to the European Medicines Agency (EMEA) through the European Union's Centralized Procedure for adjunct therapy for LGS in March 2005.

In the U.S., rufinamide was granted orphan drug designation for the treatment of LGS by the FDA in October, 2004. In addition, data from clinical trials for rufinamide in the treatment of inadequately controlled partial seizures in adults were positive. Consequently, Eisai Medical Research Inc. submitted an NDA for these indications.

With the submission, Eisai aims to strengthen its neurology franchise, which currently includes Aricept(R), for the treatment of mild to moderate Alzheimer's disease, and Zonegran(R), an anti-epileptic agent, to fulfill patients' unmet needs and contribute to increasing their benefits.


Corporate Communications Department
Eisai Co., Ltd.

[Product summary of rufinamide submitted to FDA, and explanation of LGS follow]

<Note to the editor>

[Product summary of rufinamide submitted to FDA]
Generic name :rufinamide
Pharmaceutical Forms and Strength :100mg tablet, 200mg tablet, 400mg tablet
Applied Indication :Adjunctive treatment of partial-onset seizures with and without secondary generalization in adult and adolescent patients (12 years of age and over) and adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 4 years or older

What is Lennox-Gastaut Syndrome?
LGS is a severe form of generalized epilepsy that develops in early childhood, and is caused by various brain disorders such as brain hemorrhage, encephalitis, developmental malformations of the brain or metabolic abnormalities. Tonic seizures, where muscles contract continuously, along with developmental delay and behavioral problems, are symptoms associated with LGS. At the same time, however, the most characteristic manifestation of LGS is a large variety of seizures, such as atonic seizures where there is a global loss of tone in the body causing patients to fall suddenly, and absence seizures where unconsciousness occurs for a short time. It is difficult to manage with pharmacotherapy, and in rare cases surgical treatment can be employed.