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News Release

March 30, 2005

Eisai Announces Submission of Marketing Authorization Application of the Anti-epileptic Agent Inovelon(R) in Europe

Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced that on March 29, 2005 (U.K. time), its U.K. subsidiary Eisai Ltd. (Headquarters: London, Managing Director: Paul Hooper) submitted a Marketing Authorization Application to European Medicines Agency through the European Union's Centralized Procedure for the anti-epileptic agent Inovelon(R) (generic name: rufinamide) as adjunct therapy for Lennox-Gastaut Syndrome (LGS).

Inovelon(R), 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 Inovelon(R) with Novartis Pharma AG in February 2004, has been preparing for filing in the U.S. and Europe. Inovelon(R) is shown to be effective in the treatment of seizures associated with LGS, a severe form of epilepsy that develops in early childhood, and was designated as an orphan medicinal product for this indication by European Commission in October, 2004. Based on this, Eisai Ltd. submitted a Marketing Authorization Application for Inovelon(R) for LGS.

Eisai plans to strengthen its neurology product pipeline and aims to expand business opportunities in Europe in order to fulfill patients' needs and provide new drug treatments.


Corporate Communications Department
Eisai Co., Ltd.

[Product summary of Inovelon(R) submitted to EMEA, and explanation of LGS follow]

<Note to the editor>

[Product summary of Inovelon(R) submitted to EMEA]
Product name :Inovelon(R)
Generic name :rufinamide
Pharmaceutical Forms and Strength :100mg tablet, 200mg tablet, 400mg tablet
Applied Indication :Adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS)

What is Lennox-Gastaut Syndrome?
Lennox-Gastaut Syndrome is a severe form of generalized epilepsy that develops in early childhood, 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 the most typical symptoms associated with Lennox-Gastaut Syndrome. At the same time, however, the most characteristic manifestation of the Lennox-Gastaut Syndrome is a large variety of seizures, such as atonic seizures 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 by pharmacotherapy, and in rare cases surgical treatment can be employed.