Eisai Announces Submission of Marketing Authorization Application of the Anti-epileptic Agent Inovelon 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 (generic name: rufinamide) as adjunct therapy for Lennox-Gastaut Syndrome (LGS).
Inovelon, 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 with Novartis Pharma AG in February 2004, has been preparing for filing in the U.S. and Europe. Inovelon 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 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 submitted to EMEA, and explanation of LGS follow]
<Note to the editor>
[Product summary of Inovelon submitted to EMEA]