Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that its U.K. subsidiary Eisai Ltd. (Headquarters: London, Managing Director: Paul Hooper) obtained marketing authorization approval of Zonegran
hard capsules (zonisamide), an anti-epileptic drug for the adjunctive therapy of partial seizures in adults, from the European Commission on March 10 (U.K. time).
In April 2004, Eisai obtained manufacturing, developing and marketing rights for Zonegran
in the U.S. and Europe from Elan Corporation, plc. Based on this, Eisai Ltd. succeeded a Marketing Authorization Application through the European Union's Centralized Procedure from Elan. In December 2004, Eisai Ltd. received a positive opinion for Zonegran
from the Committee For Medicinal Products for Human Use, the scientific body of the European Medicines Agency. Consequently, European Commission has granted marketing authorization approval for Zonegran
Major characteristics of Zonegran
are that it has a wide anti-seizure spectrum and its drug-drug interactions with other anti-epileptic drugs are minimal. Zonegran
was approved and launched in March 2000 in the U.S. for adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Eisai Inc., a subsidiary in the U.S., has been marketing the product since the end of April 2004. In Japan, the product was approved in 1989 and is marketed by Dainippon Pharmaceutical Co., Ltd. with the brand name Excegran
Based on the receipt of this marketing authorization, Eisai will strengthen its neurology product pipeline and aim at expanding business opportunities in Europe in order to fulfil patients' needs and contribute to further improve benefits with drug treatment.
Corporate Communications Department
Eisai Co., Ltd.