MAA filing for Zonegran® with EMEA
December 1, 2003--- Dainippon Pharmaceutical Co., Ltd ("Dainippon") announced today that Elan Pharma International Limited ("Elan") has filed through the centralized procedure the European Marketing Authorization Application for Zonegran® (zonisamide) with the European Agency for the Evaluation of Medicinal Products (EMEA).
Elan is seeking a marketing authorization from the agency for the use of Zonegran® as adjunctive therapy in the treatment of partial seizures in adults and children over twelve years old with epilepsy. The prevalence rate of epilepsy in general population is approximately one percent worldwide, and Twenty percent of epilepsy patients are poorly controlled by existing anti-epilepsy drugs.
Zonisamide is an anti-epilepsy drug developed by Dainippon Pharmaceutical Co., Ltd. and was launched in Japan as Excegran® in June 1989. In the United States, Dainippon developed zonisamide using a contract research organization and received a marketing approval from the Food and Drug Administration in March 2000. Dainippon licensed the sales and marketing rights for zonisamide to Elan for North America and the European Union. Elan launched the product as Zonegran® in the United States in April 2000. Elan expects that the net US sales of Zonegran® will exceed US$80 million from US$43 million in 2002.
Dainippon is currently conducting a clinical trial for the additional indication in Parkinson's disease in Japan.