Eisai Seeks Regulatory Approval for New Indication for Fycompa; Concludes Agreement on GI DrugBy
Eisai Co., Ltd. has submitted applications to the US Food and Drug Administration and the European Medicines Agency for the indication expansion of its in-house developed antiepileptic drug Fycompa (perampanel) as an adjunctive treatment of primary generalized tonic-clonic seizures. a severe form a generalized seizures, which account for 60% of generalized epilepsy and approximately 20% of all epilepsy cases.
Fycompa was discovered and developed by Eisai. It is approved in more than 35 countries, primarily in Europe and North America, and has been launched in the US, Europe, and Canada as an adjunctive treatment for partial-onset seizures (with or without secondary generalized seizures) in patients with epilepsy aged 12 years and older. Furthermore, a clinical study on patients with partial-onset seizures is currently underway in Asia, including Japan, and Eisai plans to submit a regulatory application covering in Japan in fiscal 2015.
In other news, Eisai and Zeria Pharmaceutical Co., Ltd., a Tokyo-based pharmaceutical company, have concluded a license agreement concerning E3710, a novel proton pump inhibitor (PPI) discovered and developed in-house by Eisai. Based on this agreement, Eisai will grant Zeria the exclusive rights to develop and co-promote, and the non-exclusive right to manufacture, E3710 in Japan. In addition, Eisai will receive down payment and additional royalties from Zeria, and after marketing authorization has been successfully obtained, Eisai will pay Zeria a certain consideration. While Zeria will develop E3710 and work to obtain marketing authorization, the two companies will collaborate on marketing E3710 after launch. E3710 is a novel PPI discovered by Eisai as a successor to Eisai’s Pariet (rabeprazole sodium).
Source: Eisai (Zeria Pharmaceutical collaboration) and Eisai (Fycompa)