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Status of the E2007 (perampanel) Development Program
Date:4/10/2008

- Termination of Parkinson's Disease Clinical Development and Focus on

Neuropathic Pain and Epilepsy Indications -

TOKYO, April 11 /PRNewswire/ -- E2007 (perampanel) is a first-in-class, orally administered, highly selective non-competitive AMPA-type glutamate receptor antagonist, in development by Eisai for several indications, including Parkinson's disease, neuropathic pain, epilepsy, multiple sclerosis and migraine prophylaxis.

The AMPA receptor is widely present in almost all excitatory neuronal synapses. It is believed to play a role in a large number of central nervous system (CNS) diseases with different underlying pathophysiology, including neurodegenerative disorders, movement disorders, pain and psychiatric disorders. Eisai has been pursuing development of perampanel for several CNS indications, some of which are currently in Phase II and Phase III. The most advanced indication is Parkinson's disease for which Eisai has been conducting three global Phase III studies (Studies 301, 302 and 309) with perampanel as add-on therapy to levodopa in patients with late-stage disease. Additionally, Eisai is preparing for global Phase III studies for epilepsy and conducting two Phase II studies for neuropathic pain.

Following the completion of the first Phase III Study 301, we recently completed the second Phase III Study 302, which was primarily conducted in North America. Study 302 is a 20-week, double-blind, placebo-controlled study comparing two doses of 2mg and 4mg of perampanel to placebo. The results, compared with placebo, did not show a significant difference in the primary endpoint of reduction of "off" time (time when signs and symptoms of Parkinson's disease return as the effect of levodopa wears off). Perampanel was generally well tolerated. After analyzing the data, Eisai has decided to discontinue the Parkinson's disease program and not pursue regulatory submissions for this indication. Eisai will focus resou
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SOURCE Eisai Co., Ltd.
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