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News Release

FOR IMMEDIATE RELEASE
November 30, 2016

EISAI TO PRESENT LATEST DATA ON PERAMPANEL AND RUFINAMIDE AT 70TH AMERICAN EPILEPSY SOCIETY ANNUAL MEETING

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the latest data on its antiepileptic drugs (AED) perampanel (product name: Fycompa®) and rufinamide (product name: Inovelon®, U.S. product name: BANZEL®) will be presented at the 70th American Epilepsy Society (AES) Annual Meeting to be held from December 2 to 6 in Houston in the United States.

For this year's AES meeting, poster presentations will be given on eight abstracts for perampanel which include the results of Phase II trials (Study 231, Study 233) of adjunctive perampanel in Japanese patients with refractory partial-onset seizures. Regarding rufinamide, a poster presentation will be given on the safety and cognitive development effects of adjunctive rufinamide in pediatric subjects with inadequately controlled Lennox-Gastaut Syndrome (LGS) from the final results of Study 303. Along with three poster presentations on health economics and outcome research, a total of 12 poster presentations will be given.

Perampanel is a first-in-class AED discovered and developed by Eisai. With epileptic seizures being mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. The agent is currently approved in more than 50 countries and territories as an adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) in adult and adolescent patients with epilepsy 12 years of age and older. In addition, perampanel is approved in more than 40 countries as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.
Furthermore, Eisai has submitted a supplemental application to the U.S. Food and Drug Administration for a partial label change for perampanel as monotherapy for treatment of partial-onset seizures in patients with epilepsy 12 years of age and older.

Rufinamide is believed to exert its antiepileptic effects by regulating activity of voltage-gated sodium channels in the brain involved in the overexcitement of neurons that potentially causes seizures, so as to prolong their inactive state. The agent is approved as an adjunctive therapy to other AEDs in the treatment of seizures associated with LGS in Europe and the United States. In Japan, the agent is approved as an adjunctive therapy to other AEDs in the treatment of tonic and atonic seizures associated with LGS when therapy with other AEDs is considered inadequate. Rufinamide is currently approved in more than 30 countries worldwide.

Eisai considers epilepsy a therapeutic area of focus and by providing multiple treatment options in addition to perampanel and rufinamide as part of an extensive epilepsy product portfolio, Eisai seeks to make continued contributions to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.


Major Poster Presentations for perampanel:
Abstract numberAbstract title
Abstract number: #2.189
Sunday December 4
Poster presentation: 10:00-16:00
Poster discussion: 12:00-14:00
Evaluation of perampanel as monotherapy for focal seizures: experience from open-label extension studies
Abstract number: #2.190
Sunday December 4
Poster presentation: 10:00-16:00
Poster discussion: 12:00-14:00
Adjunctive perampanel (PER) in patients (pts) with partial seizures or primary generalized tonic-clonic seizures (PGTCS): effect of age at diagnosis
Abstract number: #2.222
Sunday December 4
Poster presentation: 10:00-16:00
Poster discussion: 12:00-14:00
A Systematic Review of Real World Perampanel Treatment Outcomes
Abstract number: #2.225
Sunday December 4
Poster presentation: 10:00-16:00
Poster discussion: 12:00-14:00
An Indirect Treatment Comparison (ITC) of Perampanel versus Brivaracetam in Patients with Partial-Onset Seizures (POS) With or Without Secondary Generalization
Abstract number: #2.193
Sunday December 4
Poster presentation: 10:00-16:00
Poster discussion: 12:00-14:00
Long-term efficacy and safety of adjunctive perampanel: pooled analyses of the open-label extension (OLE) studies
Abstract number: #2.191
Sunday December 4
Poster presentation:10:00-16:00
Poster discussion: 12:00-14:00
Phase II trials of adjunctive perampanel in Japanese patients with refractory partial-onset seizures, an open-label, ascending-high-dose study (study 231)
and long-term extension study (study 233)
Abstract number: #3.238
Monday December 5
Poster presentation: 8:00-14:00
Poster discussion: 12:00-14:00
Adjunctive Perampanel in Patients With Drug-Resistant Partial Seizures With and Without Concurrent VNS Therapy in Phase III Studies
Abstract number: #3.255
Monday December 5
Poster presentation: 8:00-14:00
Poster discussion: 12:00-14:00
Health Care Resource Utilization Before and After Perampanel Initiation for the Treatment of Epilepsy in the United States

Major Poster Presentations for rufinamide:
Abstract numberAbstract title
Abstract number: #3.363
Monday December 5
Poster presentation: 12:00-18:00
Poster discussion: 12:00-14:00
Safety and Cognitive Development Effects of Adjunctive Rufunamide in
Pediatric Subjects With Inadequately Controlled Lennox-Gastaut Syndrome(LGS): Final Results From Study 303

Major Poster Presentations on Health Economics and Outcome Research:
Abstract numberAbstract title
Abstract number: #2.332
Sunday December 4
Poster presentation: 10:00-16:00
Poster discussion: 12:00-14:00
Racial Differences in the Incidence and Prevalence of Epilepsy in United
States Veteran Population
Abstract number: #2.335
Sunday December 4
Poster presentation: 10:00-16:00
Poster discussion: 12:00-14:00
Estimating the Economic Burden of Caregiving in Epilepsy
Abstract number: #2.338
Sunday December 4
Poster presentation: 10:00-16:00
Poster discussion: 12:00-14:00
The Caregiver's Direct Medical Costs in Epilepsy

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120