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News Release

FOR IMMEDIATE RELEASE
November 24, 2017

EISAI TO PRESENT LATEST DATA ON PERAMPANEL AND RUFINAMIDE AT 71ST 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 71st American Epilepsy Society (AES) Annual Meeting to be held from December 1 to 5, 2017 in Washington D.C. in the United States.

As major presentations, for perampanel this includes a report on the extrapolation of data from Phase III clinical studies on adjunctive treatment to evaluate perampanel for use as monotherapy for partial seizures. Regarding rufinamide, a poster presentation will be given on long-term safety and efficacy of rufinamide for patients with Lennox-Gastaut syndrome (LGS) in a real-world setting in Japan. A total of nine poster presentations will be given at this year's AES meeting.

Perampanel is a first-in-class AED discovered at Eisai's Tsukuba Research Laboratories. It is available in tablet form to be taken once daily, and a new oral suspension formulation has been approved and is being marketed in the United States. A highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors, it is approved in countries around the world as an adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. Furthermore, perampanel is approved for use as monotherapy for partial-onset seizures in patients with epilepsy 12 years of age and older in the United States.

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.

Eisai considers neurology a therapeutic area of focus, and strives to maximize the value of perampanel and rufinamide to further contribute to addressing 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: #1.301
Saturday December 2
Poster presentation: 12:00-18:00
Poster discussion: 12:00-14:00
Impact of Adjunctive Perampanel on Healthcare Resource Utilization Based on the Number of Baseline Antiepileptic Drugs
Abstract number: #2.262
Sunday December 3
Poster presentation: 10:00-16:00
Poster discussion: 12:00-14:00
The Effects of Perampanel (PER) and Common-Use Antiepileptic Drugs (AEDs) on Secondarily Generalized Tonic-Clonic Seizures (SGTCS) in a Rat Amygdala Kindling Model
Abstract number: #2.290
Sunday December 3
Poster presentation: 10:00-16:00
Poster discussion: 12:00-14:00
Healthcare Resource Utilization Before and After Perampanel as Monotherapy Based on Claims Data Analysis
Abstract number: #3.261
Monday December 4
Poster presentation: 8:00-14:00
Poster discussion: 12:00-14:00
Assessment of the Long-Term Efficacy and Safety of Adjunctive Perampanel in Adolescent Patients: Post Hoc Analysis of Open-Label Extension (OLEx) Studies
Abstract number: #3.263
Monday December 4
Poster presentation: 8:00-14:00
Poster discussion: 12:00-14:00
Time to Prerandomization Monthly Seizure Count for Perampanel in Patients with Primary Generalized Tonic-Clonic (PGTC) Seizures: A Potential New Clinical Endpoint
Abstract number: #3.267
Monday December 4
Poster presentation: 8:00-14:00
Poster discussion: 12:00-14:00
Clinical Factors Associated with a Major Response (≥75% Reduction in Seizure Frequency per 28 Days) in Phase III Trials of Adjunctive Perampanel in Patients (pts) with Partial Seizures: Post Hoc Multivariate Analysis
Abstract number: #3.266
Monday December 4
Poster presentation: 8:00-14:00
Poster discussion: 12:00-14:00
Extrapolation of Efficacy and Safety Data of Adjunctive Perampanel (PER) from Phase III Trials in Patients (Pts) with Partial Seizures to Evaluate PER as Monotherapy
Abstract number: #3.430
Monday December 4
Poster presentation: 8:00-14:00
Poster discussion: 12:00-14:00
Retrospective, Phase IV Study of Perampanel in Real-World Clinical Care of Patients with Epilepsy: An Interim Analysis
Major Poster Presentations for rufinamide:
Abstract numberAbstract title
Abstract number: #1.311
Saturday December 2
Poster presentation: 12:00-18:00
Poster discussion: 12:00-14:00
Long-Term Safety and Efficacy of Rufinamide for Patients with Lennox-Gastaut Syndrome in a Real-World Setting in Japan

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