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Eisai Presents Research on FYCOMPA(TM) (perampanel) CIII at The American Academy of Neurology’s 66th Annual Meeting

April 25, 2014

WOODCLIFF LAKE, N.J., April 25, 2014 /PRNewswire/ — Eisai Inc. announced today that six abstracts highlighting data analyses for FYCOMPA(TM) (perampanel) will be presented at the 66(th) annual American Academy of Neurology (AAN) meeting, taking place in Philadelphia, PA from April 26( )- May 3.

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“Eisai and its epilepsy franchise are committed to expanding its knowledge of current products and developing new medications for the treatment of epilepsy. The data analyses being presented at AAN add to the growing body of clinical research surrounding FYCOMPA,” said Lynn Kramer, MD, President of the Neuroscience and General Medicine Product Creation Unit and Chief Clinical Officer of Eisai Company Ltd.

FYCOMPA is an adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and older.

The following perampanel data are being presented at this year’s AAN meeting:


              Abstract Name/Description           Abstract Number/Session
              -------------------------           -----------------------

    Effect of Adjunctive Perampanel
     on Cognition in Adolescents
     with Inadequately Controlled
     Partial-Onset Seizures             Emerging Science Poster Presentation

                                        Poster Number: P4.344;

    This Phase II study compared the    Poster Session: 4
     short-term effect on cognition      seizures were randomized to
     of perampanel versus placebo        receive once-daily placebo or
     when administered as adjunctive     perampanel (2, 4, 8 or 12 mg/
     therapy in adolescents with         day).
     refractory partial-onset
     seizures. Patients ages 12 to
     <18 years receiving one to
     three antiepileptic drugs
     (AEDs) and experiencing
     uncontrolled partial-onset
    --------------------------------                              -----------------

    Analysis of Falls in Epilepsy
     Patients with Partial-Onset
     Seizures in Perampanel Phase
     III Trials                         Poster Number: P3.272;

                                        Poster Session: 3

    This post-hoc analysis assessed
     data from Phase III clinical
     trials of perampanel, examining
     the number of falls patients
     with uncontrolled partial-
     onset seizures experienced
     while randomized to receive
     perampanel once daily (2, 4, 8
     or 12 mg doses) or placebo.
    --------------------------------

    Interim Efficacy and Safety
     Analysis of Adjunctive
     Perampanel in the Adolescent
     Population from the Extension
     Phase of 3 Double-Blind,
     Placebo-Controlled, Phase III
     (Core) Studies in Patients with
     Refractory Partial-Onset
     Seizures                           Poster Number: P3.271;

                                        Poster Session: 3

    This interim analysis provided
     additional efficacy and safety
     data for adjunctive perampanel
     in 124 adolescents ages 12-17
     years with refractory partial-
     onset seizures who participated
     in the extension phase of three
     double-blind, randomized,
     placebo-controlled Phase III
     studies.
    --------------------------------

    Efficacy and Safety of
     Adjunctive Perampanel Based on
     Number of Antiepileptic Drugs
     at Baseline                        Poster Number: P3.273;

                                        Poster Session: 3

    This post-hoc analysis examined
     the efficacy and safety of
     perampanel based on number of
     concomitant antiepileptic drugs
     (AEDs) at baseline.
    --------------------------------

    Review of Aggression in Adults
     and Adolescents in Perampanel
     Phase III Epilepsy Clinical
     Trials                             Poster Number: P3.009;

                                        Poster Session: 3

    This post-hoc analysis examined
     aggression-related safety data
     from the pooled results of
     three Phase III perampanel
     trials. Both adult and
     adolescent populations were
     included in the analysis.
    -------------------------------

    Perampanel Clinical Studies:
     Analysis of Psychiatric and
     Behavioral Events                  Poster Number: P3.268;

                                        Poster Session: 3

    This analysis of psychiatric and
     behavioral safety data provided
     context and additional detail
     for the serious psychiatric and
     behavioral reactions reported
     in perampanel clinical trials
     and described in the US
     prescribing information.
    --------------------------------

Important Safety Information

WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS

    --  Serious or life-threatening psychiatric and behavioral adverse reactions
        including aggression, hostility, irritability, anger, and homicidal
        ideation and threats have been reported in patients taking FYCOMPA
    --  These reactions occurred in patients with and without prior psychiatric
        history, prior aggressive behavior, or concomitant use of medications
        associated with hostility and aggression
    --  Advise patients and caregivers to contact a healthcare provider
        immediately if any of these reactions or changes in mood, behavior, or
        personality that are not typical for the patient are observed while
        taking FYCOMPA or after discontinuing FYCOMPA
    --  Closely monitor patients particularly during the titration period and at
        higher doses
    --  FYCOMPA should be reduced if these symptoms occur and should be
        discontinued immediately if symptoms are severe or are worsening

Serious Psychiatric and Behavioral Reactions

Hostility- and aggression-related adverse reactions occurred in 12% and 20% of clinical trial patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 6% of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of treatment, although new events continued to be observed through more than 37 weeks. These effects in FYCOMPA-treated patients led to dose reduction, interruption, and discontinuation more frequently than placebo-treated patients. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. Patients taking FYCOMPA should avoid the use of alcohol. Patients, their caregivers, and families should be informed that FYCOMPA may increase the risk of psychiatric events. Patients should be monitored during treatment and for at least one month after the last dose of FYCOMPA, and especially when taking higher doses and during the initial few weeks of drug therapy (titration period) or at other times of dose increases.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including FYCOMPA, increase the risk of suicidal thoughts or behavior in patients. Anyone considering prescribing FYCOMPA or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients, their caregivers, and families should be informed of the risk and advised to monitor and immediately report the emergence or worsening of depression, suicidal thoughts or behavior, thoughts about self-harm, and/or any unusual changes in mood or behavior. Should suicidal thoughts or behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Dizziness and Gait Disturbance

FYCOMPA caused dose-related increases in events related to dizziness and disturbance in gait or coordination. Dizziness and vertigo were reported in 35% and 47% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 10% of placebo-treated patients. Gait disturbance related events were reported in 12% and 16% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 2% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase.

Somnolence and Fatigue

FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 7% of placebo patients. Fatigue-related events were reported in 12% and 15% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 5% of placebo patients. In the controlled Phase III epilepsy clinical trials, these adverse reactions occurred mostly during the titration phase. Patients should be advised against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of FYCOMPA is known.

Falls

Falls were reported in 5% and 10% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 3% of placebo-treated patients.

Withdrawal of AEDs

A gradual withdrawal is generally recommended with antiepileptic drugs to minimize the potential of increased seizure frequency.

Most Common Adverse Reactions

In clinical trials, the most frequently reported dose-related adverse reactions in patients receiving FYCOMPA 8 mg or 12 mg vs placebo (>=4% and at least 1% higher than the placebo group) included dizziness (36% vs 9%), somnolence (16% vs 7%), fatigue (10% vs 5%), irritability (9% vs 3%), falls (7% vs 3%), nausea (7% vs 5%), ataxia (5% vs 0%), balance disorder (4% vs 1%), gait disturbance (4% vs 1%), vertigo (4% vs 1%), and weight gain (4% vs 1%).

Drug Interactions

FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of FYCOMPA were decreased when administered with carbamazepine, phenytoin and oxcarbazepine. Concomitant use with strong CYP3A inducers such as St. John’s wort and rifampin should be avoided. Multiple dosing of FYCOMPA 12 mg/day enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion, and depression. These effects may also be seen when FYCOMPA is used in combination with other CNS depressants.

Pregnancy Category C and Lactation

FYCOMPA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Physicians are advised to recommend that pregnant patients taking FYCOMPA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Caution should be exercised when FYCOMPA is administered to a nursing woman.

Hepatic and Renal Impairment

Use in patients with severe hepatic or severe renal impairment is not recommended. Dosage adjustments are recommended in patients with mild or moderate hepatic impairment. Use with caution in patients with moderate renal impairment.

Drug Abuse and Dependence

FYCOMPA is a Schedule III controlled drug substance and has the potential to be abused or lead to drug dependence.

Please see the FYCOMPA (perampanel) CIII Full Prescribing Information

About Epilepsy

Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. According to the Institute of Medicine, epilepsy is one of the most common neurological disorders, affecting 2.2 million people in the United States. About 60 percent of people with epilepsy have partial-onset seizures. In about 25 to 30 percent of patients with epilepsy, seizures cannot be controlled with treatment.

About FYCOMPA (perampanel)

FYCOMPA is an oral medication and is the first FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist. Glutamate is the primary excitatory neurotransmitter in the central nervous system. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans has not been fully elucidated.

Discovered and developed by Eisai, FYCOMPA has been approved in more than 30 countries.

FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets.

Epilepsy is a therapeutic area of focus for Eisai. The company continues to make further contributions to help address the diversified needs of epilepsy patients and their families as part of its corporate human health care (hhc) mission.

Eisai Inc.

At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.


    Media Inquiries         Investor Inquiries

    Laurie Landau           Alex Scott

    Eisai Inc.              Eisai Inc.

    201-746-2510            201-746-2177

    Laurie_Landau@eisai.com Alex_Scott@eisai.com

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SOURCE Eisai Inc.


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