Eisai Presents New Data Analyses on Fycompa® (Perampanel) at American Epilepsy Society Annual Meeting

Eisai Presents New Data Analyses on Fycompa® (Perampanel) at American Epilepsy
                            Society Annual Meeting

  PR Newswire

  HATFIELD, England, December 6, 2013

HATFIELD, England, December 6, 2013 /PRNewswire/ --

Eisai today announced that 16 abstracts highlighting new data analyses on
Fycompa ^® (perampanel) will be presented at the 67th annual American Epilepsy
Society (AES) meeting in Washington, D.C. between 6-10 December. Perampanel is
indicated in the European Union (EU) for the adjunctive treatment of
partial-onset seizures, with or without secondarily generalised seizures, in
patients with epilepsy aged 12 years and older. ^[1]

"These data analyses highlight Eisai's clinical research with Fycompa and
reinforce our commitment to the epilepsy community," commented Lynn Kramer,
MD, President of the Neuroscience and General Medicine Product Creation Unit
and Chief Clinical Officer of Eisai Product Creation Systems, Eisai's research
and development organisation.

The following abstracts regarding perampanel will be presented at this year's
AES Meeting:

    Abstract Number Abstract Name
                    Assessment of Liver Toxicity in Perampanel-Treated
    1.140           Subjects: Pooled Results From Phase III Clinical Trials

    Poster Session  Antonio Laurenza, Haichen Yang, Betsy Williams, Sharon
    1               Zhou, Jim Ferry
                    Lack of Effect of Perampanel on QT Interval Duration:
                    Results From a Thorough QT Analysis and Pooled Phase III
                    Clinical Trials
    1.141
                    Haichen Yang, Antonio Laurenza, Betsy Williams, Anna
    Poster Session  Patten, Ziad Hussein, Jim Ferry
    1               Efficacy and Safety of Perampanel in the Subgroup of
                    Elderly Patients Included in the Phase III Epilepsy
    1.142           Clinical Trials

    Poster Session  Betsy Williams, Robert Wechsler, Antonio Laurenza, Haichen
    1               Yang, Sharon Zhou, Ilo Leppik
                    Pharmacokinetics of Perampanel: Results From Phase I
    1.143           Clinical Pharmacology Studies

    Poster Session  Barry E. Gidal, Antonio Laurenza, Haichen Yang, Betsy
    1               Williams, David A. Verbel, Jim Ferry
                    GABA vs. Non-GABA Mechanism of Action of Concomitant
                    Antiepileptic Drugs: Post-hoc Analysis of Pooled
    1.144           Perampanel Phase III Studies

    Poster Session  Mare Muller, Haichen Yang, Betsy Williams, Tony Ma,
    1               Antonio Laurenza, Steve Chung
                    Subgroup Analysis by Gender in Perampanel Phase III
    1.145           Studies of Patients Diagnosed With Partial-Onset Seizures

    Poster Session  Blanca Vazquez, Haichen Yang, Betsy Williams, Sharon Zhou,
    1               Antonio Laurenza
                    Review of Psychiatric and Behavioral Events in Perampanel
    1.146           Clinical Studies

    Poster Session  Alan B. Ettinger, Antonia LoPresti, Haichen Yang, Betsy
    1               Williams, Sharon Zhou, Randi Fain, Antonio Laurenza
                    Pooled Perampanel Phase III Trials: Time to Onset and
    1.147           Duration for Most Common Adverse Events

    Poster Session  David Ko, Haichen Yang, Betsy Williams, Dongyuan Xing,
    1               Antonio Laurenza
    1.154           Evaluation of Abuse Potential of Perampanel

    Poster Session  Jim Ferry, Haichen Yang, Betsy Williams, Kate Bradshaw,
    1               Reginald V. Fant, Antonio Laurenza
                    Efficacy and Safety of Adjunct Perampanel Based on Number
                    of Antiepileptic Drugs at Baseline and Baseline Predictors
    1.230           of Efficacy: Phase III Post-Hoc Analysis

    Poster Session  Tracy Glauser, Antonio Laurenza, Haichen Yang, Betsy
    1               Williams, Dongyuan Xing, Randi Fain
                    Lesional vs. Non-lesional Partial Epilepsy: Post-hoc
    2.048           Analysis of Pooled Perampanel Phase III Studies

    Poster Session  Stephanie Marsh, Haichen Yang, Betsy Williams, Steve
    2               Huang, Antonio Laurenza, Steve Chung
                    Efficacy and Safety of Perampanel in Patients With
                    Neurologic & Psychiatric Comorbidities: Post-hoc Analysis
    2.049           of Phase III Epilepsy Trials

    Poster Session  David Squillacote, Haichen Yang, Betsy Williams, Sharon
    2               Zhou, Antonio Laurenza, Victor Biton
                    Analysis of Aggression in Perampanel Phase III Epilepsy
    2.050           Clinical Trials

    Poster Session  Antonia LoPresti, Alan B. Ettinger, Haichen Yang, Betsy
    2               Williams, Sharon Zhou, Randi Fain, Antonio Laurenza
                    Effect of Ketoconazole on Perampanel Pharmacokinetics
    2.063
                    Rama Maganti, Antonio Laurenza, Haichen Yang, Betsy
    Poster Session  Williams, David A. Verbel, Edgar Schuck, Jim Ferry, Barry
    2               E. Gidal
                    Exploration of Adverse Events by Region, and Detailed
                    Focus on Psychiatric Events, With Long-term Open-label
                    Perampanel Treatment
    2.148
                    Elinor Ben-Menachem, Gregory Krauss,
    Poster Session
    2               Michelle Gee, Makarand Bagul, Dinesh Kumar
                    Long-term Retention, and Reasons for Discontinuations,
                    With Perampanel Treatment in Pharmacoresistant Focal
    3.211           Seizures

    Poster Session  Jerry Shih, Emilio Perucca, Michelle Gee, Makarand Bagul,
    3               Dinesh Kumar

The on-going research into perampanel underscores Eisai's human health care
(hhc) mission, the company's commitment to innovative solutions in disease
prevention, cure and care for the health and wellbeing of people worldwide.

Notes to Editors

About Perampanel

Perampanel is licensed in the European Union (EU) for the adjunctive treatment
of partial-onset seizures with or without secondarily generalised seizures in
patients with epilepsy aged 12 years and older. ^[ ^1 ^]

Perampanel is a highly selective, non-competitive AMPA
(alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate
receptor antagonist that has demonstrated seizure reduction in Phase II and
III studies. AMPA receptors, widely present in almost all excitatory neurons,
transmit signals stimulated by the excitatory neurotransmitter glutamate
within the brain and are believed to play a role in central nervous system
diseases characterised by excess neuroexcitatory signalling including
epilepsy. ^[ ^1 ^]

Further information for healthcare professionals can be found at
http://www.fycompa.eu

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world,
affecting approximately eight in 1,000 people in Europe, and an estimated 50
million people worldwide. ^[2] ^, ^[3] Epilepsy is a chronic disorder of the
brain that affects people of all ages. It is characterised by abnormal
discharges of neuronal activity causing seizures. Seizures can vary in
severity, from brief lapses of attention or jerking of muscles, to severe and
prolonged convulsions. Depending on the seizure type, seizures may be limited
to one part of the body, or may involve the whole body. Seizures can also vary
in frequency from less than one per year, to several per day. Epilepsy has
many possible causes but often the cause is unknown.

About Eisai EMEA in Epilepsy

Eisai is committed to developing and delivering highly beneficial new
treatments to help improve the lives of people with epilepsy. The development
of AEDs is a major strategic area for Eisai in Europe, the Middle East,
Africa, Russia and Oceania (EMEA).

In the EMEA region, Eisai currently has four marketed treatments including:

  *Zonegran ^® (zonisamide) as monotherapy and adjunctive therapy in adults,
    adolescents and children above the age of 6 with partial-onset seizures,
    with or without secondary generalisation. (Zonegran is under license from
    the originator Dainippon Sumitomo Pharma)
  *Zebinix ^® (eslicarbazepine acetate) as adjunctive therapy in adult
    patients with partial-onset seizures, with or without secondary
    generalisation. (Zebinix is under license from BIAL)
  *Inovelon ^® (rufinamide) for the adjunctive treatment of seizures
    associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide
    was originally developed by Novartis)
  *Fycompa ^® (perampanel) for use as an adjunctive treatment for
    partial-onset seizures, with or without secondarily generalised seizures,
    in patients with epilepsy aged 12 years and older

About Eisai

Eisai is one of the world's leading research and development (R&D) based
pharmaceutical companies and we define our corporate mission as "giving first
thought to patients and their families and to increasing the benefits health
care provides," which we call human health care ( hhc ).

Eisai concentrates its R&D activities in three key areas:

  *Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight
    loss
  *Oncology including: anticancer therapies; tumour regression, tumour
    suppression, antibodies, etc.
  *Vascular/Immunological reaction including: thrombocytopenia, rheumatoid
    arthritis, psoriasis, inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of
Japan, Eisai employs more than 10,000 people worldwide. From its EMEA
Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business
operations to include Europe, the Middle East, Africa, Russia and Oceania
(EMEA). Eisai EMEA has sales and marketing operations in over 20 markets,
including the United Kingdom, Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Ireland, Italy, Norway, Portugal, Russia, Slovakia,
Spain, Switzerland, Sweden, the Netherlands and the Middle East.

For further information please visit our web site http://www.eisai.co.uk

References

1. Fycompa. Summary of Product Characteristics (updated November 2012)
http://www.medicines.org.uk/emc/medicine/26951/SPC/Fycompa+2mg%2c4mg%2c6mg%2c8mg%2c10mg%2c12mg+film-coated+tablets/
[
http://www.medicines.org.uk/emc/medicine/26951/SPC/Fycompa+2mg%2c4mg%2c6mg%2c8mg%2c10mg%2c12mg+film-coated+tablets
]

2. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [
http://www.ibe-epilepsy.org/downloads/EURO Report 160510.pdf ] [Accessed 18
July 2012].

3. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224–2233.

Date of preparation:December 2013 Job code: perampanel-UK2145

Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte
Andrews, +44(0)7908-314-155 / +44(0)7947-231-513, Cressida_Robson@eisai.net,
Charlotte_Andrews@eisai.net. Tonic Life Communications, Frances Murphy /
Nicola Lilley, +44(0)207798-9262 / +44-(0)207-798-9905,
frances.murphy@toniclc.com, nicola.lilley@toniclc.com
 
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