Key Data Highlight Positive Results for Fycompa® (Perampanel) at the American Epilepsy Society Annual Meeting 2015

Hatfield, England (ots/PRNewswire) -

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN/US
JOURNALISTS

Key data at the American Epilepsy Society (AES) 69th Annual
Meeting in Philadelphia, 4-8 December, will show results from 15
posters on the safety, efficacy, and long-term effects of adjunctive
Fycompa® (perampanel) in patients with epilepsy.

"These new data at AES 2015 reinforce Eisai's investment in
epilepsy treatment options with the potential to improve outcomes in
different patient populations. Epilepsy is a challenging condition to
manage, it is therefore important that we strive to find effective
treatments to support people with epilepsy," comments Neil West, Vice
President, Global Neurology Business Unit, Eisai EMEA.

The continued development of its epilepsy portfolio 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. Eisai is committed to the
therapeutic area of epilepsy and to address the unmet medical needs
of people with epilepsy and their families.

The following abstracts are accepted for presentation at the AES
annual meeting:

Abstract Number Abstract details

Abstract number: Effect of Adjunctive Perampanel in Pediatric
Subjects
#1.184 With Epilepsy: Preliminary Safety and Efficacy Results
Saturday 5 December From Study 232
12:00-14:00
Hall A, Level 200 Ronald Davis, Jose A. Ferreira, Dinesh Kumar,
Haichen
Yang, Antonio Laurenza,Sharon Dispoto

This analysis reports preliminary safety
and efficacy
findings from an open-label Phase II pilot
study of
perampanel oral suspension in pediatric
subjects aged 2
to <12 years old with epilepsy.

Abstract number: Pharmacokinetics of Perampanel in Children with
Epilepsy
#1.187 Aged 2-<12 Years
Saturday 5 December
12:00-14:00 Ben Renfroe, Yuko Umetsu, Mark Mintz, Sharon Dispoto,
Jim
Hall A, Level 200 Ferry, Bhaskar Rege, Haichen Yang, Antonio
Laurenza, Ziad
Hussein

This analysis reports the pharmacokinetics
of perampanel
as adjunctive therapy in children compared
to adolescents.

Abstract number: Efficacy of Perampanel by Baseline Seizure
Frequency in
#1.188 Patients with Partial Seizures (Phase III Double-Blind
Saturday 5 December Studies)
12:00-14:00
Hall A, Level 200 Ben Renfroe, Yuko Umetsu, Mark Mintz, Sharon
Dispoto, Jim
Ferry, Bhaskar Rege, Haichen Yang, Antonio
Laurenza, Ziad
Hussein

This analysis evaluates the efficacy of
perampanel in
subjects with drug-resistant partial
seizures based on
their seizure frequency at the time of
enrollment in
three Phase III perampanel double-blind
studies.

Abstract number: Suicidality Events in Patients With Primary
Generalized
#1.189 Tonic-Clonic Seizures (PGTCS): A Review of Study 332
Saturday 5 December
12:00-14:00 Alan B Ettinger, Ben Renfroe, Cindy Dobrinsky,
Haichen
Hall A, Level 200 Yang, Antonio Laurenza, Betsy Williams,Anna
Patten,
Francesco Bibbiani

This analysis of a randomized
double-blind,
placebo-controlled study of subjects 12
years of age or
older with uncontrolled PGTCS reviews
suicidal behavior
and ideation using adverse event reporting
and the
Columbia Suicide Severity Rating Scale
(C-SSRS).

Abstract number: Psychiatric and Behavioral Events with
Perampanel in
#1.190 Patients with Primary Generalized Tonic-Clonic Seizures
Saturday 5 December (PGTCS): Study 332
12:00-14:00
Hall A, Level 200 Cindy Dobrinsky, Alan B Ettinger, William
Rosenfeld,
Betsy Williams, Antonio Laurenza, Haichen
Yang, Anna
Patten, Francesco Bibbiani

This analysis of a randomized
double-blind,
placebo-controlled study of subjects 12
years of age or
older with uncontrolled PGTCS reviews
psychiatric and
behavioral events using adverse event
reporting to
further understand perampanel and
psychiatric and
behavioral events.

Abstract number: Subanalysis by Baseline Antiepileptic Drugs
(AEDs):
#1.191 Results From Perampanel Study 332 in Patients With
Saturday 5 December Primary Generalized Tonic-Clonic Seizures
(PGTCS)
12:00-14:00
Hall A, Level 200 Batool Kirmani, Antonio Laurenza, Haichen Yang,
Betsy
Williams, Anna Patten, Francesco Bibbiani

This sub-analysis evaluates the efficacy
and safety of
perampanel by baseline antiepileptic drugs
in subjects 12
years of age or older with uncontrolled
PGTCS and taking
1-3 concomitant antiepileptic drugs.

Abstract number: Review of Pregnancy Events in Perampanel
Clinical Studies
#1.192
Saturday 5 December Blanca Vazquez, Cindy Dobrinsky, Haichen
Yang, Betsy
12:00-14:00 Williams, Dinesh Kumar, Antonio Laurenza, Cynthia
Harden
Hall A, Level 200
This review compiles pregnancy data from
perampanel
clinical studies.

Abstract number: Effect of Duration of Epilepsy on Adjunctive
Perampanel
#1.193 Treatment in Patients With Drug-Resistant Partial
Saturday 5 December Seizures
12:00-14:00
Hall A, Level 200 Jonathan Halford, Haichen Yang, Betsy
Williams,Tony Ma,
Antonio Laurenza

This analysis reports efficacy results of
perampanel
adjunctive therapy in subjects with
drug-resistant
partial seizures stratified by duration of
epilepsy.

Abstract number: Analysis of Falls in the Phase III Perampanel
Study of
#1.194 Primary Generalized Tonic-Clonic Seizures (PGTCS)
Saturday 5 December
12:00-14:00 Ilo E Leppik, Betsy Williams, Tony Ma,Anna
Patten,Antonio
Hall A, Level 200 Laurenza, Francesco Bibbiani

This analysis is a systematic review of
reported falls
evaluated to establish whether the fall
was related to a
seizure.

Abstract number: Clinical Laboratory Evaluation and TEAEs Related
to
#1.195 Cardiac, Hepatic and Renal Disorders: Perampanel PGTC
Saturday 5 December Phase III Study
12:00-14:00
Hall A, Level 200 W. Alvin McElveen, David G. Vossler, Betsy
Williams,
Antonio Laurenza, Anna Patten, Francesco
Bibbiani

This analysis evaluated laboratory tests
and
treatment-emergent adverse events related
to these tests,
as well as cardiac-, hepatic- and
renal-related
treatment-emergent adverse events, in
subjects aged 12
years or older enrolled in a primary
generalized
tonic-clonic seizure Phase III study.

Abstract number: Long-Term Perampanel Treatment in Patients With
#1.196 Drug-Resistant Partial Seizures: greater than or equal
Saturday 5 December to 75% Responders and Seizure-Free Status
12:00-14:00
Hall A, Level 200 Haichen Yang, Gregory Krauss, Betsy Williams,
Tony
Ma, Antonio Laurenza

This analysis reports on subjects with
drug-resistant
partial seizures who have experienced a
75% reduction in
seizures or seizure freedom with long-term
perampanel
therapy.

Abstract number: Efficacy and tolerability of perampanel in
patients (pts)
#2.250 with secondarily generalized (SG) or primary generalized
Sunday 6 December tonic-clonic seizures (PGTC): a pooled analysis
of four
12:00-14:00 randomized, Phase III studies
Hall A, Level 200
Terence O'Brien, Anna Patten, Francesco
Bibbiani, Haichen
Yang, Betsy Williams, Antonio Laurenza

This post-hoc analysis evaluated efficacy
and
tolerability of perampanel across all four
Phase III
studies in patients with secondarily
generalized or
primary generalized tonic-clonic seizures.

Abstract number: Efficacy and safety of adjunctive perampanel
(PER) in
#2.263 adolescents with inadequately controlled partial-onset
Sunday 6 December seizures (POS): randomized, double-blind and
open-label
12:00-14:00 extension (OLE) study
Hall A, Level 200
Vicente Villanueva, Ben Renfroe, Haichen
Yang, Betsy
Williams, Dinesh Kumar, Antonio Laurenza

This is an analysis of long-term efficacy
and
tolerability of adjunctive perampanel from
the blinded
and open-label extension phases of Study
235, a
randomized, double-blind,
placebo-controlled Phase II
study of adjunctive perampanel in
adolescent patients
with inadequately controlled partial-onset
seizures.

Abstract number: Long-term cognitive effects of adjunctive
perampanel
#3.260 (PER) in adolescents for treatment of partial-onset
Monday 7 December seizures (POS): randomized, double-blind and
open-label
12:00-14:00 extension (OLE) study
Hall A, Level 200
Randi Fain, Kimford J Meador, Lieven
Lagae, Haichen Yang,
Betsy Williams, Dinesh Kumar, Antonio
Laurenza

This analysis is an examination of the
long-term
cognitive effects of adjunctive
perampanel, based on the
blinded and open-label extension phases of
Study 235.

Abstract number: Effect of adjunctive perampanel on growth and
development
#3.262 in adolescents with inadequately controlled partial-onset
Monday 7 December seizures (POS): randomized, double-blind and
open-label
12:00-14:00 extension (OLE) study
Hall A, Level 200
Dinesh Kumar, Lieven Lagae, J Eric Pina
Garza, Haichen
Yang, Betsy Williams, Antonio Laurenza

This is an analysis of the long-term
effects of
perampanel on growth and development of
adolescent
patients from the blinded and open-label
extension phases
of Study 235.

Notes to Editors

About Fycompa® (perampanel)

Perampanel is a highly selective, non-competitive AMPA
(alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type
glutamate receptor antagonist. 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. Perampanel is indicated for the adjunctive treatment for
partial onset seizures, with or without secondarily generalised
seizures, in patients with epilepsy aged 12 years and older and for
adjunctive treatment of primary generalised tonic-clonic seizures, in
patients with idiopathic generalised epilepsy.

Since launch, perampanel has helped treat 33,496 people living
with epilepsy across Europe.[1]

About Epilepsy

Epilepsy is one of the most common neurological conditions in the
world, affecting approximately 6 million 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 which
causes 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.

For the majority of idiopathic generalised epilepsy patients, a
primary generalised tonic-clonic (PGTC) seizure begins with or
without an aura, which is followed by rigid muscle. This leads to
violent muscle contraction (clonic phase) and a loss of
consciousness. As this is a serious event, it is seen as a major
hindrance on daily life. While the seizure generally only lasts a few
minutes, the patient will often feel confused or drowsy for a short
period of time before returning to normal.[4],[5] PGTC seizures can
also result in risk of injury and sudden unexplained death in
epilepsy (SUDEP).[6]

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:

- Fycompa® (perampanel) Perampanel is indicated for use as a
once-daily, adjunctive therapy for both primary generalised
tonic-clonic seizures with idiopathic generalised epilepsy and for
adjunctive treatment of partial onset seizures, with or without
secondary generalised seizures, in patients with epilepsy aged 12
years or older
- Inovelon® (rufinamide) for the adjunctive treatment of seizures
associated with Lennox-Gastaut Syndrome in patients >4 years.
(Rufinamide was originally developed by Novartis)
- Zonegran® (zonisamide) as monotherapy in the treatment of partial
seizures, with or without secondary generalisation, in adults with
newly diagnosed epilepsy and as adjunctive therapy in the treatment
of partial seizures, with or without secondary generalisation, in
adults, adolescents and children aged six years and above.
(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)

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based
pharmaceutical company headquartered in Japan. 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 our human health care (hhc) philosophy. With over 10,000
employees working across our global network of R&D facilities,
manufacturing sites and marketing subsidiaries, we strive to realise
our hhc philosophy by delivering innovative products in multiple
therapeutic areas with high-unmet medical needs, including Oncology
and Neurology.

As a global pharmaceutical company, our mission extends to
patients around the world through our investment and participation in
partnership-based initiatives to improve access to medicines in
developing and emerging countries.

For more information about Eisai Co., Ltd., please visit
http://www.eisai.com

References

1. Eisai Data on File, 2015

2. Epilepsy in the WHO European Region: Fostering Epilepsy Care in
Europe.
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
(Accessed November 2015)

3. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A
review with economic modeling. Epilepsia 2007:48(12):2224-33

4. Epilepsy Foundation. Types of seizures. Available at:
http://www.epilepsy.com/learn/types-seizures. (Accessed November
2015)

5. Epilepsy Foundation. IGE Summary. Available at: http://www.epil
epsy.com/information/professionals/about-epilepsy-seizures/idiopathic
-generalized-epilepies. (Accessed November 2015)

6. Smithson WH et al, Curr Neurol Neurosci Rep 2014 Dec;
14(12):502

Date of preparation: November 2015

Job code: Fycompa-UK0242

ots Originaltext: Eisai
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Eisai
Cressida Robson/Benjamin Speller
+44(0)7908 314 155/+44(0)845 676 1244
Cressida_Robson@eisai.net
Ben_Speller@eisai.net

Tonic Life Communications : Madeleine Nelson/Callum Haire
+44(0)7792473840/+44(0)7725440867
Madeleine.Nelson@toniclc.com
Callum.Haire@toniclc.com