First-in-class Epilepsy Treatment Fycompa® (perampanel) Receives Marketing Authorisation for Primary Generalised Tonic-clonic Seizures

Hatfield, England (ots/PRNewswire) -

New indication for anti-convulsant treatment to reduce serious
seizures for

idiopathic generalised epilepsy

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR AUSTRIA/SWISS/U.S.
JOURNALISTS

The European Commission (EC) has today granted marketing
authorisation approval for Fycompa(R) (perampanel), for use as a
once-daily, adjunctive therapy for primary generalised tonic-clonic
(PGTC) seizures in adults and adolescents (>12 years) with idiopathic
generalised epilepsy (IGE). The number of anti-epileptic drugs (AEDs)
licensed for the treatment of PGTC seizures is limited,[1] and
perampanel, the first new treatment for PGTC in IGE in five years,[2]
offers clinicians a first-in-class treatment that reduces PGTC
seizures. These seizures increase the risk of injury and sudden
unexplained death in epilepsy (SUDEP).

One third more patients experienced a reduction in seizure
frequency with perampanel over 28 days versus placebo (50% responder
rate 64.2% vs 39.5%, respectively; P=0.0019).[3] Perampanel further
demonstrates a reduction in PGTC seizure frequency (per 28 days)
versus placebo (76.5% vs 38.4%, respectively; P<0.0001).[4]
Furthermore, 31% of patients are seizure free during the 13-week
maintenance period when treated with perampanel as an adjunctive
therapy, compared to 12% in the placebo group.[3] The most common
treatment-emergent adverse events were dizziness, fatigue, headache,
somnolence and irritability.[3]

"Perampanel demonstrates significant seizure reduction, improved
seizure freedom rates and measurable improvements in quality of life,
providing physicians with a much needed new treatment option for
people living with this severe form of epilepsy. Using a
Fycompa-based treatment regime will give physicians another treatment
option for primary generalised tonic-clonic seizures, to ensure the
best quality of life is achieved at the earliest opportunity."
comments Bernhard Steinhoff, Medical Director and Executive Chief
Physician, Kork Epilepsy Centre, Germany.

Generalised tonic-clonic seizures can be a dangerous type of
epilepsy[4] and are associated with high levels of stigma.[5] The
seizures start with a loss of consciousness and a sudden contraction
of the muscles, which can cause the person to fall down (tonic
phase). This is followed by violent convulsions (clonic phase) until
the muscles finally relax.[6] While the seizure generally only lasts
a few minutes, the person will often feel confused or drowsy for a
few minutes or up to a few days before returning to normal.[4],[6]
Despite treatment, around 20% of people with idiopathic generalised
epilepsy remain uncontrolled.[7]

Perampanel is the only licensed anti-epileptic drug (AED) to
selectively target initiation and spread of seizures through
inhibition of AMPA receptors, a protein in the brain which plays a
critical role in the spread of seizures.[8] In addition, perampanel
has the added benefit of convenient, once-daily dosing at bedtime,
and is the only new generation partial epilepsy treatment approved to
treat adolescents (>12 years) with epilepsy from launch. Perampanel
is also indicated for the adjunctive treatment of partial-onset
seizures, with or without secondarily generalised seizures, in
patients with epilepsy aged 12 years and older.[9]

"Idiopathic generalised epilepsy affects the old, the young and
everyone in between. Now that perampanel has received marketing
authorization people across Europe will be able to benefit from a
first-in-class treatment option." commented Neil West, Vice
President, Global Neurology Business Unit, Eisai EMEA.

The continued development of perampanel underscores Eisai's human
health care mission, the company's commitment to innovative solutions
in disease prevention, cure and care for the health and well-being of
people worldwide. Eisai is committed to the therapeutic area of
epilepsy and addressing the unmet medical needs of patients with
epilepsy and their families. Eisai is proud to market more epilepsy
products in EMEA than any other company.

Notes to Editors

About Fycompa(R) (perampanel)

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.

Since launch perampanel has helped treat 33,496 people living with
epilepsy across Europe.[10]

Further information for healthcare professionals can be found at
http://www.eisai.co.uk

About Study 332[4]

Perampanel was administered via oral tablets, once daily, up to 8
mg/day (titration phase) and then maintained on maximum tolerated
dose (the 13 week maintenance phase). The study period was divided
into the pre-randomisation phase (screening and baseline periods): up
to 12 weeks, the randomisation phase (treatment): 17 weeks (titration
phase, 4 weeks; maintenance phase, 13 weeks) followed by an extension
phase.

This Phase III, double-blind, randomised, placebo-controlled,
multicentre, parallel-group trial evaluates the efficacy and safety
of adjunctive perampanel for refractory tonic-clonic seizures,
compared to placebo, amongst 164 patients aged 12 years and older
with PGTC seizures receiving one to maximum of three anti-epileptic
drugs. The study was conducted across centres in the U.S., Europe,
Japan and Asia.

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.[8],[10] Epilepsy is a
collection of syndromes that have many possible causes but often the
cause is unknown. 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.

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 few
minutes or up to a few days before returning to normal.[4],[6] PGTC
seizures can also result in risk of injury and sudden unexplained
death in epilepsy (SUDEP).[11]

About Eisai EMEA in Epilepsy

Eisai is committed to the development and delivery of 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(R) (perampanel) Perampanel is indicated for use as a once-daily,
adjunctive therapy for both primary generalised tonic-clonic seizures and for
adjunctive treatment of partial onset seizures, with or without secondary generalised
seizures, in patient patient with epilepsy aged 12 years or older.
- Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated
with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally
developed by Novartis)
- Zonegran(R) (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
generalisation, in adults, adolescents and children aged six years and above.
(Zonegran is under license from the originator Dainippon Sumitomo Pharma).
- Zebinix(R) (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. Rheims S and Ryvlin P. Exp Opin Pharmacother.
2014;15:1417-1426.

2. Eisai. Data on file. 2015

3. French J et al. Adjunctive Perampanel RCT for PGTC seizures.
Association of British Neurologists annual meeting 2015; Abstract
#53141

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

5. Bandstra, NF, et al. Stigma of Epilepsy. Can J Neurol Sci
2008:35:436-440

6. Epilepsy Action. Generalised seizures.
https://www.epilepsy.org.uk/info/seizures/generalised-seizures.
Accessed May 2015

7. Faught E. Rev Neurol Dis 2004;1:S34-S43

8. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug
target. Epilepsy Currents 2011;11:56-63.

9. Fycompa, Summary of Product Characteristics (updated September
2014) http://www.medicines.org.uk/emc/medicine/26951/

10. Pugliatti M et al. Estimating the cost of epilepsy in Europe:
A review with economic modeling. Epilepsia 2007: 48(12) 2224 - 2233.

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

Date of preparation: June 2015
Job code: Fycompa-UK0203

ots Originaltext: Eisai
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