First-In-Class Epilepsy Treatment Fycompa® (Perampanel) Now Available in Russia for Primary Generalised Tonic-Clonic Seizures

Hatfield, England (ots/PRNewswire) -

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

New anti-convulsant treatment to reduce serious seizures for
idiopathic generalised epilepsy, now available in Russia

Fycompa® (perampanel), a convenient, once-daily epilepsy
treatment, launches in Russia today, for primary generalised
tonic-clonic (PGTC) seizures in adults and adolescents (>=12 years)
with idiopathic generalised epilepsy (IGE).[1] The number of
anti-epileptic drugs (AEDs) licensed for the treatment of PGTC
seizures is limited[2] and as many as 20 percent (%) of people with
idiopathic generalised epilepsy (IGE) remain uncontrolled, despite
treatment.[3] Perampanel is the first new treatment for PGTC seizures
in IGE in five years.[4]

There are approximately 496, 920 people in Russia with epilepsy;
one third of these have idiopathic generalised epilepsy and
approximately 60% of these (103,525 people), will experience PGTC
seizures.[5],[6],[7] Perampanel offers clinicians a first-in-class
treatment that reduces PGTC seizures, which are dangerous epileptic
events.[8] These seizures increase the risk of injury, such as
fractured bones, shoulder dislocation and burns.[9] PGTC seizures
also increase the risk of sudden unexplained death in epilepsy
(SUDEP) and are known to lead to atypical absence status epilepticus
(ASE),[10] seizures that may last for extended time periods.

"Primary generalised tonic-clonic seizures can cause serious
injuries and can even be fatal. The availability of perampanel, which
reduces the frequency of seizures, is welcome news for Russian people
aged 12 years and over and living with this form of epilepsy,"
comments Elena Belousova, Director of Psychoneurology and
Epileptology, Moscow Research Institute of Paediatrics.

Grand mal (PGTC) 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.[11] While the seizure
generally lasts a few minutes, the person will often feel confused or
drowsy for up to a few minutes or up to a few hours, before returning
to normal.[8]

Perampanel is the first-and-only licensed AED to selectively
target the 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.[12] 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.[1]

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).[13] Perampanel
demonstrates a reduction in PGTC seizure frequency (per 28 days)
versus placebo (76.5% vs 38.4%, respectively; P<0.0001).[13]
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.[13]

In a global, double-blind, randomised, multicentre, parallel-group
study of 164 people with idiopathic generalised epilepsy and primary
generalised tonic-clonic seizures, the most common treatment-emergent
adverse events are dizziness, fatigue, headache, somnolence and
irritability.[13]

"The launch of perampanel is positive news for people living with
PGTC seizures in Russia. It ensures that people will be able to
access a new first-in-class treatment option to significantly improve
seizure control for people aged 12 years and above, living with
idiopathic generalized epilepsy," comments Olga Konopleva Sales and
Marketing Director, General Manager, Russia.

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® (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.

Since launch perampanel has helped treat 39,588 people living with
epilepsy across Europe.[14]

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

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.[11],[15] It 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 short
period of time before returning to normal.[8] PGTC seizures can also
result in risk of injury and sudden unexplained death in epilepsy
(SUDEP).[10]

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® (perampanel) is indicated for use as a once-daily,
adjunctive therapy for both primary generalised tonic-clonic
seizures in 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 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. Fycompa Summary of Product Characteristics (SPC), Available at:
http://www.medicines.org.uk/emc/medicine/26951 Accessed June 2015

2. Rheims S and Ryvlin P. Exp Opin Pharmacother.
2014;15:1417-1426.

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

4. Eisai. Data on file. 2015

5. Panayiotopoulous CP, The Epilepsies: Seizures, Syndromes and
Management. 2015. Bladan Medical Publishing

6. Hauser WA et al. Incidence of Epilepsy and Unprovoked Seizures
in Rochester, Minnesota: 1935-1982. 1993. Epilepsia 34(3);453-468

7. Hauser WA et al. The epidemiology of epilepsy in the Russian
Federation. Epilepsy Research (2010) Volume 92, Issues 2-3, Pages
209-218

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

9. Asadi-Pooya AA et al. Seizure 2012;21:165-168.

10. IGE Summary. Epilepsy Foundation http://www.epilepsy.com/infor
mation/professionals/about-epilepsy-seizures/idiopathic-generalized-e
pilepsies Accessed June 2015

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

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

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

14. Eisai. Data on file. 2015

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

Date of preparation: July 2015 Job code: Fycompa-UK0211

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

Contact:
Eisai
Cressida Robson/Ben Speller
+44(0)7908 314 155/+44(0)7908 409 416
Cressida_Robson@eisai.net
Ben_Speller@eisai.net / Tonic Life Communications
Elisabeth Neal/Deepa Patel
+44(0) 07896 954 865/+44(0)7725 440 867
Elisabeth.Neal@toniclc.com
Deepa.Patel@toniclc.com