First-in-class Epilepsy Treatment Fycompa® (Perampanel) Launches In Portugal

Hatfield, England (ots/PRNewswire) -

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

Fycompa(R) (perampanel), the first in an entirely new class of
treatment for partial onset seizures (the most common form of
epilepsy), launches today in Portugal. The therapy is indicated for
the adjunctive treatment of partial onset seizures, with or without
secondary generalised seizures, in patients with epilepsy aged 12
years and older.[1]

Perampanel is the only licensed anti-epileptic drug (AED) to
selectively target AMPA receptors, a protein in the brain which plays
a critical role in the spread of seizures.[2] This mechanism of
action is different to other currently available AEDs. In addition,
perampanel has the added benefit of convenient, once-daily dosing at
bedtime[1] and, significantly, is the only new-generation partial
epilepsy treatment approved to treat adolescents (>12 years) with
epilepsy from launch.

Epilepsy is one of the most common neurological conditions in the
world, and in Europe approximately six million people live with the
condition.[3] The successful treatment of partial onset seizures
remains a significant challenge in some patients and the incidence of
uncontrolled partial epilepsy remains high despite the existence of
many AEDs. Currently, between 20-40% of patients with newly diagnosed
epilepsy will become refractory to treatment.[4]

"New treatment options like perampanel are very important for
people with partial onset epilepsy in Portugal who live with
uncontrolled seizures. Epilepsy remains a challenging condition to
treat and new treatment options with a different mode of action are
welcomed by doctors." comments Nuno Canas, Department of Neurology,
Hospital Egas Moniz.

Perampanel's launch in Portugal is based on three randomised,
double-blind, placebo-controlled and dose-escalated global pivotal
Phase III studies (304, 305, 306)[5], [6],[7] and an open extension
study (307)[8]. The three global pivotal studies show consistent
results in the efficacy and tolerability of perampanel as an
adjunctive therapy in people with partial onset seizures, with or
without secondary generalised seizures. The most commonly reported
adverse events were dizziness, somnolence, fatigue, headache, falls,
irritability and ataxia.[6],[7],[8] Results from the open extension
study also demonstrate perampanel's efficacy and favorable
tolerability profile over the longer term. [9]

The launch of perampanel in Portugal 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 addressing the unmet medical needs of patients
with epilepsy and their families.

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.[1]

About Epilepsy

Epilepsy is one of the most common neurological conditions in the
world, affecting approximately six million people in Europe, and an
estimated 50 million people worldwide. [9],[10] 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:

- Fycompa(R) (perampanel) for use as an adjunctive treatment for partial onset
seizures, with or without secondary generalised seizures, in patients with epilepsy
aged 12 years and 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 generalised seziures, in adults with newly diagnosed epilepsy and as
adjunctive therapy in the treatment of partial seizures, with or without secondary
generalised, in adults, adolescents and children aged six years and above. (Zonegran
is under license from the originator company Dainippon Sumitomo Pharma).

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 (updated September
2014): http://www.medicines.org.uk/emc/medicine/26951

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

3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering
Epilepsy Care in Europe 2010. Available at; http://www.ilae.org/Visit
ors/Documents/ILAEAnnual-Report2010Final_000.pdf (Accessed July 2015)

4. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia
2007: 48 (Suppl1) 3 - 7

5. French JA et al. Adjunctive perampanel for refractory
partial-onset seizures: randomized phase III study 304. Neurology
2012:79(6):589-596

6. French JA et al. Evaluation of adjunctive perampanel in
patients with refractory partial-onset seizures: Results
of randomized global phase III study 305. Epilepsia
2013:54(1):117-125

7. Krauss GM et al. Randomized phase III study 306: Adjunctive
perampanel for refractory partial-onset seizures. Neurology
2012:78(18):1408-1415

8. Krauss GL et al. Long-term safety of perampanel and seizure
outcomes in refractory partial-onset seizures and secondarily
generalised seizures: Results from Phase III extension study 307.
Epilepsia 2014;55:1058-1068

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

10. 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: August 2015

Job code: Perampanel-UK2187

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

Contact:
Media Enquiries
Eisai
Cressida Robson / Ben Speller
+44(0)7908-314-155/+44(0)7947-231-513
Cressida_Robson@eisai.net
Ben_Speller@eisai.net

Tonic Life Communications
Elisabeth Neal / Deepa Patel
+44(0)7896-954-865 /+44(0)7725-440-867
Elisabeth.Neal@toniclc.com
Deepa.Patel@toniclc.com