New Data for Zonegran® (Zonisamide), Fycompa® (Perampanel) and Zebinix® (Eslicarbazepine Acetate) to be Presented at the

   New Data for Zonegran® (Zonisamide), Fycompa® (Perampanel) and Zebinix®
 (Eslicarbazepine Acetate) to be Presented at the World Congress of Neurology

  PR Newswire

  HATFIELD, England, September 21, 2013

HATFIELD, England, September 21, 2013 /PRNewswire/ --

           PRESS RELEASE FOR EUROPEAN MEDIA ONLY NOT FOR U.S. MEDIA

       Eisai demonstrates commitment to continuous research in epilepsy

New data from three abstracts on Eisai's epilepsy portfolio are to be
presented at this year's World Congress of Neurology (WCN) in Vienna. The
abstracts include a long-term safety and efficacy clinical study of Zonegran
^® (zonisamide) monotherapy, ^[1] and two real-life safety and efficacy
studies of Fycompa ^® (perampanel) ^[2] and Zebinix ^® (eslicarbazepine
acetate). ^[3][*]

The first abstract to be presented at the WCN on Sunday 22 September shows
that zonisamide monotherapy demonstrated favourable long-term safety and
maintenance of efficacy in the study group (n=295), with no new or unexpected
safety findings. ^[ ^1 ^] This double-blind, extension study looked at the
long-term safety and maintenance of efficacy of zonisamide versus
carbamazepine monotherapy for partial seizures in adults with newly diagnosed
epilepsy. The incidence of treatment-emergent adverse events (TEAEs) was
similar for both zonisamide and carbamazepine (52.6% vs. 46.2%) as was the
proportion of patients remaining seizure free for over 24 months (32.3% vs.
35.2%, intent to treat population). ^[ ^1 ^]

Zonisamide is an anti-epileptic drug (AED) with multiple mechanisms of action
and a structure which is chemically unrelated to any other AED. ^[4] In July
2012, zonisamide received EMA approval as monotherapy in the treatment of
partial seizures, with or without secondary generalisation, in adults with
newly diagnosed epilepsy. ^[ ^4 ^] Since March 2005, zonisamide has been used
as an adjunctive therapy in the treatment of partial seizures, with or without
secondary generalisation, in adults. ^[ ^4 ^]

Further data to be presented on Wednesday 25 September for eslicarbazepine
acetate show nearly 20% (19.8%) of patients achieved seizure freedom, of which
65% had 0-1 previous AED exposures. Over 50% (52%) experienced a 50% or
greater seizure frequency reduction. ^[ ^3 ^] This study focused on the safety
and efficacy of eslicarbazepine acetate in everyday clinical practice. Data
from the study were gathered in a retrospective, multicentre audit across
seven sites in the United Kingdom between 2009 and 2013 (n=202). Adverse
events reported were consistent with eslicarbazepine acetate's known safety
profile. ^[ ^3 ^]

--------------------------------------------------

[*]. Zebinix is under license from BIAL

Eslicarbazepine acetate is a third generation sodium channel blocker that
selectively targets slow inactivated sodium channels. It is indicated as
adjunctive therapy for adults with partial onset seizures, with or without
secondary generalisation, and has an oral, once-daily dose regimen. ^[5]

Additional data to be presented on Wednesday 25 September demonstrate that
perampanel is well tolerated and leads to a significant improvement in seizure
control for 22% of patients (75-100% reduction in seizure frequency). ^[ ^2 ^]
The study retrospectively examined data from 58 people who have received
perampanel since 2009 and looks specifically at treatment response and adverse
effects. The most common adverse effects reported include vertigo (31%),
fatigue (14%) and nausea (7%). Adverse effects, in particular vertigo, can be
avoided by taking perampanel immediately before bedtime or by dose reduction.
^[ ^2 ^] ^, ^[6]

Perampanel is the first and only licensed AED to selectively target AMPA
receptors postsynaptically, which play an important role in the spread of
epileptic seizures. ^[ ^6 ^] Perampanel can be given once-daily and is
indicated as adjunctive therapy for adolescents and adults with partial onset
seizures, with or without secondary generalisation. ^[ ^6 ^]

"We are delighted to present new data on our key epilepsy products at this
year's WCN and are committed to conducting long-term and real-life studies
such as these to increase our knowledge of these products and help people with
epilepsy across Europe," commented Jenny Brown, Strategic Alliance & Marketing
Director, Eisai EMEA. "The results demonstrate the strength and breadth of our
epilepsy portfolio, which offers a range of once-daily treatment options for
people with partial epilepsy, whether newly diagnosed or for those who require
multiple anti-epileptic agents."

The continued development of its epilepsy portfolio underscores Eisai's human
health care 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.
Eisai is proud to currently market more epilepsy products in EMEA than any
other company.

Notes to Editors

About Zonegran (zonisamide)

Zonisamide is licensed in Europe as monotherapy in the treatment of partial
seizures, with or without secondary generalisation, in adults with newly
diagnosed epilepsy. In addition, zonisamide is also indicated as adjunctive
therapy in the treatment of partial seizures, with or without generalisation,
in adults with epilepsy and has received European Medicines Agency's Committee
for Medicinal Products for Human Use (CHMP) positive opinion for its use as a
once-daily, adjunctive treatment of partial seizures, with or without
secondary generalisation, in children aged six and above. ^[7] It has a broad
spectrum of anti-epileptic modes of action and has no appreciable effects on
steady-state plasma concentrations of other AEDs, such as phenytoin,
carbamazepine and valproate. ^[ ^4 ^] Zonisamide is one of only four AEDs with
level A efficacy/effectiveness evidence as initial monotherapy for adults with
partial onset seizures. ^[8]

Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The
recommended daily dose for monotherapy use is 100mg once daily. In the third
and fourth weeks the dose may be increased to 200mg daily and then increased
to 300mg daily after the next two weeks. The recommended initial daily dose
for adjunctive use is 50mg in two divided doses. After one week the dose may
be increased to 100 mg daily and thereafter the dose may be increased at
weekly intervals, in increments of up to 100 mg. ^[ ^4 ^]

For more information please visit: http://www.zonegran.eu

About Fycompa (perampanel)

Perampanel is licensed in the European Union (EU) as an adjunctive treatment
for people aged 12 years and older with partial onset seizures, with or
without secondarily generalised seizures. ^[ ^5 ^]

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. ^[ ^5 ^]

For more information please visit: http://www.fycompa.eu

About Zebinix ^® (eslicarbazepine acetate)

Eslicarbazepine acetate is a voltage-gated sodium channel blocker. ^[9] It
selectively targets the slow inactivated state of the sodium ion channel ^[10]
^, ^[11] (which have been implicated in the pathogenesis of epilepsy), ^[12]
preventing its return to the active state, and thereby reduces repetitive
neuronal firing. ^[ ^9 ^] Recent studies have also demonstrated that
eslicarbazepine acetate effectively inhibits voltage-gated calcium channels,
therefore enhancing its potential as an anti-epileptic agent. ^[13] Further,
eslicarbazepine acetate does not inhibit potassium efflux, ^[14] which may
reduce the potential for repetitive neuronal firings. ^[15] The efficacy of
eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase
II study ^[ ^14 ^] and three subsequent phase III randomised, placebo
controlled studies in 1049 patients with refractory partial onset seizures.
^[16] ^, ^[17] ^, ^[18]

For more information please visit: http://www.eisai.co.uk

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. ^[19] ^, ^[20] 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 adult
    patients 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, France, Germany, Italy, Spain, Switzerland,
Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic,
Slovakia, the Netherlands, Belgium, Russia and the Middle East.

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



References

1. Baulac M, et al. A double-blind extension study to assess long-term
safety/efficacy of zonisamide versus carbamazepine monotherapy for treatment
of newly diagnosed partial epilepsy. WCN 2013 abstract 2015

2. Rohracher A, et al. Treatment response and adverse effects of perampanel
add-on treatment 58 patients with refractory focal epilepsy. WCN 2013 abstract
235

3. Keogh S, et al. Safety and efficacy of eslicarbazepine acetate (Zebinix) in
everyday clinical practice using a retrospective multicentre audit. WCN 2013
abstract 3219

4. Eisai Ltd 2013. Zonegran Summary of Product Characteristics [
http://www.medicines.org.uk/emc/medicine/16240/SPC/Zonegran+25%2c+50%2c+100+mg+Hard+Capsules
](last updated February 2013)

5. Eisai Ltd 2013. Zebinix Summary of Product Characteristics [
http://www.medicines.org.uk/emc/medicine/22376/SPC/Zebinix+800mg+tablets ]
(last updated April 2013)

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

7. Opinion of the Committee for Medicinal Products for Human use on a type II
variation to the terms of the marketing authorsation for Zonegran, European
Medicines Agency 2013

8. Glauser T. et al. Updated ILAE evidence review of antiepileptic drug
efficacy and effectiveness as initial monotherapy for epileptic seizures and
syndromes.
http://www.ilae.org/Visitors/Documents/Guidelines-epilepsia-12074-2013.pdf
[Accessed April 2013]

9. Almeida L, Soares-da-Silva P. Neurotherapeutics. 2007 Jan;4(1):88-96

10. Elger C et al. Epilepsia 2013; 54(8): 1453-1461.

11. Hebeisen S et al. Epilepsia 2012; 53 (Suppl. 5): 1-245.

12. Vilin YY and Ruben PC. Cell Biochem Biophys 2001; 35(2):171-190.

13. Brady K et al. Abstract presented at International Epilepsy Congress 2011
p858.

14. Elger et al. Epilepsia, 48(3):497-504, 2007

15. Soares-da-silva et al. Epilepsia. 52(Suppl. 6):23-263, 2011

16. Elger C, Halász P, Maia J et al. Epilepsia. 2009; 50(3):454-463

17. Ben-Menachem E, et al. Epilepsy Research 2010;89:278-285.

18. Gil-Nagel A, Lopes-Lima J, Maia J et al. Acta Neurol Scand 2009: 120:
281-28719. Epilepsy in the WHO European Region: Fostering Epilepsy Care in
Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
[Accessed 18 July 2012].

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

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



Date of preparation: September 2013 Job code: Perampanel-UK2139

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)207-798-9262 /+44-(0)207-798-9905,
frances.murphy@toniclc.com / nicola.lilley@toniclc.com
 
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