Novel Once-Daily Epilepsy Treatment now Available in France

Hatfield, England (ots/PRNewswire) -

Reimbursement granted for Zebinix(R) as adjunctive therapy
for adults with

partial-onset seizures

Eisai Europe Limited announces the launch of Zebinix(R)
(eslicarbazepine acetate) in France. Upon launch, this novel epilepsy
drug will receive full reimbursements from the French health
authorities.

Once-daily eslicarbazepine acetate is indicated as an adjunctive
(add-on) therapy for adults with partial-onset seizures, with or
without secondary generalisation (where the seizure extensively
affects a patient's consciousness by spreading to both sides of the
brain).[1]

"Whilst epilepsy can be managed with medication, a third of
epilepsy patients still suffer from uncontrollable seizures after
treatment, putting them at risk of poor health, reduced likelihood of
employment and an increased risk of psychological comorbidities, such
as depression and anxiety,[2] commented, Arnaud Biraben, Consultant
Neurologist, Pontchaillou Hospital, France. "The launch of
eslicarbazepine acetate in France is a welcome addition to our
treatment armamentarium which may help uncontrolled patients manage
their condition and see an improvement in their health-related
quality of life".

Epilepsy is one of the most common neurological disorders
affecting more than six million people across Europe.[3] In France,
in excess of 500,000 patients suffer from the condition with an
annual cost to health services estimated at more than EUR3.5
billion.[4]

Dr Bettina Bauer, Head of EU Epilepsy Business Unit, Eisai Europe
Ltd commented; "The availability of Zebinix(R) in France provides
patients with uncontrolled seizures a new option that may help to
match their individual treatment needs." She added; "Eisai is
committed to provide patients and their families with improved
quality of life by bringing effective treatments to those that need
it, as displayed by our human health care mission".

"The launch of Zebinix(R) is a positive step for patients in
France who do not achieve adequate seizure control, commented Michaël
Perrin, Director of Eisai Epilepsy franchise. Eisai is working with
the regional health authorities to ensure the treatment is available
as soon as possible to patients that require it the most".

Eslicarbazepine acetate was approved in April 2009 by the
European Commission following data which showed that it reduces
seizure frequency and has an overall positive efficacy and safety
profile.[1,5] Eslicarbazepine acetate is already available in
Albania*, Austria, Czech Republic, Cyprus*, Denmark, England,
Finland, Germany, Greece, Iceland, Malta*, Norway, Portugal*,
Republic of Ireland, Scotland, Sweden, Spain (co-promotion with BIAL,
the developer of Zebinix (R)) and Wales.

*Exclusively by BIAL

Notes to Editors

Zebinix(R) is the EU trade name for eslicarbazepine acetate

Zebinix(R) is under license from BIAL

About epilepsy, partial-onset seizures and their treatment

Epilepsy is a chronic neurological disease characterised by
abnormal discharges of neuronal activity causing seizures. Depending
on the seizure type, seizures may be limited to one part of the body,
or may be generalised to involve the whole body. Patients may also
experience abnormal sensations, altered behaviour or altered
consciousness. Epilepsy is a disorder with many possible causes.
Often the cause of epilepsy is unknown. However, anything that
disturbs the normal pattern of neuron activity - from illness to
brain damage to tumours, can lead to seizures.[6]

Epilepsy is characterised by abnormal firing of impulses from
nerve cells in the brain. In partial-onset seizures, these bursts of
electrical activity are initially focused in specific areas of the
brain,[7] but may become more generalised;[7] the symptoms vary
according to the affected areas.[8]

Treatment of partial-onset seizures, the most common type of
epilepsy, presents a constant challenge - Up to 30% of patients with
partial seizures do not achieve remission despite appropriate therapy
with anti-epileptic drugs.[9] Hence, there is a need for new
anti-epileptic agents that offer effective reduction in seizure
frequency.

About Zebinix(R)(eslicarbazepine acetate)

Eslicarbazepine acetate is indicated as adjunctive therapy in
adults with partial-onset seizures with or without secondary
generalisation.[1] Eslicarbazepine acetate is a once-daily,
voltage-gated sodium channel blocker.[10,11] It preferably targets
the inactivated state of the sodium ion channel, preventing its
return to the active state, and thereby reduces repetitive neuronal
firing.[11] The efficacy of eslicarbazepine acetate was demonstrated
in an initial proof-of-concept phase II study[12] and three
subsequent phase III randomised, placebo controlled studies in 1049
patients with refractory partial onset seizures.[10,13,14]

Clinical data

The EU approval was based on data from a phase II and three phase
III clinical trials.[10,12,13,14] Patients recruited in the phase III
trials had a history of at least four partial seizures per month
despite treatment between one to three concomitant anti-epileptic
drugs.[10,13,14]

During the trials, patients were randomised to various dosages of
Zebinix(R) or placebo and after a 2-week titration period, were
assessed over a 12-week maintenance period, with continued follow-up
over a one year open-label period.[10,13,14]

Efficacy

Over the 12-week maintenance period, Zebinix(R) 800mg and 1200mg
once-daily significantly reduced seizure frequency, and was
significantly more effective than placebo.[10,13,14,15] Long-term
safety and maintenance of therapeutic effect was demonstrated in
one-year open-label extensions of these studies. [15,16,17]

Tolerability and drug interactions [10,12,13,14,18]

In the Phase III clinical trials adverse events mainly occurred
during the first 6 weeks of treatment and the majority of patients
experienced adverse events of mild to moderate intensity. After the
initial 6 weeks of treatment there were no observed differences in
the incidence of side effects between patients treated with
Zebinix(R) and the placebo group. The most common treatment-emergent
adverse events in the pivotal studies were dizziness, headache and
somnolence.

License Agreement

Eisai Europe Limited , a European subsidiary of Eisai Co., Ltd. ,
announced in February 2009 that it had entered into a license and
co-promotion agreement with BIAL - Portela & C(a), S.A.
(Headquarters: São. Mamede do Coronado, Portugal, Chairman: Luís
Portela & CEO: António Portela, "BIAL"), which gave Eisai Europe
Limited rights to sell BIAL's anti-epileptic drug
Zebinix(R)(eslicarbazepine acetate) in Europe.

About Eisai Europe 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 the
European market.

In Europe, Eisai currently has three marketed treatments
including:

- Zonegran(R) (zonisamide) as adjunctive therapy in adult patients with
partial-onset seizures, with or without secondary generalisation
- Zebinix(R) (eslicarbazepine acetate) as adjunctive therapy in adult patients
with partial-onset seizures, with or without secondary generalization
- Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated
with Lennox-Gastaut Syndrome in patients >4 years

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical
companies and has defined its 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
recently expanded their UK Hatfield facility which now supports the
company's growing European, Middle Eastern and African (EMEA)
business.

Eisai concentrates its R&D activities in three key areas:

- Neuroscience, including: Alzheimer's disease, multiple sclerosis,
neuropathic pain, epilepsy, depression
- Oncology including: anticancer therapies; tumour regression, tumour
suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
- Vascular/Immunological reaction including: acute coronary syndrome,
atherothrombotic disease, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home
market of Japan, Eisai employs more than 11,000 people worldwide. In
Europe, Eisai undertakes sales and marketing operations in over 20
markets, including the United Kingdom, France, Germany, Italy, Spain,
Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway,
Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, and
Belgium.

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

About BIAL

Founded in 1924, BIAL is an international pharmaceutical group
with products available in more than 40 countries throughout four
continents. BIAL is a privately held Portuguese research based
pharmaceutical company and the largest Portuguese pharmaceutical
company, based in S. Mamede do Coronado, Portugal, responsible for
the research and development of eslicarbazepine acetate (Zebinix(R)).

It is the partner of choice for many companies, having a strong
presence in the Iberian Peninsula as well as in over 10 countries in
Latin America and in around 20 French or Portuguese speaking African
countries.

BIAL is strongly committed to therapeutic innovation investing
more than 20% of its turnover in research and development every year.
Key research areas for BIAL are the central nervous system, the
cardiovascular system and allergen immunotherapy. BIAL currently has
several other innovative programs under development, which the
company expects to bring to the market within the next years, thereby
strengthening its position throughout Europe.

Further information about BIAL can be found at
http://www.bial.com

References
1. Summary of Product Characteristics Zebinix(R) (eslicarbazepine acetate)(updated
November 2011)
2. Titlic, M. Basic, S. Hajnek, S. Comorbidity psychiatric disorders in epilepsy: a
review of literature. Bratisl Lek Listy (Bratislava Medical Journal) 2009; 110 (2): 105
- 109
3. Epilepsy must become a higher priority in Europe. The Lancet Neurology. 2010 Oct;
9(10): 941
4. Comité National Epilepsie (Last accessed 21.02.2012)
http://www.comite-national-epilepsie.fr
5. Cramer JA, Elger C, Halasz P, et al, editors. An evaluation of quality of life and
depressive symptoms during long-term treatment with eslicarbazepine acetate:
BIA-2093-301 study [abstract 3.197]. American Epilepsy Society Congress; 2008 5-9
December; Seattle, WA.
6. Epilepsy Research UK. What is Epilepsy? Fact sheet. Avaiable from URL:
http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm (accessed March
2012)
7. Epilepsy Action. Describing Seizure Types. Avaiable at URL
http://www.epilepsy.org.uk/info/seizures/ataglance (Accessed March 2012)
8. NHS Choices. Symptoms of Epilepsy. Available at URL
http://www.nhs.uk/Conditions/Epilepsy/Pages/Symptoms.aspx (Accessed March 2012)
9. Rauchenzauner M, Luef G. Update on the treatment of partial onset epilepsy: a role
of eslicarbazepine. Neurophsyiactric Disease and Treatment. 2010 Nov; 6(1): 723-730
10. Elger C, Halász P, Maia J et al. Efficacy and safety of eslicarbazepine acetate as
adjunctive treatment in adults with refractory partial-onset seizures: A randomized,
double-blind, placebo-controlled, parallel-group phase III study. Epilepsia 2009;
50(3):454-463.
11. Almeida L, Soares-da-Silva P. Eslicarbazepine acetate (BIA 2-093).
Neurotherapeutics. 2007 Jan;4(1):88-96.
12. Elger et al. Eslicarbazepine Acetate: A Double-blind, Add-on Placebo-controlled
Exploratory Trial in Adult Patients with Partial-onset seizures. Epilepsia,
48(3):497-504, 2007
13. Ben-Menachem E, Gabbai A, Hufnagel A, Maia J, Almeida L, Soares-da-Silver P.
Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy;
Epilepsy Research 2010;89:278-285.
14. Lopes-Lima J, Gil-Nagel A, Maia J et al. Efficacy and safety of 800 and 1200 mg
eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset
seizures. Acta Neurol Scand 2009: 120: 281-287.
15. Halász P, Elger C, Guekht A, et al. Long-term efficacy and safety of
eslicarbazepine acetate: Results of a 1-year open-label extension study in
partial-onset seizures in adults with epilepsy. Epilepsia, 51(10):1963-1969, 2010.
16. Lopes-Lima J, Gil-Nagel A, Maia J, et al. Long-term treatment of partial epilepsy
with eslicarbazepine acetate (ESL): results of a one-year open-label extension of study
BIA-2093-303 (Abstract No. 3.227). Epilepsia. 2008;49(Suppl. 7):441-2.
17. Gabbai A, Ben-Menachem E, Maia J, et al. Long-term treatment of partial epilepsy
with eslicarbazepine acetate (ESL): results of a one-year open-label extension of study
BIA-2093- 302 (Abstract No. 3.208). Epilepsia. 2008;49(Suppl. 7):432-3.
18. Cramer J, Maia J, Almeida L, et al. Quality-of-life improvement during long-term
treatment with eslicarbazepine acetate (Abstract No. T278) Epilepsia 2009:50 (Suppl.
4):123.

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

Contact:
Media Enquiries, Eisai Europe Ltd, Cressida Robson,
+44-7908-314-155, Cressida_Robson@eisai.net; Tonic Life
Communications,
Benjamyn Tan / Leah Peyton,
+44-(0)207-798-9262, +44-(0)7788-191434,
benjamyn.tan@toniclc.com / eisaiepilepsy@toniclc.com