Once-Daily Epilepsy Treatment now Available in Sweden

Hatfield, England (ots/PRNewswire) -

?

Reimbursement granted for Zebinix(R) (eslicarbazepine
acetate) as adjunctive

therapy for adults with partial-onset seizures

Eisai Europe Limited today announces the launch of Zebinix(R)
(eslicarbazepine acetate) which will receive full reimbursement from
the Swedish health authorities.

Once-daily Zebinix is indicated as an adjunctive (add-on) therapy
for adults with partial-onset seizures, with or without secondary
generalisation.[1]

"Up to a third of epilepsy patients do not achieve adequate
seizure control after their first anti-epileptic treatment, there is
therefore a key medical need for effective adjunctive therapeutic
options for epilepsy patients. Zebinix will provide clinicians in
Sweden with an important additional treatment option to help patients
with uncontrollable seizures manage their condition", [2] said
Professor Elinor Ben-Menachem, Department of Clinical Neuroscience
and Physiology Sahlgrenska Academy University of Göteborg, Sweden.

Epilepsy is one of the world's most common neurological
disorders. The disease affects more than six million people across
Europe,[3] and at least 60,000 people in Sweden.[4] The total health
care costs and productivity losses due to epilepsy in Sweden is
estimated at EUR441million, corresponding to an annual per-patient
cost of EUR8,275.[5]

Dr Sten Friberg, Nordic Medical Director, Eisai Europe Ltd
commented; "Eisai is committed to bringing effective treatments to
patients to help improve their quality of life, as displayed by our
human health care mission. Studies have shown Zebinix to be effective
in reducing seizure frequency and provide significant improvements to
the patient's quality of life.[6,7,8,9,10,11] The launch will provide
patients in Sweden with an effective option to manage their
seizures."

Eslicarbazepine acetate was approved by the European Commission
following data which showed that it reduces seizure frequency and has
an overall positive efficacy and safety profile.[6-8] Eslicarbazepine
acetate is already available in Albania*, Austria, Czech Republic,
Cyprus*, Denmark, England, Finland, France, Germany, Greece, Iceland,
Malta*, Norway, Portugal*, Republic of Ireland, Scotland, Sweden,
Spain (co-promotion with BIAL, the developer of Zebinix) 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.[12]

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,[13] but may become more generalised;[13]the symptoms vary
according to the affected areas.[14]

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.[15] 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.[16] It selectively targets the
inactivated state of the sodium ion channel, preventing its return to
the active state, and thereby reduces repetitive neuronal firing.[16]
Recent studies have also demonstrated that eslicarbazepine acetate
effectively inhibits voltage-gated calcium channels, therefore
enhancing its potential as an anti-epileptic agent.[17] The efficacy
of eslicarbazepine acetate was demonstrated in an initial
proof-of-concept phase II study[18] and three subsequent phase III
randomised, placebo controlled studies in 1049 patients with
refractory partial onset seizures.[6-8]

Clinical data

The EU approval was based on data from a phase II and three phase
III clinical trials.[6-8,18] 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.[6-8]

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.[6-11]

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.[6-8,18] Long-term safety
and maintenance of therapeutic effect was demonstrated in one-year
open-label extensions of these studies.[9-11]

Tolerability and drug interactions[6-8,18]

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:

- 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 generalisation (Zebinix is
under licensed from BIAL)
- 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 50 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. Svenska Epilepsiförbundet. Worthwhile to know about epilepsy.
http://epilepsi.se/Worthwhile-to-know-about-epilepsy.html (accessed
May 2012)

5. Bolin K, Lundgren A, Berggren F, Källén K. Epilepsy in Sweden:
health care costs and loss of productivity-a register-based approach.
Eur J Health Econ. 2011 http://www.ncbi.nlm.nih.gov/pubmed/22042322
(Accessed May 2012)

6. 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.

7. 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.

8. Gil-Nagel A, Lopes-Lima J, 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.

9. 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.

10. 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.

11. 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.

12. Epilepsy Research UK. What is Epilepsy? Fact sheet.:
http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm
(accessed March 2012)

13. Epilepsy Action. Describing Seizure Types.
http://www.epilepsy.org.uk/info/seizures/ataglance (Accessed March
2012)

14. NHS Choices. Symptoms of Epilepsy.
http://www.nhs.uk/Conditions/Epilepsy/Pages/Symptoms.aspx (Accessed
March 2012)

15. 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

16. Almeida L, Soares-da-Silva P. Eslicarbazepine acetate (BIA
2-093). Neurotherapeutics. 2007 Jan;4(1):88-96.

17. Brady K et al. The effects of Eslicarbazepine,
R-Licarbazepine, Oxcarbazepine and Carbamazepine on ion transmission
through Cav3.2 channels. Abstract presented at International Epilepsy
Congress 2011 p858.

18. 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

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