All Wales Strategic Medical Group Approves Zebinix® (Eslicarbazepine Acetate) - Once Daily Anti-Epileptic Treatment

All Wales Strategic Medical Group Approves Zebinix® (Eslicarbazepine Acetate)
                    - Once Daily Anti-Epileptic Treatment

  PR Newswire

  HATFIELD, England, November 22, 2012

HATFIELD, England, November 22, 2012 /PRNewswire/ --

The All Wales Strategic Medical Group (AWSMG) has approved Zebinix ^®
(eslicarbazepine acetate) for the treatment of partial seizures in highly
refractory patients who remain uncontrolled with, or are intolerant to, other
anti-epileptic medicine combinations. Eslicarbazepine acetate is licenced in
Europe as an adjunctive therapy for adults with partial-onset seizures with or
without secondary generalisation. ^[ ^1]

"There are 32,000 people in Wales living with epilepsy. Epilepsy is a complex
condition which can be very difficult to treat. Up to 70 per cent of people
with epilepsy could have their seizures controlled but only 52 per cent
actually do. We welcome the decision by the AWSMG to make Zebinix available as
an add-on treatment for people with difficult to control epilepsy who could
benefit from this epilepsy medicine," commented Ann Sivapatham, Epilepsy
Action's Wales Manager.

Epilepsy affects nearly 32,000 people in Wales. ^[2] The successful treatment
of partial-onset seizures (the most common form of epilepsy) remains a
significant challenge in some patients and the incidence of uncontrolled
partial epilepsy remains high, between 20 - 40% of patients with epilepsy have
remained poorly controlled despite these treatments, despite many existing
anti-epileptic drugs (AEDs). ^[3]

Nick Burgin, Director Market Access, Eisai EMEA & Russia explained: "We are
delighted that AWSMG has approved Zebinix for partial epilepsy. We want to
ensure that patients have access to innovative treatments, encouraging better
patient outcomes and faster uptake of new medicines."

Zebinix was approved by the European Commission following data which showed
that it reduces seizure frequency and has an overall positive efficacy and
safety profile.Zebinix 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.

Notes to Editors

Zebinix ^® is the EU trade name for eslicarbazepine acetate

Zebinix ^® is under license from BIAL except in those countries marked with an
asterix, where it is exclusively by 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. ^[4]

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, ^[5] but may become more
generalised, the symptoms vary according to the affected areas. ^[6]

Epilepsy is one of the world's most common neurological disorders, affecting
more than six million people across Europe. ^[7] With significant health care
costs and economic impacts, ^[8] uncontrolled seizures also increase the risk
of psychological comorbidities, such as anxiety and depression. ^[9]

About Zebinix ^® (eslicarbazepine acetate)

Eslicarbazepine acetate is a voltage-gated sodium channel blocker. ^[10] It
preferably targets the inactivated state of the sodium ion channel, preventing
its return to the active state, and thereby reduces repetitive neuronal
firing. ^[ ^10 ^] Recent studies have also demonstrated that eslicarbazepine
acetate effectively inhibits voltage-gated calcium channels, therefore
enhancing its potential as an anti-epileptic agent. ^[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. ^[13] ^,
^[14] ^, ^[15]

Clinical data

The EU approval was based on data from a phase II and three phase III clinical
trials. ^[ ^9, ^10, ^11 ^, ^12 ^] 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 ^] ^, ^[ ^11 ^]
^, ^[ ^12 ^]

During the trials, patients were randomised to various dosages of Zebinix ^®
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 ^, ^11 ^, ^12 ^, ^16 ^, ^17 ^, ^18]

Efficacy

Over the 12-week maintenance period, Zebinix ^® 800mg and 1200mg once-daily
significantly reduced seizure frequency, and was significantly more effective
than placebo. ^[ ^9 ^, ^10 ^, ^11 ^, ^12 ^] Long-term safety and maintenance
of therapeutic effect was demonstrated in one-year open-label extensions of
these studies. ^[ ^13 ^, ^14 ^, ^15 ^]

Tolerability ^[ ^9, ^10 ^, ^11 ^, ^12 ^]

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 ^® 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 & Cª, S.A. (Headquarters: São. Mamede do Coronado,
Portugal, "BIAL"), which gave Eisai Europe Limited rights to sell BIAL's
anti-epileptic drug Zebinix ^® (eslicarbazepine acetate) in Europe.

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
and Russia (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
  *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 recently expanded their UK Hatfield commercial, research and
manufacturing facility which now supports the company's growing EMEA business.

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 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, Belgium, Luxembourg, the Middle East and Russia.

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 ^® ).

It is the partner of choice for many pharma 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. AWSMG advice on Zebinix available at:
http://www.wales.nhs.uk/sites3/Documents/371/Eslicarbazepine%20%28Zebinix%29%20FAR.pdf
[ http://www.wales.nhs.uk/sites3/Documents/371/Eslicarbazepine %28Zebinix%29
FAR.pdf ]

2. Joint Epilepsy Council.
http://www.jointepilepsycouncil.org.uk/downloads/2011/Joint%20Epilepsy%20Council%20Prevalence%20and%20Incidence%20September%2011.pdf
[ http://www.jointepilepsycouncil.org.uk/downloads/2011/Joint Epilepsy Council
Prevalence and Incidence September 11.pdf ] 

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

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

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

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

7. The Lancet Neurology. 2010 Oct; 9(10): 941

8. Pugliatti M et al. Epilepsia 2007: 48(12) 2224 - 2233.

9. Titlic, M. Basic, S. Hajnek, S. Bratisl Lek Listy (Bratislava Medical
Journal) 2009; 110 (2): 105 - 109

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

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

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

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

14. Ben-Menachem E, Gabbai A, Hufnagel A, Maia J, Almeida L, Soares-da-Silver
P. Epilepsy Research 2010;89:278-285.

15. Gil-Nagel A, Lopes-Lima J, Maia J et al. Acta Neurol Scand 2009: 120:
281-287

16. Halász P, Elger C, Guekht A, et al. Epilepsia, 51(10):1963-1969, 2010

17. Gabbai A, Ben-Menachem E, Maia J, et al. Epilepsia. 2008;49(Suppl.
7):432-3

18. Lopes-Lima J, Gil-Nagel A, Maia J, et al. Epilepsia. 2008;49(Suppl.
7):441-2.



Date of preparation: November 2012

Zebinix-UK2265

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, Benjamyn Tan / Hollie
Matthews, +44(0)20-7798-9262 / +44(0)207-798-9992, benjamyn.tan@toniclc.com ,
eisaiepilepsy@toniclc.com
 
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