Once-Daily Adjunctive Epilepsy Treatment Zebinix® (Eslicarbazepine Acetate) Shown to be Effective, Retained and Well-Tolerated

 Once-Daily Adjunctive Epilepsy Treatment Zebinix® (Eslicarbazepine Acetate)
   Shown to be Effective, Retained and Well-Tolerated in Everyday Clinical

  PR Newswire

  HATFIELD, England, June 30, 2014

HATFIELD, England, June 30, 2014 /PRNewswire/ --

The results of an interim analysis of the non-interventional EPOS ( E
slicarbazepine acetate in P artial- O nset S eizure) study presented this week
at the XXI European Congress on Epileptology (ECE) in Stockholm, Sweden, show
that once-daily Zebinix ^® (eslicarbazepine acetate) is effective, retained
and well-tolerated when given as an add-on to anti-epileptic monotherapy to
adults in routine clinical practice. ^[1] Eslicarbazepine acetate, a novel
anti-epilepsy treatment for adult individuals with partial epilepsy, targets
sodium channels, stabilising their inactive state. It is indicated as
adjunctive therapy in adults with partial onset seizures, with or without
secondary generalisation. ^[2]

The aim of the EPOS study was to assess retention rate, effectiveness, safety
and tolerability of eslicarbazepine acetate as the only add-on to monotherapy
in a real world clinical setting in eight European countries (UK, Ireland,
Denmark, Sweden, Norway, France, Czech Republic and Germany). ^[ ^1 ^]

The successful treatment of partial onset seizures (the most common type of
epilepsy) remains a challenge. Currently, up to a third of people with
epilepsy do not achieve seizure freedom despite appropriate therapy with
anti-epileptic drugs. ^[3]

"Many people with epilepsy are not able to achieve seizure freedom despite
treatment," commented Martin Holtkamp, Principal Investigator, University
Hospital Charité, Germany. "The EPOS study provides valuable insights into the
use of eslicarbazepine acetate in routine clinical practice, with these
interim results demonstrating that it is effective, well-tolerated and
well-retained as an adjunctive therapy."

The interim analysis reviewed data from 109 adults (mean age 45.3±16.5 years;
59.6% male) with uncontrolled partial onset seizure under antiepileptic
monotherapy for whom the physician had independently decided to initiate
add-on treatment with eslicarbazepine acetate. The mean eslicarbazepine
acetate daily dose after titration was 907.1mg±300.0 mg. Levetiracetam (32.1%)
and lamotrigine (23.9%) were the most frequently preferred combination
treatments. ^[ ^1 ^]

At six-months, the eslicarbazepine acetate retention rate was 82.6%, with
seizure freedom reported over the same period by 47.8% of patients. ^[ ^1 ^]
Adverse events occurred in 29 people during the observation period. The most
frequently reported adverse events were dizziness (6.4%), headache (5.5%) and
fatigue (4.6%). ^[ ^1 ^]

The continued development of eslicarbazepine acetate 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. 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,
Finland, Spain (co-promotion with BIAL, the developer of eslicarbazepine
acetate), Wales and the U.S**.

*Exclusively by BIAL

**Eslicarbazepine acetate is sold in the U.S. under the trade name APTIOM ^®

Notes to Editors 

About Zebinix ^® (eslicarbazepine acetate)

Eslicarbazepine acetate is indicated as adjunctive therapy in adults with
partial onset seizures, with or without secondary generalisation. ^[ ^2 ^]

Eslicarbazepine acetate is a voltage-gated sodium channel blocker. ^[4] The
molecule interacts competitively with the inactive state of the sodium ion
channel ^[ ^4 ^] ^, ^[5] preventing its return to the active state, and
thereby inhibiting repetitive neuronal firing. ^[ ^4 ^] The efficacy of
eslicarbazepine acetate was demonstrated in an initial proof-of-concept Phase
II study ^[6] andfour subsequent Phase III randomised, placebo controlled
studies in 1,703 adult patients withpartial onset seizures refractory to
treatment with one to three concomitant anti-epileptic drugs. ^[ ^2 ^] , ^[7]
^, ^[8] ^, ^[9] ^, ^[10] ^, ^[11]

Zebinix ^® is the EU trade name for eslicarbazepine acetate

Zebinix ^® is under license from BIAL

For further 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. ^[12] ^, ^[13] Epilepsy is a chronic disorder of the
brain that affects people of all ages. It is characterised by abnormal
discharges of neuronal activity which causes 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 ^® (perampanel) for the adjunctive treatment for partial onset
    seizures, with or without secondarily generalised seizures, in patients
    with epilepsy aged 12 years and older
  *Zonegran ^® (zonisamide) as monotherapy in the treatment of partial
    seizures, with or without secondary generalisation, in adults with newly
    diagnosed epilepsy and as adjunctive therapy in the treatment of partial
    seizures, with or without secondary generalisation, in adults,
    adolescents, and children aged 6 years and above (Zonegran is under
    license from the originator Dainippon Sumitomo Pharma)
  *Zebinix ^® (eslicarbazepine acetate) as adjunctive therapy in adults with
    partial onset seizures, with or without secondary generalisation (Zebinix
    is under license from BIAL). Eisai received a sole license to market,
    promote and distribute Zebinix ^® in the following European Countries:
    Austria, Belgium, Bulgaria, Czech Republic, Belarus, Bosnia, Croatia,
    Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
    Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Monaco,
    Netherlands, Norway, Poland, Romania, Russia, Serbia, Slovakia, Slovenia,
    Spain (co-promotion with Bial from launch) Sweden, Switzerland, Turkey,
    Ukraine and the United Kingdom
  *Inovelon ^® (rufinamide) for the adjunctive therapy in the treatment of
    seizures associated with Lennox-Gastaut syndrome (LGS) in patients four
    years of age and older (Rufinamide was originally developed by Novartis)

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
  *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, Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Ireland, Italy, Norway, Portugal, Russia, Slovakia,
Spain, Switzerland, Sweden, the Netherlands and the Middle East.

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

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, responsible for the research and
development of eslicarbazepine acetate (Zebinix ^® ).

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


1. Holtkamp M et al. Eslicarbazepine acetate as add-on treatment to
antiepileptic monotherapy in adults with partial-onset seizures: real-world
data on retention, dosing, patient reported seizure outcome and safety from an
interim analysis of the open-label non-interventional study EPOS. Abstract
presented at ECE 2014. P140

2. Zebinix , Summary of Product Characteristics (updated March 2014):

3. Kwan P, Brodie MJ. Early identification of refractory epilepsy. New
England Journal of Medicine 2000:342:314-9

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

5. Elger C et al. Pharmacokinetics and tolerability of eslicarbazepine
acetate and oxcarbazepine at steady state in healthy volunteers.Epilepsia

6. Elger et al. Eslicarbazepine Acetate: A Double-blind, Add-on,
Placebo-controlled Exploratory Trial in Adult Patients with Partial-onset
Seizures. Epilepsia 2007:48(3):497-504

7. Elger C 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

8. Ben-Menachem E et al. Eslicarbazepine acetate as adjunctive therapy in
adult patients with partial epilepsy; Epilepsy Research 2010:89:278-285

9. Gil-Nagel A 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

10. Sperling M et al. Adjunctive Eslicarbazepine acetate in patients with
seizures: efficacy result s of a 12 week randomized placebo-controlled study.
Abstract presented at AES 2013. #3.210

11. Abou-Khalil B et al. Eslicarbazepine acetate as adjunctive therapy in
patients with refractory partial-onset seizures: safety results of a 12-week
randomized placebo-controlled study. Abstract presented at AES 2013. #2.128

12. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (accessed
June 2014)

13. 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: June 2014  Job code: Zebinix-UK2308 

Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson/Ben Speller,
+44(0)7908 314 155/+44(0) 7908 409416, Cressida_Robson@eisai.net ,
Ben_Speller@eisai.net. Tonic Life Communications, Frances Murphy/Nicola
Lilley, +44(0)207 798 9262 /+44 (0) 207 798 9905, frances.murphy@toniclc.com,
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