Large Pan-European Pooled Analyses of Zebinix® (eslicarbazepine acetate) Real-World Data to Assess Use for Partial Epilepsy in Clinical Practice

Porto, Portugal and Hatfield, England (ots/PRNewswire) -

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN/CZECH REPUBLIC
JOURNALISTS

Further insights into seizure control and safety profile of
epilepsy drug in the treatment of newly diagnosed partial onset
(focal) seizures in adults

BIAL and Eisai announce the methodology of a planned, large,
pooled analyses of real-world efficacy and safety data for adjunctive
once-daily Zebinix® (eslicarbazepine acetate) to be presented for the
first time at the 12th European Congress on Epileptology (ECE) 2016,
Prague, Czech Republic.[1]

Once-daily eslicarbazepine acetate is indicated as adjunctive
therapy in adults with partial-onset seizures with or without
secondary generalisation.[2]

Abstract #P578 - Mc Murray R et al[1] - 12 September 13:00-14:30

The study will comprise pooled analysis in over 1,500 adult
patients from databases across Europe to provide further information
on dosing patterns, combinations, and response to treatment with
once-daily eslicarbazepine acetate. This large pooled analyses of
patient-level data will provide additional information on the
effectiveness and tolerability of eslicarbazepine acetate in routine
clinical practice, thereby complementing evidence from clinical
trials.

Abstract #0002 - Ben-Menachem et al[3] - 14 September 11.30-13.00

Abstract #P615 - E Trinka E et al[4] - 14 September 13:00-14:30

Further data at this year's ECE includes outcomes from an
investigational Phase III study[3],[4] in 785 eligible patients for
eslicarbazepine acetate in a monotherapy setting compared with
twice-daily controlled-release (CR) carbamazepine. Seizure freedom
rates with eslicarbazepine acetate were 71.1% (n=388) and 75.6%
(n=397) with carbamazepine CR at >=6 months (average risk difference
-4.28%, 95%CI -10.3, 1.74%).[3],[4] Patients experiencing at least
one treatment emergent adverse event were similar between
eslicarbazepine acetate and carbamazepine CR (75.3% vs 77.7%
respectively).[3],[4]

Abstract #0034 - Villanueva V et al[5] - 13 September 11:30-13:00

Results from a one-year retrospective observational study,
EARLY-ESLI, in 253 patients aged >=18 with partial-onset seizures
receiving eslicarbazepine acetate after first-line monotherapy
failure will be presented. During follow-up 31.6% reported adverse
events, and 3.6% discontinued treatment due to AEs.[5] At 12 months,
the retention rate was 92.9%, 62.3% of patients were seizure free,
37.3% were seizure free for one year, 82.5% were responders, and 5.6%
did worse. The main side-effects were somnolence (8.7%), dizziness
(5.1%), and hyponatremia (3.5%; n=9).[5] A total 127 patients (50.2%)
converted (withdrew) to monotherapy for at least six months.

"These new data confirm our commitment to continue to develop
treatments that help people with epilepsy to get on with their lives
through seizure control, tolerability, and convenience. The planned
real-world study will help improve the knowledge and understanding
around the use of eslicarbazepine acetate in routine clinical
practice," states Patrício Soares-da-Silva, Head of Research &
Development, BIAL

Eslicarbazepine acetate is available in Albania*, Austria, Czech
Republic, Cyprus*, Denmark, Finland, France, Germany (co-promotion
with BIAL, the developer of eslicarbazepine acetate), Greece,
Iceland, Italy, Malta*, Norway, Portugal*, Republic of Ireland,
Russia***, Scotland, Slovakia, Sweden, Spain (co-promotion with
BIAL), UK (co-promotion with BIAL) and the U.S and Canada**.

*Exclusively by BIAL

**Eslicarbazepine acetate is sold in the U.S. and Canada under the
trade name Aptiom®

***Exalief® is the trade name for eslicarbazepine acetate in
Russia

Abstract Number
Timing of presentation Abstract
details

Eslicarbazepine acetate Effectiveness of
eslicarbazepine acetate as
Abstract number: #P578 adjunctive
therapy for partial epilepsy in clinical
Poster Session
practice: design of a European pooled analysis of
Pharmacology
/ AEDs 3 real-world data
Monday 12 September Rob
McMurray, Camilla Karlsson, Rui Sousa, Vicente
13.00 - 14.30
Villanueva
Poster Area (Forum Hall
Foyer)

Abstract number: #0034 EARLY-ESLI study: Efficacy,
tolerability and
Platform Session 6 conversion to
monotherapy with eslicarbazepine
Antiepileptic Drugs 2
acetate after first monotherapy failure
Tuesday 13 September
V Villanueva, A Gómez, M Garcés, P Bermejo, J
11:30-13:00
Montoya, M Toledo, FJ López-González, X Rodriguez, D

Forum Hall Campos, P Martínez, P Giner, J Zurita, J

Rodríguez-Uranga, J Ojeda, JA Mauri, J
Ruiz-Giménez,
JJ Poza, A Massot, M
Bonet

Abstract number: #0002 Efficacy of
eslicarbazepine acetate versus
Platform Session 13
controlled-release carbamazepine as monotherapy in
Antiepileptic
Drugs 3 patients with newly diagnosed partial-onset seizures

Wednesday 14 September E Ben-Menachem, E. Trinka, P Kowacs, C
Elger, J
11:30-13:00 Moreira, R Pinto, F Ikedo, A
Pereira, JF Rocha,
Forum Hall P Soares-da-Silva

Abstract number: #P615 Safety and tolerability of
eslicarbazepine acetate as
Poster Session monotherapy
in patients with newly diagnosed
Pharmacology / AEDs 8
partial-onset seizures
Wednesday 14 September E Trinka, E
Ben-Menachem, P Kowacs, C Elger, J
13:00-14:30
Moreira, R Pinto, F Ikedo, A Pereira, JF Rocha,
Location
P Soares-da-Silva
Poster Area (Forum Hall
Foyer)

Notes to Editors

About Zebinix® (eslicarbazepine acetate)

Eslicarbazepine acetate is currently marketed in Europe and Russia
by BIAL-Portela & Cª, S.A and by BIAL´s licensee, Eisai Europe
Limited, a European subsidiary of Eisai Co., Ltd. under the trade
name Zebinix® or Exalief®. In the United States and Canada
eslicarbazepine acetate (tradename Aptiom®) is marketed by Sunovion
Pharmaceuticals Inc., under an exclusive license from BIAL.

Eslicarbazepine acetate is a voltage-gated sodium channel blocker.
It selectively targets the slow inactivated state of the sodium ion
channel (which have been implicated in the pathogenesis of epilepsy),
preventing its return to the active state, and thereby reduces
repetitive neuronal firing.[6] Further, eslicarbazepine acetate does
not inhibit potassium efflux, which may reduce the potential for
repetitive neuronal firings.[7] The efficacy of eslicarbazepine
acetate was demonstrated in an initial proof-of-concept phase II
study[8] and three subsequent phase III randomised, placebo
controlled studies in 1,049 people with refractory partial onset
seizures.[9],[10],[11]

About BIAL

Founded in 1924, BIAL is an international pharmaceutical company
with the mission to discover, develop and provide therapeutic
solutions within the area of health. In recent decades, BIAL has
focused on quality, innovation and internationalisation.

Being the partner of choice for many companies, BIAL is strongly
committed to therapeutic innovation, investing more than 20% of its
turnover in Research and Development (R&D) every year.

BIAL has established an ambitious R&D program centred on the
central nervous, cardiovascular system and allergy immunotherapy.
BIAL's innovative programmes focus on continuing the clinical
development of its anti-epileptic Zebinix®/Aptiom® (on the market in
Europe and the USA), as well as opicapone for Parkinson's disease.

The company expects to introduce more new medicines and vaccines
to the market in the next years, strengthening its position worldwide
and accomplishing the company's purpose of "Caring for your Health".

For more information about BIAL, please visit http://www.bial.com
.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based
pharmaceutical company headquartered in Japan. 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 our human health care (hhc) philosophy. With over 10,000
employees working across our global network of R&D facilities,
manufacturing sites and marketing subsidiaries, we strive to realise
our hhc philosophy by delivering innovative products in multiple
therapeutic areas with high-unmet medical needs, including Oncology
and Neurology.

As a global pharmaceutical company, our mission extends to
patients around the world through our investment and participation in
partnership-based initiatives to improve access to medicines in
developing and emerging countries.

For more information about Eisai Co., Ltd., please visit
http://www.eisai.com

References

1. McMurray R, et al. Effectiveness of eslicarbazepine
acetate as adjunctive therapy for partial epilepsy in clinical
practice: design of a European pooled analysis of real-world data;
European Congress on Epileptology 2016: Abstract #P578

2. Zebinix® (eslicarbazepine acetate) SPC - Available at: http
://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Infor
mation/human/000988/WC500047225.pdf [updated 19th May 2016].
Accessed September 2016

3. Ben-Menachem E, et al. Efficacy of eslicarbazepine acetate
versus controlled-release carbamazepine as monotherapy in patients
with newly diagnosed partial-onset seizures; European Congress on
Epileptology 2016: Abstract #0002

4. Trinka E, et al. Safety and tolerability of eslicarbazepine
acetate as monotherapy in patients with newly diagnosed partial-onset
seizures; European Congress on Epileptology 2016: Abstract #P615

5. Villanueva V, et al. EARLY-ESLI study: Efficacy,
tolerability and conversion to monotherapy with eslicarbazepine
acetate after first monotherapy failure: Abstract #0034

6. Hebeisen S, et al. Eslicarbazepine and the enhancement of
slow inactivation of voltage-gated sodium channels: a comparison with
carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology 2015;
89:122-35

7. Soares-da-Silva P, et al. Eslicarbazepine acetate for the
treatment of focal epilepsy: an update on its proposed mechanisms of
action. Pharmacol Res Perspect. 2015; 3:e00124

8. Elger C, et al. Eslicarbazepine acetate: A double-blind,
add-on, placebo-controlled exploratory trial in adult patients with
partial-onset seizures. Epilepsia 2007; 48:497-504

9. Elger C, et al. Efficacy and safety of eslicarbazepine
acetate as adjunctive treatment in adults with refractory
partial-onset seizures: A randomised, double-blind,
placebo-controlled, parallel-group phase III study. Epilepsia.
2009;50:454-63

10. Ben-Menachem E, et al. Eslicarbazepine acetate as
adjunctive therapy in adult patients with partial epilepsy. Epilepsy
Res. 2010;89(2-3):278-85

11. 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;
120:281-87

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

Contact:
BIAL
Susana Vasconcelos
+351 229866100 / +351 229866148
susana.vasconcelos@bial.com. Eisai
Cressida Robson / Ben Speller
+44 7908 314 155 / +44 7908 409416
cressida_robson@eisai.net/ Ben_Speller@eisai.net. Tonic Life
Communications
Carys Thomas Ampofo / Chris Caudle
+44 7973 821 113 / + 44 7958 585 406
Carys.Thomas-Ampofo@toniclc.com
Chris.Caudle@toniclc.com