European Commission Grants Marketing Authorisation for Zebinix® (eslicarbazepine acetate) for the Treatment of Partial-Onset Seizures in Children

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

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS

The European Commission extended the Marketing Authorisation for
Zebinix® (eslicarbazepine acetate) as a once-daily adjunctive
treatment for patients aged above six years with partial-onset
(focal) seizures with or without secondary generalisation.[1]

Eslicarbazepine acetate was previously indicated only for the
adjunctive treatment of adults aged over 18 with partial-onset
seizures with or without secondary generalisation.[2]

The variation to the license is based on data from one Phase III
study (305), one Phase II study (208) and from population PK
modelling and exposure-efficacy analyses. The Commission considered
the efficacy results from the mentioned studies to be acceptable for
an extension of the Marketing Authorization. The safety analyses show
no new or unexpected safety findings and eslicarbazepine acetate does
not appear to have negative neurocognitive consequences (power of
attention, information processing and working memory).[1],[3]

"We welcome the decision of the European Commission to extend the
licence for once daily eslicarbazepine acetate to paediatric
patients. Bial has an ongoing commitment to all people living with
epilepsy and this important milestone reinforces this commitment, as
well as the company's mission to care for the health of people
worldwide," comments António Portela, CEO, Bial.

"We are pleased to be able to offer the paediatric neurology
community a new treatment option to consider when caring for children
aged above six years and adolescents with partial onset seizures.
Eisai recognise the importance of delivering new clinical treatments
in this particular group of patients," comments Neil West, Vice
President, Global Neurology Business Unit, Eisai.

Notes to Editors

About Zebinix® (eslicarbazepine acetate)

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.[4]

Further, eslicarbazepine acetate does not inhibit potassium
efflux, which may reduce the potential for repetitive neuronal
firings.[5] The efficacy of eslicarbazepine acetate in adult patients
was demonstrated in an initial proof-of-concept phase II study[6] and
three subsequent phase III randomised, placebo controlled studies in
1,049 people with refractory partial-onset seizures.[7],[8],[9]

Eslicarbazepine acetate is indicated as adjunctive therapy in
adults, adolescents and children aged above 6 years, with
partial-onset seizures with or without secondary generalisation.

Eslicarbazepine acetate is currently marketed in Europe and Russia
by Bial 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.

About Epilepsy

Epilepsy is one of the most common neurological conditions in the
world, affecting approximately 6 million people in Europe, and an
estimated 50 million people worldwide.[10],[11] Epilepsy is a chronic
disorder of the brain that affects people of all ages, and is a
common neurological disorder in childhood, with approximately 100,000
children and adolescents diagnosed every year.[12] 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 Bial

Founded in 1924, Bial's mission is to discover, develop and
provide therapeutic solutions within the area of health. In recent
decades, Bial has strategically focused on quality, innovation and
internationalisation.

Being the partner of choice for many pharma 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 programme centred in
neurosciences, cardiovascular system and allergic immunotherapy. The
company expects to continue to introduce 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. European Commission: Community register of medicinal products for
human use. Product Information - Zebinix. Available at:
http://ec.europa.eu/health/documents/community-register/html/h514.htm
Last updated December 2016

2. Zebinix SMPC, Available at http://www.ema.europa.eu/docs/en_GB/do
cument_library/EPAR_-_Product_Information/human/000988/WC500047225.pd
f Last updated: May 2016

3. Moreira J, et al. J Neurol Sci 2015;357:e432-456 (abstract 1513;
WFN15-1735; e439)

4. 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

5. 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

6. 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

7. 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

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

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;
120:281-87

10. Epilepsy in the WHO European Region: Fostering Epilepsy Care in
Europe. Available at:
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
Accessed November 2016

11. Pugliatti M, et al. Estimating the cost of epilepsy in Europe: A
review with economic modeling. Epilepsia 2007:48(12):2224-33

12. Forsgren L, et al. The epidemiology of epilepsy in Europe - a
systematic review. Eur J Neurol. 2005; 12(4):245-53

December 2016

Zebinix-EU0112

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
+44 7908 314 155
Cressida_Robson@eisai.net

Tonic Life Communications: Carys Thomas Ampofo / Stan Jackson
+44 7973 821 113 /+44 7747 718 279
Carys.Thomas-Ampofo@toniclc.com Stan.Jackson@toniclc.com

Original-Content von: Eisai, übermittelt durch news aktuell