Exalief (Eslicarbazepine Acetate) Soon to be Available in Russia as a Once Daily Adjunctive Treatment of Partial Onset Seizures in Adults
Novel, anti-epilepsy treatment Exalief® will soon be available in Russia. (Exalief is also marketed under the trade name Zebinix in Europe). Once-daily eslicarbazepine acetate is indicated in Europe as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.[1]
"Eslicarbazepine acetate will provide doctors with a new, easy to titrate, adjunctive therapy with a beneficial safety profile to help those with inadequately controlled partial onset epilepsy to improve their condition. Approximately one third of people with epilepsy do not achieve adequate control of epileptic seizures whilst taking their first antiepileptic drug, so there is a continued need for additional effective options," commented Professor Pavel Vlasov, Neurology and Neurosurgery department at the Moscow State University of Medicine and Stomatology.
Epilepsy is one of the most common neurological conditions in the world.[2] Around three out of every 1,000 people in Russia live with the condition, 82% of which have partial epilepsy.[3] Despite many anti-epileptic drugs (AEDs) available, the successful treatment of partial onset seizures remains a significant challenge in some patients. Currently, between 20-40% of patients with newly diagnosed epilepsy will become refractory to treatment.[4]
Eslicarbazepine acetate, a sodium channel blocker that differentially and selectively targets slow inactivated sodium channels, was approved by the European Commission in 2009 based on data submitted which showed that it reduces seizure frequency by up to 45% in patients with partial epilepsy.[5],[6],[7] Long-term studies also show that up to 18% of patients achieved seizure freedom with eslicarbazepine acetate,[8],[9] while a phase IV study (n=254) demonstrated that 48% of patients became seizure free and 82% of patients stayed on treatment over a six month period when Exalief was prescribed as a first-line adjunctive treatment.[10] A long-term open-label extension study demonstrated a statistically significant improvement in quality of life from baseline, including seizure worry, energy/fatigue, medication effects and cognitive and social function.[9] Eslicarbazepine acetate also shows a maintained activity in human tissue in which resistance to carbamazepine is observed.[11]
"We are delighted that once-daily Exalief will soon be launched in Russia and will provide an effective and well tolerated alternative treatment to help people with epilepsy manage their seizures. Eisai is committed to provide effective treatments to patients to help improve their quality of life, as underscored by our human health care mission," commented Olga Konopleva, Managing Director, Eisai Russia.
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, Italy, 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
Zebinix is the EU trade name for eslicarbazepine acetate
Exalief® was developed and discovered by BIAL
About Exalief®(eslicarbazepine acetate)
Eslicarbazepine acetate is indicated as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.[1]The clinical trial programme is also underway for eslicarbazepine acetate as a paediatric and monotherapy treatment.
Eslicarbazepine acetate is a voltage-gated sodium channel blocker.[12] It selectively targets the slow inactivated state of the sodium ion channel[13],[14] (which have been implicated in the pathogenesis of epilepsy),[15] preventing its return to the active state, and thereby reduces repetitive neuronal firing.[9] Further, eslicarbazepine acetate does not inhibit potassium efflux,[16] which may reduce the potential for repetitive neuronal firings.[12] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study[16] and three subsequent phase III randomised, placebo controlled studies in 1049 patients with refractory partial onset seizures.[5],[6],[7]
For more 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.[17],[18] 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:
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.
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 (Exalief®).
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. Eisai Ltd 2014. Exalief® (eslicarbazepine acetate) summary of product characteristics (last updated November 2014): http://www.medicines.org.uk/emc/medicine/22376/SPC/Zebinix+800mg+tablets/
2. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf (Accessed January 2015)
3. Guekht A. et al. The epidemiology of epilepsy in the Russian Federation. Epilepsy Res 2010; 92(2-3):209-218
4. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3-7
5. 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
6. Ben-Menachem E et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy; Epilepsy Research 2010;89:278-285
7. 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
8. Hufnagel A et al. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res. 2013 Feb;103(2-3):262-269
9. Halász P 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 2010; 51(10):1963-1969
10. Holtkamp 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. ECE abstract 2014
11. Doeser et al. Targeting pharmacoresistant epilepsy and epileptogenesis with a dual-purpose antiepileptic drug. Brain 2014. http://dx.doi.org/101093/brain/awu339
12. Almeida L, Soares-da-Silva P. Eslicarbazepine Acetate (BIA 2-093). Neurotherapeutics. 2007 Jan;4(1):88-96
13. Elger C et al. Pharmacokinetics and tolerability of eslicarbazepine acetate and oxcarbazepine at steady state in healthy volunteers. Epilepsia 2013; 54(8): 1453-1461
14. 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 Feb; 89:122-135. Doi 10.1016/j.neuropharm.2014.09.008.
15. Vilin YY and Ruben PC. Slow Inactivation in Voltage-Gated Sodium Channels. Cell Biochem Biophys 2001; 35(2):171-190
16. 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
17. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed January 2015)
18. 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: January 2015
Job code: Zebinix-UK2317
 Soon to be Available in Russia as a Once Daily Adjunctive Treatment of Partial Onset Seizures in Adults)
