Once-daily Epilepsy Treatment Zebinix® (Eslicarbazepine Acetate) Now Available with Full Reimbursement in Finland

News provided by

Eisai Europe Limited

03 Feb, 2014, 00:01 GMT

HATFIELD, England, February 3, 2014 /PRNewswire/ --

Eisai announces today that Zebinix® (eslicarbazepine acetate), a novel anti-epilepsy treatment, has received full reimbursement from the Finnish Health Authorities. Once-daily eslicarbazepine acetate, is indicated as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.[1]

"Up to a third of people with epilepsy do not achieve adequate seizure control after their first anti-epileptic treatment so there is a continued need for additional effective options. Eslicarbazepine acetate will provide doctors with a new, easy to titrate, adjunctive therapy to help those with inadequately controlled partial onset epilepsy improve their condition," commented Dr. Jukka Peltola, Tampere University Hospital.

Epilepsy is one of the most common neurological conditions in the world and affects approximately 56,000 people in Finland.[2],[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 third generation 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],[10] while a real-world, retrospective, multicentre audit (n=202) show up to 19.8% of patients achieved seizure freedom with the AED.[11] 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.[12]

Dr. Sten Friberg, Nordic Medical Director for Eisai AB commented: "We are delighted that Zebinix has received 100% reimbursement status in Finland and will provide an effective and well tolerated alternative treatment to help people with epilepsy manage their seizures. Eisai is committed to bringing effective treatments such as this to patients to help improve their quality of life, as underscored by our human health care mission."  

The launch of eslicarbazepine acetate in Finland 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, Spain (co-promotion with BIAL, the developer of eslicarbazepine acetate) and Wales.

*Exclusively by BIAL

Notes to Editors

Zebinix® is the EU trade name for eslicarbazepine acetate

Zebinix® is under license from BIAL

About Zebinix®(eslicarbazepine acetate)

Eslicarbazepine acetate is a voltage-gated sodium channel blocker.[13] It selectively targets the slow inactivated state of the sodium ion channel[14],[15] (which have been implicated in the pathogenesis of epilepsy),[16] preventing its return to the active state, and thereby reduces repetitive neuronal firing.[9] Further, eslicarbazepine acetate does not inhibit potassium efflux,[17] which may reduce the potential for repetitive neuronal firings.[18] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study[13] 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.[19],[20] 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 use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
  • Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by Novartis)
  • Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
  • Zonegran® (zonisamide) as monotherapy in adults and adjunctive therapy in adults, adolescents and children aged six years and above with partial onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)

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 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 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, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Russia 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, 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 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 2013. Zebinix® (eslicarbazepine acetate) summary of product characteristics (last updated April 2013): 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 December 2013)

3. Finnish Epilepsy Association (FEA) http://www.epilepsia.fi/epilepsialiitto/in_english (Accessed December 2013)

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):262-9

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, 51(10):1963-1969, 2010.

10. Lopes-Lima J, et al. Long-term treatment of partial epilepsy with eslicarbazepine acetate (ESL): Results of a one-year open-label extension of study BIA-2093-303. Epilepsia 2008; 49(Supplement 7) 441 Abstract 3.227.4

11. Keogh S, et al. Safety and efficacy of eslicarbazepine acetate (Zebinix) in everyday clinical practice using a retrospective multicentre audit. ILAE UK Poster. 2013; 34.

12. 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, 51(10):1963-1969, 2010.

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

14. Elger C et al. Pharmacokinetics and tolerability of eslicarbazepine acetate and oxcarbazepine at steady state in healthy volunteers. Epilepsia 2013; 54(8): 1453-1461.

15. Hebeisen S et al. The effects of eslicarbazepine and R-licarbazepine on sodium currents through Nav1.7 and

Nav1.8 channels. Epilepsia 2012; 53 (Suppl. 5): 1-245.

16. Vilin YY and Ruben PC. Slow Inactivation in Voltage-Gated Sodium Channels. Cell Biochem Biophys 2001; 35(2):171-190.

17. 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

18. Soares-da-silva et al. Assessment of Quality-Of-Life and Depressive Symptoms During Long-Term Treatment with Eslicarbazepine Acetate: BIA-2093-302 Study. Epilepsia 2011; 52(Suppl. 6):23-263

19. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed December 2013)

20. 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: February 2014
Job code: Zebinix-UK2302