Italian Medicines Agency (AIFA) Approves the Reimbursement of Zebinix® (eslicarbazepine acetate) as an Adjunctive Treatment to be Administered Once Daily in the Treatment of Partial Epilepsy in Adults

HATFIELD, England, May 12, 2014 /PRNewswire/ --

Zebinix^® (eslicarbazepine acetate), a novel anti-epilepsy treatment for adult individuals suffering from partial epilepsy, has received reimbursement under the class A-PHT category from the Italian Medicines Agency (AIFA). Once-daily eslicarbazepine acetate is indicated as adjunctive therapy in adults suffering from epilepsy with partial onset seizures, with or without secondary generalisation.^[1]

"New, effective and well tolerated treatments with a well-balanced effectiveness/tolerability ratio are welcomed by doctors and patients," commented Prof. Roberto Michelucci. "The reimbursement of eslicarbazepine acetate in Italy too is a concrete and positive step forward as it means that we will have access to a new treatment option for the treatment of individuals with epilepsy."

In Italy, there are approximately 400,000 people with epilepsy and 25,000 new cases are diagnosed every year.^[2] For the majority of people with epilepsy, seizures can be controlled with one antiepileptic drug; however, 30% of individuals with treated partial onset epilepsy still experience refractory seizures.^[3]

Eslicarbazepine acetate, a new, third generation sodium channel blocker, targets sodium channels, stabilising their inactive state. Eslicarbazepine acetate was approved by the European Commission in 2009 based on data submitted which showed a reduction of seizure frequency by up to 45% in patients with partial epilepsy.^[4],[5],[6] Long-term studies also show that up to 18% of patients achieved freedom from seizures with eslicarbazepine acetate as an adjunctive treatment.^[7],[8] A long-term open-label extension study demonstrated a statistically significant improvement in the score for overall quality of life from baseline.^[8]

Giuseppe Lo Presti, Epilepsy Business Unit Director, Eisai Italy commented; "We are delighted to announce the launch of Zebinix® in Italy. Improved quality of life is one of the top priorities for doctors and patients with epilepsy alike. Eisai is committed to support research in this area by marketing and campaigning for the reimbursement of effective and well tolerated epilepsy treatments, such as Zebinix^®."

The launch of eslicarbazepine acetate in Italy 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) 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.^[9] The molecule interacts competitively with the inactive state of the sodium ion channel^[9],[10] preventing its return to the active state, and thereby inhibiting repetitive neuronal firing.^[9] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study^[11] and three subsequent phase III randomised, placebo controlled studies in 1049 adult patients with refractory partial onset seizures.^[4],[5],[6]

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.^[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:

• 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). Zonegran in paediatric indication is not yet reimbursed in Italy
• Zebinix^® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
• Inovelon^® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by Novartis)
• 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. Fycompa is not yet marketed in Italy

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 January 2014): http://www.medicines.org.uk/emc/medicine/22376/SPC/Zebinix+800mg+tablets/

2. Associazione Italiana contro l'Epilessia, Epilessia e Crisi, 2013 http://www.aice-epilessia.it/index.php?option=com_content&view=article&id=39&Itemid=27 (Accessed December 2013)

3. Kwan P, Brodie MJ. Early identification of refractory epilepsy. NEJM 2000; 342:314-9

4. 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.

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

6. 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.

7. 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.

8. Halász P et al. Long-term efficacy and safety of eslicarbazepine acetate:Results of a 1-year open-label extension study in partial-onsetseizures in adults with epilepsy. Epilepsia, 51(10):1963-1969, 2010.

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

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

11. 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

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

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: May 2014

Job code: Zebinix-UK2305