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

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

  PR Newswire

  HATFIELD, England, February 3, 2014

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  Edi to rs

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

Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson/Charlotte Andrews,
+44(0)7908 314 155/+44(0)7947 231 513, Cressida_Robson@eisai.net,
Charlotte_Andrews@eisai.net ; Tonic Life Communications: Frances Murphy/Nicola
Lilley, +44(0)207 798 9262 /+44 (0) 207 798 9905, frances.murphy@toniclc.com,
nicola.lilley@toniclc.com
 
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