Zonegran® (Zonisamide) Approved for Use in Children and Adolescents by Scottish Medicines Consortium (SMC)

Hatfield, England (ots/PRNewswire) -

Zonegran(R) (zonisamide) has been approved by the Scottish
Medicines Consortium (SMC) for the treatment of partial epilepsy in
adolescents and children aged six years and above in Scotland.[1]
This decision follows zonisamide's paediatric license extension
approval by the European Commission (EC) on 3 October 2013.

Already available in Scotland as adjunctive therapy for the
treatment of partial seizures, with or without secondary
generalisation, in adults, zonisamide is a second generation
anti-epileptic drug (AED) with multiple mechanisms of action and a
chemical structure unrelated to any other AEDs.[2]

"Uncontrolled epilepsy can affect all aspects of children and
their family's lives and so new, effective and well tolerated
medications are always needed," commented Professor Martin Brodie,
Director of the Epilepsy Unit at the Western Infirmary in Glasgow.
"My extensive experience of treating adults with zonisamide in
Scotland has demonstrated its effectiveness in reducing partial onset
seizures[3] and I look forward to seeing this opportunity extended to
children and adolescents."

Epilepsy is one of the most common neurological diseases and
affects around 54,000 people in Scotland.[4] Across the United
Kingdom around 63,400 children and young people aged 18 years and
under have epilepsy.[5] The successful treatment of partial onset
seizures (the most common type of epilepsy) remains a challenge with
more than 30% of people not able achieve seizure control with current
treatments.[6]

"We are delighted that Zonegran can now be prescribed for children
in Scotland," commented Patrick Standen, EMEA Brand Director, Eisai
Europe Ltd. "As an emerging leader in the field of epilepsy, Eisai is
committed to the development of innovative therapies such as this to
help people with epilepsy."

The zonisamide paediatric approval in Scotland was based on Study
312 (CATZ) published in Epilepsia in July 2013.[7] These data from a
double-blind, randomised, multicentre, placebo-controlled Phase III
study, showed that that significantly more patients aged six to 17
responded positively to treatment with zonisamide (50%) versus
treatment with placebo (31%),[7] Safety and tolerability assessments
showed that the overall incidence of treatment-emergent adverse
events (TEAEs) was similar for zonisamide versus placebo and that
there were low rates of serious TEAEs in both groups.[7]

Zonisamide was approved in Europe in 2005 as an adjunctive therapy
in the treatment of partial seizures, with or without secondary
generalisation, in adults. In July 2012, the EC approved zonisamide
as monotherapy in the treatment of partial seizures, with or without
secondary generalisation, in adults with newly diagnosed epilepsy.[2]

The continued development of zonisamide 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. Eisai is committed to the therapeutic
area of epilepsy and addressing the unmet medical needs of people
with epilepsy and their families. Eisai is proud to market currently
more epilepsy products in EMEA than any other company.

Notes to Editors

About Zonegran (zonisamide)

Zonisamide is licensed in Europe as monotherapy in the treatment
of partial seizures, with or without secondary generalisation, in
adults with newly diagnosed epilepsy. Zonisamide is also indicated as
adjunctive therapy in the treatment of partial seizures, with or
without secondary generalisation, in adults, adolescents and children
aged six years and above.[2] It has a broad spectrum of
anti-epileptic modes of action and has no appreciable effects on
steady-state plasma concentrations of other AEDs, such as phenytoin,
carbamazepine and valproate.[2] Zonisamide is one of only four AEDs
with level A efficacy/effectiveness evidence as initial monotherapy
for adults with partial onset seizures.[8]

Zonisamide is available in 25mg, 50mg, and 100mg capsule
strengths. The recommended daily dose for monotherapy use is 100mg
once daily. In the third and fourth weeks the dose may be increased
to 200mg daily and then increased to 300mg daily after the next two
weeks. The recommended initial daily dose for adjunctive use is 50mg
in two divided doses. After one week the dose may be increased to
100mg daily and thereafter the dose may be increased at weekly
intervals, in increments of up to 100mg.[2]

For more information please visit: http://www.zonegran.eu

About Epilepsy

Epilepsy is one of the most common neurological conditions in the
world, affecting approximately one in every one hundred people in
Europe, and an estimated 50 million people worldwide.[9],[10]
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(R) (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(R) (rufinamide) for the adjunctive treatment of seizures associated
with Lennox-Gastaut Syndrome in patients greater than or equal to4 years. (Rufinamide
was originally developed by Novartis)
- Zebinix(R) (eslicarbazepine acetate) as adjunctive therapy in adult patients
with partial onset seizures, with or without secondary generalisation. (Zebinix is
under license from BIAL)
- Zonegran(R) (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
management
- 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

References

1) Scottish Medical Consortium advice on Zonegran
2) Eisai Ltd 2013. Zonegran summary of product characteristics (last updated
October 2013)
https://www.medicines.org.uk/emc/medicine/16240/SPC/Zonegran+25%2c+50%2c+100+mg+Hard+Capsules
3) Stephen LJ, et al. A prospective audit of adjunctive zonismade in an everyday
clinical setting. Epilepsy & Behavior. 2010:17;455-460
4) Epilepsy Scotland Facts and figures available at:
http://www.epilepsyscotland.org.uk/facts-and-figures/info_96.html. (Accessed 09
January 2014).
5) Joint Epilepsy Council of the UK and Ireland. Epilepsy prevalence, incidence
and other statistics. September 2011
6) Brodie MJ. et al. Patterns of treatment response in newly diagnosed epilepsy.
Neurology 2012:78;1548-1554
7) Guerrini R. et al. A randomized phase III trial of adjunctive zonisamide in
pediatric patients with partial epilepsy. Epilepsia 2013 Aug;54(8):1473-80
8) Glauser T. et al. Updated ILAE evidence review of antiepileptic drug efficacy
and effectiveness as initial monotherapy for epileptic seizures and syndromes.
Epilepsia 2013 Mar;54(3):551-63
9) Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with
economic modeling. Epilepsia 2007:48(12)2224-2233.
10) Epilepsy in the WHO European Region
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed 10
April 2012].

Date of preparation: February 2014
Job code: Zonegran-UK2519

ots Originaltext: Eisai Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media Enquiries: Tonic Life Communications, Frances Murphy/Nicola
Lilley , +44(0)207-798-9262 / +44-(0)207-798-9905,
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Ltd,
Cressida Robson/Charlotte Andrews, +44(0)7908-314-155 /
+44(0)7947-231-513,
Cressida_Robson@eisai.net, Charlotte_Andrews@eisai.net