EMA Accepts Eisai's License Extension Application for Zonisamide in Epilepsy

Hatfield, England (ots/PRNewswire) -

Eisai today announced that the European Medicines Agency (EMA)
has accepted for review their application to extend the use of
zonisamide as monotherapy for newly diagnosed epilepsy patients with
partial seizures, with and without second generalisation.

Zonisamide is a second generation anti-epileptic drug with
multiple mechanisms of action, with a chemical structure unrelated to
other anti-epileptic drugs, and with pharmacokinetic properties
allowing a once daily regimen. It is approved in the European Union
as an adjunctive therapy in the treatment of partial seizures (with
or without secondary generalisation) in adults with epilepsy.[1]

Epilepsy is one of the most common neurological conditions in the
world, affecting approximately 8 in 1,000 people in Europe.[2] There
is an estimated six million people living with epilepsy in Europe[3]
and estimated 50 million people worldwide.[4]

The efficacy and safety of zonisamide as monotherapy has been
demonstrated in a double-blind, randomised, multicentre study which
compared the efficacy and safety of once-daily zonisamide with
twice-daily controlled release carbamazepine (CBZ) as monotherapy in
583 adults with newly diagnosed partial epilepsy. The study's primary
endpoint was the proportion of seizure-free patients at 6 months (per
protocol population). The results of the study showed that zonisamide
was effective and well tolerated in newly diagnosed epilepsy patients
when used as monotherapy.[5]

"As a research-based pharmaceutical company with a particular
focus on epilepsy, we are not only committed to bringing innovative
new therapies to market, but also ensuring that we maximise the
clinical benefits of our currently licensed products," said Dr
Bettina Bauer, Head of EU Epilepsy Business Unit, Eisai Europe; "If
approved as monotherapy zonisamide will offer newly diagnosed
epilepsy patients a new option to help improve their seizure
control."

About zonisamide

Zonisamide is licensed as adjunctive therapy in the treatment of
partial seizures (with or without generalization) in adults with
epilepsy. It has a broad spectrum of anti-epileptic modes of action
and has no appreciable effects on steady-state plasma concentrations
of other anti-epileptic drugs, such as phenytoin, carbamazepine, and
valproate.[1]

Zonisamide is available in 25mg, 50mg, and 100mg capsule
strengths. The recommended initial daily dose for adjunctive use is
50mg in two divided doses. After one week the dose may be increased
to 100 mg daily and thereafter the dose may be increased at weekly
intervals, in increments of up to 100 mg.

In the monotherapy trial the dosing was once-daily both during
titration and at the target dose. The starting dose was 100mg
once-daily in the evening and was up-titrated every two weeks; up to
an initial target dose of 300 mg/day zonisamide or 600 mg/day
carbamazepine. Subjects treated with zonisamide were more likely to
experience loss of appetite (7.8% versus 1.7%) and weight loss (6.8%
versus 0%); 13.2% of subjects lost greater than or equal to10% of
their body weight, and 0.7% lost greater than or equal to20%. There
were more reports of psychiatric disorders (9.3% versus 4.7%), and
fewer reports of dizziness (3.9% versus 7.7%) and rash (2.1% versus
4.3%) in subjects treated with zonisamide compared to those treated
with carbamazepine. The most common adverse events were headache
(ZNS: 10.3%; CBZ: 12.3%), decreased appetite (ZNS: 7.8%; CBZ: 1.7%),
somnolence (ZNS: 6.0%; CBZ: 7.7%), dizziness (ZNS: 3.9%; CBZ: 7.7%),
weight decreased (ZNS: 6.8%; CBZ: 0%), fatigue (ZNS: 4.6%; CBZ:
4.0%), rash (ZNS: 2.1%; CBZ: 4.3%) and pyrexia (ZNS: 3.9%; CBZ:
4.0%).[1]

Zonisamide is currently being investigated in paediatrics to
assess the safety and efficacy for children and adolescents with
partial onset seizures treated with one or two other anti-epileptic
drugs.

About Epilepsy

Epilepsy is one of the most common neurological conditions in the
world, affecting approximately 8 in 1,000 people in Europe.[2] There
is an estimated six million people living with epilepsy in Europe[3]
and estimated 50 million people worldwide.[4]

Epilepsy is characterised by abnormal firing of impulses from
nerve cells in the brain causing seizures. Depending on the seizure
type, seizures may be limited to one part of the body, or may be
generalised to involve the whole body. Patients may also experience
abnormal sensations, altered behaviour or altered consciousness.

Epilepsy is a disorder with many possible causes but often the
cause of epilepsy is unknown. However, anything that disturbs the
normal pattern of neuron activity - from illness to brain damage to
tumours, can lead to seizures.[6]

About Eisai Europe 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 anti-epileptic drugs (AEDs) is a major strategic area
for Eisai in the European market.

In Europe, Eisai currently has three marketed treatments
including:

- zonisamide as adjunctive therapy in adult patients with
partial-onset seizures, with or without secondary generalization.
- Zebinix(R) (eslicarbazepine acetate) as adjunctive therapy in
adult patients with partial-onset seizures, with or without secondary
generalization. (Zebinix is under license from BIAL)
- Inovelon(R) (rufinamide) for adjunctive treatment, 4 years and
older of seizures associated with Lennox-Gastaut Syndrome.

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical
companies and has defined its 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, multiple
sclerosis, neuropathic pain, epilepsy, depression
- Oncology including: anticancer therapies; tumour regression,
tumour suppression, antibodies, etc and supportive cancer therapies;
pain relief, nausea
- Vascular/Immunological reaction including: acute coronary
syndrome, atherothrombotic disease, severe sepsis, rheumatoid arthritis,
psoriasis, Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home
market of Japan, we employ more than 11,000 people worldwide.

In Europe, Eisai undertakes sales and marketing operations in
over 20 markets, including the United Kingdom, France, Germany,
Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark,
Finland, Norway, Portugal, Iceland, Czech Republic, Hungary and
Slovakia.

For further information please visit our web site
http://www.eisai.com

References

1. Eisai Ltd. (2005). Zonegran Summary of Product Characteristics

2. Pugliatti M et al. Estimating the cost of epilepsy in Europe:
A review with economic modeling. Epilepsia 2007: 48(12) 2224 - 2233

3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering
Epilepsy Care in Europe 2010. Available from;
http://www.ilae-epilepsy.org/visitors/documents/euroreport160510.pdf
(Accessed June 2011)

4. Epilepsy Society UK: http://www.epilepsysociety.org.uk/aboutep
ilepsy/whatisepilepsy/epilepsy-didyouknow (Accessed June 2011)

5. Eisai. Data on file.

6. Epilepsy Research UK. What is Epilepsy? Fact sheet. Available
from URL:
http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm
(Accessed June 2011)

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

Contact:
Media Enquiries: Eisai Europe Ltd, Cressida
Robson,+44(0)7908-314-155, Cressida_Robson@eisai.net; Tonic Life
Communications:Helen Swift/Siobhan Reilly:
+44(0)207-798-9900/+44(0)207-798-9999,helen.swift@toniclc.com /
siobhan.reilly@toniclc.com