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Eisai Europe Limited

Inovelon(R) A New Treatment for Lennox-Gastaut Syndrome Launched in Europe

London (ots/PRNewswire)

- First Treatment Licensed Specifically for LGS Offers New Hope
for  Patients With Epilepsy
Eisai Europe Limited, (Headquarters: London, President Yutaka
Tsuchiya) today announced the launch in Germany and Scandinavia of
its new anti-epileptic agent Inovelon (rufinamide) indicated for
adjunctive therapy in Lennox-Gastaut Syndrome (LGS).
Inovelon, a structurally novel compound, is the first treatment
licensed by the European Medicines Agency (EMEA) specifically for
LGS, a severe form of generalised epilepsy that develops in early
childhood.
Symptoms of LGS include a variety of seizure types, with
tonic-atonic seizures being the most common. Atonic seizures (rapid
loss of muscle tone and consciousness), and tonic seizures (where
muscles contract continuously typically producing a stiffening of the
legs and arms) lead to the sudden falls seen in LGS patients known as
'drop attacks'. Absence seizures (staring spells) and myoclonic
seizures (sudden muscle jerks) are also commonly observed. All
children with LGS will experience varying degrees of developmental
delay and behavioral problems.
In a placebo-controlled study Inovelon was found to produce a
median reduction in seizure frequency of 42.5% (p=<0.0001) for drop
attacks, and reduce the occurrence of total seizures by 32.7%
(p=<0.0015). These differences between Inovelon and placebo were
observed as early as week two during the study, suggesting a fast
onset of action. Results from the extension study suggested that for
subjects continuing on Inovelon, seizure reduction appeared to be
maintained in the long term (up to two years).
Approximately 11,000 people across Western Europe are currently
diagnosed with LGS, and it is hoped that the launch of Inovelon will
contribute to improved patient and carer quality of life.
Notes to Editors
About Eisai Europe Ltd.
Established in 1989, Eisai Europe Ltd. is the European
pharmaceutical subsidiary of Eisai Co. Ltd., a research-based human
health care (hhc) company that discovers, develops and markets
products throughout the world. Through a global network of research
facilities, manufacturing sites and marketing subsidiaries, Eisai
actively participates in all aspects of the worldwide health care
system. Eisai focuses its efforts in two therapeutic areas;
integrative neurology and integrative oncology/critical care. Eisai
employs more than 9,000 people worldwide.
About Inovelon(R)
Inovelon is a structurally novel compound that acts as a
broad-spectrum anticonvulsant originally discovered and developed by
Novartis Pharma AG. Eisai signed an in-licensing agreement for the
compound with Novartis in February 2004.
Availability
Commercial availability of Inovelon across Europe is dependant
upon local regulatory requirements and pricing and reimbursement
negotiations. Inovelon is currently available in the following
markets;
- Austria
    - Denmark
    - Finland
    - Germany
    - Iceland
    - Norway
    - Sweden
and will be launched in other European countries in due course.

Contact:

For further information contact:, Andrew Day, Communications
Director, Eisai Europe Ltd, +44-(0)208-600-1400