Results Presented for Pivotal Phase III Clinical Trial of Adjunctive Rufinamide in Children With Inadequately Controlled Lennox-Gastaut Syndrome

Hatfield, England (ots/PRNewswire) -

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN/US JOURNALISTS

Final data to be presented for the first time at American Epilepsy
Society in Houston, Texas

Data presented today at the American Epilepsy Society (AES),
Houston, Texas, show that adjunctive Inovelon® (rufinamide) in
children aged one to four years with inadequately controlled
Lennox-Gastaut Syndrome (LGS) is well tolerated and cognitive
development and behaviour is comparable to other adjunctive
treatments.[1]

Rufinamide is indicated in the European Union for the adjunctive
treatment of seizures associated with Lennox-Gastaut Syndrome in
patients aged four years and older.[2]

Study 303 (NCT01405053), a global, randomised, multicentre,
two-year open-label study was conducted to evaluate the cognitive
development and behavioural effects, safety, and pharmacokinetics of
adjunctive rufinamide treatment in paediatric subjects aged one to
four years with inadequately controlled Lennox-Gastaut Syndrome.[3]

The primary endpoint of Study 303 was the change in Child
Behaviour Checklist (CBCL) Total Problems Score from baseline to the
end of the treatment period (106 weeks), which examines cognitive
development and behavioural effects of subjects treated with
rufinamide.[1],[3] In Study 303, 25 children received rufinamide and
12 received another approved anti-epileptic drug as add-on to their
existing regimen.[1]

Using the Child Behaviour Checklist, the cognitive development and
behaviour of children who received rufinamide was comparable to that
of subjects who received another approvedanti-epileptic drug (LS mean
difference [95% CI] +2.60 [-10.5,15.7]; p=0.6928).[1]

The treatment-emergent adverse event (TEAE) incidence was similar
between the rufinamide group (88.0%) and the any-other anti-epileptic
drug group (83.3%), with most events considered mild or moderate.
Vomiting (20%, n=5) and somnolence (16%, n=4) were the only
treatment-related TEAEs reported in >2 children who received
rufinamide.[1]

"Lennox-Gastaut Syndome is a rare and severe form of epilepsy
where children can have up to 100 seizures a day, causing multiple
developmental issues. It is important to understand the impact of
anti-epileptic drugs on the behavioural and cognitive development of
these children. These data show adjunctive rufinamide has an impact
on behavioural development comparable with other treatments,"
comments Alexis Arizmanoglou, Associate Professor of Neurology and
Child Neurology, College de Medicine des Hopitaux de Paris.

Lennox-Gastaut Syndrome is a severe form of childhood-onset
epilepsy that appears most often in children aged two to six. It is
characterised by frequent and multiple seizure types, behavioural
issues, mental retardation and resistance to medication or
therapies.[4] Although incidence is estimated to 0.1 in 100,000
people per year, the prevalence is high (5-10% of people with
epilepsy), representing 1-2% of all childhood epilepsies.[4]

"Eisai is committed to the ongoing development of rufinamide for
this very rare and severe condition. Eisai seeks to improve the lives
of patients and families through continued development of our
products in epilepsy," comments Neil West, Vice President, Global
Neurology Business Group, Eisai EMEA.

Notes to Editors

About Inovelon® (rufinamide)

Rufinamide is a triazole derivative that is structurally unrelated
to currently marketed antiepileptic drugs (AEDs).[5],[6] It is
believed to regulate the activity of sodium channels in the brain
which carry excessive electrical charges.[5] Rufinamide was approved
for adjunctive therapy for seizures associated with Lennox-Gastaut
Syndrome in Europe (under the brand name Inovelon) in 2007 in
patients four years of age and older. Rufinamide is available as
film-coated tablets containing 100mg, 200mg and 400mg rufinamide and
as a 40mg/ml oral suspension.[2]

About Epilepsy

Epilepsy is one of the most common neurological conditions in the
world, affecting approximately six million people in Europe, and an
estimated 50 million people worldwide.[7] 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 nature and 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) is indicated for use as a once-daily,
adjunctive therapy for both primary generalised tonic-clonic
seizures in idiopathic generalised epilepsy and for partial onset
seizures, with or without secondary generalisation, in patients
aged 12 years or older
- Inovelon® (rufinamide) is indicated for the adjunctive treatment of
seizures associated with Lennox-Gastaut Syndrome in patients >=4
years. (Rufinamide was originally developed by Novartis)
- Zonegran® (zonisamide) as monotherapy in the treatment of partial
seizures, with or without secondary generalisation, in adults with
newly diagnosed epilepsy and as adjunctive therapy in the treatment
of partial seizures, with or without secondary generalisation, in
adults, adolescents and children aged six years and above.
(Zonegran is under license from the originator Dainippon Sumitomo
Pharma)
- Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult
patients with partial onset seizures, with or without secondary
generalisation (Zebinix is under license from Bial)

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based
pharmaceutical company headquartered in Japan. 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 our human health care (hhc) philosophy. With over 10,000
employees working across our global network of R&D facilities,
manufacturing sites and marketing subsidiaries, we strive to realise
our hhc philosophy by delivering innovative products in multiple
therapeutic areas with high unmet medical needs, including Oncology
and Neurology.

As a global pharmaceutical company, our mission extends to
patients around the world through our investment and participation in
partnership-based initiatives to improve access to medicines in
developing countries.

For more information about Eisai Co., Ltd., please visit
http://www.eisai.com

References

1. Arzimanoglou A et al. Safety and Cognitive Development Effects
of Adjunctive Rufinamide in Pediatric Subjects With Inadequately
Controlled Lennox-Gastaut Syndrome (LGS): Final Results From Study
303. Presented at American Epilepsy Society 2016

2. Inovelon® (rufinamide) SPC - Inovelon Tablets and Oral
Suspension. Available at: http://www.ema.europa.eu/docs/en_GB/docume
nt_library/EPAR_-_Summary_for_the_public/human/000660/WC500032938.pdf
Accessed November 2016

3. Study of Rufinamide in Pediatric Subjects 1 to Less Than 4
Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled
With Other Anti-epileptic Drugs (NCT01405053). Available at:
https://clinicaltrials.gov/ct2/show/record/NCT01405053 Accessed
November 2016

4. Tyagi S, et al. Pharmacological management of Lennox-Gastaut
Syndrome-a difficult-to-treat form of childhood-onset epilepsy: an
overview. International Journal of Pharma and Bio Sciences.
2010:1(3). Available at: http://www.ijpbs.net/issue-3/82.pdf .
Accessed August 2016

5. Wier H et al. Rufinamide for Pediatric Patients with
Lennox-Gastaut Syndrome. Pediatric Drugs 2011;13(2):97-106

6. Xu M et al. Pharmacokinetics and Tolerability of Rufinamide
Following Single and Multiple Oral Doses and Effect of Food on
Pharmacokinetics in Healthy Chinese Subjects. European Journal of
Drug Metabolism and Pharmacokinetics 2016;41(5):541-548

7. Epilepsy in the WHO European Region: Fostering Epilepsy Care in
Europe.
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
(Accessed June 2016)

December 2016

Inovelon-EU0029

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

Contact:
Eisai
Cressida Robson / Ben Speller
+44-7908-314-155 / +44-7908-409-416
Cressida_Robson@eisai.net / Ben_Speller@eisai.net

Tonic Life Communications
Alex Davies / Stan Jackson
+44-7896-954-865 / +44-7747-718-279
Alex.Davies@toniclc.com / Stan.Jackson@toniclc.com

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