Wealth of Data for Fycompa® (perampanel) and Inovelon® (rufinamide) to be Presented at the American Epilepsy Society (AES) Annual Meeting

Hatfield, England (ots/PRNewswire) -

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

Data from nine abstracts for Eisai's epilepsy treatments
perampanel and rufinamide will be presented at the 70th Annual
Meeting of the American Epilepsy Society (AES), 2-6 December,
Houston, Texas, which provide further insight into their long-term
use in people with epilepsy.

Perampanel is indicated in the European Union for patients aged 12
years and older, for adjunctive treatment of partial-onset seizures
(POS), with or without secondarily generalised seizures, and for
adjunctive treatment of primary generalised tonic-clonic (PGTC)
seizures in patients with idiopathic generalised epilepsy (IGE).[1]

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

"These data provide real world insights into the activity of
perampanel and rufinamide in potential patients over a wide range of
ages. Through new and continued research with perampanel and
rufinamide, we aim to further educate the epilepsy community about
these debilitating diseases," comments Lynn Kramer, MD, Chief
Clinical Officer and Chief Medical Officer, Neurology Business Group,
Eisai.

The development of its epilepsy portfolio 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 neurology and to address the unmet medical needs
of people with neurological conditions and their families.

Perampanel abstracts at AES (presented in the George R Brown
Convention Center, Hall A3, Level 3):

Abstract Number Abstract details

Poster # 2.189 Evaluation of perampanel as monotherapy for
focal
Date: Sunday 4 seizures: experience from open-label
extension studies
December
Time: 10:00-16:00
Location: Hall A3, Kwan P, Mintzer S, Laurenza A, Patten A,
Cartwright K
B3

Poster # 2.190 Adjunctive perampanel (PER) in patients
(pts) with partial
Date: Sunday 4 seizures or primary generalized tonic-clonic
seizures
December (PGTCS): effect of age at diagnosis
Time: 10:00-16:00
Location: Hall A3, Kramer L, Patten A, Laurenza A, French JA
B3

Poster # 2.193 Long-term efficacy and safety of adjunctive
perampanel:
Date: Sunday 4 pooled analyses of the open-label extension
(OLE) studies
December
Time: 10:00-16:00
Location: Hall A3, Rektor I, Krauss GL, Inoue Y, Kaneko S,
Williams B, Patten
B3 A, Bibbiani F, Laurenza A, Wechsler RT

Poster # 2.222 A systematic review of real world perampanel
treatment
Date: Sunday 4 outcomes
December
Time: 10:00-16:00
Location: Hall A3, Krauss G, Tsong W, Steinhoff BJ
B3

Poster # 2.225 An indirect treatment comparison (ITC) of
perampanel
Date: Sunday 4 versus brivaracetam in patients with
partial-onset
December seizures with or without secondary
generalisation
Time: 10:00-16:00
Location: Hall A3, Tsong W, Kockelmann E, Tremblay G, Mehlig H,
and Patel V
B3

Poster # 3.238 Adjunctive perampanel in patients with
drug-resistant
Date: Monday 5 partial seizures with and without concurrent
vagal nerve
December stimulation therapy in Phase III studies

Time: 08:00-14:00
Location: Hall A3,
B3 Laurenza A, Klein P, Williams B, Patten A

Poster # 2.191 Phase II trials of adjunctive perampanel in
Japanese
Date: Sunday 4 patients with refractory partial-onset
seizures, an
December open-label, ascending-high-dose study (study
231) and
Time: 10:00-16:00 long-term extension study (study 233)

Location: Hall A3,
B3 Hiramatsu H, Saeki K, Ohnishi A, Kaneko S,
Inoue Y

Poster # 3.232 Factors influencing the efficacy of
perampanel:
Date: Monday, multivariate analysis of a randomized,
double-blind,
December 5 placebo-controlled Phase III study

Time: 08:00-14:00
Location: Hall A3,
B3 Nishida T, Inoue Y, Kaneko S, Saeki K,
Ishikawa K

Rufinamide abstracts at AES (in the George R Brown Convention
Center, Hall A3, Level 3):

Abstract Number Abstract details

Poster # 3.363 Safety and Cognitive Development Effects of
Adjunctive
Date: Monday 5 Rufinamide in Pediatric Subjects With
Inadequately
December Controlled Lennox-Gastaut Syndrome (LGS):
Final Results

Time: 08:00-14:00 From Study 303
Arzimanoglou A, Ferreira J, Satlin A, Olhaye
O, Kumar D,
Location: Hall A3, Dhadda S, Bibbiani F
B3

Notes to Editors

About Fycompa® (perampanel)

Perampanel is a first-in-class, non-competitive AMPA
(alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate
receptor antagonist on post-synaptic neurons.[1] AMPA receptors,
widely present in almost all excitatory neurons, transmit signals
stimulated by the excitatory neurotransmitter glutamate within the
brain, and are believed to play a role in central nervous system
diseases characterised by excess neuroexcitatory signalling,
including epilepsy.[3] Since launch, approximately 52,000 people
living with epilepsy have been treated with perampanel.[4]

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 treatment 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 treatment 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. Fycompa® (perampanel) Summary of Product Characteristics
(SmPC) Available at: http://www.ema.europa.eu/docs/en_GB/document_lib
rary/EPAR_-_Product_Information/human/002434/WC500130815.pdf Accessed
November 2016

2. Inovelon® (rufinamide) Summary of Product Characteristics
(SmPC). Available at: http://www.ema.europa.eu/docs/en_GB/document_li
brary/EPAR_-_Summary_for_the_public/human/000660/WC500032938.pdf
Accessed November 2016

3. Lee K et al. AMPA Receptors as Therapeutic Targets for
Neurological Disorders 2016;103:203-261

4. Eisai. Data on File 2016. DOF PER112

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. Available at:
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
Accessed November 2016

December 2016

Fycompa-EU0185

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

Contact:
Media Enquiries - 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

Original-Content von: Eisai, übermittelt durch news aktuell