New Data for Fycompa® (perampanel) and Inovelon® (rufinamide) Further Validate Long-Term Seizure Control and Safety Profile for Both Treatments Across a Range of Epilepsy Seizure Types

Hatfield, England (ots/PRNewswire) -

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS

Eisai present several abstracts on new data at 12th European
Congress on Epileptology (ECE) for epilepsy treatments

Data from several abstracts for Eisai's epilepsy treatments
Fycompa® (perampanel) and Inovelon® (rufinamide) will be presented at
the 12th European Congress on Epileptology (ECE), 11-15 September
2016, Prague, Czech Republic. These new data augment previous
evidence on the efficacy and safety for these agents in different
epilepsy seizure types, including generalised tonic clonic seizures
(primary and secondary), and Lennox-Gastaut Syndrome.

Perampanel is indicated in the European Union for the adjunctive
treatment of partial-onset seizures, with or without secondary
generalised seizures, and for primary generalised tonic clonic
seizures, in patients with idiopathic generalised epilepsy (IGE) aged
12 years and older.[1] Rufinamide is indicated in the European Union
as adjunctive therapy for the treatment of seizures associated with
Lennox-Gastaut Syndrome in patients 4 years of age and older.[2]

"The data presented at ECE reinforce Eisai's continued focus on
epilepsy treatment options that have the potential to improve
outcomes in different patient populations. Epilepsy is a challenging
condition to manage - those affected by it just want to get on with
life through better seizure control and acceptable tolerability.
Building the evidence for perampanel and rufinamide is therefore
vital to enable clinicians to better understand and optimise
treatment outcomes in clinical practice," comments Neil West, Vice
President, Global Neurology Business Group, Eisai EMEA.

Data from several analyses will be presented for the 332
randomised, placebo-controlled, clinical trial[3] of adjunctive
perampanel including an interventional open label extension study,[4]
and post-hoc analyses of study 332[5] in myoclonic and absence
seizures.

Abstract #0074 - Perucca E et al[6] - 12 September 11:30-13:00

Adjunctive perampanel was associated with improved seizure control
in patients with partial-onset seizures treated for up to four years
(n=78) and particularly in subjects with secondary generalised
seizures at baseline. No new safety signals were seen during
long-term perampanel exposure.

Abstract #0073 - O'Brien T et al[5] - 14 September 11:30-13:00

Epilepsy drugs can paradoxically increase seizure activity, and
most notably absence or myoclonic seizures.[7] Outcomes in a
post-hoc analysis of the 17-week core phase of study 332 showed that
compared with placebo, adjunctive perampanel did not show clear
evidence for worsening of myoclonic or absence seizures. However, the
study was not powered to detect differences in these seizure types.

Abstract #P555 - Weschler R et al[4] - 14 September 13:00-14:30

In an interventional open label extension study,[4] 138 IGE
patients with drug-resistant primary generalised tonic clonic
seizures who received long-term adjunctive perampanel for up to 142
weeks (2.7 years), had a favourable risk-benefit ratio. Outcomes were
consistent with the known safety profile for perampanel. A total 120
patients (87%) experienced treatment-emergent adverse events (AEs)
including 20 (14.5%) with severe AEs, 18 (13%) with serious AEs, and
13 (9.4%) with AEs that lead to withdrawal.

Abstract #P590 - Auvin S et al[8]- 13 September 13:00-14:30

Results from a recent European patient registry study[8] for
safety in 111 patients of all ages (>=4 years) with Lennox-Gastaut
Syndrome suggest the potential for rufinamide and 'other'
antiepileptic drugs in the long-term treatment of LGS. After 12
months, the proportion of patients rated as 'minimally', 'much', or
'very much' improved in control of all seizures was 47.6% (n=20/42)
for rufinamide and 39.4% (n=13/33) for 'other' antiepileptic drugs.
Treatment related adverse events were 40.6% for rufinamide and 27.7%
for 'other' drugs.[8] The most frequently reported rufinamide-related
adverse events (>=5% patients) were somnolence (7.8%) and decreased
appetite (6.3%).

Abstract #P622 - Brandt C et al[9]- 14 September 13:00-14:30

There are limited published data on the treatment of adults with
Lennox-Gastaut Syndrome. In analyses of a registry study,[8] data on
adults (>=18 years; n=24) were extracted and analysed. At month 24,
the proportion of patients rated as 'minimally', 'much', or 'very
much' improved in control of all seizures was 71.4% (n=5/7) for
rufinamide 50% (n=2/4) with 'other' antiepileptic drugs. Adverse
events were seen in 50% of patients on rufinamide compared with 37.5%
for 'other' drugs.[9]

Abstract Number
Timing of presentation Abstract
details

Perampanel Marked Reduction in
Secondarily Generalised Seizures
Abstract number: #0074 in
Patients Treated With Perampanel for 3 and 4 Years
Platform
Session 1 Emilio Perucca, Gregory L Krauss, Patrick Kwan,

Antiepileptic Drugs 1 Elinor Ben-Menachem, Xue-feng Wang, Jerry
Shih,
Monday 12 September Betsy Williams, Antonio Laurenza,
Haichen Yang
11.30 - 13.00
Congress Hall

Abstract
number: #0073 Myoclonic and Absence Seizures in Patients With

Platform Session 13 Idiopathic Generalized Epilepsy (IGE):
Exploratory
Antiepileptic Drugs 3 Outcomes in a Phase III
PGTC Study With Adjunctive
Wednesday 14 September Perampanel

11.30 - 13.00 Terence J O'Brien,
Bernhard J Steinhoff, Antonio
Forum Hall Laurenza,
Anna Patten, Francesco Bibbiani, Haichen Yang

Abstract number: #P555 Long-term safety and efficacy of
adjunctive
Poster Session perampanel in patients with
drug-resistant primary
Pharmacology / AEDs 10 generalised
tonic clonic seizures in idiopathic
Wednesday 14 September
generalised epilepsy: results of an open-label extension
13.00 -
14.30 Robert T Wechsler, Jacqueline French, Eugen Trinka,
Poster Area (Forum Hall Christian Brandt, Terence O'Brien,
Francesco
Foyer) Bibbiani, Anna Patten,
Antonio Laurenza

Rufinamide

Abstract number: #P590 European non-interventional registry study
of
Poster Session antiepileptic drug use in patients
with
Pharmacology / AEDs 5 Lennox-Gastaut Syndrome

Tuesday 13th September Stéphane Auvin, Rob McMurray, Christian
Brandt,
13.00 - 14.30 Marina Nikanorova

Poster Area (Forum Hall
Foyer)

Abstract
number: #P622 Use of rufinamide and other antiepileptic drugs in

Poster Session the management of adult patients (greater
than or
Pharmacology / AEDs 9 equal to18 years) with
Lennox-Gastaut Syndrome
Wednesday 14 September Christian
Brandt, Rob McMurray, Stéphane Auvin,
13.00 - 14.30
Marina Nikanorova
Poster Area (Forum Hall
Foyer)

The continued 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 epilepsy and their families.

Notes to Editors

About Fycompa® (perampanel)

Perampanel is a highly selective, non-competitive AMPA
(alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type
glutamate receptor antagonist. 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.

Since launch, approximately 52,000 people living with epilepsy
across the EMEA region* have been treated with perampanel.[10]

* EMEA countries are Germany, Italy, UK, Spain, France,
Switzerland, Netherlands, Ireland, Sweden, Norway, Denmark, Austria,
Belgium, Czech Republic, Portugal, Greece, Australia, Russia,
Slovakia, Israel.

Fycompa® (perampanel) - Study 332[3]

Study 332 is a double-blind, randomised, placebo-controlled,
multicentre, parallel-group Phase III trial to evaluate the efficacy
and safety of adjunctive perampanel for refractory PGTC seizures in
idiopathic generalised epilepsy. 164 people (>=12 years old) with
PGTC seizures and IGE (diagnoses confirmed by independent reviewers),
despite treatment with one to three concomitant AEDs, were randomised
to receive perampanel (8 mg/d or highest tolerated dose) or placebo
in a 1:1 ratio.

About Inovelon® (rufinamide)

Rufinamide was approved for adjunctive therapy for Lennox-Gastaut
Syndrome in Europe (under the brand name Inovelon) in 2007. Inovelon
is available in 19 European countries as film-coated tablets
containing 100mg, 200mg, and 400mg rufinamide. It is available in
some countries as an oral suspension in orange flavour 40mg/ml
concentration. The oral suspension formulation is bioequivalent to
the tablet formulation on a milligram per milligram basis and in is
available in the Denmark, France, Germany, Portugal, Spain, and the
United Kingdom.

About Epilepsy

Epilepsy is one of the most common neurological conditions in the
world, affecting approximately 6 million people in Europe, and an
estimated 50 million people worldwide.[11] 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.

For the majority of idiopathic generalised epilepsy patients, a
primary generalised tonic clonic (PGTC) seizure begins with or
without an aura (sensory or psychic phenomena), which is followed by
loss of consciousness and muscle rigidity (tonic phase). This is
followed by violent muscle contraction (clonic phase). As this is a
serious event, it is seen as a major hindrance on daily life. While
the seizure generally only lasts a few minutes, the patient will
often feel confused or drowsy for a short period of time before
returning to normal.[12],[13] PGTC seizures can also result in injury
and sudden unexplained death in epilepsy (SUDEP).[14]

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) 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. Fycompa® (perampanel) SPC - Fycompa
2mg,4mg,6mg,8mg,10mg,12mg film-coated tablets. Available at:
https://www.medicines.org.uk/emc/medicine/26951 [updated 1 March
2016]. Accessed August 2016

2. Inovelon® (rufinamide) SPC - Inovelon Tablets and Oral
Suspension. Available at:
http://www.medicines.org.uk/emc/medicine/20165/SPC/ [updated 6
August 2013]. Accessed August 2016

3. French A, et al. Perampanel for tonic-clonic seizures in
idiopathic generalised epilepsy. Neurology 2015;85:950-57

4. Wechsler R, et al. Long-term safety and efficacy of
adjunctive perampanel in patients with drug-resistant primary
generalised tonic-clonic seizures in idiopathic generalised epilepsy:
results of an open-label extension; European Congress on Epileptology
2016: Abstract #P555

5. O'Brien T, et al. Myoclonic and Absence Seizures in
Patients With Idiopathic Generalised Epilepsy (IGE): Exploratory
Outcomes in a Phase III PGTC Study With Adjunctive Perampanel;
European Congress on Epileptology 2016: Abstract #0073

6. Perucca E, et al. Marked Reduction in Secondarily
Generalised Seizures in Patients Treated With Perampanel for 3 and 4
Years; European Congress on Epileptology 2016: Abstract #0074

7. Perucca E, et al. Antiepileptic drugs as a cause of
worsening seizures. Epilepsia 1998;39(1):5-17

8. Auvin S, et al. European non-interventional registry study
of antiepileptic drug use in patients with Lennox-Gastaut syndrome;
European Congress on Epileptology 2016: Abstract #P590

9. Brandt C, et al. Use of rufinamide and other antiepileptic
drugs in the management of adult patients (>=18 years) with
Lennox-Gastaut syndrome; European Congress on Epileptology 2016:
Abstract #P622

10. Eisai. Data on File 2016. DOF PER112

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

12. Epilepsy Foundation. Types of seizures. Available at:
http://www.epilepsy.com/learn/types-seizures . (Accessed June 2016)

13. Epilepsy Foundation. IGE Summary. Available at: http://www
.epilepsy.com/information/professionals/about-epilepsy-seizures/idiop
athic-generalized-epilepsies/idiopathic . (Accessed June 2016)

14. Smithson WH, et al. Sudden Unexpected Death in Epilepsy:
Addressing the Challenges. Curr Neurol Neurosci Rep 2014; 14(12):502

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

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