First Clinical Experiences With Fycompa® (perampanel) Show "Clear Therapeutic Benefit"

Hatfield, England (ots/PRNewswire) -

New data on early real life experience show perampanel is
effective and well

tolerated in patients with difficult-to-treat partial epilepsy

The antiepileptic drug (AED) Fycompa (perampanel), shows a clear
therapeutic benefit in difficult-to-treat patients with partial
epilepsy according to the investigators of two new analyses on early
clinical experience of perampanel, presented on 9th May at the joint
meeting of the German and Austrian Societies for Epileptology and the
Swiss League Against Epilepsy in Interlaken, Switzerland.[1],[2]
Perampanel was approved for use in the Europe Union in July 2012 and
is now prescribed in several European countries, including Germany,
Austria and Switzerland.[3]

The two analyses examined independently and on their own
initiative data from two major German epilepsy centres and
investigated effects on seizure frequency and potential side effects
of perampanel treatment in clinical practice. The results describe
the first real life experiences of perampanel as an adjunctive
therapy in patients with refractory partial epilepsy.

"The results of these early analyses are a promising indication of
the clinical benefit perampanel can offer to patients with partial
epilepsy, and are particularly significant for patients who have
previously tried a number of AEDs or are taking a combination of
therapies, yet still experience a high seizure frequency," said
Professor Bernard Steinhoff from the Epilepsy Centre Kork in
Kehl-Kork, Germany. "Around 30% of patients with epilepsy are, or
become, refractory to treatment with available antiepileptic drugs,
meaning there is still a significant need for novel and effective
AEDs. Our findings show perampanel is of clear therapeutic benefit as
an adjunctive therapy."

In the larger of the two analyses, led by Professor Bernard
Steinhoff, at the Epilepsy Centre Kork in Kehl-Kork, 100 patients
were treated. 45 of these patients were followed up for at least six
months. 47% of the 45 patients had a reduction in seizure frequency
of at least 50% compared to baseline, and 16% became seizure free.
62% (n=28) of patients experienced adverse events, with somnolence
and dizziness most frequently reported, and as a result, five
patients discontinued treatment. At the end of the six month follow
up period, 71% of patients had continued treatment with
perampanel.[1]

The second analysis, conducted at the Epilepsy-Center
Berlin-Brandenburg (led by Professor Martin Holtkamp) involved 19
patients with partial-onset seizures (94.7% with a history of
secondary generalisation). Outcomes were assessed by follow-up
telephone interviews after 2.7 months (mean). Patients had suffered
from intractable epilepsy (52.6% with temporal lobe epilepsy) for an
average of 23.7 years, and had previously been treated with an
average number of nine AEDs. Their current medication consisted of
2.1 AEDs.

Four patients (21.1%) experienced more than a 50% decrease of
seizure frequency with perampanel, a further five patients (26.3%)
observed a positive effect, although less than a 50% reduction in
seizure frequency. Four patients had discontinued treatment, two due
to side effects.[2]

Perampanel is the only approved AED in Europe that selectively
targets AMPA receptors, which are thought to play a central role in
seizure generation and spread.[4] The first-in-class treatment
selectively targets the transmission of seizures by blocking the
effects of glutamate, which can trigger and maintain seizures. In
addition, perampanel has the added benefit of convenient, once-daily
dosing taken at bedtime.[5]

"These new, early, real-world data continue to confirm the
clinical value of Fycompa," said Gary Hendler, Eisai President & CEO,
EMEA. "Sharing first clinical experiences on new treatments is
vitally important and will help clinicians to optimally manage their
patients' epilepsy. Additional investigational studies on the use of
Fycompa in a clinical setting are very much welcomed and will help to
build a clearer picture of the drug's clinical profile and additional
benefit."

Perampanel is licensed as an adjunctive treatment for people aged
12 years and older with partial-onset seizures, with or without
secondarily generalised seizures[5], and is the only third generation
epilepsy treatment approved for use in adolescents. It was approved
by the European Commission in July 2012 and the US FDA in October
2012. In Europe, it is currently available in the UK, Denmark,
Germany, Sweden, Norway and Austria. Swissmedic, the Swiss Agency for
Therapeutic Products, approved perampanel for use on 17 December
2012.

The development of perampanel underscores Eisai's human health
care mission, the company's commitment to innovative solutions in
disease prevention, cure and care for the health and well being of
people worldwide. Eisai is committed to the therapeutic area of
epilepsy and addressing the unmet medical needs of patients and their
families. Eisai is proud to currently market more epilepsy products
in Europe, the Middle East and Africa (EMEA) than any other company.

Notes to Editors

About Perampanel

Perampanel is a highly selective, non-competitive AMPA (
alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type
glutamate receptor antagonist that has demonstrated seizure reduction
in Phase II and III studies. 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, neurodegenerative
disorders, movement disorders, pain and psychiatric disorders.[5]

Further information for healthcare professionals can be found at
http://www.eisai.co.uk

About Epilepsy

Epilepsy is one of the most common neurological conditions in the
world, affecting approximately eight in 1,000 people in Europe, and
an estimated 50 million people with the condition worldwide.[6],[7]
Epilepsy is a chronic disorder of the brain that affects people of
all ages. It is characterised by abnormal discharges of neuronal
activity causing seizures. Seizures can vary in 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 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 AEDs is a major strategic area for Eisai in Europe,
the Middle East and Africa (EMEA).

In the EMEA region, Eisai currently has four marketed treatments
including:

- Zonegran(R) (zonisamide) as monotherapy and adjunctive therapy in adult
patients with partial-onset seizures, with or without secondary generalisation.
(Zonegran is under license from the originator Dainippon Sumitomo Pharma). In
Switzerland, Zonegran is only approved as adjunctive therapy.
- Zebinix(R) (eslicarbazepine acetate) as adjunctive therapy in adult patients
with partial-onset seizures, with or without secondary generalisation. (Zebinix is
under license from BIAL). Zebinix is not approved by Swissmedic.
- Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated
with Lennox-Gastaut Syndrome in patients >4 years
- Fycompa(R) (perampanel) for use as an adjunctive treatment for partial onset
seizures, with or without secondarily generalised seizures, in patients with epilepsy
aged 12 years and older

About Eisai

Eisai is one of the world's leading research and development (R&D)
based pharmaceutical companies.

Eisai concentrates its R&D activities in three key areas:

- Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight
loss
- Oncology including: anticancer therapies; tumour regression, tumour
suppression, antibodies, etc
- Vascular/Immunological reaction including: thrombocytopenia, rheumatoid
arthritis, psoriasis, inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home
market of Japan, Eisai employs more than 10,000 people worldwide.
From its Knowledge Centre in Hatfield, UK, Eisai has recently
expanded its business operations to include Europe, the Middle East
and Africa (EMEA). Eisai EMEA has sales and marketing operations in
over 20 markets, including the United Kingdom, France, Germany,
Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark,
Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands,
Belgium and the Middle East.

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

References

1. Geithner J, Frenck W, Holtkamp M. Effectiveness and side
effects of perampanel: a first utilization study. Poster P06
presented at 8th joint three country meeting of the German and
Austrian Societies for Epileptology and the Suisse League against
Epilepsy, Interlaken, Switzerland 2013

2. Steinhoff BJ et al. First clinical experiences with perampanel.
Poster P08 presented at 8th joint three country meeting of the German
and Austrian Societies for Epileptology and the Suisse League against
Epilepsy, Interlaken, Switzerland 2013

3. EMA Authorisation Details: http://www.ema.europa.eu/ema/index.j
sp?curl=pages/medicines/human/medicines/002434/human_med_001572.jsp&m
id=WC0b01ac058001d124 [Last accessed April 2013]

4. Rogawski MA. Epilepsy Currents 2011;11:56-63

5. Fycompa Summary of Product Characteristics. 2012

6. Epilepsy in the WHO European Region: Fostering Epilepsy Care in
Europe
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
[Accessed August 2012]

7. Pugliatti M, et al. Epilepsia Estimating the cost of epilepsy
in Europe: a review with economic modelling. 2007: 48(12);2224-2233

Date of preparation: May 2013
Job code: perampanel-UK2126

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

Contact:
Media Enquiries, Eisai Europe Ltd, Charlotte Andrews / Cressida
Robson, +44(0)7908-314-155, Cressida_Robson@eisai.net,
Charlotte_andrews@eisai.net; Tonic Life Communications, Siobhan
Reilly /
Nicola Lilley, +44(0)207-798-999/+44(0)207-798-9905,
siobhan.reilly@toniclc.com, nicola.lilley@toniclc.com