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

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

  PR Newswire

  HATFIELD, England, May 9, 2013

HATFIELD, England, May 9, 2013 /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 9 ^th 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 ^® (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 ^® (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 ^® (rufinamide) for the adjunctive treatment of seizures
    associated with Lennox-Gastaut Syndrome in patients >4 years
  *Fycompa ^® (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.jsp?curl=pages/medicines/human/medicines/002434/human_med_001572.jsp∣=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

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
 
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