Scottish Medicines Consortium Approves Fycompa® (Perampanel) - Once Daily Anti-Epileptic Treatment

  Scottish Medicines Consortium Approves Fycompa® (Perampanel) - Once Daily
                           Anti-Epileptic Treatment

  PR Newswire

  HATFIELD, England, December 10, 2012

HATFIELD, England, December 10, 2012 /PRNewswire/ --

Fycompa (perampanel), a treatment for partial epilepsy, is now approved for
use in Scotland after a decision by The Scottish Medicines Consortium (SMC).
^[1] It is approved for use as a second-line adjunctive treatment in patients
with refractory partial-onset epilepsy. ^[ ^1 ^]

Almost 54,000 people in Scotland ^[2] have epilepsy, one of the most common
neurological diseases. The number of people affected by the condition has been
on the increase in Scotland, which saw nearly a 40% increase in six years
signifying a critical need for effective treatments for managing the
condition. ^[ ^2 ^] The SMC approval for perampanel is the first health
technology appraisal (HTA) globally.

"This approval from the SMC is a positive step in the management of people
with epilepsy in Scotland. Uncontrolled seizures have a severe impact on
everyday function and quality of life and so we look forward to the
possibility of being able to offer our epilepsy patients a new treatment
option," comments Professor Martin Brodie, Professor of Medicine and Clinical
Pharmacology at the University of Glasgow and Director of the Epilepsy Unit at
the city's Western Infirmary.

The data supports the use of perampanel as a new therapeutic option for this
hard-to-treat patient population. The successful treatment of partial-onset
seizures (the most common form of epilepsy) remains a significant challenge in
some patients and the incidence of uncontrolled partial epilepsy remains high,
despite many existing anti-epileptic drugs (AEDs); between 20 - 40% of
patients with epilepsy have remained poorly controlled despite these
treatments. ^[3] Fycompa is licensed as an adjunctive treatment for
partial-onset seizures with or without secondarily generalised seizures in
patients with epilepsy aged 12 years and older. ^[4]

Nick Burgin, Director Market Access, Eisai EMEA & Russia explained: "We are
delighted that SMC has approved perampanel for partial epilepsy - this is the
first health technology approval (HTA) in Europe and demonstrates the SMC's
commitment to giving patients access to innovative medicines - encouraging
better patient outcomes. We hope to see other HTA bodies following their lead
and approving perampanel across Europe."

Discovered and developed by Eisai in the UK and Japan, perampanel is the first
and only licensed AED in Europe with a mode of action that selectively targets
AMPA receptors, which are thought to play a central role in seizure generation
and spread. ^[ ^5] This 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, ^[6] and it is the only
third generation epilepsy treatment approved for adolescents which can lead to
earlier seizure control in younger patients.

The European Commission's (EC) Marketing Authorisation Approval of perampanel
was based on three global pivotal Phase III studies with 1,480 subjects. These
randomised, double-blind, placebo-controlled, and dose-escalated studies
showed consistent results in the efficacyand tolerability of perampanel as an
adjunctive therapy in patients with partial-onset seizures (with or without
secondary generalisations). ^[7] ^, ^[8] ^, ^[9] The most commonly reported
adverse events were dizziness, headaches, somnolence, irritability, fatigue,
falls, and ataxia. ^[ ^7 ^] ^, ^[8],[9]

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.

Notes to Editors

About Perampanel

Perampanel is licensed in Europe Union as an adjunctive treatment for people
aged 12 years and older with partial-onset seizures, with or without
secondarily generalised seizures.

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 signaling including epilepsy
.

Further information for healthcare professionals can be found at
http://www.fycompa.eu

About the Perampanel pooled data (Study 306 ,  305 and 304)

The pooled Phase III data analysed the efficacy of once-daily perampanel in
reducing partial-onset seizures, the most common form of epilepsy, and its
effectiveness and flexibility of use as add-on therapy. Perampanel is licensed
for the adjunctive treatment of partial-onset seizures with or without
secondarily generalized seizures in patients with epilepsy. The Scottish
Medicines Consortium (SMC) considers perampanel when positioned for use as a
second-line adjunctive treatment in patients with refractory partial onset
epilepsy i.e. patients who have previously received monotherapy and are not
seizure free after at least one other adjunctive therapy.

Results from two separate analyses of pooled data from the perampanel pivotal
Phase III clinical trial programme endorse the efficacy and safety of the new
AED at clinically relevant doses. ^[10] In addition, the results show that
perampanel decreased the frequency of both complex partial seizures and
secondarily generalised seizures. ^[11] In a third analysis of the pooled
trial data, patients with uncontrolled partial-onset seizures taking any of
the five most commonly-used AEDs with perampanel as an add-on therapy
experienced a reduction in their seizure frequency. Patients generally
received additional benefit from increased doses of perampanel. ^[12]

The clinical development plan for perampanel consisted of three global Phase
III studies (studies 306, 305 and 304). The key goal of Study 306 ^[7 ^] was
to identify the minimal effective dose and included four treatment arms
(placebo, 2mg, 4mg, and 8mg). Study 304 ^[8 ^] and Study 305 ^[9 ^] included
three arms (placebo, 8mg, and 12mg) and were to evaluate a more extended dose
range. The studies were similar in design: global, randomised, double-blind,
placebo-controlled, dose-escalation, parallel-group studies. The primary and
secondary endpoints were the same in all the studies: percentage change in
seizure frequency, 50% responder rate, percentage reduction of complex partial
plus secondarily generalised seizures, and evaluation for dose response. The
primary endpoint for the EMA is 50% responder rate and for the FDA is median
percent change in seizure frequency.

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. ^[13] ^, ^[14] 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, Africa
and Russia (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)
  *Zebinix ^® (eslicarbazepine acetate) as adjunctive therapy in adult
    patients with partial-onset seizures, with or without secondary
    generalisation. (Zebinix is under license from BIAL)
  *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 recently expanded their UK Hatfield commercial, research and
manufacturing facility which now supports the company's growing EMEA business.

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 11,000 people worldwide. In Europe, Eisai
undertakes sales and marketing operations in over 20 markets, including the
United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland,
Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic,
Slovakia, the Netherlands, Belgium, Luxembourg, the Middle East and Russia.
For further information please visit our web site http://www.eisai.com .

References

1. SMC website http://www.scottishmedicines.org.uk

2. http://www.bbc.co.uk/news/uk-scotland-glasgow-west-15888339 

3. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48
(Suppl1) 3-7

4. Fycompa. Summary of Product Characteristics. August 2012

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

6. Fycompa Summary of Product Characteristics. 2012

7. Krauss G L et al. Neurology 2012; 78: 1408-1415.

8. French JA. Neurology 2012;79:589-596.

9. French J A et al.Epilepsia 2012. Article in press

10. Ben-Menachem E,Krauss GL, Noachtar S et al. Abstract presented at ECE 2012

11. Steinhoff BJ, Gauffin H, McKee P et al. Abstract presented at ECE 2012

12. Trinka E, Straub H, Squillacote D et al. Abstract presented at ECE 2012

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

14. Pugliatti M, et al. Epilepsia 2007: 48(12);2224-2233.

Date of preparation: December 2012Job Code: Perampanel-UK2116



Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte
Andrews, +44(0)7908-314-155/ +44(0)7947-231-513, Cressida_Robson@eisai.net ,
Charlotte_Andrews@eisai.net. Tonic Life Communications, Benjamyn Tan / Hollie
Matthews, +44(0)20-7798-9262 / +44(0)207-798-9992, benjamyn.tan@toniclc.com,
eisaiepilepsy@toniclc.com
 
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