New First-in-class Treatment Fycompa® Launches in Norway for Most Common Form of Epilepsy

Hatfield, England (ots/PRNewswire) -

Eisai today launches Fycompa(R) (perampanel) in Norway as a
treatment for partial-onset seizures, with or without secondarily
generalised seizures, in people with epilepsy aged 12 years and
older.[1] Perampanel is the first in an entirely new class of
treatment for uncontrolled partial epilepsy, the most common form of
the condition.

There are more than 45,000 people in Norway with epilepsy.[2] The
successful treatment of partial-onset seizures remains a significant
challenge in some patients and the incidence of uncontrolled partial
epilepsy remains high despite the availability of many anti-epileptic
drugs (AEDs). Currently, between 20 - 40% of patients with newly
diagnosed epilepsy will become refractory to treatment.[3]

Perampanel is the first and only licensed AED to selectively
target AMPA receptors, a protein in the brain which plays a critical
role in causing seizures.[4] This mechanism of action is different to
other, currently available AEDs. In addition, perampanel has the
added benefit of convenient, once-daily dosing at bedtime[1] and,
significantly, is the only new-generation partial epilepsy treatment
approved to treat adolescents with epilepsy from launch.

"Doctors and patients in Norway will welcome perampanel as a new
option for the treatment of partial onset epilepsy. It may help
people living with epilepsy to achieve better seizure control," said
dr. Karl Otto Nakken from the National Center for Epilepsy, Oslo
university hospital. "Perampanel could also help to optimise
adherence in patients through once daily dosing, and thereby improve
outcomes for these patients and reduce the potential drug burden a
person with epilepsy may experience."

The efficacy, safety and tolerability of perampanel have been
demonstrated by three Phase III global, randomised, double-blind,
placebo-controlled, dose-escalation studies in 1,480 epilepsy
patients. They showed consistent results in the efficacy and
tolerability of perampanel as an adjunctive therapy in people with
partial-onset seizures (with or without secondary
generalisations).[5],[6],[7] The most commonly reported adverse
events were dizziness, somnolence, fatigue, headache, falls,
irritability and ataxia.[5],[6],[7]

The Norwegian price for perampanel was received from the Norwegian
Board of Health Supervision on 15 November 2012. Perampanel received
CHMP positive opinion in May 2012, was approved by the EC on 23 July
2012 and first launched in the UK on 13 September 2012. The FDA
accepted the resubmission of New Drug Application for perampanel in
March 2012 and has assigned a Prescription Drug User Free Act (PDUFA)
target date of 22 October 2012.

The development of perampanel 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 well being of
people worldwide. Eisai is committed to the therapeutic area of
epilepsy and addressing the unmet medical needs of patients with
epilepsy and their families. Eisai is proud to currently market more
epilepsy products in Europe, the Middle East, Africa and Russia
(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.[1]

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.[8]
In addition, the results show that perampanel decreased the frequency
of both complex partial seizures and secondarily generalised
seizures.[9] 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.[10]

The clinical development plan for perampanel consisted of three
global Phase III studies (studies 306, 305 and 304). The key goal of
Study 306[5] was to identify the minimal effective dose and included
four treatment arms (placebo, 2mg, 4mg, and 8mg). Study 304[6] and
Study 305[7] 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.[11],[12]
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(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)
- 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)
- 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 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, multiple sclerosis,
neuropathic pain, epilepsy, depression
- Oncology including: anticancer therapies; tumour regression, tumour
suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
- Vascular/Immunological reaction including: acute coronary syndrome,
atherothrombotic disease, rheumatoid arthritis, psoriasis, Crohn's 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. Fycompa. Summary of Product Characteristics. August 2012

2. http://www.rightdiagnosis.com/e/epilepsy/stats-country.htm
(last accessed Nov 2012)

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

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

5. Krauss GM. Serratosa JM, Villanueva V et al. Neurology 2012:
http://www.neurology.org [Accessed August 2012].

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

7. French JA et al. (305) Epilepsia 2012:1-9. In press online.

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

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

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

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

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

Date of preparation: January 2013

Job code: Perampanel-EU0026

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

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)207-798-9262 / +44(0)207-7798-9992,
hollie.matthews@toniclc.com, eisaiepilepsy@toniclc.com