Eisai Disagrees with German Institute for Quality and Efficiency in Health Care (IQWiG) Report on Innovative Antiepileptic Drug Fycompa® (Perampanel) for the Treatment of Partial Epilepsy

Hatfield, England (ots/PRNewswire) -

In the assessment report by the Institute for Quality and
Efficiency in Health Care (IQWiG) on Fycompa(R) (perampanel),
published today on the Federal Joint Committee (G-BA) website, the
institute did not attest an additional benefit. Comments on the
report and its proposed conclusion can be submitted to the G-BA up
until 07 January 2013. The G-BA will decide on the additional benefit
in March 2013 after reviewing comments and the discussion from an
oral hearing of experts end of January. The current IQWiG assessment
has no implications on the reimbursement of perampanel or doctors'
ability to prescribe this new partial epilepsy treatment.

Eisai today expressed its strong disappointment with IQWiG in
regards to their assessment of the additional benefit, of the new
epilepsy treatment perampanel compared to a treatment defined by the
G-BA. It is reported that additional benefit is unproven based on
methodological considerations.[1] No statement was made regarding
clinical efficacy and safety. Perampanel is the first in an entirely
new class of treatment for uncontrolled partial epilepsy with a novel
mechanism of action that is different from all other anti-epileptic
drugs (AEDs). The company believes that, while discussing at length
methodological aspects of analyses, IQWiG failed to adequately
interpret the patient-relevant benefits and responsibly recognise the
innovative nature of the new drug in a clinical setting with a high
unmet need.

Perampanel is indicated as an adjunctive treatment for partial
seizures (the most common form of epileptic seizures), with or
without secondarily generalised seizures, in patients with epilepsy
aged 12 years and older.[2] It was first launched in Europe in
Germany and the UK in September 2012 and has been well received by
both patients and doctors. It is the first and only licensed AED to
selectively target AMPA receptors which play a critical role in
causing seizures.[3] It blocks the effects of glutamate, which can
trigger and maintain seizures.

"We believe we provided compelling evidence of the additional
benefit of perampanel based on the advice received by the G-BA. By
taking a negative view, IQWiG ignores the therapeutic value that this
first-in-class new AED brings to the real-life clinical setting.
There still remains a very high need for new drugs to reduce seizures
in patients with refractory partial epilepsy," points out Franz
Wetzel, Epilepsy Business Unit Director, Eisai Germany. "In addition,
perampanel has the further benefit of convenient, once-daily dosing
at bedtime and it is the only new-generation partial epilepsy
treatment approved to treat adolescents with epilepsy from launch."

Nick Burgin, European Director of Market Access, Eisai added; "We
are dismayed by this critical assessment of perampanel. Even while
facing measures to cut costs in the current economic climate it
remains important to consider the pressing needs of the patients for
new, innovative medicines. Eisai will make all efforts to have
available data adequately considered in order to achieve recognition
of the resulting additional benefit.

An estimated 500.000 - 650.000 people with epilepsy live in
Germany.[4] Epilepsy is one of the most common neurological
conditions in the world.[5] The successful treatment of partial-onset
seizures remains a challenge. Up to 30% of patients with
partial-onset seizures do not achieve seizure freedom despite
appropriate therapy with anti-epileptic drugs.[6]

Perampanel was approved by the European Commission on 23 July 2012
and is currently available in the UK, Denmark, Germany, Austria and
Sweden. Swissmedic, the Swiss Agency for Therapeutic Products
approved perampanel for use on 17 December 2012. The FDA approved
perampanel for use in the US on 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 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.[2]

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, neurodegenerative
disorders, movement disorders, pain and psychiatric disorders.[2]

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. Efficacy end points for studies 304, 305, and 306 were
pooled according to randomised treatment: placebo, perampanel 2, 4, 8
or 12mg. The full ITT (intention-to-treat) analysis set included
1,478 patients from studies 304 (n=387), 306 (n=386) and 306 (n=705).

Median reductions in partial seizure frequency were greater with
perampanel 4 mg (-23.3%), 8 mg (-28.8%), and 12 mg (-27.2%) than
placebo (-12.8%; p<0.01, each dose vs. placebo). Median (95% CI)
differences from placebo in changes in partial seizure frequency were
-12.2% (-20.1 to -4.6), -17.9% (-24.1 to -11.8), and -15.8% (-23.0 to
-8.7) for perampanel 4, 8, and 12 mg, respectively.

Fifty percent responder rates were greater with perampanel 4 mg
(28.5%), 8 mg (35.3%), and 12 mg (35.0%) than placebo (19.3%; p<0.05,
each dose vs placebo). Median reductions in complex partial seizure
frequency were greater with perampanel 4 mg (-31.2%), 8 mg (-35.6%),
and 12 mg (-28.6%) than placebo (-13.9%).

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.[7]
In addition, the results show that perampanel decreased the frequency
of both complex partial seizures and secondarily generalised
seizures.[8] 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.[9]

Perampanel was generally well tolerated; most adverse events were
mild/moderate.

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.[10],[11]
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, 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. Dossierbewertung A12-12 Version 1.0 Perampanel -
Nutzenbewertung gemäss Section 35a SGB V 13.12.2012

2. Fycompa. Summary of Product Characteristics. August 2012

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

4. Pfäfflin, M. Epidemiologie der Epilepsien (online). 2011 URL:
http//www.izepilepsie.de/home/showdoc.id.387.aid.4163.html.

5. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering
Epilepsy Care in Europe 2010. Available at;
http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf
(Accessed June 2011)

6. Kwan P, Brodie MJ Early identification of refractory epilepsy.
New England Journal of Medicine 2000; 342:314-9

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

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

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

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

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

Date of preparation: December 2012

Job code: Perampanel - UK2118

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

Contact:
Media Enquiries: Eisai Europe Ltd, Tonic Life Communications,
Cressida Robson / Charlotte Andrews, +44(0)7908-314-155/
+44(0)7947-231-513, Cressida_Robson@eisai.net,
Charlotte_Andrews@eisai.net,
Benjamyn Tan / Hollie Matthews, +44(0)20-7798-9262,
+44(0)207-798-9900
benjamyn.tan@toniclc.com, eisaiepilepsy@toniclc.com