Eisai Disagrees with German Institute for Quality and Efficiency in Health Care (IQWiG) Report on Innovative Antiepileptic Drug

  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

  PR Newswire

  HATFIELD, England, December 18, 2012

HATFIELD, England, December 18, 2012 /PRNewswire/ --

In the assessment report by the Institute for Quality and Efficiency in Health
Care (IQWiG) on Fycompa® (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 12mg (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 ^® (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. Dossierbewertung A12-12 Version 1.0 Perampanel - Nutzenbewertung gemäß §
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

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
 
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