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<4523.F><4523.T>

Mon Dec 17, 2012 7:02pm EST

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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, December 18, 2012 /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   

Eisai Europe Limited

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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