Eisai Appalled by the German Federal Joint Committee's Decision on Innovative Antiepileptic Drug Fycompa® (perampanel)<4523.F><4523.T>

Thu Mar 7, 2013 3:26pm EST

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Eisai Appalled by the German Federal Joint Committee's Decision on Innovative
Antiepileptic Drug Fycompa® (perampanel)

FRANKFURT, Germany and HATFIELD, England, March 7, 2013 /PRNewswire/ --

    The German Federal Joint Committee (G-BA), the decision-making body of the
self-governing medical system in Germany, today announced that it considers the
additional benefit of Fycompa(R) (perampanel) unproven when compared to two other
treatments as defined by the G-BA.[1] Perampanel is indicated as an adjunctive treatment
of partial-onset seizures with or without secondarily generalised seizures in patients
with epilepsy aged 12 years and older.[2] Perampanel is the first in an entirely new
class of innovative treatment for uncontrolled partial epilepsy with a novel mechanism
of action that is different from all other anti-epileptic drugs (AEDs).  

    Eisai is appalled by the G-BA's ruling. This decision follows the German Institute
for Quality and Efficiency in Health Care (IQWiG) assessment, published 17 December 2012
which reported that the benefit of perampanel is unproven based on methodological
grounds. The company believes that the G-BA failed to adequately interpret the proven
patient-relevant benefits substantiated in the submitted benefit dossier and to
responsibly recognise the innovative nature of the new drug in a clinical setting with a
highly unmet medical need.  

    Eisai diligently developed the benefit dossier following scientific advice from the
G-BA. In addition, Eisai provided further evidence in a written statement preceding the
G-BA Oral Hearing on 29 January 2013, and re-iterated the additional benefit perampanel
provides to patients, especially to patients who require new options to help manage
their seizures. Eisai maintains that the submitted benefit dossier contains a
methodologically robust comparative analysis against the appropriate comparative
therapy, lamotrigine, as defined by the G-BA. On the advice of the G-BA, Eisai also
performed an indirect analysis using published clinical data for lamotrigine. Eisai
strongly believes that it has provided compelling evidence to demonstrate the additional
benefit of perampanel.  

    "I cannot understand the decision by the G-BA, from my personal clinical experience,
it is definitely certain that perampanel provides additional benefit for patients with
partial onset seizures. I can see this additional benefit in my clinical practice every
day. There are still a large number of patients requiring new and innovative treatments
like perampanel to help them manage their seizures," said Professor Bernhard Steinhoff
from Epilepsiezentrum Kork, Kehl-Kork, Germany  

    Nick Burgin, European Director of Market Access, Eisai added; "We believe the G-BA
decision failed to take into account the patient need for new innovative treatments.
Further they did not acknowledge the patient-value of perampanel that was demonstrated
in the comprehensive analyses submitted. This is a clear example where this process of
evaluation does not reflect the additional patient benefit seen in clinical experience
in an area of high unmet need."  

    In Germany, approximately one out of 200 people has epilepsy equating to an
estimated 400,000 people in the country living with the condition.[3] Epilepsy is one of
the most common neurological conditions in the world.[4] The successful treatment of
partial-onset seizures remains a challenge as over 30% of patients do not achieve
seizure freedom despite appropriate therapy with anti-epileptic drugs.[5]  

    Many of these patients have exhausted other treatment options. The clinical
experience with perampanel shows that it reduces the frequency of both complex partial
and secondarily generalised in these difficult to treat patients.[6]  

    Perampanel was first launched in Europe in Germany and the UK in September 2012. It
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.[7] It blocks the effects of glutamate, which can trigger and maintain
seizures.  

    Perampanel was approved by the European Commission on 23 July 2012. The FDA approved
perampanel for use in the US on 22 October 2012. In Europe, it is currently available in
the UK, Denmark, Germany, Austria, Sweden, Norway and Switzerland.  

    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 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 / http://www.fycompa.de  

    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.[8] In addition, the results show that perampanel decreased
the frequency of both complex partial seizures and secondarily generalised seizures.[6]
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. http://www.g-ba.de/informationen/beschluesse/1664 (Accessed March 2013)  

    2. Fycompa. Summary of Product Characteristics. August 2012  

    3. Pfäfflin, M. und May, T. Wieviele Patienten mit Epilepsien gibt es in Deutschland
und wer behandelt sie? Neurol Rehabil, 2000; 6, (2) 77-81.  

    4. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in
Europe 2010. Available at;
http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf (Accessed June
2011)  

    5. Brodie MJ et al, Neurology 2012; 78:1548-1554  

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

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

    8. Ben-Menachem E,Krauss GL, Noachtar S 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: March 2013  

    Job code: Perampanel - UK2119   

Eisai Europe Limited

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, Moira Gitsham /
Nicola Lilley, +44 (0) 207 798 9992/+44(0)20 7798 9905, 
moira.gitsham@toniclc.com / nicola.lilley@toniclc.com /
eisaiepilepsy@toniclc.com
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