New First-in-class Treatment Fycompa® Launches in Norway for Most Common Form of Epilepsy<4523.F><4523.T>

Sun Jan 6, 2013 7:02pm EST

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

HATFIELD, England, January 7, 2013 /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   

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