New Approach for the Treatment of Epilepsy Authorized by Health Canada - FYCOMPA(TM) (perampanel) is Now Available as an

New Approach for the Treatment of Epilepsy Authorized by Health Canada - 
FYCOMPA(TM) (perampanel) is Now Available as an Adjunctive Treatment for Adult 
Patients 
First and Only Selective, Non-Competitive AMPA Glutamate Receptor Antagonist 
MISSISSAUGA, ON, July 10, 2013 /CNW/ - Eisai Limited is pleased to announce 
the Health Canada authorization and availability of FYCOMPA (perampanel) 
indicated as an adjunctive therapy in the management of partial-onset 
seizures, in adult patients with epilepsy who are not satisfactorily 
controlled with conventional therapy. 
FYCOMPA is a first-in-class treatment authorized by Health Canada that 
selectively and non-competitively targets post-synaptic AMPA glutamate 
receptors, representing a new approach to seizure control. 
Health Canada's authorization of FYCOMPA was primarily based on three Phase 
III studies (304, 305 and 306). These multi-centre, randomized, double-blind, 
placebo-controlled, parallel group studies evaluated the efficacy and safety 
of FYCOMPA compared to placebo given as an adjunctive therapy in patients with 
partial-onset seizures. The studies demonstrated that FYCOMPA significantly 
reduced seizure frequency in patients with partial-onset seizures with or 
without secondarily generalized seizures.(1) 
"FYCOMPA represents an innovative approach in the treatment of epilepsy and a 
much needed option for Canadian patients and physicians," says Dr. Neelan 
Pillay, Clinical Professor, Director Adult Epilepsy Program, EEG and Evoked 
Potentials, Department of Clinical Neurosciences, Foothills Medical Centre. 
"When added to their current treatment regimen, FYCOMPA is shown to 
significantly reduce seizures in patients." 
In Canada, 300,000 Canadians currently live with epilepsy(2), and an estimated 
15,500 are diagnosed each year(3). Despite the high epilepsy incidence, there 
still remains a relatively low understanding and awareness of this 
neurological disorder.(4) 
"Health Canada's authorization of FYCOMPA marks another important milestone 
for Canadian epilepsy patients with partial-onset seizures who now have a new 
option that is proven to control their seizures," says Oliver Technow, 
President and General Manager, Eisai Limited. "Eisai's human healthcare (hhc) 
philosophy centres around improving the health and quality of life for 
patients and their families and we are committed to improving these lives by 
providing innovative therapies that can have a positive impact." 
"The epilepsy community celebrates the authorization of FYCOMPA as an 
additional tool to manage the disorder," says Gail Dempsey, President, 
Canadian Epilepsy Alliance. "Access to new options is key - every patient 
responds differently to a treatment and it is our goal as a community to 
ensure the tools are available, so that patients can live a fulfilling and 
rewarding life." 
In the three clinical studies, most adverse events in all treatment groups 
were considered mild or moderate in severity. The most common adverse events 
(greater than or equal to 5 per cent) in patients treated with FYCOMPA were 
dizziness, somnolence, fatigue, irritability, nausea, ataxia and falls. 
About Epilepsy
Epilepsy is a medical condition that produces seizures affecting a variety of 
mental and physical functions. About 70 per cent of people with epilepsy have 
partial-onset seizures.(5) In about 30 per cent of patients with epilepsy, 
seizures cannot be controlled with treatment.(6) 
About FYCOMPA (perampanel)
FYCOMPA is an oral medication taken once-daily and is the first Health 
Canada-authorized selective and non-competitive post-synaptic AMPA 
(alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor 
antagonist. AMPA receptors, widely present in almost all excitatory neurons, 
transmit signals stimulated by the excitatory neurotransmitter glutamate 
within the brain. Glutamate is the primary excitatory neurotransmitter in the 
central nervous system. 
Discovered and developed by Eisai, FYCOMPA has been licensed in more than 30 
countries including, the U.S., U.K., Germany, Sweden, Norway, Denmark, Austria 
and Switzerland. 
FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated 
tablets.(7) 
Epilepsy is a therapeutic area of focus for Eisai. The company continues to 
make further contributions to help address the diversified needs of epilepsy 
patients and their families as part of its corporate human health care (hhc) 
mission. 
For more information on FYCOMPA, please refer to the product monograph for 
complete prescribing instructions. 
About Eisai Limited
Eisai established the Canadian pharmaceutical company Eisai Limited in 2010. 
As a wholly-owned subsidiary of Eisai Inc., Eisai Limited is based in 
Mississauga, Ontario, one of the largest biopharmaceutical clusters and 
medical communities in North America. For more information about Eisai in 
Canada, please visit www.eisai.ca 
About Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. 
pharmaceutical companies (based on retail sales). The Company began marketing 
its first product in the United States in 1997 and has rapidly grown to become 
a fully integrated pharmaceutical business. With operations now in North and 
South America, Eisai provides innovative treatments to patients in the US, 
Canada, Mexico and Brazil. Eisai's areas of commercial focus include 
neurology, gastrointestinal disorders and oncology/critical care. The Company 
serves as the U.S. pharmaceutical operating company of Eisai Co., Ltd., a 
research-based human health care (hhc) company that discovers, develops and 
markets products throughout the world. 
Eisai Inc. has a global product creation organization that includes U.S. - 
based R&D facilities in Massachusetts, New Jersey, North Carolina and 
Pennsylvania as well as manufacturing facilities in Maryland and North 
Carolina. The Company's areas of R&D focus include neuroscience, oncology, 
vascular, inflammatory and immunological reaction, and antibody-based programs. 
About Eisai Co., Ltd.
Eisai Co., Ltd. is one of the world's leading R&D-based pharmaceutical 
companies that has defined its corporate mission as "giving first thought to 
patients and their families and to increasing the benefits health care 
provides," which we call human health care (hhc). 
Eisai concentrates its R&D activities in three key areas: 


    --  Neuroscience: Alzheimer's disease, multiple sclerosis,
        neuropathic pain, epilepsy, depression, etc.
    --  Oncology: Anticancer therapies; tumour regression, tumour
        suppression, antibodies, etc. and Supportive cancer therapies;
        pain relief, nausea, etc.
    --  Vascular/Immunological Reaction: Acute coronary syndrome,
        atherothrombotic disease, sepsis, rheumatoid arthritis,
        psoriasis, Crohn's disease, etc.

With operations in Canada, the U.S., Asia, Europe and its domestic home market 
of Japan, we employ more than 11,000 people worldwide.

REFERENCES

(1) FYCOMPA Canadian Product Monograph
(2) Canadian League Against Epilepsy - 
http://www.clae.org/html/en/general_information.html. Last accessed on June 
4(th), 2013.
(3) Canadian League Against Epilepsy - 
http://www.clae.org/html/en/general_information.html. Last accessed on June 
4(th), 2013.
(4) Canadian League Against Epilepsy - 
http://www.clae.org/html/en/general_information.html. Last accessed on June 
4(th), 2013.
(5) Canadian League Against Epilepsy - 
http://www.clae.org/html/en/general_information.html. Last accessed on June 
4(th), 2013.
(6 )Canadian League Against Epilepsy - 
http://www.clae.org/html/en/general_information.html. Last accessed on June 
4(th), 2013.
(7) FYCOMPA Canadian Product Monograph

Media Inquiries Karen Law Eisai Limited 905-361-7136

SOURCE: Eisai Limited

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CO: Eisai Limited
ST: Ontario
NI: HEA ECOSURV 

-0- Jul/10/2013 10:50 GMT


 
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