Eisai's Named Patient Access Programme for Fycompa® (perampanel) Available from 1 January 2014

  Eisai's Named Patient Access Programme for Fycompa® (perampanel) Available
                             from 1 January 2014

  PR Newswire

  HATFIELD, England, December 11, 2013

HATFIELD, England, December 11, 2013 /PRNewswire/ --

 Named patient access programme ensures patients receive uninterrupted supply
            of Fycompa at no cost to the German healthcare system

Eisai today announces that Fycompa ^® (perampanel) will be ready to be
supplied on a named patient basis from the 1 January 2014 onwards. This
follows the temporary suspension of the commercial distribution (Aussetzen des
Vertriebes) of the antiepileptic drug (AED) in Germany earlier this year.

The named patient access programme will be managed by Clinigen Global Access
Programs (Clinigen GAP), part of Clinigen Group plc and will ensure that all
patients on the programme continue to receive an uninterrupted supply of
Fycompa ^® at no cost to the German healthcare system. For all further
enquiries and further information about the access programme, contact Clinigen
GAP :

Tel: +49-(0)69-22223413 Fax: 0800 5892457 Email:
customer.services@clinigengroup.com (Please note that to ensure successful
communication, we recommend to add this email address to your approved list of
contacts)

Discovered and developed by Eisai in the UK and Japan, perampanel is the first
and only approved AED in Europe with a mode of action that selectively targets
AMPA receptors, thought to play a central role in seizure generation and
spread. ^[1] The successful treatment of partial-onset seizures remains a
challenge for patients and physicians as over 30% of patients do not achieve
seizure freedom, despite appropriate therapy with AEDs, making new innovative
therapeutic options important. ^[2] 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]

Fycompa was granted marketing authorisation by the European Commission on 23
July 2012 and is indicated for the adjunctive treatment of partial-onset
seizures with or without secondarily generalised seizures in patients with
epilepsy aged 12 years and older. Swissmedic, the Swiss agency for the
authorisation and supervision of therapeutic products, approved perampanel for
use in December 2012.

Eisai is a leading research and development based pharmaceutical company. The
company's Corporate Philosophy is to give first thought to patients and their
families, and to increase the benefits that health care provides to them.
Eisai calls this philosophy human healthcare ( hhc ). Eisai's belief is that
the hhc philosophy is its primary objective and that only through focusing on
the needs of the patient and wider global healthcare system that sales and
earnings will be generated. Guided by the hhc philosophy, Eisai will continue
to work to achieve sustainable enhancement of value through its business
activities worldwide.

Notes for editors:

About perampanel

Perampanel is licensed in the European Union (EU) as an adjunctive treatment
for people aged 12 years and older with partial-onset seizures, with or
without secondarily generalised seizures. ^[4]

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. ^[4]

Further information for healthcare professionals can be found at
http://www.eisai.co.uk / http://www.fycompa.eu

About epilepsy

Epilepsy is one of the most common neurological conditions in the world,
affecting approximately one in every one hundred people in Europe, and an
estimated 50 million people worldwide. ^[5],[6] 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 EMEA 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, Russia and Oceania (EMEA). Eisai is proud to currently market more
epilepsy products in Europe than any other company.

In the EMEA region, Eisai currently has four marketed treatments including:

  *Zonegran ^® (zonisamide) as monotherapy and adjunctive therapy in adults,
    adolescents and children above the age of 6 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. (Rufinamide
    was originally developed by Novartis)

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. Perampanel was approved for use by
Swissmedic in December 2012.

About Eisai

Eisai is one of the world's leading research and development (R&D) based
pharmaceutical companies and we define our 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, 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 10,000 people worldwide. From its recently
expanded Knowledge Centre in Hatfield, UK, which now includes an additional
high potency, global packaging capability, Eisai has recently expanded its
business operations to include Europe, the Middle East, Africa, Russia and
Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20
markets, including the United Kingdom, France, Germany, Italy, Spain,
Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal,
Czech Republic, Slovakia, Russia, the Netherlands, Belgium, and the Middle
East.

For further information please visit our web site http://www.eisai.co.uk

About Clinigen

The Clinigen Group is a specialty global pharmaceutical company headquartered
in the UK, with offices in the US and Japan. The Group has three operating
businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply
(Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen GAP
develops and implements global access programs for biotechnology and
pharmaceutical companies and has provided access to unlicensed, licensed and
end-of-lifecycle products to thousands of patients.

For further information please visit: http://www.clinigengroup.com   

References

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

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

3.  Pfäfflin, M. et al, Neurol Rehabil, 2000; 6, (2) 77-81.

4.  Fycompa. Summary of Product Characteristics (updated November 2013) 

http://www.medicines.org.uk/EMC/medicine/26951/SPC/Fycompa+2mg,4mg,6mg,8mg,10mg,12mg+film-coated+tablets


5.  Epilepsy in the WHO European Region: Fostering Epilepsy Care in  Europe
. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf  
[Accessed 10 April 2012].

6.  Pugliatti M, et al. Epilepsia 2007: 48(12) 2224 - 2233.

Job code: Perampanel-UK2147 Date of preparation: December 2013

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 / Fran
Murphy +44(0)20-7798-9900/+44(0)207-798-992, fran.murphy@toniclc.com,
moira.gitsham@toniclc.com, eisaiepilepsy@toniclc.com
 
Press spacebar to pause and continue. Press esc to stop.