Eisai Partners With Clinigen to Provide a Named Patient Access Programme for Fycompa® (Perampanel) in Germany

 Eisai Partners With Clinigen to Provide a Named Patient Access Programme for
                       Fycompa® (Perampanel) in Germany

  PR Newswire

  HATFIELD, England, September 9, 2013

HATFIELD, England, September 9, 2013 /PRNewswire/ --



 New named patient access programme ensures continued supply of anti-epilepsy
             treatment at no cost to the German healthcare system

Today, Eisai EMEA announces the establishment of a named patient access
programme to ensure that patients continue to receive an uninterrupted supply
of the anti-epilepsy drug Fycompa (perampanel), following the temporary
suspension of commercial distribution (Aussetzen des Vertriebes) in Germany.
This access programme will be managed by Clinigen Global Access Programs
(Clinigen GAP), part of Clinigen Group plc. The access programme is not
expected to be utilised until the beginning of 2014 as there are sufficient
stocks of Fycompa in Germany to meet demand until the end of December. 

Under the access programme, all patients will receive an uninterrupted supply
at no cost to the German healthcare system. For all further enquiries and
further information about the access programme, contact Clinigen GAP:

Tel: 069 22223413 Fax: 0800 5892457 Email:
customer.services@clinigengroup.com

"We deeply regret the need to take the difficult decision to suspend Fycompa
from commercial distribution in Germany but as approximately 3,000 - 4,000
people with epilepsy in Germany have benefitted from this treatment since its
launch in September 2012, our priority is to ensure that these patients
continue to receive an uninterrupted supply of the treatment. For this reason,
Eisai has partnered with a specialist provider, Clinigen GAP, to put a patient
access programme in place, so that patients can continue to receive Fycompa
after the temporary suspension has come into effect and German stock of the
drug is exhausted at the end of the year," says Gary Hendler, President and
CEO, Eisai EMEA.  

The access programme will remain in place until commercial distribution
resumes. The company intends to submit Fycompa for reassessment at the
earliest opportunity. 

Discovered and developed by Eisai in the UK and Japan, Fycompa is the first
and only approved anti-epileptic drug 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 anti-epileptic
drugs, making new innovative therapeutic options very important. ^[2]

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. 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]

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 focussing on
the needs of the patient and the 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.de

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 adult
    patients 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

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

4. Fycompa Summary of Product Characteristics. 2012

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-UK2138 Date of preparation: August 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; College Hill Life
Sciences Melanie Toyne-Sewell / Stefanie Bacher / Jen Lewis, +44 (0)20 7457
2020, clinigen@collegehill.com
 
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