Fycompa® (Perampanel) to be Resubmitted Early to German Federal Joint Committee (G-BA) for Additional Benefit Assessment

    Fycompa® (Perampanel) to be Resubmitted Early to German Federal Joint
              Committee (G-BA) for Additional Benefit Assessment

  PR Newswire

  HATFIELD, England, February 10, 2014

HATFIELD, England, February 10, 2014 /PRNewswire/ --

PRESS RELEASE NOT FOR U.S. MEDIA

Early resubmission opportunity for epilepsy drug perampanel welcomed by Eisai
                                      

The German Federal Joint Committee (G-BA), the decision-making body of the
self-governing healthcare system in Germany, recently confirmed that Eisai
will be able to resubmit early its anti-epileptic drug (AED) Fycompa ^®
(perampanel) for reassessment of its additional therapeutic benefits.
Perampanel is indicated for the adjunctive treatment of partial onset
seizures, with or without secondarily generalised seizures, in people with
epilepsy aged 12 years and older. ^[1]

The confirmation from the G-BA gives Eisai the right to resubmit perampanel
for additional benefit reassessment within three months now. Once resubmitted,
the new G-BA decision is expected to be published within 6 months.

"It is right that the G-BA has permitted the early resubmission of Fycompa in
Germany," said Gary Hendler, President & CEO, Eisai EMEA. "Patients are
Eisai's first concern and we strongly believe they should be given access to
treatment that provides a clear clinical benefit. Since the launch of Fycompa
across Europe in September 2012, its clinical benefit has been recognised in
approximately 4,000 people with epilepsy in Germany and we hope it will be
available to many more in the near future."

Eisai temporarily suspended perampanel from distribution in Germany (Aussetzen
des Vertriebes) following the previous negative G-BA ruling in June 2013 and
established a named patient access programme, managed by Clinigen Group plc,
to ensure that people with epilepsy continue to receive a supply of the AED at
no cost to the German healthcare system whilst the G-BA considered an early
resubmission.

"The G-BA decision is good news for patients and doctors in Germany," said
Professor Bernhard Steinhoff from Epilepsiezentrum Kork, Kehl-Kork, Germany.
"Epilepsy affects hundreds of thousands of people in Germany and treatment
options such as Fycompa are a welcome addition to our treatment
armamentarium."

"We are pleased to learn that the G-BA has agreed to reassess perampanel early
and continue to follow all AED assessment procedures closely," commented
Professor Heinz Beck, President of the German Society of Epilepsy (DGfE). "The
provision of expert clinical advice for people with epilepsy is an important
part of our work and key developments such as this are always interesting."

In Germany, approximately one in every 200 people has epilepsy, which equates
to an estimated 400,000 people in the country who live with the condition.
^[2] Epilepsy is one of the most common neurological conditions in the world.
^[3] The successful treatment of partial-onset seizures remains a challenge as
over 30% of patients do not achieve seizure freedom despite appropriate
therapy with AEDs. ^[4]

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. ^[5]

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 health care ( hhc ). Eisai's believes that
the hhc philosophy is its primary objective and that only through focusing on
the needs of the patient and the wider global healthcare system that sales and
earnings will be generated. Guided by our hhc philosophy, Eisai will continue
to work to achieve sustainable enhancement of value through its business
activities worldwide.

Notes to 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. ^[ ^1]

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. ^[ ^1]

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

About Perampanel in Germany

Professor Bernhard Steinhoff and colleagues recently reported their first
real-life clinical experiences with perampanel in a cohort of consecutive
patients with difficult-to-treat epilepsiesfrom theirtertiary referral
epilepsy centre, Epilepsiezentrum Kork, in Kehl-Kork, Germany (September 2012
to June 2013). ^[ ^6] Fourty-six percent of 74 patients with mostly refractory
focal epilepsies and a minimum of 6 months follow-up(mean age 38.4 years,
range 15-71 years, 81% on two or three baseline AEDs) receiving perampanel
analysedshoweda reduction of seizure frequency of at least 50%, with 14% of
the total group becoming seizure free. Adverse events were reported in 40
patients (54%),most frequentlysomnolence (n = 31, 42%) and dizziness (n =
13, 18%). Adverse events usually did not lead to discontinuation and could
often be prevented or reduced with the strategy to use perampanel at
bedtime.Six-month retention rate was 70%. The mean dosage was 8.8 mg, with a
favorable response observed at low doses of 4 mg in some patients. The authors
conclude that perampanel appeared to be a promising new AED in this refractory
patient population, with a new mode of action and a unique pharmacologic
profile. ^[ ^7]

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 worldwide. ^[7] ^, ^[8] Epilepsy is a chronic disorder of the
brain that affects people of all ages. It is characterised by abnormal
discharges of neuronal activity which causes 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).

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

  *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
  *Inovelon ^® (rufinamide) for the adjunctive treatment of seizures
    associated with Lennox-Gastaut Syndrome in patients > 4 years. (Rufinamide
    was originally developed by Novartis)
  *Zebinix ^® (eslicarbazepine acetate) as adjunctive therapy in adult
    patients with partial onset seizures, with or without secondary
    generalisation. (Zebinix is under license from BIAL)
  *Zonegran ^® (zonisamide) as monotherapy in adults and adjunctive therapy
    in adults, adolescents and children aged six years and above with partial
    onset seizures, with or without secondary generalisation. (Zonegran is
    under license from the originator Dainippon Sumitomo Pharma)

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 EMEA
Knowledge Centre in Hatfield, UK, 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, Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Ireland, Italy, Norway, Portugal, Russia, Slovakia,
Spain, Switzerland, Sweden, the Netherlands 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.Fycompa. Summary of Product Characteristics f a date is already decided
    tion is available (updated November 2013)
    http://www.medicines.org.uk/emc/medicine/26951/SPC/Fycompa+2mg%2c4mg%2c6mg%2c8mg%2c10mg%2c12mg+film-coated+tablets/
2.Pfäfflin, M. und May, T. Wieviele Patienten mit Epilepsien gibt es in
    Deutschland und wer behandelt sie? Neurol Rehabil, 2000; 6, (2) 77-81.
3.ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care
    in Europe 2010. Available at;
    http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf
    (Accessed June 2011)
4.Brodie MJ et al, Neurology 2012; 78:1548-1554
5.Rogawski MA. Epilepsy Currents 2011;11:56-63
6.Steinhoff B, et al. First clinical experiences with perampanel - The Kork
    experience in 74 patients. Epilepsia 2014 (55) s1, 16-18.
7.Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.
    http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed
    December 2013)
8.Pugliatti M, et al. Estimating the cost of epilepsy in Europe: A review
    with economic modeling. Epilepsia 2007; 48(12) 2224-2233.

Date of preparation: February 2014 Job code: Perampanel-UK2143

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, Frances Murphy/Nicola
Lilley, +44(0)207 798 9262 /+44 (0) 207 798 9905, frances.murphy@toniclc.com,
nicola.lilley@toniclc.com
 
Press spacebar to pause and continue. Press esc to stop.