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New First-in-class Epilepsy Treatment Fycompa® (perampanel) Launches in Spain

New First-in-class Epilepsy Treatment Fycompa® (perampanel) Launches in Spain

  PR Newswire

  HATFIELD, England, January 16, 2014

HATFIELD, England, January 16, 2014 /PRNewswire/ --

Fycompa ^® (perampanel), the first in an entirely new class of treatment for
partial onset seizures (the most common form of epilepsy), launches today in
Spain. The new therapy 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. ^[1]

Perampanel is the only licensed anti-epileptic drug (AED) to selectively
target AMPA receptors, a protein in the brain which plays a critical role in
the spread of seizures. ^[2] 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.

Epilepsy is one of the most common neurological conditions in the world. ^[3]
Around 400,000 people in Spain live with the condition. ^[ ^4]

" Almost a third of people with partial epilepsy continue to experience
seizures despite the treatment options currently available, " commented Dr.
José Serratosa, an Epileptologist at the Epilepsy Unit of theFundación
Jiménez Díaz University Hospital, Madrid. " New treatment options such as
this are a welcome  addition to doctors '  epilepsy treatment armamentarium.
"

Perampanel's reimbursement approval in Spain is based on three randomised,
double-blind, placebo-controlled and dose-escalated global pivotal Phase III
studies (304, 305, 306) and an open-label extension study (307). The three
global pivotal studies show consistent results in the efficacyand tolerability
of perampanel as an adjunctive therapy in people with partial onset seizures,
with or without secondary generalisation. ^[5] ^, ^[6] ^, ^[7] The most
commonly reported adverse events were dizziness, somnolence, fatigue,
headache, falls, irritability and ataxia. ^[ ^5 ^] ^, ^[ ^6 ^] ^, ^[ ^7 ^]
Results from the open-label extension study also demonstrate perampanel's
efficacy and favorable tolerability profile over the longer term. ^[8]

Dr. Javier Sánchez, Medical Manager, Eisai Spain, commented: "We're pleased to
announce the launch of perampanel in Spain. As an emerging leader in the field
of epilepsy, Eisai is committed to developing innovative therapies to meet the
unmet needs of people with epilepsy who need alternative treatment options to
help them achieve seizure control."

Discovered and developed by Eisai in Europe and Japan, perampanel is
manufactured in the UK and was approved by the European Commission on 23 July
2012.

The launch of perampanel in Spain 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 wellbeing of people worldwide.



Notes to Editors

About Perampanel

Fycompa 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. ^[ ^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 ^]

For more information please visit: http://www.fycompa.eu 

About the Perampanel Pooled Data (Study 306, 305 and 304) ^[ ^5 ^] ^, ^[ ^6 ^]
^, ^[ ^7 ^]

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. Efficacy end points
for studies 304, 305, and 306 were pooled according to randomised treatment:
placebo, perampanel 2, 4, 8 or 12mg. The full ITT (intention-to-treat)
analysis set included 1,478 patients from studies 304 (n=387), 306 (n=386) and
306 (n=705).

Median reductions in partial seizure frequency were greater with perampanel 4
mg (-23.3%), 8 mg (-28.8%), and 12 mg (-27.2%) than placebo (-12.8%; p<0.01,
each dose vs placebo). Median (95% CI) differences from placebo in changes in
partial seizure frequency were -12.2% (-20.1 to -4.6), -17.9% (-24.1 to
-11.8), and -15.8% (-23.0 to -8.7) for perampanel 4, 8, and 12 mg,
respectively. ^[ ^9]

50% responder rates were greater with perampanel 4 mg (28.5%), 8 mg (35.3%),
and 12mg (35.0%) than placebo (19.3%; p<0.05, each dose vs placebo). Median
reductions in complex partial seizure frequency were greater with perampanel 4
mg (-31.2%), 8 mg (-35.6%), and 12 mg (-28.6%) than placebo (-13.9%). ^[ ^1 ^]

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. ^[ ^9 ^] In addition, the results show that
perampanel decreased the frequency of both complex partial seizures and
secondarily generalised seizures. ^[10] 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. ^[11]

Perampanel was generally well tolerated; most adverse events were
mild/moderate.

About 307 ^[ ^8 ^]

The 307 study (n=1,218) was designed to evaluate safety, tolerability, and
seizure outcome data during long-term treatment with once-daily adjunctive
perampanel (up to 12 mg/day) in people with refractory partial onset seizures.
It was an open-label extension (OLE) study for people completing the
double-blind phase of three pivotal Phase III trials (studies 304, 305, and
306). 

The study consisted of two phases: an open-label treatment phase (including a
16-week conversion period and a planned 256-week maintenance period) and a
4-week follow-up phase. People were blindly titrated during the Conversion
Period to their individual maximum tolerated dose (maximum 12 mg/day). Adverse
events (AEs) were monitored throughout the study and seizure frequency
recorded. The interim data cut-off date for analyses was 1 December 1 2010.

At the interim cut-off date, 1186 patients were in the safety analysis set;
1089 (91.8%) patients had >16 weeks' exposure to perampanel, 580 (48.9%)
patients had >1 year of exposure, and 19 (1.6%) patients had >2 years'
exposure. At the interim analysis, 840 (70.8%) patients remained on perampanel
treatment. The large majority of patients (n=1084 [91%]) were titrated to 10
mg or 12 mg/day. Median (range) duration of exposure was 51.4 (1.1-128.1)
weeks. 

In the ITT analysis set (n=1207), the frequency of all seizures decreased over
the first 26 weeks of perampanel treatment in patients with at least 26 weeks'
exposure to perampanel (n=1006 [83.3%]); this reduction was maintained in
patients with at least one year of exposure (n=588 [48.7%]). The overall
median percent changes in seizure frequency in patients included in each
13-week interval of perampanel treatment were -39.2% for weeks 13-26 (n=1114),
-46.5% for Weeks 40-52 (n=731), and 58.1% for Weeks 92-104 (n=59). Overall
responder rates in patients included in each 13-week interval of perampanel
treatment were 41.4% for Weeks 13-26 (n=1114), 46.9% for Weeks 40-52 (n=731)
and 62.7% for weeks 92-104 n=59). During the blinded conversion period, the
reduction in seizure frequency in patients previously randomised to placebo
(-42.4%, n=369) was similar to that in patients previously randomised to
perampanel (-41.5%, n=817).

Treatment-emergent AEs were reported in 87.4% of patients. The most frequent
were dizziness (43.9%), somnolence (20.2%), headache (16.7%), and fatigue
(12.1%). Serious AEs were reported in 13.2% of patients.

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. ^[ ^12] ^, ^[ ^13] 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).

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

  *Zonegran ^® (zonisamide) as monotherapy in the treatment of partial
    seizures, with or without secondary generalisation, in adults with newly
    diagnosed epilepsy and as adjunctive therapy in the treatment of partial
    seizures, with or without generalisation, in adults, adolescents and
    children aged six years and above. (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 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, France, Germany, Italy, Spain, Switzerland,
Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic,
Slovakia, the Netherlands, Belgium, Russia and the Middle East.

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

References

1. SPC Fycompa (updated November 2012). Available at:
http://www.medicines.org.uk/emc/medicine/26951/ [Accessed September 2013]

2. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target.
Epilepsy Currents 2011;11:56-63

3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care
in Europe 2010. Available at;
http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf
(Accessed September 2013)

4. García-Ramos R, et al. FEEN: Informe sociosanitario FEEN sobre la epilepsia
en España. Neurología. 2011;26:548-55.
http://www.elsevier.es/sites/default/files/elsevier/eop/S2173-5808(11)00042-3.pdf
(Accessed September 2013)

5. Krauss GM. et al. Randomized phase III study 306: Adjunctive perampanel for
refractory partial-onset seizures. Neurology 2012; 78:1408-1415

6. French JA. Adjunctive perampanel for refractory partial-onset seizures:
randomized phase III study 304. Neurology 2012;79:589-596

7. French JA et al. Evaluation of adjunctive perampanel in patients with
refractory partial-onset seizures: Results of randomized global phase III
study 305. Epilepsia 2012:1-9

8. Krauss GL et al. Perampanel, a selective, noncompetitive
α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist, as
adjunctive therapy for refractory partial-onset seizures: interim results from
phase III, extension study 307. Epilepsia, 2013;54(1):126-34.

9. Ben-Menachem E,Krauss GL, Noachtar S et al. Abstract presented at ECE 2012

10. Steinhoff BJ, Gauffin H, McKee P et al. Abstract presented at ECE 2012

11. Trinka E, Straub H, Squillacote D et al. Abstract presented at ECE 2012

12. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed
September 2013]. 13. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224-2233.

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

Date of preparation: January 2014 Job code: Perampanel-UK2142

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
 
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