Eisai Supports 18 Abstracts at the European Congress on Epileptology 2014

  Eisai Supports 18 Abstracts at the European Congress on Epileptology 2014

  PR Newswire

  HATFIELD, England, June 23, 2014

HATFIELD, England, June 23, 2014 /PRNewswire/ --

New data from across Eisai's epilepsy portfolio are to be presented at this
year's European Congress on Epileptology (ECE) in Stockholm. New safety data
on the behavioural and metabolic profile of Fycompa ^® (perampanel) will be
presented in one poster and two podium presentations, with ten additional real
world clinical experience posters arising from Eisai-supported
Investigator-Initiated Studies to be presented. New data for Zonegran ^®
(zonisamide) as adjunctive and monotherapy, and two abstracts related to
Inovelon ^® (rufinamide) will also be presented at ECE. Seizure outcomes and
safety data from an interim analysis of the on-going non-interventional EPOS
study ( E slicarbazepine acetate in P artial- O nset S eizures) for Zebinix ^®
(eslicarbazepine acetate) will feature in a best poster presentation.

To complement the new data at ECE, Eisai will hold an educational symposium on
Monday 30 June, 16.30-18.00 CET in Room A2, titled ' Making a mark in epilepsy
care: Can we do more? ' . Topics covered will include management of the
transition from child to adult epilepsy care, compliance challenges and the
impact of new anti-epileptic drugs on anticonvulsant treatment selection in
the add-on setting. 

"These new data to be presented at ECE 2014 reinforce Eisai's on-going
commitment to provide treatment options for managing epilepsy in different
patient populations," commented Neil West, Head of Epilepsy Business Unit,
Eisai EMEA. "Epilepsy remains a challenging condition to treat and data such
as these can provide an important insight into how our epilepsy products can
support people with epilepsy."

The continued development of its epilepsy portfolio 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. Eisai is committed to the therapeutic area of epilepsy and to
address the unmet medical needs of people with epilepsy and their families.
Eisai is proud to currently market more epilepsy products in EMEA than any
other company.

Data to be presented at ECE include:


    Abstract Session       Abstract Number/Name
    Perampanel
                           P558

                           Impact of adjunctive perampanel on behaviour
                           in adolescents with refractory partial-onset
    Antiepileptic drugs 8  seizures

    Exhibition Hall,       Lieven Lagae, Imre Velkey, Makarand Bagul,
    Wednesday 2 July,      Haichen Yang, Antonio Laurenza, Dinesh Kumar
    13:30-14:30
                           009

    Pharmacology Platform  Evaluation of metabolic parameters over time
    Session: Antiepileptic in the perampanel pooled Phase III epilepsy
    drugs 1                studies

    Room A4, Monday 30     Martin J Brodie, Philip N Patsalos, Makarand
    June, 11:30-13:00      Bagul, Antonio Laurenza
                           010

                           Effects of perampanel on metabolic
    Pharmacology Platform  parameters in patients with refractory
    Session: Antiepileptic partial-onset seizures in extension study
    drugs 1                307

    Room A4, Monday 30     Philip N Patsalos, Martin J Brodie, Makarand
    June, 11:30-13:00      Bagul, Karen Cartright, Haichen Yang
    Best Poster
    Presentation,

    Poster Presentation
    Area A, Monday 30      P126
    June, 11:00-11:30
                           Efficacy and tolerance of perampanel in
    Antiepileptic drugs 2  pharmacoresistant epilepsy in children and
                           young people
    Exhibition Hall,
    Monday 30 June,        Sunny Philip, Bernie Concannon, Deborah
    13:30-14:30            Morris, Stefano Seri, Shakti Agrawal
                           P137

                           Efficacy and tolerability of perampanel in
                           patients with refractory partial epilepsy in
    Antiepileptic drugs 3  a tertiary epilepsy centre

    Exhibition Hall,       Katarzyna A Sieradzan, Consultant
    Monday 30 June,        Neurologist and Epileptologist, Helen
    13:30-14:30            Hodgson, Epilepsy Specialist Nurse
                           P334
    Antiepileptic drugs 4
                           A service evaluation of perampanel in
    Exhibition Hall,       Cornwall
    Tuesday 1 July,
    13:30-14:30            Mary Parrett, Brendan McLean
    Best Poster
    Presentation,

    Poster Presentation
    Area A, Tuesday 1
    July, 11:00-11:30
                           P343
    Antiepileptic drugs 5
                           Seizure response to perampanel in a severe
    Exhibition Hall,       refractory group of epilepsy patients
    Tuesday 1 July,
    13:30-14:30            Flynn C, Delanty N
                           P562

                           Perampanel in the treatment of epilepsy; a
    Antiepileptic drugs 8  multicentre evaluation

    Exhibition Hall,       Ioannis Manidakis, Hannah Cock, Dora
    Wednesday 2 July,      Loszardi, Nicholas Moran, Lina Nashef, Mark
    13:30-14:30            Richardson, Robert Elwes
                           P335

    Antiepileptic drugs 4  A service evaluation of perampanel (Fycompa)
                           at Leeds General Infirmary
    Exhibition Hall,
    Tuesday 1 July,        Jo Geldard, Elizabeth Wright, Melissa
    13:30-14:30            Maguire and Peter Goulding
                           P563
    Antiepileptic drugs 8
                           Clinical experience with perampanel in a
    Exhibition Hall,       regional epilepsy clinic
    Wednesday 2 July,
    13:30-14:30            Helen Coyle, Rajiv Mohanraj
    Best Poster
    Presentation,

    Poster Presentation
    Area A, Monday 30      P138
    June, 11:00-11:30
                           Perampanel in South Wales: A multi-centre
    Antiepileptic drugs 3  clinical evaluation

    Exhibition Hall,       Charlotte Lawthom, Robert Powell, Erika
    Monday 30 June,        Hillman, Keri John, Alice Talbert, Khalid
    13:30-14:30            Hamandi
    Best Poster
    Presentation,

    Poster Presentation
    Area A, Monday 30      P119
    June, 11:00-11:30
                           Adjunctive perampanel in highly
    Antiepileptic drugs 1  drug-resistant localization-related epilepsy
                           - a prospective audit
    Exhibition Hall,
    Monday 30 June,        Kevin Kelly, Linda J Stephen, Pamela Parker,
    13:30-14:30            Martin J Brodie
    Best Poster
    Presentation,

    Poster Presentation    P573
    Area A, Wednesday 2
    July, 11:00-11:30      First clinical experiences with perampanel
                           in Vienna
    Antiepileptic drugs 9
                           Katharina K. Kottmel, Simone Geiblinger,
    Exhibition Hall,       Susanne Pirker, Elisabeth Freydl, E.
    Wednesday 2 July,      Langenberger, Franz Riederer, Chirstian
    13:30-14:30            Sedlacek, Christoph Baumgartner
    Zonisamide
    Best Poster
    Presentation,

    Poster Presentation
    Area A, Wednesday 2    P554
    July, 11:00-11:30
                           Long-term efficacy of zonisamide versus
    Antiepileptic drugs 7  carbamazepine monotherapy for treatment of
                           adults with newly diagnosed partial
    Exhibition Hall,       epilepsy: analysis by baseline seizure types
    Wednesday 2 July,
    13:30-14:30            Michel Baulac, Anna Patten, Luigi Giorgi
                           P557

                           Effects of adjunctive zonisamide treatment
    Antiepileptic drugs 7  on weight and body mass index in paediatric
                           patients with partial epilepsy
    Exhibition Hall,
    Wednesday 2 July,      Lieven Lagae, Luigi Giorgi, Anna Patten,
    13:30-14:30            Makarand Bagul
    Rufinamide
    Best Poster
    Presentation,

    Poster Presentation    P336
    Area A, Tuesday 1
    July, 11:00-11:30      Use of adjunctive rufinamide for patients
                           with Lennox-Gastaut syndrome in clinical
    Antiepileptic drugs 4  practice

    Exhibition Hall,       Stéphane Auvin, Anaïs Papon Vanina
    Tuesday 1 July,        Bellavoine, Thomas Storme, Dana Merdariu,
    13:30-14:30            Adina Ilea, Olivier Bourdon, Jennifer Corny
                           P352

                           European non-interventional registry study
    Antiepileptic drugs 6  of antiepileptic drug use in patients with
                           Lennox-Gastaut syndrome: interim analysis
    Exhibition Hall,
    Tuesday 1 July,        Axel Panzer, Stéphane Auvin, Erwin Hauser,
    13:30-14:30            Makarand Bagul
    Eslicarbazepine acetate
    Best Poster            P140
    Presentation,
                           Eslicarbazepine acetate as add-on treatment
    Poster Presentation    to antiepileptic monotherapy in adults with
    Area A, Monday 30      partial-onset seizures: real-world data on
    June, 11:00-11:30      retention, dosing, patient reported seizure
                           outcome and safety from an interim analysis
    Antiepileptic drugs 3  of the open-label non-interventional study
                           EPOS
    Exhibition Hall,
    Monday 30 June,        Martin Holtkamp, Makarand Bagul, Edgar
    13:30-14:30            Kockelmann

Notes to Editors 

About Fycompa ^®  (perampanel) 

Perampanel 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 ^]

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

About Zonegran ^®  (zonisamide) 

Zonisamide is indicated as monotherapy in the treatment of partial seizures,
with or without secondary generalisation, in adults with newly diagnosed
epilepsy. ^[2] Zonisamide is also indicated as adjunctive therapy in the
treatment of partial seizures, with or without secondary generalisation, in
adults, adolescents and children aged six years and above. ^[ ^2 ^]

Zonisamide has a broad spectrum of anti-epileptic modes of action and has no
appreciable effects on steady-state plasma concentrations of other AEDs, such
as phenytoin, carbamazepine and valproate. ^[ ^2 ^] Zonisamide is one of only
four AEDs with level A efficacy/effectiveness evidence as initial monotherapy
for adults with partial onset seizures. ^[3]

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

About Inovelon ^®  (rufinamide) 

Rufinamide is indicated as an adjunctive therapy in the treatment of seizures
associated with Lennox-Gastaut syndrome (LGS) in patients four years of age
and older. ^[4]

Rufinamide is a triazole derivative that is structurally unrelated to
currently marketed anti-epileptic drug. It is believed to regulate the
activity of sodium channels in the brain which carry excessive electrical
charges. The agent was approved for adjunctive therapy for seizures associated
with LGS in Europe (under the brand name Inovelon) in 2007. ^[ ^4 ^] Inovelon
is available as film-coated tablets containing 100mg, 200mg, and 400mg
rufinamide and as a 40 mg/ml oral suspension.

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

About Zebinix ^® (eslicarbazepine acetate)

Eslicarbazepine acetate is indicated as adjunctive therapy in adults with
partial onset seizures, with or without secondary generalisation. ^[5]

Eslicarbazepine acetate is a voltage-gated sodium channel blocker. ^[6] The
molecule interacts competitively with the inactive state of the sodium ion
channel, ^[ ^6 ^] ^, ^[7] preventing its return to the active state, and
thereby inhibiting repetitive neuronal firing. ^[ ^6 ^] The efficacy of
eslicarbazepine acetate was demonstrated in an initial proof-of-concept Phase
II study ^[8] and four subsequent Phase III randomised, placebo controlled
studies in 1,703 adult patients with refractory partial onset seizures. ^[ ^5
^] ^, ^[9] ^, ^[10] ^, ^[11]

Zebinix ^® is the EU trade name for eslicarbazepine acetate

Zebinix ^® is under license from BIAL

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

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 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 the adjunctive treatment for partial onset
    seizures, with or without secondarily generalised seizures, in patients
    with epilepsy aged 12 years and older
  *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 secondary generalisation, in adults,
    adolescents, and children aged 6 years and above (Zonegran is under
    license from the originator Dainippon Sumitomo Pharma)
  *Zebinix ^® (eslicarbazepine acetate) as adjunctive therapy in adults with
    partial onset seizures, with or without secondary generalisation (Zebinix
    is under license from BIAL)
  *Inovelon ^® (rufinamide) for the adjunctive therapy in the treatment of
    seizures associated with Lennox-Gastaut syndrome (LGS) in patients four
    years of age and older (Rufinamide was originally developed by Novartis)

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
    management
  *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 BIAL 

Founded in 1924, BIAL is an international pharmaceutical group with products
available in more than 50 countries throughout four continents. BIAL is a
privately held Portuguese research based pharmaceutical company and the
largest Portuguese pharmaceutical company, based in S. Mamede do Coronado,
Portugal, responsible for the research and development of eslicarbazepine
acetate (Zebinix ^® ).

It is the partner of choice for many companies, having a strong presence in
the Iberian Peninsula as well as in over 10 countries in Latin America and in
around 20 French or Portuguese speaking African countries.

BIAL is strongly committed to therapeutic innovation investing more than 20%
of its turnover in research and development every year. Key research areas for
BIAL are the central nervous system, the cardiovascular system and allergen
immunotherapy. BIAL currently has several other innovative programs under
development, which the company expects to bring to the market within the next
years, thereby strengthening its position throughout Europe.

Further information about BIAL can be found at http://www.bial.com

References

1. Fycompa, Summary of Product Characteristics (updated November 2013):
http://www.medicines.org.uk/emc/medicine/26951/

2. Zonegran, Summary of Product Characteristics (updated October 2013):
http://www.medicines.org.uk/emc/medicine/16240/

3. Glauser T. et al. Updated ILAE evidence review of antiepileptic drug
efficacy and effectiveness as initial monotherapy for epileptic seizures and
syndromes. Epilepsia2013:54(3):551-63

4. Inovelon, Summary of Product Characteristics (updated August 2013):
http://www.medicines.org.uk/emc/medicine/20165/

5. Zebinix , Summary of Product Characteristics (updated March 2014):
http://www.medicines.org.uk/emc/medicine/22376/ 

6. Almeida L, Soares-da-Silva P.Eslicarbazepine Acetate (BIA 2-093).
Neurotherapeutics. 2007:4(1):88-96

7. Elger C et al. Pharmacokinetics and tolerability of eslicarbazepine acetate
and oxcarbazepine at steady state in healthy volunteers.Epilepsia
2013:54(8):1453-1461

8. Elger et al. Eslicarbazepine Acetate: A Double-blind, Add-on,
Placebo-controlled Exploratory Trial in Adult Patients with Partial-onset
Seizures. Epilepsia 2007:48(3):497-504

9. Elger C et al. Efficacy and safety of eslicarbazepine acetate as adjunctive
treatment in adults with refractory partial-onset seizures: A randomized,
double-blind, placebo-controlled, parallel-group phase III study. Epilepsia
2009:50(3):454-463

10. Ben-Menachem E et al. Eslicarbazepine acetate as adjunctive therapy in
adult patients with partial epilepsy; Epilepsy Research 2010:89:278-285

11. Gil-Nagel A et al. Efficacy and safety of 800 and 1200 mg eslicarbazepine
acetate as adjunctive treatment in adults with refractory partial-onset
seizures. Acta Neurol Scand 2009:120: 281-287

12. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed
June 2014)

13. 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: June 2014

Job code: Perampanel-UK2154

Contact: INVITATION TO EUROPEAN HEALTHCARE AND MEDICAL JOURNALISTS : A press
conference, hosted by Eisai, will be held at the ECE congress on Sunday 29
June, 12.00-14.30, to discuss 'Real World Innovation in Epilepsy Management'.
To register your interest or for further details, please contact: Nicola
Lilley, Tonic Life Communications, +44(0)207-798-9905,
nicola.lilley@toniclc.com Media Enquiries: Eisai Europe Ltd, Cressida
Robson/Ben Speller, +44(0)7908-314-155/+44(0)7908-409416,
Cressida_Robson@eisai.net, Ben_Speller@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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