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 (Eslicarbazepine acetate in Partial-Onset Seizures) 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.
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.
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. 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.
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. Zonisamide is one of only four AEDs with level A efficacy/effectiveness evidence as initial monotherapy for adults with partial onset seizures.
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.
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. 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.
Eslicarbazepine acetate is a voltage-gated sodium channel blocker. The molecule interacts competitively with the inactive state of the sodium ion channel,, preventing its return to the active state, and thereby inhibiting repetitive neuronal firing. The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept Phase II study and four subsequent Phase III randomised, placebo controlled studies in 1,703 adult patients with refractory partial onset seizures.,,,
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
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., 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)
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
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
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. Epilepsia 2013:54(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
SOURCE Eisai Europe Limited