Eisai

Wealth of Data for Fycompa® (perampanel) and Inovelon® (rufinamide) to be Presented at the American Epilepsy Society (AES) Annual Meeting

Hatfield, England (ots/PRNewswire) - FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN/US JOURNALISTS

Data from nine abstracts for Eisai's epilepsy treatments perampanel and rufinamide will be presented at the 70th Annual Meeting of the American Epilepsy Society (AES), 2-6 December, Houston, Texas, which provide further insight into their long-term use in people with epilepsy.

Perampanel is indicated in the European Union for patients aged 12 years and older, for adjunctive treatment of partial-onset seizures (POS), with or without secondarily generalised seizures, and for adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in patients with idiopathic generalised epilepsy (IGE).[1]

Rufinamide is indicated in the European Union for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients with epilepsy aged four years and older.[2]

"These data provide real world insights into the activity of perampanel and rufinamide in potential patients over a wide range of ages. Through new and continued research with perampanel and rufinamide, we aim to further educate the epilepsy community about these debilitating diseases," comments Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai.

The 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 neurology and to address the unmet medical needs of people with neurological conditions and their families.

Perampanel abstracts at AES (presented in the George R Brown Convention Center, Hall A3, Level 3):



Abstract Number      Abstract details


Poster # 2.189       Evaluation of perampanel as monotherapy for 
focal                      
Date: Sunday 4       seizures: experience from open-label 
extension studies
December
Time: 10:00-16:00       
Location: Hall A3,   Kwan P, Mintzer S, Laurenza A, Patten A, 
Cartwright K
B3                  


Poster # 2.190       Adjunctive perampanel (PER) in patients 
(pts) with partial
Date: Sunday 4       seizures or primary generalized tonic-clonic
seizures
December             (PGTCS): effect of age at diagnosis         
Time: 10:00-16:00                         
Location: Hall A3,   Kramer L, Patten A, Laurenza A, French JA
B3                  


Poster # 2.193       Long-term efficacy and safety of adjunctive 
perampanel:
Date: Sunday 4       pooled analyses of the open-label extension 
(OLE) studies
December                    
Time: 10:00-16:00   
Location: Hall A3,   Rektor I, Krauss GL, Inoue Y, Kaneko S, 
Williams B, Patten
B3                   A, Bibbiani F, Laurenza A, Wechsler RT


Poster # 2.222       A systematic review of real world perampanel
treatment
Date: Sunday 4       outcomes
December
Time: 10:00-16:00                            
Location: Hall A3,   Krauss G, Tsong W, Steinhoff BJ
B3                  


Poster # 2.225       An indirect treatment comparison (ITC) of 
perampanel
Date: Sunday 4       versus brivaracetam in patients with 
partial-onset
December             seizures with or without secondary 
generalisation           
Time: 10:00-16:00                             
Location: Hall A3,   Tsong W, Kockelmann E, Tremblay G, Mehlig H,
and Patel V
B3


Poster # 3.238       Adjunctive perampanel in patients with 
drug-resistant
Date: Monday 5       partial seizures with and without concurrent
vagal nerve
December             stimulation therapy in Phase III studies    

Time: 08:00-14:00                             
Location: Hall A3,
B3                   Laurenza A, Klein P, Williams B, Patten A


Poster # 2.191       Phase II trials of adjunctive perampanel in 
Japanese
Date: Sunday 4       patients with refractory partial-onset 
seizures, an
December             open-label, ascending-high-dose study (study
231) and                                     
Time: 10:00-16:00    long-term extension study (study 233)       

Location: Hall A3,
B3                   Hiramatsu H, Saeki K, Ohnishi A, Kaneko S, 
Inoue Y


Poster # 3.232       Factors influencing the efficacy of 
perampanel:
Date: Monday,        multivariate analysis of a randomized, 
double-blind,
December 5           placebo-controlled Phase III study          

Time: 08:00-14:00                             
Location: Hall A3,
B3                   Nishida T, Inoue Y, Kaneko S, Saeki K, 
Ishikawa K 

Rufinamide abstracts at AES (in the George R Brown Convention Center, Hall A3, Level 3):



Abstract Number      Abstract details


Poster # 3.363       Safety and Cognitive Development Effects of 
Adjunctive
Date: Monday 5       Rufinamide in Pediatric Subjects With 
Inadequately
December             Controlled Lennox-Gastaut Syndrome (LGS): 
Final Results                                                        

Time: 08:00-14:00    From Study 303
Arzimanoglou A, Ferreira J, Satlin A, Olhaye
O, Kumar D,
Location: Hall A3,   Dhadda S, Bibbiani  F
B3                   

Notes to Editors

About Fycompa® (perampanel)

Perampanel is a first-in-class, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist on post-synaptic neurons.[1] 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.[3] Since launch, approximately 52,000 people living with epilepsy have been treated with perampanel.[4]

About Inovelon® (rufinamide)

Rufinamide is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs).[5],[6] It is believed to regulate the activity of sodium channels in the brain which carry excessive electrical charges.[5] Rufinamide was approved for adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome in Europe (under the brand name Inovelon) in 2007 in patients four years of age and older. Rufinamide is available as film-coated tablets containing 100mg, 200mg and 400mg rufinamide and as a 40mg/ml oral suspension.[2]

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately six million people in Europe, and an estimated 50 million people worldwide.[7] 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 nature and 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) is indicated for use as a once-daily, 
  adjunctive treatment for both primary generalised tonic-clonic 
  seizures in idiopathic generalised epilepsy and for partial onset 
  seizures, with or without secondary generalisation, in patients 
  aged 12 years or older
- Inovelon® (rufinamide) is indicated for the adjunctive treatment of
  seizures associated with Lennox-Gastaut Syndrome in patients >=4 
  years. (Rufinamide was originally developed by Novartis)
- 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 six years and above. 
  (Zonegran is under license from the originator Dainippon Sumitomo 
  Pharma)
- Zebinix® (eslicarbazepine acetate) as adjunctive treatment in adult
  patients with partial onset seizures, with or without secondary 
  generalisation (Zebinix is under license from Bial) 

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. 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 our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com

References

1. Fycompa® (perampanel) Summary of Product Characteristics (SmPC) Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002434/WC500130815.pdf Accessed November 2016

2. Inovelon® (rufinamide) Summary of Product Characteristics (SmPC). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000660/WC500032938.pdf Accessed November 2016

3. Lee K et al. AMPA Receptors as Therapeutic Targets for Neurological Disorders 2016;103:203-261

4. Eisai. Data on File 2016. DOF PER112

5. Wier H et al. Rufinamide for Pediatric Patients with Lennox-Gastaut Syndrome. Pediatric Drugs 2011;13(2):97-106

6. Xu M et al. Pharmacokinetics and Tolerability of Rufinamide Following Single and Multiple Oral Doses and Effect of Food on Pharmacokinetics in Healthy Chinese Subjects. European Journal of Drug Metabolism and Pharmacokinetics 2016;41(5):541-548

7. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. Available at: http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf Accessed November 2016

December 2016

Fycompa-EU0185

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