Eisai

First-In-Class Epilepsy Treatment Fycompa® (Perampanel) Now Available in Russia for Primary Generalised Tonic-Clonic Seizures

Hatfield, England (ots/PRNewswire) - PRESS RELEASE FOR RUSSIAN MEDIA ONLY: NOT FOR AUSTRIA/SWISS/U.S. JOURNALISTS

New anti-convulsant treatment to reduce serious seizures for idiopathic generalised epilepsy, now available in Russia

Fycompa® (perampanel), a convenient, once-daily epilepsy treatment, launches in Russia today, for primary generalised tonic-clonic (PGTC) seizures in adults and adolescents (>=12 years) with idiopathic generalised epilepsy (IGE).[1] The number of anti-epileptic drugs (AEDs) licensed for the treatment of PGTC seizures is limited[2] and as many as 20 percent (%) of people with idiopathic generalised epilepsy (IGE) remain uncontrolled, despite treatment.[3] Perampanel is the first new treatment for PGTC seizures in IGE in five years.[4]

There are approximately 496, 920 people in Russia with epilepsy; one third of these have idiopathic generalised epilepsy and approximately 60% of these (103,525 people), will experience PGTC seizures.[5],[6],[7] Perampanel offers clinicians a first-in-class treatment that reduces PGTC seizures, which are dangerous epileptic events.[8] These seizures increase the risk of injury, such as fractured bones, shoulder dislocation and burns.[9] PGTC seizures also increase the risk of sudden unexplained death in epilepsy (SUDEP) and are known to lead to atypical absence status epilepticus (ASE),[10] seizures that may last for extended time periods.

"Primary generalised tonic-clonic seizures can cause serious injuries and can even be fatal. The availability of perampanel, which reduces the frequency of seizures, is welcome news for Russian people aged 12 years and over and living with this form of epilepsy," comments Elena Belousova, Director of Psychoneurology and Epileptology, Moscow Research Institute of Paediatrics.

Grand mal (PGTC) seizures start with a loss of consciousness and a sudden contraction of the muscles, which can cause the person to fall down (tonic phase). This is followed by violent convulsions (clonic phase) until the muscles finally relax.[11] While the seizure generally lasts a few minutes, the person will often feel confused or drowsy for up to a few minutes or up to a few hours, before returning to normal.[8]

Perampanel is the first-and-only licensed AED to selectively target the initiation and spread of seizures through inhibition of AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures.[12] Perampanel is also 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]

One third more patients experienced a reduction in seizure frequency with perampanel over 28 days versus placebo (50% responder rate 64.2% vs 39.5%, respectively; P=0.0019).[13] Perampanel demonstrates a reduction in PGTC seizure frequency (per 28 days) versus placebo (76.5% vs 38.4%, respectively; P<0.0001).[13] Furthermore, 31% of patients are seizure free during the 13-week maintenance period when treated with perampanel as an adjunctive therapy, compared to 12% in the placebo group.[13]

In a global, double-blind, randomised, multicentre, parallel-group study of 164 people with idiopathic generalised epilepsy and primary generalised tonic-clonic seizures, the most common treatment-emergent adverse events are dizziness, fatigue, headache, somnolence and irritability.[13]

"The launch of perampanel is positive news for people living with PGTC seizures in Russia. It ensures that people will be able to access a new first-in-class treatment option to significantly improve seizure control for people aged 12 years and above, living with idiopathic generalized epilepsy," comments Olga Konopleva Sales and Marketing Director, General Manager, Russia.

The continued development of perampanel underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to market more epilepsy products in EMEA than any other company.

Notes to Editors

About Fycompa® (perampanel)

Perampanel is a highly selective, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist. 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.

Since launch perampanel has helped treat 39,588 people living with epilepsy across Europe.[14]

Further information for healthcare professionals can be found at http://www.eisai.co.uk

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately 6 million people in Europe, and an estimated 50 million people worldwide.[11],[15] It is a collection of syndromes that have many possible causes but often the cause is unknown. 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.

For the majority of idiopathic generalised epilepsy patients, a primary generalised tonic-clonic (PGTC) seizure begins with or without an aura which is followed by rigid muscle. This leads to violent muscle contraction (clonic phase) and a loss of consciousness. As this is a serious event, it is seen as a major hindrance on daily life. While the seizure generally only lasts a few minutes, the patient will often feel confused or drowsy for a short period of time before returning to normal.[8] PGTC seizures can also result in risk of injury and sudden unexplained death in epilepsy (SUDEP).[10]

About Eisai EMEA in Epilepsy

Eisai is committed to the development and delivery of 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 therapy for both primary generalised tonic-clonic 
  seizures in idiopathic generalised epilepsy and for adjunctive 
  treatment of partial onset seizures, with or without secondary 
  generalised seizures, in patients with epilepsy aged 12 years or 
  older.
- Inovelon® (rufinamide) 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 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). 

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 and emerging countries.

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

References

1. Fycompa Summary of Product Characteristics (SPC), Available at: http://www.medicines.org.uk/emc/medicine/26951 Accessed June 2015

2. Rheims S and Ryvlin P. Exp Opin Pharmacother. 2014;15:1417-1426.

3. Faught E. Rev Neurol Dis 2004;1:S34-S43;

4. Eisai. Data on file. 2015

5. Panayiotopoulous CP, The Epilepsies: Seizures, Syndromes and Management. 2015. Bladan Medical Publishing

6. Hauser WA et al. Incidence of Epilepsy and Unprovoked Seizures in Rochester, Minnesota: 1935-1982. 1993. Epilepsia 34(3);453-468

7. Hauser WA et al. The epidemiology of epilepsy in the Russian Federation. Epilepsy Research (2010) Volume 92, Issues 2-3, Pages 209-218

8. Epilepsy Foundation. Types of seizures. Available at: http://www.epilepsy.com/learn/types-seizures. Last Accessed May 2015

9. Asadi-Pooya AA et al. Seizure 2012;21:165-168.

10. IGE Summary. Epilepsy Foundation http://www.epilepsy.com/information/professionals/about-epilepsy-seizures/idiopathic-generalized-epilepsies Accessed June 2015

11. Epilepsy Action. Generalised seizures. https://www.epilepsy.org.uk/info/seizures/generalised-seizures. Accessed May 2015

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

13. French J et al. Adjunctive perampanel RCT for PGTC seizures. Association of British Neurologists annual meeting 2015; Abstract #53141

14. Eisai. Data on file. 2015

15. 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: July 2015  Job code: Fycompa-UK0211   

Contact:

Eisai
Cressida Robson/Ben Speller
+44(0)7908 314 155/+44(0)7908 409 416
Cressida_Robson@eisai.net
Ben_Speller@eisai.net / Tonic Life Communications
Elisabeth Neal/Deepa Patel
+44(0) 07896 954 865/+44(0)7725 440 867
Elisabeth.Neal@toniclc.com
Deepa.Patel@toniclc.com
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