Eisai Speechless With G-BA Decision Which Ignores the Demand of Epilepsy Patients and Denies the Proven Additional Benef

Generalised tonic-clonic seizures are one of the most dangerous types of seizure.[11] For the majority of patients, a primary generalised tonic-clonic (PGTC) seizure begins with a loss of consciousness without any prior warning symptoms and a sudden tonic contraction of the muscles, causing the patient to fall down (tonic phase).[11] This is followed by violent convulsions (clonic phase) until the muscles finally relax, and the patient is left with a disturbance 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.[12]

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, Commonwealth of Independent States and Oceania (EMEA).

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

- Fycompa(R) (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
- Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated
with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally
developed by Novartis)
- Zonegran(R) (zonisamide) as monotherapy in the treatment of partial onset
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(R) (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 various 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. G-BA assessment dossier. Available at: https://www.g-ba.de/informationen/beschluesse/2091/ Accessed: November 2014

2. German Epilepsy Association (DE). Opinion of epilepsy self-help associations in Germany to benefit assessment of antiepileptic Fycompa(R) (active ingredient: perampanel) by the Institute for Quality and Efficiency in Health Care (IQWiG) from 08.15.2014. Available at: http://www.epilepsie-vereinigung.de/2014/09/stellungnahme-de... de-deutschland/ Accessed: October 2014

3. Steinhoff BJ et al. A multicentre survey of clinical experiences with perampanel in real life in Germany and

Austria. Epilepsy Res 2014:108(5):986-988

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

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

6. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at: http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport16... Accessed: October 2014

7. Pfäfflin, M. Epidemiologie der Epilepsien. Available at: http//www.izepilepsie.de/home/showdoc.id.387.a... Accessed: October 2014

8. Schmidt D. Drug treatment of epilepsy: options and limitations. Epilepsy & Behavior 2009:15:56-65

9. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510... Accessed: October 2014

10. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007:48(12):2224-2233

11. Blumenfeld H et al. Cortical and subcortical networks in human secondarily generalized tonic-clonic seizures. Brain. 2009:132:999-1012

12. Epilepsy Action. Generalised seizures. https://www.epilepsy.org.uk/info/seizures/generalised-seizur... (accessed July 2014)

Date of preparation: November 2014

Job code: Perampanel-UK2179

CONTACT: Media Enquiries: Eisai Europe Ltd, 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, Ainsley Cooper/NicolaLilley , +44-(0)207-798-1037/+44-(0)207-798-9905,Ainsley.Cooper@toniclc.com, Nicola.Lilley@toniclc.com