Publicado 10/02/2014 01:02
- Comunicado -

Fycompa® (Perampanel) to be Resubmitted Early to German Federal Joint Committee (G-BA) for Additional Benefit Assessment

        
        - 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)
        - 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)
        - Zonegran(R) (zonisamide) as monotherapy in adults and adjunctive therapy in
          adults, adolescents and children aged six years and above with partial onset seizures,
          with or without secondary generalisation. (Zonegran is under license from the
          originator Dainippon Sumitomo Pharma)

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
          loss
        - 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 Clinigen

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen GAP develops and implements global access programs for biotechnology and pharmaceutical companies and has provided access to unlicensed, licensed and end-of-lifecycle products to thousands of patients.

For further information please visit: http://www.clinigengroup.com

References

        
        1) Fycompa. Summary of Product Characteristics f a date is already decided
          tion is available (updated November 2013)
          http://www.medicines.org.uk/emc/medicine...
        2) Pfäfflin, M. und May, T. Wieviele Patienten mit Epilepsien gibt es in
          Deutschland und wer behandelt sie? Neurol Rehabil, 2000; 6, (2) 77-81.
        3) 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
          June 2011)
        4) Brodie MJ et al, Neurology 2012; 78:1548-1554
        5) Rogawski MA. Epilepsy Currents 2011;11:56-63
        6) Steinhoff B, et al. First clinical experiences with perampanel - The Kork
          experience in 74 patients. Epilepsia 2014 (55) s1, 16-18.
        7) Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.
          http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510... (Accessed
          December 2013)
        8) 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: February 2014
        Job code: Perampanel-UK2143

CONTACT: Media Enquiries: Eisai Europe Ltd, Cressida Robson / CharlotteAndrews, +44(0)7908 314 155 / +44(0)7947 231 513,Cressida_Robson@eisai.net, Charlotte_Andrews@eisai.net ; Tonic LifeCommunications, 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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