|By PR Newswire||
|December 10, 2013 07:02 PM EST||
HATFIELD, England, December 11, 2013 /PRNewswire/ --
Named patient access programme ensures patients receive uninterrupted supply of Fycompa at no cost to the German healthcare system
Eisai today announces that Fycompa® (perampanel) will be ready to be supplied on a named patient basis from the 1 January 2014 onwards. This follows the temporary suspension of the commercial distribution (Aussetzen des Vertriebes) of the antiepileptic drug (AED) in Germany earlier this year.
The named patient access programme will be managed by Clinigen Global Access Programs (Clinigen GAP), part of Clinigen Group plc and will ensure that all patients on the programme continue to receive an uninterrupted supply of Fycompa® at no cost to the German healthcare system. For all further enquiries and further information about the access programme, contact Clinigen GAP:
Fax: 0800 5892457
Email: firstname.lastname@example.org (Please note that to ensure successful communication, we recommend to add this email address to your approved list of contacts)
Discovered and developed by Eisai in the UK and Japan, perampanel is the first and only approved AED in Europe with a mode of action that selectively targets AMPA receptors, thought to play a central role in seizure generation and spread. The successful treatment of partial-onset seizures remains a challenge for patients and physicians as over 30% of patients do not achieve seizure freedom, despite appropriate therapy with AEDs, making new innovative therapeutic options important. In Germany, approximately one out of 200 people has epilepsy equating to an estimated 400,000 people in the country living with the condition.
Fycompa was granted marketing authorisation by the European Commission on 23 July 2012 and 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. Swissmedic, the Swiss agency for the authorisation and supervision of therapeutic products, approved perampanel for use in December 2012.
Eisai is a leading research and development based pharmaceutical company. The company's Corporate Philosophy is to give first thought to patients and their families, and to increase the benefits that health care provides to them. Eisai calls this philosophy human healthcare (hhc). Eisai's belief is that the hhc philosophy is its primary objective and that only through focusing on the needs of the patient and wider global healthcare system that sales and earnings will be generated. Guided by the hhc philosophy, Eisai will continue to work to achieve sustainable enhancement of value through its business activities worldwide.
Notes for editors:
Perampanel is licensed in the European Union (EU) as an adjunctive treatment for people aged 12 years and older with partial-onset seizures, with or without secondarily generalised seizures.
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.
Epilepsy is one of the most common neurological conditions in the world, affecting approximately one in every one hundred 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 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. 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). Eisai is proud to currently market more epilepsy products in Europe than any other company.
In the EMEA region, Eisai currently has four marketed treatments including:
- Zonegran® (zonisamide) as monotherapy and adjunctive therapy in adults, adolescents and children above the age of 6 with partial onset seizures, with or without secondary generalisation. (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).
- Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by Novartis)
Fycompa® (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. Perampanel was approved for use by Swissmedic in December 2012.
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 recently expanded Knowledge Centre in Hatfield, UK, which now includes an additional high potency, global packaging capability, 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, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, Russia, the Netherlands, Belgium, and the Middle East.
For further information please visit our web site http://www.eisai.co.uk
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
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2. Brodie MJ et al, Neurology 2012; 78:1548-1554.
3. Pfäfflin, M. et al, Neurol Rehabil, 2000; 6, (2) 77-81.
4. Fycompa. Summary of Product Characteristics (updated November 2013)
5. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed 10 April 2012].
6. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224 - 2233.
Job code: Perampanel-UK2147
Date of preparation: December 2013