Eisai Partners With Clinigen to Provide a Named Patient Access Programme for Fycompa® (Perampanel) in Germany

HATFIELD, England, September 9, 2013 /PRNewswire/ --



New named patient access programme ensures continued supply of anti-epilepsy treatment at no cost to the German healthcare system

Today, Eisai EMEA announces the establishment of a named patient access programme to ensure that patients continue to receive an uninterrupted supply of the anti-epilepsy drug Fycompa (perampanel), following the temporary suspension of commercial distribution (Aussetzen des Vertriebes) in Germany. This access programme will be managed by Clinigen Global Access Programs (Clinigen GAP), part of Clinigen Group plc. The access programme is not expected to be utilised until the beginning of 2014 as there are sufficient stocks of Fycompa in Germany to meet demand until the end of December.  

Under the access programme, all patients will receive an uninterrupted supply at no cost to the German healthcare system. For all further enquiries and further information about the access programme, contact Clinigen GAP:

Tel: 069 22223413
Fax: 0800 5892457
Email: customer.services@clinigengroup.com

"We deeply regret the need to take the difficult decision to suspend Fycompa from commercial distribution in Germany but as approximately 3,000 - 4,000 people with epilepsy in Germany have benefitted from this treatment since its launch in September 2012, our priority is to ensure that these patients continue to receive an uninterrupted supply of the treatment. For this reason, Eisai has partnered with a specialist provider, Clinigen GAP, to put a patient access programme in place, so that patients can continue to receive Fycompa after the temporary suspension has come into effect and German stock of the drug is exhausted at the end of the year," says Gary Hendler, President and CEO, Eisai EMEA.    

The access programme will remain in place until commercial distribution resumes. The company intends to submit Fycompa for reassessment at the earliest opportunity.  

Discovered and developed by Eisai in the UK and Japan, Fycompa is the first and only approved anti-epileptic drug in Europe with a mode of action that selectively targets AMPA receptors, thought to play a central role in seizure generation and spread.^[1] 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 anti-epileptic drugs, making new innovative therapeutic options very important.^[2]

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. In Germany, approximately one out of 200 people has epilepsy equating to an estimated 400,000 people in the country living with the condition.^[3]

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 focussing on the needs of the patient and the 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:

About perampanel

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.^[4]

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.^[4]

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

About 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.^[5],[6] 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 adult patients 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

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 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

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.  Rogawski MA. Epilepsy Currents 2011;11:56-63.

2.  Brodie MJ et al, Neurology 2012; 78:1548-1554.

3.  Pfäfflin, M. und May, T. Wieviele Patienten mit Epilepsien gibt es in Deutschland und wer behandelt sie? Neurol Rehabil, 2000; 6, (2) 77-81.

4.  Fycompa Summary of Product Characteristics. 2012

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-UK2138
Date of preparation: August 2013