Eisai Announces That it Will Suspend Temporarily Commercial Distribution of Innovative Antiepileptic Drug Fycompa® (Perampanel) in Germany

HATFIELD, England, June 25, 2013 /PRNewswire/ --

The company continues to disagree with the German Federal Joint Committee's (G-BA) decision on drug's additional benefits but will continue patient access

Eisai today announces, with regret, that it will suspend temporarily commercial distribution (Aussetzen des Vertriebes) of Fycompa in Germany. Eisai is unable to accept the assessment, under the current AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) process, of no additional benefit to inappropriate comparators for this highly innovative, first in class product. Eisai hopes that this situation will be temporary and will submit Fycompa for reassessment at the earliest opportunity. Commercial availability of Fycompa will continue until the end of the year. Thereafter, a continued access programme will be put in place. Eisai will announce the details of the continued access programme shortly.

The German Society for Epileptology (DGfE) and German Society for Neurology (DGN), representing epileptologists and neurologists in Germany, agree that the G-BA's understanding that new anti-epileptic drugs should be compared to single substances is not applicable to the situation of refractory epilepsy, for which an additional benefit should be assessed by considering efficacy in patients drug-resistant to standard therapies. The organisations also confirm that new epilepsy treatment options are needed to help patients improve seizure control and tolerability.

"We deeply regret having to take the difficult decision to suspend temporarily our innovative new anti-epileptic drug Fycompa from commercial distribution in Germany. We continue to disagree with the decision made by the GB-A in its current assessment of Fycompa. We are hopeful that this will be rectified in the potential changes in the German Law on Medicine." said Gary Hendler, President and CEO, Eisai EMEA. "We are watching closely for any further developments, we are positive we will be able to resolve the situation and re-start commercial distribution of Fycompa in Germany. We intend to submit Fycompa for reassessment at the earliest opportunity. Since the drug's launch in September 2012, its clinical benefit has been recognised in approximately 3000-4000 patients suffering with epilepsy in Germany and our first concern is therefore for these patients. As a demonstration of our strong belief in Fycompa and our commitment to people suffering with epilepsy in Germany, Eisai will ensure that all patients will continue to receive access to this first-in-class treatment."

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 authorization 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 believes 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 our hhc philosophy, Eisai will continue to work to achieve sustainable enhancement of value through its business activities worldwide.

***ENDS***

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, neurodegenerative disorders, movement disorders, pain and psychiatric disorders. ^[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, the Netherlands, Belgium, and the Middle East.

For further information please visit our web site http://www.eisai.co.uk

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.

Date of preparation: June 2013

Job code: Perampanel – UK2130