Eisai Europe Limited

First Clinical Experiences With Fycompa® (perampanel) Show "Clear Therapeutic Benefit"

Hatfield, England (ots/PRNewswire) - New data on early real life experience show perampanel is effective and well

tolerated in patients with difficult-to-treat partial epilepsy

The antiepileptic drug (AED) Fycompa (perampanel), shows a clear therapeutic benefit in difficult-to-treat patients with partial epilepsy according to the investigators of two new analyses on early clinical experience of perampanel, presented on 9th May at the joint meeting of the German and Austrian Societies for Epileptology and the Swiss League Against Epilepsy in Interlaken, Switzerland.[1],[2] Perampanel was approved for use in the Europe Union in July 2012 and is now prescribed in several European countries, including Germany, Austria and Switzerland.[3]

The two analyses examined independently and on their own initiative data from two major German epilepsy centres and investigated effects on seizure frequency and potential side effects of perampanel treatment in clinical practice. The results describe the first real life experiences of perampanel as an adjunctive therapy in patients with refractory partial epilepsy.

"The results of these early analyses are a promising indication of the clinical benefit perampanel can offer to patients with partial epilepsy, and are particularly significant for patients who have previously tried a number of AEDs or are taking a combination of therapies, yet still experience a high seizure frequency," said Professor Bernard Steinhoff from the Epilepsy Centre Kork in Kehl-Kork, Germany. "Around 30% of patients with epilepsy are, or become, refractory to treatment with available antiepileptic drugs, meaning there is still a significant need for novel and effective AEDs. Our findings show perampanel is of clear therapeutic benefit as an adjunctive therapy."

In the larger of the two analyses, led by Professor Bernard Steinhoff, at the Epilepsy Centre Kork in Kehl-Kork, 100 patients were treated. 45 of these patients were followed up for at least six months. 47% of the 45 patients had a reduction in seizure frequency of at least 50% compared to baseline, and 16% became seizure free. 62% (n=28) of patients experienced adverse events, with somnolence and dizziness most frequently reported, and as a result, five patients discontinued treatment. At the end of the six month follow up period, 71% of patients had continued treatment with perampanel.[1]

The second analysis, conducted at the Epilepsy-Center Berlin-Brandenburg (led by Professor Martin Holtkamp) involved 19 patients with partial-onset seizures (94.7% with a history of secondary generalisation). Outcomes were assessed by follow-up telephone interviews after 2.7 months (mean). Patients had suffered from intractable epilepsy (52.6% with temporal lobe epilepsy) for an average of 23.7 years, and had previously been treated with an average number of nine AEDs. Their current medication consisted of 2.1 AEDs.

Four patients (21.1%) experienced more than a 50% decrease of seizure frequency with perampanel, a further five patients (26.3%) observed a positive effect, although less than a 50% reduction in seizure frequency. Four patients had discontinued treatment, two due to side effects.[2]

Perampanel is the only approved AED in Europe that selectively targets AMPA receptors, which are thought to play a central role in seizure generation and spread.[4] The first-in-class treatment selectively targets the transmission of seizures by blocking the effects of glutamate, which can trigger and maintain seizures. In addition, perampanel has the added benefit of convenient, once-daily dosing taken at bedtime.[5]

"These new, early, real-world data continue to confirm the clinical value of Fycompa," said Gary Hendler, Eisai President & CEO, EMEA. "Sharing first clinical experiences on new treatments is vitally important and will help clinicians to optimally manage their patients' epilepsy. Additional investigational studies on the use of Fycompa in a clinical setting are very much welcomed and will help to build a clearer picture of the drug's clinical profile and additional benefit."

Perampanel is licensed as an adjunctive treatment for people aged 12 years and older with partial-onset seizures, with or without secondarily generalised seizures[5], and is the only third generation epilepsy treatment approved for use in adolescents. It was approved by the European Commission in July 2012 and the US FDA in October 2012. In Europe, it is currently available in the UK, Denmark, Germany, Sweden, Norway and Austria. Swissmedic, the Swiss Agency for Therapeutic Products, approved perampanel for use on 17 December 2012.

The development of perampanel underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients and their families. Eisai is proud to currently market more epilepsy products in Europe, the Middle East and Africa (EMEA) than any other company.

Notes to Editors

About Perampanel

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.[5]

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

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people with the condition worldwide.[6],[7] 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 Europe 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 and Africa (EMEA).

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

- Zonegran(R) (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). In
  Switzerland, Zonegran is only approved as adjunctive therapy.
- 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). Zebinix is not approved by Swissmedic.
- Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated
  with Lennox-Gastaut Syndrome in patients >4 years
- 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

About Eisai

Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies.

Eisai concentrates its R&D activities in three key areas:

- Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight
- 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 Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East and Africa (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


1. Geithner J, Frenck W, Holtkamp M. Effectiveness and side effects of perampanel: a first utilization study. Poster P06 presented at 8th joint three country meeting of the German and Austrian Societies for Epileptology and the Suisse League against Epilepsy, Interlaken, Switzerland 2013

2. Steinhoff BJ et al. First clinical experiences with perampanel. Poster P08 presented at 8th joint three country meeting of the German and Austrian Societies for Epileptology and the Suisse League against Epilepsy, Interlaken, Switzerland 2013

3. EMA Authorisation Details: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002434/human_med_001572.jsp&mid=WC0b01ac058001d124 [Last accessed April 2013]

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

5. Fycompa Summary of Product Characteristics. 2012

6. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed August 2012]

7. Pugliatti M, et al. Epilepsia Estimating the cost of epilepsy in Europe: a review with economic modelling. 2007: 48(12);2224-2233

Date of preparation: May 2013
Job code: perampanel-UK2126


Media Enquiries, Eisai Europe Ltd, Charlotte Andrews / Cressida
Robson, +44(0)7908-314-155, Cressida_Robson@eisai.net,
Charlotte_andrews@eisai.net; Tonic Life Communications, Siobhan
Reilly /
Nicola Lilley, +44(0)207-798-999/+44(0)207-798-9905,
siobhan.reilly@toniclc.com, nicola.lilley@toniclc.com

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