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

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Fycompa® (Perampanel) to beFycompa® (Perampanel) to be Resubmitted Early to German Federal Joint Committee (G-BA) for Additional Benefit Assessment PR Newswire HATFIELD, England, February 10, 2014 PRESS RELEASE NOT FOR U.S. MEDIA Early resubmission opportunity for epilepsy drug perampanel welcomed by Eisai The German Federal Joint Committee (G-BA), the decision-making body of the self-governing healthcare system in Germany, recently confirmed that ®Eisai will be able to resubmit early its anti-epileptic drug (AED) Fycompa (perampanel) for reassessment of its additional therapeutic benefits. Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in people with [1]epilepsy aged 12 years and older. The confirmation from the G-BA gives Eisai the right to resubmit perampanel for additional benefit reassessment within three months now. Once resubmitted, the new G-BA decision is expected to be published within 6 months. "It is right that the G-BA has permitted the early resubmission of Fycompa in Germany," said Gary Hendler, President & CEO, Eisai EMEA. "Patients are Eisai's first concern and we strongly believe they should be given access to treatment that provides a clear clinical benefit.

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• Publié par: eisai-europe-limited
• Publié le: 09 février 2014
• Nombre de lectures: 9
• Langue: English

Extrait

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

PR Newswire

HATFIELD, England, February 10, 2014

PRESS RELEASE NOT FOR U.S. MEDIA

Early resubmission opportunity for epilepsy drug perampanel welcomed by Eisai  

The German Federal Joint Committee (G-BA), the decision-making body of the self-governing healthcare system in Germany, recently confirmed that Eisai will be able to resubmit early its anti-epileptic drug (AED) Fycompa^® (perampanel) for reassessment of its additional therapeutic benefits. Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.^[1]

The confirmation from the G-BA gives Eisai the right to resubmit perampanel for additional benefit reassessment within three months now. Once resubmitted, the new G-BA decision is expected to be published within 6 months.

"It is right that the G-BA has permitted the early resubmission of Fycompa in Germany," said Gary Hendler, President & CEO, Eisai EMEA. "Patients are Eisai's first concern and we strongly believe they should be given access to treatment that provides a clear clinical benefit. Since the launch of Fycompa across Europe in September 2012, its clinical benefit has been recognised in approximately 4,000 people with epilepsy in Germany and we hope it will be available to many more in the near future."

Eisai temporarily suspended perampanel from distribution in Germany (Aussetzen des Vertriebes) following the previous negative G-BA ruling in June 2013 and established a named patient access programme, managed by Clinigen Group plc, to ensure that people with epilepsy continue to receive a supply of the AED at no cost to the German healthcare system whilst the G-BA considered an early resubmission.

"The G-BA decision is good news for patients and doctors in Germany," said Professor Bernhard Steinhoff from Epilepsiezentrum Kork, Kehl-Kork, Germany. "Epilepsy affects hundreds of thousands of people in Germany and treatment options such as Fycompa are a welcome addition to our treatment armamentarium."

"We are pleased to learn that the G-BA has agreed to reassess perampanel early and continue to follow all AED assessment procedures closely," commented Professor Heinz Beck, President of the German Society of Epilepsy (DGfE). "The provision of expert clinical advice for people with epilepsy is an important part of our work and key developments such as this are always interesting."

In Germany, approximately one in every 200 people has epilepsy, which equates to an estimated 400,000 people in the country who live with the condition.^[2] Epilepsy is one of the most common neurological conditions in the world.^[3] The successful treatment of partial-onset seizures remains a challenge as over 30% of patients do not achieve seizure freedom despite appropriate therapy with AEDs.^[4]

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.^[5]

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 health care (hhc). Eisai's believes that the hhc philosophy is its primary objective and that only through focusing 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.

Notes to 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.^[1]

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.^[1]

Further information for healthcare professionals can be found at http://www.fycompa.eu  

About Perampanel in Germany

Professor Bernhard Steinhoff and colleagues recently reported their first real-life clinical experiences with perampanel in a cohort of consecutive patients with difficult-to-treat epilepsies from their tertiary referral epilepsy centre, Epilepsiezentrum Kork, in Kehl-Kork, Germany (September 2012 to June 2013).^[6] Fourty-six percent of 74 patients with mostly refractory focal epilepsies and a minimum of 6 months follow-up (mean age 38.4 years, range 15-71 years, 81% on two or three baseline AEDs) receiving perampanel analysed showed a reduction of seizure frequency of at least 50%, with 14% of the total group becoming seizure free. Adverse events were reported in 40 patients (54%), most frequently somnolence (n = 31, 42%) and dizziness (n = 13, 18%). Adverse events usually did not lead to discontinuation and could often be prevented or reduced with the strategy to use perampanel at bedtime. Six-month retention rate was 70%. The mean dosage was 8.8 mg, with a favorable response observed at low doses of 4 mg in some patients. The authors conclude that perampanel appeared to be a promising new AED in this refractory patient population, with a new mode of action and a unique pharmacologic profile.^[7]

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 worldwide.^[7],[8] Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity which causes 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).

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

• 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
• Inovelon^® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by Novartis)
• Zebinix^® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
• Zonegran^® (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/26951/SPC/Fycompa+2mg%2c4mg%2c6mg%2c8mg%2c10mg%2c12mg+film-coated+tablets/
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/EUROReport160510.pdf (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.pdf (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