Eisai Europe Limited

First-In-Class Treatment Fycompa® (Perampanel) Launched in Finland for Most Common Form of Epilepsy

Hatfield, England (ots/PRNewswire) - Epilepsy treatment Fycompa(R)(perampanel) has today been approved for basic reimbursement in Finland. Perampanel is indicated as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.[1]

Perampanel is the first and only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in causing seizures.[2] This mechanism of action is different to other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime[1] and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch.

"Perampanel is an important new treatment option for people with partial onset epilepsy in Finland, and particularly those who live with uncontrolled seizures," said Dr. Jukka Peltola, Department of Neurology, Tampere University hospital. "Epilepsy remains a challenging condition to treat, so perampanel will be welcomed by doctors across the country as an alternative option which may help people with epilepsy to achieve better seizure control."

Epilepsy is one of the most common neurological conditions in the world and in Finland alone approximately 56,000 people live with the condition.[3] Despite many AEDs, the successful treatment of partial onset seizures remains a significant challenge in some patients. Currently, between 20-40% of patients with newly diagnosed epilepsy will become refractory to treatment.[4]

Perampanel was approved by the European Commission on 23 July 2012 based on three randomised, double-blind, placebo-controlled and dose-escalated global pivotal Phase III studies (304, 305, 306) and an open-label extension study (307). The three global pivotal studies show consistent results in the efficacyand tolerability of perampanel as an adjunctive therapy in people with partial onset seizures, with or without secondary generalisation.[5],[6],[7] The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.[5],[6],[7] Results from the open-label extension study also demonstrate perampanel's efficacy and favorable tolerability profile over the longer term.[8]

Sten Friberg, Nordic Medical Director for Eisai AB commented, "We are delighted to announce the launch of Fycompa in Finland. As an emerging leader in the field of epilepsy, Eisai is committed to the development of innovative therapies such as this to help people with epilepsy achieve seizure control."

The launch of perampanel in Finland underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people 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]

For more information please visit: http://www.fycompa.eu

About the Perampanel Pooled Data (Study 306, 305 and 304)[5],[6],[7]

The pooled Phase III data analysed the efficacy of once-daily perampanel in reducing partial onset seizures, the most common form of epilepsy, and its effectiveness and flexibility of use as add-on therapy. Efficacy end points for studies 304, 305, and 306 were pooled according to randomised treatment: placebo, perampanel 2, 4, 8 or 12mg. The full ITT (intention-to-treat) analysis set included 1,478 patients from studies 304 (n=387), 306 (n=386) and 306 (n=705).

Median reductions in partial seizure frequency were greater with perampanel 4 mg (-23.3%), 8 mg (-28.8%), and 12 mg (-27.2%) than placebo (-12.8%; p<0.01, each dose vs placebo). Median (95% CI) differences from placebo in changes in partial seizure frequency were -12.2% (-20.1 to -4.6), -17.9% (-24.1 to -11.8), and -15.8% (-23.0 to -8.7) for perampanel 4, 8, and 12 mg, respectively.[9]

50% responder rates were greater with perampanel 4 mg (28.5%), 8 mg (35.3%), and 12 mg (35.0%) than placebo (19.3%; p<0.05, each dose vs placebo). Median reductions in complex partial seizure frequency were greater with perampanel 4 mg (-31.2%), 8 mg (-35.6%), and 12 mg (-28.6%) than placebo (-13.9%).[1]

Results from two separate analyses of pooled data from the perampanel pivotal Phase III clinical trial programme endorse the efficacy and safety of the new AED at clinically relevant doses.[9] In addition, the results show that perampanel decreased the frequency of both complex partial seizures and secondarily generalised seizures.[10] In a third analysis of the pooled trial data, patients with uncontrolled partial onset seizures taking any of the five most commonly-used AEDs with perampanel as an add-on therapy experienced a reduction in their seizure frequency. Patients generally received additional benefit from increased doses of perampanel.[11]

Perampanel was generally well tolerated; most adverse events were mild/moderate.

About 307[8]

The 307 study (n=1,218) was designed to evaluate safety, tolerability, and seizure outcome data during long-term treatment with once-daily adjunctive perampanel (up to 12 mg/day) in people with refractory partial onset seizures. It was an open-label extension (OLE) study for people completing the double-blind phase of three pivotal Phase III trials (studies 304, 305, and 306).

The study consisted of two phases: an open-label treatment phase (including a 16-week conversion period and a planned 256-week maintenance period) and a 4-week follow-up phase. People were blindly titrated during the Conversion Period to their individual maximum tolerated dose (maximum 12 mg/day). Adverse events (AEs) were monitored throughout the study and seizure frequency recorded. The interim data cut-off date for analyses was 1 December 1 2010.

At the interim cut-off date, 1186 patients were in the safety analysis set; 1089 (91.8%) patients had >16 weeks' exposure to perampanel, 580 (48.9%) patients had >1 year of exposure, and 19 (1.6%) patients had >2 years' exposure. At the interim analysis, 840 (70.8%) patients remained on perampanel treatment. The large majority of patients (n=1084 [91%]) were titrated to 10 mg or 12 mg/day. Median (range) duration of exposure was 51.4 (1.1-128.1) weeks.

In the ITT analysis set (n=1207), the frequency of all seizures decreased over the first 26 weeks of perampanel treatment in patients with at least 26 weeks' exposure to perampanel (n=1006 [83.3%]); this reduction was maintained in patients with at least one year of exposure (n=588 [48.7%]). The overall median percent changes in seizure frequency in patients included in each 13-week interval of perampanel treatment were -39.2% for weeks 13-26 (n=1114), -46.5% for Weeks 40-52 (n=731), and 58.1% for Weeks 92-104 (n=59). Overall responder rates in patients included in each 13-week interval of perampanel treatment were 41.4% for Weeks 13-26 (n=1114), 46.9% for Weeks 40-52 (n=731) and 62.7% for weeks 92-104 n=59). During the blinded conversion period, the reduction in seizure frequency in patients previously randomised to placebo (-42.4%, n=369) was similar to that in patients previously randomised to perampanel (-41.5%, n=817).

Treatment-emergent AEs were reported in 87.4% of patients. The most frequent were dizziness (43.9%), somnolence (20.2%), headache (16.7%), and fatigue (12.1%). Serious AEs were reported in 13.2% of patients.

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.[12],[13]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).

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

- Zonegran(R) (zonisamide) as monotherapy in the treatment of partial
  seizures, with or without secondary generalisation, in adults with newly diagnosed
  epilepsy and as adjunctive therapy in the treatment of partial seizures, with or
  without generalisation, in adults adolescents and children aged six years and above.
  (Zonegran is under license from the originator Dainippon Sumitomo Pharma).
- 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).
- Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated
  with Lennox-Gastaut Syndrome in patients >4 years (Rufinamide was originally developed
  by Novartis)
- 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 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, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Russia and the Middle East.

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

References

1. Fycompa. Summary of Product Characteristics (updated November 2012) http://www.medicines.org.uk/emc/medicine/26951/SPC/Fycompa+2mg%2c4mg%2c6mg%2c8mg%2c10mg%2c 12mg+film-coated+tablets/ 2. Rogawski MA. Epilepsy Currents 2011;11:56-63.

4. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3 - 7

5. Krauss GM. et al. Randomized phase III study 306: Adjunctive perampanel for refractory partial-onset seizures. Neurology 2012; 78:1408-1415

6. French JA. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 2012;79:589-596

7. French JA et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305. Epilepsia 2012:1-9

8. Krauss GL et al. Perampanel, a selective, noncompetitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist, as adjunctive therapy for refractory partial-onset seizures: interim results from phase III, extension study 307. Epilepsia, 2013;54(1):126-34.

9. Ben-Menachem E,Krauss GL, Noachtar S et al. Abstract presented at ECE 2012

10. Steinhoff BJ, Gauffin H, McKee P et al. Abstract presented at ECE 2012

11. Trinka E, Straub H, Squillacote D et al. Abstract presented at ECE 2012

12. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.

http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [http://www.ibe-epilepsy.org/downloads/EURO Report 160510.pdf ] [Accessed 18 July 2012].

13. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224-2233.

Date of preparation: December 2013

Job code: Perampanel-UK2144

Contact:

Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte
Andrews , +44(0)7908-314-155/+44(0)7947-231-513 ,
Cressida_Robson@eisai.net , Charlotte_Andrews@eisai.net. Tonic Life
Communications, Frances Murphy/Nicola Lilley, +44(0)207-798-9262
/+44-(0)207-798-9905, frances.murphy@toniclc.com,
nicola.lilley@toniclc.com



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