New First-In-Class Treatment Fycompa® Launches Today for People With the Most Common Form of Epilepsy

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• Publié par: eisai-europe-limited
• Nombre de lectures: 129
• Langue: English

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New First-In-Class Treatment Fycompa® Launches Today for People With the Most Common Form of Epilepsy

PR Newswire HATFIELD, England, September 13, 2012

HATFIELD,England,September 13, 2012/PRNewswire/ -- Europe first region in the world to gain access to this new therapy for partial seizures ® Fycompa (perampanel)is the first in a new class of epilepsy treatments, with demonstrated efficacy in partial onset seizures, in particular with secondary [1] generalisations. InEurope, perampanel is indicated for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised [1] seizures, in patients with epilepsy aged 12 years and older.Following the UK launch, perampanel will also be launched inGermany,AustriaandDenmark this month. Discovered and developed by Eisai in the UK andJapan, perampanel is the first and only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a receptor in the brain which plays a critical role in the initiation and spread of [2] seizures. Thismechanism of action is different to any other licensed AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at [1] bedtime andsignificantly, is the only third generation partial-onset epilepsy treatment licensed to treat adolescent epilepsy from launch. Improved epilepsy care is crucial. Currently, the cost burden of epilepsy in [3] Europewhilst at least one-in-fouris estimated to stand at €20 billion annually, of the 33,000 deaths attributed to the condition each year in the region are [4] preventable. Inparticular, the successful management of partial-onset seizures (the most common form of epilepsy) remains a significant challenge in some patients, and incidence of uncontrolled seizures remains high, despite many existing AEDs. "Perampanel provides doctors and patients with a unique new option for the treatment of drug-resistant partial onset epilepsy that could play an important role in improving seizure control for many people acrossEurope. It has the added benefit of once-daily dosing, which will optimise adherence in patients already taking more than one antiepileptic drug," said Professor Martin Brodie, Clinical and Research Director at the Epilepsy Unit in the University of Glasgow, Scotland, "Adolescents and adults with epilepsy need new treatment options. Around one in three will have uncontrolled seizures, even after trying a range of drug options." The European Commission's (EC) Marketing Authorisation Approval of perampanel was based on three global pivotal Phase III studies of 1,480 people. These randomised, double-blind, placebo-controlled, and dose-escalated studies showed consistent results in the efficacyand tolerability of perampanel, as an adjunctive therapy in patients with partial onset seizures (with or without [5],[6],[7] secondary generalisations).The most commonly reported adverse

events were dizziness, somnolence, fatigue, headache, falls, irritability and [5],[6],[7] ataxia. Perampanel received CHMP positive opinion inMay 2012and was approved by the EC on23 July 2012. The FDA accepted the resubmission of New Drug Application for perampanel inMarch 2012and has assigned a Prescription Drug User Free Act (PDUFA) target date of22 October 2012. The worldwide supply of perampanel will be packaged and manufactured at Eisai's EMEA (Europe, the Middle East,AfricaandRussia) headquarters in Hatfield, UK. The development of perampanel underscores Eisai'shuman health care(hhc) 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 with epilepsy and their families. Eisai is proud to currently market more epilepsy products inEurope, theMiddle East,Africa andRussia(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 [1] disorders. Further information for healthcare professionals can be found at http://www.fycompa.eu About the Perampanel Phase III studies (Study 306,305 and 304) The clinical development plan for perampanel consisted of three global Phase III studies (studies 306, 305 and 304). The key goal of Study 306 was to identify the minimal effective dose and included four treatment arms (placebo, 2mg, 4mg, and 8mg). Studies 304 and 305 included three arms (placebo, 8mg, and 12mg) and were to evaluate a more extended dose range. The studies were similar in design: global, randomised, double-blind, placebo- controlled, dose-escalation, parallel-group studies. The primary and secondary endpoints were the same in all the studies: percentage change in seizure frequency, 50% responder rate, percentage reduction of complex partial plus secondarily generalised seizures, and evaluation for dose response. The primary endpoint for the EMA is 50% responder rate and for the FDA is median percent change in seizure frequency. [5] Study 306 Study 306 showed that perampanel was well-tolerated and effective in reducing median seizure frequency and increasing responder rates. Specifically the results showed:

The 50% responder rates compared to placebo for the ITT (intention-to-treat) o ulationwere:

2mg = 20.6% (p=ns), 4mg = 28.5% (p=0.013), and 8mg = 34.9% (p<0.001) versus 17.9% with placebo. The median percent change in seizure frequency for the ITT population shown: 2mg = -13.6% (p=0.4197), 4mg = -23.3% (p=0.003), 8mg = -30.8% (p<0.0001) versus -10.7% with placebo The most frequent treatment-emergent adverse events were dizziness, somnolence and headache.

[7] Study 305 The was a significant difference in median percent change in seizure frequency with perampanel 8mg and 12mg. Specifically the preliminary results for Study 305 showed:

The 50% responder rates compared to placebo for the ITT population were:

8mg = 33.3% (p=0.0018), 12mg = 33.9% (p < 0.001) versus 14.7% with placebo

The median percent change in seizure frequency for the ITT population were:

8mg = -30.5% (p< 0.001), 12mg = -17.6% (p=0.011) versus -9.7% with placebo

The most reported adverse events were dizziness, somnolence, fatigue and headache.

[7] Study 304 Study 304 showed consistent results in the efficacy and tolerability of perampanel given as a treatment for patients with partial-onset seizures. Specifically:

The 50% responder rates compared to placebo for the ITT population were:

8mg = 37.6% (p=0.0760), 12mg = 36.1% (0.0914) versus 26.4% with placebo.

The median percent change in seizure frequency for the ITT population were:

8mg = -26.3% (0.0261), 12mg = -34.5% (p=0.0158) versus -21.0% with placebo

The most common side effects were dizziness, somnolence, headache, falls, irritability and ataxia

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people inEurope, and an estimated 50 [8],[9] million people with the condition worldwide.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

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 (eslicarbazepineacetate) 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 ® 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 recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company's growing EMEA business. Eisai concentrates its R&D activities in three key areas: Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic disease, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S.,Asia,Europeand its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. InEurope, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom,France,Germany,Italy,Spain,Switzerland,Sweden,Ireland, Austria,Denmark,Finland,Norway,Portugal,Iceland,Czech Republic,Slovakia, the Netherlands,Belgium,Luxembourg, theMiddle EastandRussia. For further information please visit our web site http://www.eisai.com References 1. Fycompa.Summary of Product Characteristics.August 2012 2. RogawskiMA. Epilepsy Currents 2011;11:56-63. 4. InternationalBureau for Epilepsy. "Fostering Epilepsy Care in Europe"report. http://www.ibe-epilepsy.org/news/european-epilepsy-report/ [AccessedAugust 2012]. 5. KraussGM. Serratosa JM, Villanueva V et al. Neurology 2012: Available at:

http://www.neurology.org/ [http://www.neurology.org ]. 6. FrenchJA. Neurology 2012;79:589-596. 7. FrenchJ, et al. 2011, IEC Rome. Abstract# 122/ Ref 020. 8. Epilepsyin the WHO European Region: Fostering Epilepsy Care inEurope. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed10 April 2012]. 9. PugliattiM, et al. Epilepsia 2007: 48(12) 2224 - 223

Date of preparation:September 2012 Job code: Perampanel-UK2047