New First-in-Class Treatment Fycompa® Launches in Denmark for Most Common Form of Epilpesy

New First-in-Class Treatment Fycompa® Launches in Denmark for Most Common Form of Epilpesy

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New First-in-Class Treatment Fycompa® Launches in Denmark for Most Common Form of Epilpesy PR Newswire HATFIELD, England, September 18, 2012 HATFIELD, England, September 18, 2012 /PRNewswire/ -- ®Fycompa (perampanel), is launched today in Denmark as the first in an entirely new class of treatment for uncontrolled partial epilepsy (the most common form of the condition). The new therapy has demonstrated efficacy in partial onset seizures, in particular with secondary generalisations. It is indicated as an adjunctive treatment for partial-onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and [1]older. Following the UK and Germany, Denmark is one of the first countries in Europe to launch Fycompa. 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 [2]causing seizures. This mechanism of action is different to other, currently available AEDs. In addition, perampanel has the added benefit of convenient, [1]once-daily dosing at bedtime and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch. [3]There are approximately 46,000 people in Denmark living with epilepsy. The successful treatment of partial-onset seizures remains a significant challenge in some patients and the incidence of uncontrolled partial epilepsy remains high despite many AEDs.

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New First-in-Class Treatment Fycompa® Launches in Denmark for Most Common Form of Epilpesy
PR Newswire HATFIELD, England, September 18, 2012
HATFIELD,England,September 18, 2012/PRNewswire/ --® Fycompa (perampanel),is launched today inDenmarkas the first in an entirely new class of treatment for uncontrolled partial epilepsy (the most common form of the condition). The new therapy has demonstrated efficacy in partial onset seizures, in particular with secondary generalisations.It is indicated as an adjunctive treatment for partial-onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and [1] older. Followingthe UK andGermany,Denmarkis one of the first countries in Europeto launch Fycompa. 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 [2] causing seizures.This mechanism of action is different to other, currently available AEDs. In addition, perampanel has the added benefit of convenient, [1] once-daily dosing at bedtimeand, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch. [3] There are approximately 46,000 people inDenmarkliving with epilepsy.The successful treatment of partial-onset seizures remains a significant challenge in some patients and the incidence of uncontrolled partial epilepsy remains high despite many AEDs. Currently, between 20 - 40% of patients with newly [4] diagnosed epilepsy will become refractory to treatment. "Perampanel provides doctors and patients with a very welcome new option for the treatment of partial-onset epilepsy that could potentially help people in Denmarkliving with epilepsy achieve better seizure control", said Elinor Ben-Menachem, Professor of Neurology and Epilepsy at the Institute for Clinical Neurosciences, Sahlgrenska Academy, Göteborg,Sweden. "In addition, it has the added benefit of once daily dosing, which will optimise adherence in patients already receiving therapy." Perampanel's approval by the European Commission (EC) was based on three global pivotal Phase III studies with 1,480 subjects. These randomised, double-blind, placebo-controlled and dose-escalated studies showed consistent results in the efficacyand tolerability of perampanel as an adjunctive therapy in people [5],[6],[7] with partial-onset seizures (with or without secondary generalisations). The most commonly reported adverse events were dizziness, somnolence, [5],[6],[7] fatigue, headache, falls, irritability and ataxia. The Danish price for Fycompa was received from the Danish Health and Medicines Authority on5 September 2012. Perampanelreceived CHMP positive opinion inMay 2012, was approved by the EC on23 July 2012and first launched in the UK on13 September 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 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) population were: 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.
[6] 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
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 inEurope, theMiddle East,Africaand Russia(EMEA). 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. FrenchJA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3 - 7 5. KraussGM. Serratosa JM, Villanueva V et al. Neurology 2012: http://www.neurology.org/ AccessedAugust 2012]. 6. FrenchJA. Neurology 2012;79:589-596. 7. FrenchJA et al. (305) Epilepsia 2012:1-9. In press online. 8. Epilepsyin the WHO European Region: Fostering Epilepsy Care inEurope. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [AccessedAugust 2012]. 9. PugliattiM, et al. Epilepsia 2007: 48(12) 2224 - 2233. Date ofre aration:2012Se tember
Job code: Perampanel-EU0021