New First-In-Class Treatment Fycompa® [black triangle drug] Launches Today for Most Common Form of Epilepsy

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• Publié par: eisai-europe-limited
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New First-In-Class Treatment Fycompa® [black triangle drug] Launches Today for Most Common Form of Epilepsy PR Newswire HATFIELD, England, September 13, 2012

HA TFIELD,England,September 13, 2012/PRNewswire/ -- UK first country in Europe to gain access to new therapy for partial epilepsy ® Fycompa ▼ (perampanel), discovered and developed by Eisai in the UK andJapan, is launched today 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 [1] aged 12 years and older. The worldwide supply of this new drug will be manufactured, packaged and distributed from the company's new £100 million facility in Hatfield,Hertfordshire. Perampanel is the first and only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, areceptor in the [2] brain which plays a critical role in the spread of epileptic seizures.This mechanism of action is different to other, [1] currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtimeand significantly, is the only third generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch. [3] There are approximately 600,000 individuals in the UK with epilepsy, and 496,000 inEnglandepilepsy care is. Improved [4] crucial as there are around 1000 epilepsy-related deaths each year in the UK, most of which are associated with seizures. [5] Just over a third of these deaths are young adults and childrenand of the total number of deaths, about 400 per year, [4] are thought to be avoidable. A lthoughup to 70 per cent of people with epilepsy have the potential to be seizure-free through accurate diagnosis and [6] optimal treatment, according to the Joint Epilepsy Council, this is achieved in only around half of all patients. "The successful management of partial-onset seizures remains a significant challenge in many epilepsy patients, and the incidence of uncontrolled seizures remains too high, despite existing treatments," points out Dr Fergus Rugg-Gunn, consultant neurologist at the UCLH NHS Foundation Trust. "Perampanel provides doctors and patients with an important new option for the treatment of partial-onset epilepsy and may play a key role in improving seizure management in poorly controlled adults and adolescents." "In order for young people living with epilepsy to reach their full potential in education, employment and social interaction, their seizures need to be under control as far as possible and their condition needs to be better understood by those around them," says David Ford, Chief Executive of Young Epilepsy. "Currently more than one in three people with epilepsy still have uncontrolled seizures, even after their first or second drug therapy, a number that is still far too high." Perampanel's approval by the European Commission (EC) was based on three global pivotal Phase III studies with 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 people with partial-onset seizures (with or without [7,8,9] secondary generalisations).The most commonly reported adverse events were dizziness, somnolence, fatigue, [7,8,9] headache, falls, irritability and 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 A ct(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,A fricaandRussia(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-isoxazolepropionicacid)-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 [1] including epilepsy, neurodegenerative disorders, movement disorders, pain and psychiatric 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.  [7] 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.

[9] 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.

[8] 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 in [10,11] EuropeEpilepsy is a chronic disorder of the brain, and an estimated 50 million people with the condition worldwide. 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,A fricaandRussia(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.,A sia,Europeand its domestic home market ofJapan, Eisai employs more than 11,000 people worldwide. InEurope, Eisai undertakes sales and marketing operations in over 20 markets, including theUnited Kingdom, France,Germany,Italy,Spain,Switzerland,Sweden,Ireland,A ustria,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. Date of preparation:September 2012 Job code: Perampanel-UK2067 References 1. Fycompa.Summary of Product Characteristics. August 2012 2. RogawskiMA. Epilepsy Currents 2011;11:56-63. 3. JointEpilepsy Council. Epilepsy prevalence, incidence and other statistics. September 2011 . Last accesses 6 September 2012 . 4. NationalInstitute for Clinical Excellence (2002) National clinical audit of epilepsy-related death. London Institute for: National Clinical Excellence. 5. TheNational Sentinel Audit of Epilepsy Related Death, The Stationary Office, London , 2002, adjusted for the 2005 number of reported deaths in The Report by the All Party Parliamentary Group on Epilepsy, Wasted Money, Wasted Lives. 6. MoranNF, Poole K, Bell G et al. (2004) Epilepsy in the United Kingdom : seizure frequency and severity, anti-epileptic drug utilization and impact on life in 1652 people with epilepsy. Seizure 13: 425-33. 7. KraussGM. Serratosa JM, Villanueva V et al. Neurology 2012: http://www.neurology.org/ [Accessed August 2012 ]. 8. FrenchJA. Neurology 2012;79:589-596. 9. FrenchJA et al. (305) Epilepsia 2012:1-9. In press online. 10. Epilepsyin the WHO European Region: Fostering Epilepsy Care in Europe . http://www.ibe- epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed August 2012 ]. 11. PugliattiM, et al. Epilepsia 2007: 48(12) 2224 - 2233.