Eisai to Submit Marketing Authorization Applications in the U.S. and EU for Perampanel as Adjunctive Therapy for Partial Seizures in Patients with Epilepsy

HATFIELD, England, January 25, 2011 /PRNewswire/ --

- Submissions Planned for First Quarter of Fiscal 2011

Eisai announced today that it will submit Marketing Authorization Applications in the United States and the European Union for the investigational compound perampanel (E2007) based on the results of three Phase III pivotal studies. Perampanel is a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai for adjunctive treatment of partial seizures in patients with epilepsy. Partial seizures involve epileptic activity in just a part of the brain and the symptoms experienced depend on which area of the brain is affected.

The clinical development plan for perampanel consisted of three global Phase III studies: Studies 306, 305 and 304 in which a total of 1,490 patients participated. 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, randomized, double-blind, placebo-controlled, dose-escalation, parallel-group studies. The primary and secondary endpoints were the same in all the studies: standard median percent seizure reduction, 50% responder rate, percentage reduction of complex partial plus secondarily generalized seizures, and evaluation for dose response.

Each of the studies showed consistent results in the efficacy and tolerability of perampanel given as an adjunctive therapy in patients with partial seizures.

Based upon these study results, Eisai intends to submit regulatory applications simultaneously in the U.S. and EU during the first quarter of our Fiscal Year 2011.

The development of perampanel is an example of Eisai's human health care corporate mission. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families.

About Perampanel

Eisai is currently developing perampanel for the potential treatment of partial seizures in patients with epilepsy. Perampanel is a highly selective, non-competitive AMPA (a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated broad-spectrum anti-seizure effects 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 characterized by excess neuroexcitatory signalling including epilepsy, neurodegenerative disorders, movement disorders, pain and psychiatric disorders.

If approved, perampanel will be the first product in this class.

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately 8 in 1,000 people in Europe(i). There is an estimated 2.4 million people living with epilepsy in Europe(ii) and estimated 50 million people worldwide.(iii)

Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterized 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 anti-epileptic drugs (AEDs) is a major strategic area for Eisai in the European market.

In Europe, Eisai currently has three marketed treatments including:

    
    - Zonegran(R) (zonisamide) as adjunctive therapy in adult
      patients with partial-onset seizures, with or without secondary
      generalisation
    - Zebinix(R) (eslicarbazepine acetate) as adjunctive therapy in
      adult patients with partial-onset seizures, with or without secondary
      generalization
    - Inovelon(R) (rufinamide) for the treatment of seizures associated
      with Lennox-Gastaut Syndrome

About Eisai

Eisai is one of the world's leading research-based pharmaceutical companies that has defined its 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 research activities in three key areas

    
    - Integrative Neuroscience including: Epilepsy, Alzheimer's
      disease, multiple sclerosis, neuropathic pain and depression
    - Integrative Oncology including: anticancer therapies; tumour
      regression, tumour suppression, antibodies, etc and supportive cancer
      therapies; pain relief and nausea
    - Vascular/Immunological Reaction including: acute coronary
      syndrome, atherothrombotic disease, sepsis, rheumatoid arthritis,
      psoriasis and Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employ more than 11,000 people worldwide.

In Europe, 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, Hungary, and Slovakia.

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

References

(i) Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224 - 2233

(ii) Forsgren L, Beghi E, Oun A, Sillanpaa M. The epidemiology of epilepsy in Europe - a systematic review. Eur J Neurol. 2005 Apr;12(4):245-53

(iii) Epilepsy Society UK: http://www.epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy-didyouknow Last accessed Dec 2010