Swissmedic Accepts MAA Filing of Eisai's perampanel for the Treatment of Epilepsy

HATFIELD, England, September 14, 2011 /PRNewswire/ --

Eisai today announced that perampanel, a treatment for partial-onset seizures in patients with epilepsy, has been accepted for review by Swissmedic, the Swiss Agency for Therapeutic Products. Perampanel is a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist.

Epilepsy is one of the most common neurological conditions in the world.^[1] An estimated 70,000 people live with epilepsy in Switzerland.^[2] The successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge. Up to 30% of patients with partial-onset seizures do not achieve seizure freedom despite appropriate therapy with anti-epileptic drugs.^[3]

"The acceptance by Swissmedic to review perampanel for use in Switzerland is a positive step forward in the approval process. Uncontrolled seizures can severely impact patient quality of life and a new anti-epileptic drug that offers improved seizure control is an important development in the management of epilepsy," commented, Dr Bettina Bauer, Head of EU Epilepsy Business Unit, Eisai Europe. "Perampanel is an exciting new product that has the potential to address the strong unmet need in epilepsy patients and fits entirely within Eisai's human health care mission."

The efficacy, safety and tolerability of perampanel has been demonstrated by three Phase III global, randomised, double-blind, placebo-controlled, dose-escalation studies in 1,480 epilepsy patients. The primary and secondary endpoints were the same in all the studies: 50% responder rate, standard median percent seizure reduction, percentage reduction of complex partial plus secondarily generalised seizures, and evaluation for dose response.

Each of the studies showed consistent results in the efficacy and tolerability of perampanel in patients with partial-onset seizures.

Perampanel also has the benefit of once-daily dosing, helping to reduce the potential pill-burden a person with epilepsy may experience.  

The development of perampanel is a good example of Eisai's human health care 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.

In June 2011, the European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application (MAA) for perampanel as a treatment for partial-onset seizures in patients with epilepsy.

About Perampanel

Perampanel is a highly selective, non-competitive AMPA (α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated anti-epileptic 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 characterised 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 the perampanel Phase III studies

The clinical development plan for perampanel consisted of three global Phase III studies: Studies 306, 305 and 304 in which a total of 1,480 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, 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.

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately 8 in 1,000 people in Europe.^[4] There is an estimated 6 million people living with epilepsy in Europe^[1] and estimated 50 million people worldwide.^[5]

Epilepsy is characterised by abnormal firing of impulses from nerve cells in the brain causing seizures. Depending on the seizure type, seizures may be limited to one part of the body, or may be generalised to involve the whole body. Patients may also experience abnormal sensations, altered behaviour or altered consciousness.

Epilepsy is a disorder with many possible causes. Often the cause of epilepsy is unknown. However, anything that disturbs the normal pattern of neuron activity - from illness to brain damage to tumours, can lead to seizures.^[6]

In partial-onset seizures, bursts of electrical activity are initially focused in specific areas of the brain,^[7] but may become generalised; the symptoms vary according to the affected areas.^[8]

Treatment of partial-onset seizures, the most common type of epilepsy, presents a constant challenge - Up to 30% of patients with partial seizures do not achieve remission despite appropriate therapy with anti-epileptic drugs.^[3]

Furthermore, central nervous system related adverse events, such as lightheadedness (dizziness), somnolence (sleepiness), cognitive slowing (attention and memory deficits) and aggression, are highly prevalent with existing anti-epileptic agents.^[8] Hence, there is a need for new anti-epileptic agents that offer effective reduction in seizure frequency combined with a favourable safety profile.

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^® (zonisamide) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from Dainippon Sumitomo Pharma)
• Zebinix^® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL and is not marketed in Switzerland)
• Inovelon^® (rufinamide) for adjunctive treatment, 4 years and older of seizures associated with Lennox-Gastaut Syndrome

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical companies and 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 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, severe sepsis, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, we 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.com

References

1.  ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf (Accessed June 2011)

2. EPI Swiss Epilepsy Centre. Available at: http://www.swissepi.ch/web/swe.nsf/swe__swebasdocs/epi_klinik_kurzinfo_englisch?OpenDocument (Accessed August 2011)

3. Kwan P, Brodie MJ Early identification of refractory epilepsy. New England Journal of Medicine 2000; 342: 314-9.

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

5. Epilepsy Society UK: http://www.epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy-didyouknow (Accessed June 2011)

6. Epilepsy Research UK. What is Epilepsy? Fact sheet. Available at: http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm (Accessed March 16 2011)

7. Epilepsy Action. Describing Seizure Types. Available at: http://www.epilepsy.org.uk/info/seizures/ataglance (Accessed June 2011)

8. NHS Choices. Symptoms of Epilepsy. Available at: http://www.nhs.uk/Conditions/Epilepsy/Pages/Symptoms.aspx (Accessed June 2011)