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Eisai Announces Launch of Antiepileptic Drug Fycompa in U.S.

Tokyo, Jan 6, 2014 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") announced today that on January 2, 2014, its U.S. subsidiary Eisai Inc. launched the AMPA receptor antagonist Fycompa (perampanel), a first-in-class antiepileptic drug (AED) discovered and developed In-house, in the United States as an adjunctive therapy for partial-onset seizures with or without secondary generalized seizures in patients with epilepsy aged 12 and older.

Fycompa is a highly selective, noncompetitive AMPA receptor antagonist discovered and developed by Eisai. With epileptic seizures being primarily mediated by the neurotransmitter glutamate, the agent works as a first-in-class AED that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. It is approved in more than 35 countries worldwide,
mostly in Europe and North America, and has been already launched in Canada and in a number of European countries. In the United States, following approval by the U.S. Food and Drug Administration (FDA) in October 2012, Fycompa was recommended to the U.S. Drug Enforcement Administration (DEA) for scheduling classification under the country's Controlled Substances Act and subsequently placed as a
Schedule III drug. The number of patients with epilepsy in the United States is approximately 2.2 million people and approximately 150,000 people are estimated to be newly diagnosed with epilepsy in that country each year. Furthermore, some 60% of patients diagnosed with epilepsy in the United States have partial seizures, of which approximately 25% to 30% are unable to control their seizures with current treatment options. Fycompa, which has a mechanism of action different to that of other licensed AEDs, offers a new treatment option for epilepsy patients with partial-onset seizures. Indicated for a wide range of patients, including adults and adolescents over 12 years of age, the agent has the added benefit of once-daily oral dosing, which is expected to reduce the potential pill-burden a patient with epilepsy may experience as well as improve patient drug compliance.

Eisai defines epilepsy as a therapeutic area of focus and in the United States markets Zonegran (under license from the originator Dainippon Sumitomo Pharma Co., Ltd.) as a treatment for partial-onset epilepsy in adults and BANZEL (under license from the originator Novartis AG) as a treatment for Lennox-Gastaut syndrome, a severe form of early childhood-onset epilepsy. By providing multiple
treatment options as part of an extensive epilepsy product portfolio, Eisai seeks to make continued contributions to addressing the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

For further information on epilepsy, Fycompa,the Phase III studies and Eisai's commitment to epilepsy, visit http://www.eisai.com/news/enews201401pdf.pdf.

About Eisai

Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.



Source: Eisai

Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120 


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