Eisai Recieves Positive Opinion For Inovelon(R) Marketing Authorization From European Committee For Medicinal Products For Human Use (CHMP)

Main Category: Epilepsy
Article Date: 23 Nov 2006 - 0:00 PDT

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Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that on November 16 (U.K. time) the company's UK subsidiary Eisai Ltd. (Headquarters: London, Managing Director: Paul Hooper) received a positive opinion that recommends a marketing approval of the anti-epileptic agent Inovelon(R) (rufinamide) for adjunctive therapy in Lennox-Gastaut Syndrome (LGS) from the Committee for Medicinal Products for Human Use (CHMP), the scientific body of the European Medicines Evaluation Agency (EMEA).

Inovelon(R) has been shown to be effective in the treatment of seizures associated with LGS, a severe form of epilepsy that develops in early childhood. The positive opinion by the CHMP was announced in response to the Marketing Authorization Application submitted by Eisai in March 2005 for an approval of Inovelon(R) for adjunctive therapy of LGS through the European Union's Centralized Procedure. Inovelon(R) was also granted orphan drug status by the European Commission in October, 2004.

Eisai is currently enhancing its neurology franchise which includes Aricept(R)(donepezil) for treatment of Alzheimer's disease and anti-epilepsy agent Zonegran(R)(zonisamide). Through these activities the company expects to make further contributions in fulfilling the needs of patients and improving benefits to patients and their families.

About Inovelon(R)

Inovelon(R) is a structurally novel compound that acts as a broad-spectrum anticonvulsant originally discovered and developed by Novartis Pharma AG. Eisai signed an in-licensing agreement for the compound with Novartis in February 2004.

Product Information submitted to CHMP

Generic Name : rufinamide

Dosage : 100 mg tablet, 200 mg tablet, 400 mg tablet

Applied Indication :

Adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 4 years and older

About Lennox-Gastaut Syndrome (LGS)

LGS is a severe form of generalized epilepsy that develops in early childhood caused by various brain disorders such as brain hemorrhage, encephalitis, developmental malformations of the brain, or metabolic abnormalities. Tonic seizures, where muscles contract continuously, along with developmental delay and behavioral problems, are the major symptoms associated with LGS. On the other hand, the most characteristic manifestation of LGS is a large variety of seizures, such as atonic seizures (sudden loss of muscle tone and consciousness, causing abrupt falls), and atypical absence (starting spells), and myoclonic (sudden muscle jerks). A surgical treatment may be employed, in case the symptoms are too difficult to manage with pharmacotherapy.

Today, an estimated number of 11,000 people in Western Europe (Austria, Denmark, Finland, France, Germany, Italy, Ireland, Spain, Sweden and UK) is said to be affected by LGS. Complete recovery, including freedom from seizures or normal development, is very unusual. There is a strong need for development of a new pharmaceutical medicine for this disorder.

About Eisai Co., Ltd.

Eisai Co., Ltd. (TSE: 4523)(OTC: ESALY) is a research-based human health care company that discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs more than 8,000 people worldwide. For more information, please visit http://www.eisai.co.jp.

Eisai Co., Ltd.
http://www.eisai.co.jp