Inovelon® launched in Germany

Eisai GmbH (Headquarters: Frankfurt, General Manager: Andreas Wiegand), the German subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced the launch of its new anti-epileptic agent Inovelon® (generic name: rufinamide) indicated for adjunctive therapy in Lennox-Gastaut Syndrome (LGS) in Germany. Inovelon® is also available in Denmark, Finland, Sweden, and Norway. In other European countries, Inovelon® will be launched in due course.

Inovelon®, a structurally novel compound that acts as a broad-spectrum anticonvulsant, is the first treatment licensed by the European Commission in January 2007 specifically for LGS, a severe form of epilepsy that develops in early childhood.

Today, approximately 11,000 people across Western Europe are diagnosed with LGS, and it is hoped that the launch of Inovelon®, together with Eisai's neurology franchise which includes Aricept® (donepezil) for treatment of Alzheimer's disease and anti-epilepsy agent Zonegran® (zonisamide), will contribute to fulfilling the benefits to patients and their families.

[Please see the following note for the product information of Inovelon® and the description of LGS]

Inovelon® 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 global rights of the compound with Novartis in February 2004. In October 2004, the drug is granted for an orphan status by the European Commission for adjunctive treatment of LGS, a severe form of epilepsy that develops in early childhood.

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.