Eisai Recieves Positive Opinion for Inovelon(R) Marketing Authorization from European Committee for Medicinal Products for Human Use (CHMP).Tokyo, Japan, Nov 20, 2006 - (JCN JCN Japan Corporate News JCN Journal of Cognitive Neuroscience JCN Journal of Cardiovascular Nursing JCN Journal of Christian Nursing JCN Job Control Number JCN Journal of Child Neurology JCN joint communications network (US DoD) Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. : 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 LGS Laser Guide Star LGS Lennox-Gastaut Syndrome LGS Leaky Gut Syndrome LGS Langer-Giedion Syndrome LGS Light Gauge Steel (steel frame construction system) LGS Looking Glass Studios (game development company) ) from the Committee for Medicinal Products for Human Use “CHMP” redirects here. For French language Canadian radio station, see CHMP-FM. CPMP, Committee for Proprietary Medicinal Products, now CHMP Committee for Medicinal Products for Human Use (CHMP CHMP Committee for Medicinal Products for Human Use CHMP Cultural Heritage Management Plan CHMP Centrale Humanitaire Médico-Pharmaceutique CHMP Certified Hazardous Materials Practitioner (Institute of Hazardous Materials Managers) ), the scientific body of the European Medicines Evaluation Agency (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ). 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. [Please see the following note for the product information of Inovelon(R) submitted to EMEA and the description of LGS] Contact: Corporate Communications Department Eisai Co., Ltd. 81-3-3817-5036 < Note to Editors > About Inovelon(R) Inovelon(R) is a structurally novel compound that acts as a broad-spectrum anticonvulsant anticonvulsant /an·ti·con·vul·sant/ (-kon-vul´sant) inhibiting convulsions, or an agent that does this. an·ti·con·vul·sant n. A drug that prevents or relieves convulsions. 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 myoclonic pertaining to myoclonus. myoclonic epilepsy see glycoproteinosis. myoclonic jerk a generalized seizure consisting of a jerk of most muscles in the body. (sudden muscle jerks). A surgical treatment may be employed, in case the symptoms are too difficult to manage with pharmacotherapy pharmacotherapy /phar·ma·co·ther·a·py/ (-ther´ah-pe) treatment of disease with medicines. phar·ma·co·ther·a·py n. Treatment of disease through the use of drugs. . 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 See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). : 4523)(OTC OTC See: Over-the-counter. OTC See over-the-counter market (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. Source: JCN http://www.japancorp.net Contact: Eisai Co., Ltd. Corporate Communications Department +81-3-3817-5120 Copyright [c] 2006 JCN Newswire. All rights reserved. A division of Japan Corporate News Network K.K. |
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