January 16, 2012
Nobelpharma and Eisai Announce Japan Launch of Anticonvulsant Agent Fostoin 750 mg for Injection
Tokyo, Jan 16, 2012 - (JCN Newswire) - Nobelpharma Co. Ltd and Eisai Co. Ltd announced today that they will launch the anticonvulsant agent Fostoin 750 mg for Injection (fosphenytoin sodium hydrate, "fostoin") on January 17. Developed in Japan by Nobelpharma, Fostoin will be marketed by Eisai and co-promoted by both companies under a previously concluded marketing agreement.
Fostoin is a water-soluble prodrug of phenytoin injection, a drug that has long been used both in Japan and overseas as a treatment for status epilepticus and other such conditions. By providing phenytoin as a water-soluble prodrug, the agent will significantly reduce local irritation during intravenous infusion and is expected to enhance tolerability. Fostoin was approved in Japan as a clinically beneficial treatment on July 1, 2011, and was subsequently listed on Japan's National Health Insurance (NHI) drug reimbursement price list on November 25.
Fostoin was designated as a drug for which here is a significant medical need by the Japanese Ministry of Health, Labour and Welfare's "Study Group on Unapproved Drugs," the predecessor to the "Study Group for Unapproved and Off-label Drugs for Which There is an Medical Need," in July 2006. The Group determined that Fostoin should not only be used to control status epilepticus, but that it was also necessary in the prevention and treatment of epileptic seizures occurring during neurosurgery or head injury and as an alternative treatment when other means of phenytoin, including oral phenytoin, are unavailable or inappropriate, two indications already approved overseas. It also recommended that clinical trials with the agent in Japan should begin as soon as possible. Following this recommendation, Nobelpharma developed Fostoin in Japan, and submitted a Manufacturing and Marketing Authorization Application seeking approval of the agent to the MHLW in June 2010.
Nobelpharma is proactively undertaking the development of drugs for which patient groups and academic societies have deemed necessary and there is a high unmet medical need, while Eisai defines epilepsy as a therapeutic area of focus and seeks to enhance its Japanese product portfolio in this field by developing new anti-epilepsy agents. Both Nobelpharma and Eisai will strive to make contributions to address the diversified needs of, and increase the benefits provided to, patients and families suffering from seizures associated with conditions such as epilepsy.
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.co.jp/index-e.html
Public Relations Department Eisai Co. Ltd T: +81-(0)3-3817-5120>
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