License Agreement for GLIADEL® WAFER in Japan Signed
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, “Eisai”) announced today that Eisai entered into a license agreement with Nobelpharma Co., Ltd. (Headquarters: Tokyo, Representative Director & CEO: Jin Shiomura, “Nobelpharma”) in which Eisai gives Norbelpharma the exclusive right to develop and commercialise GLIADEL® Wafer (polifeprosan 20 with carmustine implant) in Japan, while retaining an option right to obtain the exclusive commercialisation right of GLIADEL® Wafer in Japan once the NDA has been filed for approval.
GLIADEL® Wafer is the only FDA-approved chemotherapeutic implant (active ingredient: carmustine) for use during surgical procedures for malignant glioma. GLIADEL® Wafer has been approved in 18 countries worldwide, primarily in North America, Europe, and Southeast Asia. The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology™ refer to the use of carmustine wafers as part of the treatment strategy for malignant gliomas.
Glioma is a tumor of the brain and accounts for about 30% of primary brain tumors, of which malignant glioma prevalence is estimated to be about 2,000 or 2,500 cases per year in Japan. Early approval of GLIADEL® Wafer has been requested in Japan and it was taken as a subject in 2008 by the Investigational Committee for Usage of Unapproved Drugs, a body established by the Ministry of Health Labour and Welfare (MHWL).
Malignant gliomas are difficult to treat. Eisai expects that the development of GLIADEL® Wafer by Nobelpharma, which is actively committed to the development of drugs for highly unmet medical needs that are strongly desired by patient advocacy groups or academic society, will bring a new treatment option to patients with malignant glioma in Japan as early as possible.
Eisai Co., Ltd.
< Notes to Editors >
• GLIADEL® Wafer
GLIADEL® Wafer is approved by the U.S. FDA for the treatment of patients with newly-diagnosed high-grade malignant glioma as an adjunct to surgery and radiation, as well as for the treatment of patients with glioblastoma multiforme as an adjunct to surgery. In the U.S., since its launch in 1997, over 20,000 procedures have been performed with GLIADEL® Wafer.
GLIADEL® Wafer is a dime-sized wafer (1 mm thick and 14.5 mm in diameter) that contains 7.7 mg of carmustine. Up to eight wafers are implanted in the cavity created when a tumor is removed during surgery and the wafers delivers carmustine, a type of chemotherapy.
• About glioma
Glioma is a tumor that arises from glial cell in the brain and is malignant with poor prognosis in most cases. Glioma consists of 30% of primary brain tumor and is classified into several types according to the cell form of the tumor. The most common type is astrocytoma, which is classified into four grades (grade I to IV) according to the grade of malignancy. Grade IV astrocytoma is called glioblastoma, which has the highest degree of malignancy and also has an extremely poor prognosis. Although surgical operations (craniotomy) are performed as standard treatment for glioma, it is quite difficult to remove the tumor completely and radiation therapy and/or chemotherapy are given adjunctively in most cases.
• About Nobelpharma, Co., Ltd.
To develop the drugs of highly unmet medical needs to bring them to patients who need them most as a corporate mission, Nobelpharma, Co., Ltd. was established in 2003. Nobelpharma contributes to medical care, being deeply committed to research and development of drugs of highly unmet medical needs that include orphan drugs, drugs used in off-label, and drugs for pediatric use.
In 2008, three new drugs developed by Nobelpharma which are Nobelzin® capsules for the treatment of Wilson’s disease, Lunabell® compound tablets for the treatment of dysmenorrhea associated with endometriosis, and Nobelbar® Intravenous Phenobarbital for the treatment of neonatal convulsion and status epilepticus successively received approval from MHLW.
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