On December 18, 2012 Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") reported its U.S. subsidiary Eisai Inc. has entered into a definitive asset purchase agreement to divest U.S. rights for its Gliadel Wafer (carmustine intracranial implant wafer), an antineoplastic agent, to Arbor Pharmaceuticals, Inc. (Headquarters: Georgia, the United States; President & CEO: Ed Schutter; "Arbor") (Press release, Eisai, DEC 18, 2012, View Source [SID1234569108]). Under this agreement, Eisai Inc. will transfer the New Drug Application (NDA) (rights as the marketing authorization holder) for Gliadel to Arbor. The Eisai Group will retain all rights to Gliadel outside the United States and will continue to manufacture Gliadel at its facility in Baltimore, the United States as well as serve as the exclusive supplier of Gliadel for the global market, including in the United States and Japan.
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The Gliadel Wafer is a sustained-release formulation approved for intracranial implantation. Each wafer contains carmustine, a nitrosourea alkylating agent, distributed in a biodegradable copolymer matrix. Implanting the wafer into the brain following surgical removal of a malignant glioma allows direct delivery of chemotherapy to the tumor site. Therefore this agent can be used prior to initiating other standard therapies, such as radiation and chemotherapy.
Arbor is a pharmaceutical company with strengths in hospital-based marketing as well as promising development products in the field of neurosurgery. Eisai believes that this agreement, which enables Arbor to strengthen Gliadel-related information-provision and development activities aimed at indication expansion, will lead to maximization of Gliadel’s product and patient value. Meanwhile, Eisai will be able to strategically reallocate resources to other mid-to-long-term business growth areas so as to continue to make further contributions to address the diversified needs of, and increase the benefits provided to, patients and their families.