25 December 2012 | News | By BioSpectrum Bureau
Eisai divests rights for Glidael Wafer to Arbor
Singapore: Eisai's US subsidiary has entered into a definitive asset purchase agreement to divest US rights for its Gliadel Wafer (carmustine intracranial implant wafer), an antineoplastic agent, to Arbor Pharmaceuticals.
Under this agreement, Eisai 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 US as well as serve as the exclusive supplier of Gliadel for the global market, including in the US and Japan.
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.
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