Eisai takes over marketing authorization for Gliadel, and joins TB partnership

Japanese drug major Eisai (TYO: 4523) will become the Marketing Authorization Holder (MAH) for the antineoplastic agent Gliadel (carmustine) in Japan from December 2, having acquired this right from Japanese developer Nobelpharma.

In 2009, Eisai licensed the domestic rights to develop and commercialize Gliadel Wafer (polifeprosan 20 with carmustine implant) to Nobelpharma (The Pharma Letter April 7, 2009). In Japan, marketing authorization for Gliadel was first received in September 2012 by Nobelpharma after it conducted clinical trials of the agent. Following the transfer, both companies will continue to promote Gliadel domestically, but with Eisai also responsible for the marketing of the agent in Japan, including responding to the needs of healthcare professionals and ensuring and providing information on the proper use of Gliadel.

Gliadel was launched in Japan in January and is the only sustained-release formulation to be approved for intracranial implantation. Each wafer contains the nitrosourea alkylating agent carmustine distributed in a biodegradable polymer matrix. Implanting the agent into the brain following surgical removal of malignant glioma allows for direct delivery of chemotherapy to the tumor site, allowing Gliadel to be used prior to initiating radiation, chemotherapy and other standard therapies.