ATLANTA, GA – Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced that it has entered into a definitive asset purchase agreement to divest U.S. rights for Gliadel®Wafer (polifeprosan 20 with carmustine implant) to specialty pharmaceutical company Arbor Pharmaceuticals, Inc. As part of the transaction, which takes effect immediately, Eisai has transferred the New Drug Application (NDA) for Gliadel to Arbor, with Arbor assuming responsibilities for all regulatory obligations and further development associated with the product in the United States. Eisai will retain all rights to Gliadel outside of the United States.
In addition, the companies have entered into a long-term supply agreement under which Eisai shall serve as Arbor’s exclusive supplier of Gliadel for the U.S. market. Under the agreement, Eisai will manufacture Gliadel at its facility in Baltimore, Maryland, and will sell finished product to Arbor.
“The transition of U.S. rights for Gliadel to Arbor will ensure that patients who may benefit from treatment with Gliadel will continue to have access to it, while also enabling Eisai to reallocate funding and resources to other areas of our business to support our long term business objectives,” said Lonnel Coats, President & CEO of Eisai Inc. “As a human health care company, Eisai’s focus is always on the needs of patients and their families. As such, we are very pleased that Arbor will be taking the lead on commercializing Gliadel in the U.S. moving forward.”
“We are excited about our acquisition of U.S. rights to Gliadel and look forward to providing this important product to patients in the United States,” said Jason Wild, Chairman of the Board of Arbor Pharmaceuticals, Inc. “We believe Gliadel has significant room to grow by maximizing its current use in all appropriate patients and through additional clinical studies for expanded indications. We expect Gliadel to fit in well with the hospital franchise being built at Arbor, which includes our new drug application (NDA) filed for the approval of an orphan-designated product, nimodipine oral solution.”
“As part of the transaction Arbor will assume control of the contract sales team promoting Gliadel in the U.S. with plans to increase the promotional and medical support behind the product. In addition to Gliadel, this team will promote nimodipine oral solution and other future hospital based products once approved. Arbor will continue to support the Gliadel clinical studies underway and pursue additional clinical development opportunities,” added Ed Schutter, President and CEO of Arbor.