Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has reacquired the U.S. and Canadian rights for AZ-004 (Staccato® loxapine) from Biovail Laboratories International SRL ("BLS"), a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE and TSX: VRX) ("Valeant"). AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients. Alexza previously established a collaboration arrangement with BLS, to develop and commercialize AZ-004 in the U.S. and Canada, for which Alexza received a $40 million upfront payment. On September 28, 2010, Biovail Corporation and Valeant Pharmaceuticals International completed their merger. As part of the review of the merged company's commercial and development pipelines, BLS has decided not to continue the AZ-004 project pursuant to the terms of the agreements between BLS and Alexza. Based on the comprehensive clinical development program conducted for AZ-004 and the significant unmet medical need for patients, physicians and caregivers, Alexza intends to seek one or more pharmaceutical partners for the worldwide development and commercialization of AZ-004.
"The transaction with BLS has been of great value in allowing us to advance the development of AZ-004 and to expand our understanding of the market opportunity for this novel therapeutic," said Thomas B. King, Alexza President and CEO. "While we would have been pleased to continue what has been a great working relationship with BLS, we understand BLS' strategic interest in focusing on its core therapeutic areas. We look forward to advancing the development of AZ-004 and will provide further details regarding this program after we have our follow-on meeting with the FDA."
Under the terms of the agreements, with this termination, neither company has any ongoing or future obligations to the other.
SOURCE Alexza Pharmaceuticals, Inc.