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ACADIA Pharmaceuticals and Biovail Form Collaboration to Develop and Commercialize Pimavanserin in North America

Mon, 05/04/2009 - 4:44am
ACADIA Pharmaceuticals Inc. has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to co-develop and commercialize pimavanserin, ACADIA's proprietary and selective 5-HT2A inverse agonist, in the United States and Canada. ACADIA retains rights to pimavanserin in the rest of the world. Pimavanserin is a new chemical entity (NCE) currently in Phase III development as a treatment for Parkinson's disease psychosis. "This agreement provides Biovail with a late-stage NCE product with strong intellectual property protection that is directly on target with our specialty central nervous system focus," said Bill Wells, Biovail's Chief Executive Officer. "Pimavanserin addresses a large unmet medical need, and has the potential to make a significant difference in the lives of the millions of men and women living with Parkinson's disease. We are delighted to be partnering with ACADIA to bring this innovative treatment to market." The collaboration provides for the co-development and commercialization of pimavanserin for multiple neurological and psychiatric indications, including Parkinson's disease psychosis (PDP) and Alzheimer's disease psychosis (ADP). ACADIA will continue to manage the ongoing Phase III trials for PDP. Biovail will lead other development, manufacturing, and commercialization efforts for pimavanserin, including activities directed at ADP and other potential indications. Biovail is granted the right to develop, manufacture, and commercialize pimavanserin in the United States and Canada, while ACADIA retains rights to pimavanserin in the rest of the world. Under the terms of the collaboration, ACADIA is entitled to receive aggregate payments, excluding royalties, of up to $395 million. These include an upfront cash payment of $30 million, up to $160 million in potential milestone payments associated with the successful completion of clinical trials, regulatory submissions and approvals of pimavanserin for PDP and ADP, up to $45 million in potential milestones should the parties pursue a third indication, and up to $160 million in potential milestones as certain sales thresholds are met. ACADIA also will be entitled to receive a 15 percent royalty on annual net sales of pimavanserin up to $100 million and a 20 percent royalty on annual net sales over $100 million. In addition to product royalties, ACADIA has the option to co-promote pimavanserin in the United States. Biovail will be responsible for all future costs associated with the development, manufacturing, and commercialization of pimavanserin in all indications with the exception of specified ongoing PDP studies, which will continue to be funded by ACADIA. "Our alliance with Biovail not only helps us to advance pimavanserin as a potential first-in-class therapy for Parkinson's disease psychosis, but also enables us to broaden the pimavanserin development program to Alzheimer's disease psychosis," said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. "Biovail's strong commitment to establishing a leading North American CNS specialty franchise makes them an ideal partner for ACADIA. Together with Biovail, we have the opportunity to improve the lives of patients suffering from neurological and psychiatric disorders that lack effective therapy options."
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