Conference Call Scheduled for Today, May 4, 2009, at 8:30 a.m. Eastern Time SAN DIEGO—(BUSINESS WIRE)—May. 4, 2009—ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD) today announced that it hasestablished a collaboration with Biovail Laboratories International SRL,a subsidiary of Biovail Corporation, to co-develop and commercializepimavanserin, ACADIA’s proprietary and selective 5-HT2A inverseagonist, in the United States and Canada. ACADIA retains rights topimavanserin in the rest of the world. Pimavanserin is a new chemicalentity (NCE) currently in Phase III development as a treatment forParkinson’s disease psychosis.
“This agreement provides Biovail with a late-stage NCE product withstrong intellectual property protection that is directly on target withour specialty central nervous system focus,” said Bill Wells, Biovail’sChief Executive Officer. “Pimavanserin addresses a large unmet medicalneed, and has the potential to make a significant difference in thelives of the millions of men and women living with Parkinson’s disease.We are delighted to be partnering with ACADIA to bring this innovativetreatment to market.”
The collaboration provides for the co-development and commercializationof pimavanserin for multiple neurological and psychiatric indications,including Parkinson’s disease psychosis (PDP) and Alzheimer’s diseasepsychosis (ADP). ACADIA will continue to manage the ongoing Phase IIItrials for PDP. Biovail will lead other development, manufacturing, andcommercialization efforts for pimavanserin, including activitiesdirected at ADP and other potential indications. Biovail is granted theright to develop, manufacture, and commercialize pimavanserin in theUnited States and Canada, while ACADIA retains rights to pimavanserin inthe rest of the world.
Under the terms of the collaboration, ACADIA is entitled to receiveaggregate payments, excluding royalties, of up to $395 million. Theseinclude an upfront cash payment of $30 million, up to $160 million inpotential milestone payments associated with the successful completionof clinical trials, regulatory submissions and approvals of pimavanserinfor PDP and ADP, up to $45 million in potential milestones should theparties pursue a third indication, and up to $160 million in potentialmilestones as certain sales thresholds are met. ACADIA also will beentitled to receive a 15 percent royalty on annual net sales ofpimavanserin up to $100 million and a 20 percent royalty on annual netsales over $100 million. In addition to product royalties, ACADIA hasthe option to co-promote pimavanserin in the United States. Biovail willbe responsible for all future costs associated with the development,manufacturing, and commercialization of pimavanserin in all indicationswith the exception of specified ongoing PDP studies, which will continueto be funded by ACADIA.
“Our alliance with Biovail not only helps us to advance pimavanserin asa potential first-in-class therapy for Parkinson’s disease psychosis,but also enables us to broaden the pimavanserin development program toAlzheimer’s disease psychosis,” said Uli Hacksell, Ph.D., ChiefExecutive Officer of ACADIA. “Biovail’s strong commitment toestablishing a leading North American CNS specialty franchise makes theman ideal partner for ACADIA. Together with Biovail, we have theopportunity to improve the lives of patients suffering from neurologicaland psychiatric disorders that lack effective therapy options.”
Conference Call and Webcast Information
ACADIA will host a conference call and webcast today, May 4, 2009, at8:30 a.m. Eastern Time to discuss this collaboration. The conferencecall can be accessed by dialing 866-277-1181 for participants in theU.S. or Canada and 617-597-5358 for international callers (referencepasscode 13099931). A telephone replay of the conference call may beaccessed through May 18, 2009 by dialing 888-286-8010 for callers in theU.S. or Canada and 617-801-6888 for international callers (referencepasscode 92339018). The conference call also will be webcast live onACADIA’s website, www.acadia-pharm.com,under the investors section and will be archived there until May 18,2009.
About Pimavanserin
Pimavanserin is a new chemical entity discovered by ACADIA and currentlybeing evaluated in two Phase III pivotal trials as a treatment for PDP.Pimavanserin blocks the activity of the 5-HT2A receptor, adrug target that plays an important role in the treatment of variousneuropsychiatric disorders.
About Parkinson’s Disease Psychosis (PDP)
According to the National Parkinson Foundation, over 1.5 million peoplein the United States suffer from Parkinson’s disease. Up to 40 percentof patients with Parkinson’s disease may develop psychotic symptoms,commonly consisting of visual hallucinations and delusions. Currentlythere is no therapy in the United States approved to treat PDP. Thedevelopment of psychosis in patients with Parkinson’s disease oftendisrupts their ability to perform many of the activities of daily livingthat keeps them independent and active. As a result, PDP is associatedwith increased caregiver burden, nursing home placement, and increasedmortality.
About Alzheimer’s Disease Psychosis (ADP)
According to the Alzheimer’s Association, approximately 5.3 millionpeople in the United States have Alzheimer’s disease. While the criteriafor diagnosing Alzheimer’s disease are mostly focused on cognitivedeficits, it is the behavioral and neuropsychiatric symptoms that areoften troublesome for caregivers and lead to poor quality of life forpatients. Between 25 and 50 percent of patients with Alzheimer’s diseasemay develop ADP, which is characterized by disturbing hallucinations anddelusions. There currently is no therapy in the United States approvedfor the treatment of ADP. The presence of psychotic symptoms in patientswith Alzheimer’s disease is associated with more rapid cognitive andfunctional decline and increased institutionalization.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovative technology tofuel drug discovery and clinical development of novel treatments forcentral nervous system disorders. ACADIA is developing a portfolioconsisting of five product candidates, including pimavanserin in PhaseIII for Parkinson’s disease psychosis, a product candidate in Phase IIfor chronic pain and a product candidate in Phase I for glaucoma, bothin collaboration with Allergan, and two programs in IND-trackdevelopment. All of the product candidates in ACADIA’s pipeline emanatefrom discoveries made using its proprietary drug discovery platform.ACADIA maintains a website at www.acadia-pharm.comto which ACADIA regularly posts copies of its press releases as well asadditional information and through which interested parties cansubscribe to receive email alerts.
About Biovail Corporation
Biovail Corporation is a specialty pharmaceutical company engaged in theformulation, clinical testing, registration, manufacture, andcommercialization of pharmaceutical products. The Company is focused onthe development and commercialization of medicines that address unmetmedical needs in niche specialty central nervous system markets. Formore information about Biovail, visit the Company’s web site at www.biovail.com.
ACADIA Forward-Looking Statements
Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but arenot limited to statements related to the progress and timing of ACADIA’sdrug discovery and development programs, including clinical trials andthe results therefrom, and the benefits to be derived from ACADIA’sproduct candidates, in each case including pimavanserin, the parties’responsibilities under the collaboration, potential milestone paymentsand royalties payable pursuant to the collaboration, the potentialimpact of the collaboration on ACADIA’s development programs, and thedevelopment and clinical plans for pimavanserin. These statements areonly predictions based on current information and expectations andinvolve a number of risks and uncertainties. Actual events or resultsmay differ materially from those projected in any of such statements dueto various factors, including the risks and uncertainties inherent indrug discovery, development, commercialization and collaborations withothers, and the fact that past results of clinical trials may not beindicative of further trial results. For a discussion of these and otherfactors, please refer to ACADIA’s annual report on Form 10-K for theyear ended December 31, 2008 as well as ACADIA’s subsequent filings withthe Securities and Exchange Commission. You are cautioned not to placeundue reliance on these forward-looking statements, which speak only asof the date hereof. This caution is made under the safe harborprovisions of the Private Securities Litigation Reform Act of 1995. Allforward-looking statements are qualified in their entirety by thiscautionary statement and ACADIA undertakes no obligation to revise orupdate this press release to reflect events or circumstances after thedate hereof.
Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director,Investor Relations
Uli Hacksell, Chief Executive Officer
(858)558-2871