SAN DIEGO—(BUSINESS WIRE)—Oct. 6, 2009—ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical companyutilizing innovative technology to fuel drug discovery and clinicaldevelopment of novel treatments for central nervous system disorders,today provided an update on its Phase III program with pimavanserin forParkinson’s disease psychosis (PDP), which is being pursued incollaboration with Biovail Laboratories International SRL (“Biovail”), asubsidiary of Biovail Corporation. Following the announcement onSeptember 1st of disappointing top-line results from thefirst Phase III PDP trial, ACADIA and Biovail remain committed to thesuccessful development of pimavanserin and have established adevelopment strategy that they believe will strengthen the PDP program.The parties also intend to pursue adjunctive therapy with pimavanserinfor schizophrenia as a third indication in the collaboration.
“We remain enthusiastic about pimavanserin’s prospects in a number ofspecialty CNS indications, including schizophrenia where existing datafor the molecule as co-therapy are compelling,” said Bill Wells,Biovail’s Chief Executive Officer. “The steps we’re taking today aredesigned to fully exploit pimavanserin’s potential and to bring thisnovel therapeutic to market as quickly as possible.”
ACADIA has conducted a substantial portion of the analysis of the datafrom its first Phase III PDP trial with pimavanserin (-012 Study). Whilethe -012 Study did not meet its primary endpoint of antipsychoticefficacy and had a larger than expected placebo response, signals ofantipsychotic efficacy were observed in the pimavanserin 40 mg studyarm. These signals were most prominent in the United States portion ofthe study, which comprised nearly one-half of the patients in the trial.The efficacy signals also were supported by additional secondary andexploratory measures, including efficacy measures and favorable outcomesin assessments of sleep and caregiver burden. Several findings from the-012 Study will be used in the design of future PDP studies to helpmitigate the placebo response and to increase the chances of success.These findings relate to dose selection, the method and application ofratings, and other study design elements.
ACADIA and Biovail have agreed on a development strategy for PDP thatinvolves using the findings from the -012 Study together with those fromthe second, ongoing Phase III trial (-014 Study), which is testing 10 mgand 20 mg doses of pimavanserin, to arrive at an enhanced study designthat may be used in new Phase III trials. Accordingly, the ongoing -014Study will be concluded at its current enrollment level (about 120patients) to allow for the analysis of data as soon as practicable.Meanwhile, the parties will begin planning for a new Phase III PDP trialusing a 40 mg dose of pimavanserin. Consistent with the terms of theoriginal collaboration agreement, Biovail will be responsible for thecost of this third Phase III trial. This study is expected to start inthe first half of 2010. ACADIA will continue its ongoing open-labelsafety extension studies in patients with PDP.
In addition, Biovail intends to pursue adjunctive therapy withpimavanserin for schizophrenia as a third indication in thecollaboration. Alzheimer’s disease psychosis (ADP) remains the secondindication provided for in the collaboration. The parties currentlyintend to focus their efforts on the PDP and schizophrenia programs, butalso are moving forward with planning for an initial study in ADP.
“Together, ACADIA and Biovail are pursuing a development strategy thatstrengthens our path forward in PDP while opening up potentialopportunities for pimavanserin to address unmet medical needs ofpatients suffering from other psychiatric and neurological disorders,including schizophrenia and ADP,” said Uli Hacksell, Ph.D., ChiefExecutive Officer of ACADIA.
While pursuing its development strategy for pimavanserin, ACADIA intendsto implement cost-saving measures during October to further streamlineits operations, reduce its internal operating expenses, and provideadded financial flexibility. ACADIA currently anticipates that its cash,investment securities and payments from its collaborations before takingany cost-saving measures will be sufficient to fund its operations intothe first half of 2011, and that these measures will further extendACADIA’s cash runway.
About Pimavanserin
Pimavanserin is a 5-HT2A receptor inverse agonist in PhaseIII development as a treatment for Parkinson’s disease psychosis. Thisnew chemical entity, which was discovered by ACADIA, is a small moleculethat can be taken orally as a tablet once-a-day. ACADIA and Biovail haveformed a collaboration to co-develop and commercialize pimavanserin forneurological and psychiatric indications in the United States andCanada. ACADIA retains rights to pimavanserin in the rest of the world.
About Parkinson’s Disease Psychosis
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 isassociated with increased caregiver burden, nursing home placement, andincreased mortality.
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’s product candidates includepimavanserin in Phase III for Parkinson’s disease psychosis incollaboration with Biovail, a product candidate in Phase II for chronicpain and a product candidate in Phase I for glaucoma, both incollaboration with Allergan, as well as additional compounds inIND-track development. All of the product candidates in ACADIA’spipeline emanate from discoveries made using its proprietary drugdiscovery 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. Biovail is focused on thedevelopment 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.
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 drugdiscovery and development programs, including ongoing and futureclinical trials and the results and regulatory approvals resultingtherefrom, the potential of and the benefits to be derived from productcandidates, in each case including pimavanserin, indications to bepursued under the collaboration, the length of ACADIA’s cash runway, andthe benefits to be provided by cost-saving measures to be undertaken.These statements are only predictions based on current information andexpectations and involve a number of risks and uncertainties. Actualevents or results may differ materially from those projected in any ofsuch statements due to various factors, including the risks anduncertainties inherent in drug discovery, development, commercializationand collaborations with others, and the fact that past results ofclinical trials may not be indicative of further trial results. For adiscussion of these and other factors, please refer to ACADIA’s annualreport on Form 10-K for the year ended December 31, 2008 as well asACADIA’s subsequent filings with the Securities and Exchange Commissionand to Biovail’s annual report on Form 20-F for the year ended December31, 2008. You are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of the date hereof. Thiscaution is made under the safe harbor provisions of the PrivateSecurities Litigation Reform Act of 1995. All forward-looking statementsare qualified in their entirety by this cautionary statement and neitherACADIA nor Biovail undertakes any obligation to revise or update thispress release to reflect events or circumstances after the date hereof,except as required by law.
Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director,Investor Relations
Uli Hacksell, Ph.D., Chief ExecutiveOfficer
858-558-2871