Analyses of Pimavanserin Studies Evaluating Treatment in Alzheimer’s Disease Psychosis and Parkinson’s Disease Psychosis Published in The Journal of Prevention of Alzheimer’s Disease Suggest Potential for Treating Dementia-Related Psychosis

SAN DIEGO—(BUSINESS WIRE)—Sep. 10, 2018—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) announced today publicationof additional data from a Phase 2 single center, double-blind,placebo-controlled study to examine the safety and efficacy ofpimavanserin for the treatment of psychosis in Alzheimer’s DiseasePsychosis in The Journal of Prevention of Alzheimer’s Disease (JPAD).These results further demonstrate that pimavanserin may have thepotential to treat dementia-related psychosis, a condition which can bepresent in neurodegenerative diseases such as Alzheimer’s disease,dementia with Lewy Bodies, dementia associated with Parkinson’s disease,vascular dementia and frontotemporal dementia-spectrum disorders.

The publication (https://link.springer.com/article/10.14283/jpad.2018.30)focused on the pre-specified analysis in the subgroup of patients whohad more pronounced psychotic symptoms at baseline. In this subgroup ofpatients with more severe delusions and hallucinations, at the primaryefficacy endpoint, pimavanserin demonstrated significant improvementrelative to placebo with a similar and acceptable tolerability profile.These results were also presented recently at the Alzheimer’sAssociation International Conference in Chicago in July 2018. Theprimary results from the study were previously reported at the ClinicalTrials in Alzheimer’s Disease (CTAD) conference in Boston in October2017 and published in the Lancet Neurology in March 2018.

“The robust efficacy of pimavanserin in patients with more severepsychotic symptoms is relevant to the therapeutic benefits ofpimavanserin in a patient population with Alzheimer’s disease andpsychosis,” said lead investigator Clive Ballard, MBChB, MRCPsych,Pro-Vice-Chancellor and Executive Dean, University of Exeter MedicalSchool. “These results extend and confirm the results from the primaryanalysis as well as results from the subgroup analysis of patients withmild dementia in the pivotal Parkinson’s disease psychosis study withpimavanserin. These findings, coupled with the results from otherstudies of pimavanserin, suggest a potential role for pimavanserin intreating dementia-related psychosis in patients across a range ofneuropsychiatric conditions.”

A separate review published in JPAD (https://link.springer.com/article/10.14283/jpad.2018.29)also supports the potential use of pimavanserin in other forms ofneurodegenerative diseases, including dementia-related psychosis. Aresearch group led by Jeffrey Cummings, MD, ScD, of the Cleveland ClinicLou Ruvo Center for Brain Health, Las Vegas, NV, looked at the clinicalevidence that has been gathered to date that supports the potentialefficacy of pimavanserin in dementia-related psychosis. “Clinicalevidence is now available that supports potential efficacy ofpimavanserin in dementia-related psychosis. This includes results from asub-analysis of mildly demented patients in the Phase 3 pivotal study inpatients with Parkinson’s disease psychosis, and the Phase 2 study inpatients with Alzheimer’s disease. Based on the overlap in clinicalpresentation and pathology and the positive clinical trial results intwo neurodegenerative patient populations, we think it is important tocontinue to evaluate pimavanserin’s effect in patients withhallucinations and delusions across a number of neurodegenerativedisorders,” said Dr. Cummings.

ACADIA is currently conducting the Phase 3 HARMONY study indementia-related psychosis. This is a randomized withdrawal studydesigned to evaluate the efficacy of pimavanserin in preventing relapseof psychotic symptoms in patients with dementia-related psychosis.Patients whose dementia-related hallucinations and delusions respond to12 weeks of open-label treatment with pimavanserin are randomized, in adouble-blinded manner to continue pimavanserin therapy or to placebo.The primary endpoint of this study is the average time to relapsebetween pimavanserin and placebo. Studies suggest that 30% of patientswith dementia have psychosis, commonly consisting of hallucinations anddelusions. Serious consequences have been associated with severe orpersistent psychosis in patients with dementia. These consequences canimpact both patients and their families. Medications that are currentlyused off-label to treat dementia related psychosis have been shown toimpair cognition in this already impaired population.

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin central nervous system disorders. ACADIA has developed and iscommercializing the first and only medicine approved for the treatmentof hallucinations and delusions associated with Parkinson’s diseasepsychosis. In addition, ACADIA has ongoing clinical development effortsin additional areas with significant unmet need includingdementia-related psychosis, schizophrenia inadequate response,schizophrenia-negative symptoms, major depressive disorder and Rettsyndrome. This press release and further information about ACADIA can befound at: www.acadia-pharm.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 potential benefits ofpimavanserin in patients with dementia-related psychosis. Thesestatements 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, approval andcommercialization, and the fact that past results of clinical trials maynot be indicative of future trial results. For a discussion of these andother factors, please refer to ACADIA’s annual report on Form 10-K forthe year ended December 31, 2017 as well as ACADIA’s subsequent filingswith the Securities and Exchange Commission. You are cautioned not toplace undue reliance on these forward-looking statements, which speakonly as of 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, except as required by law.

Source: ACADIA Pharmaceuticals Inc.

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