ACADIA Pharmaceuticals Presents Caregiver Burden Data at the International Congress of Non-Motor Dysfunctions in Parkinson’s Disease and Related Disorders

Data Demonstrate a Decreased Burden Among Caregivers of Patients withParkinson’s Disease Psychosis Treated with NUPLAZID™ (Pimavanserin)

SAN DIEGO—(BUSINESS WIRE)—Dec. 8, 2014—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) today announced thepresentation of caregiver burden data from its Phase III program withNUPLAZID™ (pimavanserin) for Parkinson’s disease psychosis (PDP) at the10^th Annual International Congress of Non-Motor Dysfunctionsin Parkinson’s Disease and Related Disorders held from December 5-7 inNice, France. Data from an analysis of Phase III studies in patientswith PDP showed that treatment with NUPLAZID reduced caregiver burdencompared to PDP patients on placebo.

“The symptoms of Parkinson’s disease psychosis are a significant causeof distress to patients and their caregivers, and are associated withgreater caregiver burden, nursing home placement, functional impairmentand increased mortality,” said Dag Aarsland, M.D., Professor of ClinicalDementia Research at the Department of Neurobiology, Care Sciences andSociety, Karolinska Institute. “The benefit to caregivers observed withNUPLAZID may translate into a reduced or delayed nursing home admissionfor patients with Parkinson’s disease psychosis.”

In a poster presentation titled “Decreased Burden Among Caregivers ofPeople with Parkinson’s Disease Psychosis Treated with Pimavanserin, aSelective 5-HT_2A Inverse Agonist,” an integrated analysis ofPhase III clinical trials with NUPLAZID in PDP was performed oncaregiver burden among 268 caregivers of PDP patients from NorthAmerica. Caregiver burden was assessed using the Zarit 22-item CaregiverBurden Scale. The scale was completed by the caregiver to provide aquantitative assessment of burden associated with the patient’sfunctional behavioral impairments, the circumstances of at-home care, aswell as the caregiver’s health, social life and interpersonal relations.The objective of the analysis was to explore the effects of NUPLAZID,which has shown antipsychotic efficacy and non-sedative sleep benefits,on perceived burden in caregivers of people with PDP.

In 6-week randomized placebo-controlled Phase III trials, NUPLAZIDdemonstrated a significant improvement in caregiver burden compared toplacebo (p=0.001), as assessed by the Caregiver Burden Scale. NUPLAZIDshowed the strongest improvement on the Life-Upset subscale, whichevaluates strains on personal/life relationships and effects oncaregiver health and anxiety over care. Although no single item drovethe Caregiver Burden Scale, the strongest benefit of NUPLAZID wasobserved on Item 16 of the Responsibility subscale (p<0.001), whichasked the caregiver about the inability to take care of the relative formuch longer. In subgroup analyses, caregiver benefit with NUPLAZID wasobserved to be greater for spouses than non-spouses and for caregiverswith more severe burden at baseline.

Additionally, an interim analysis performed on the open-label safetyextension study in patients with PDP showed that caregivers ofNUPLAZID-treated patients demonstrated reduced caregiver burden thatpersisted through 9 months, as assessed by the Caregiver Burden Scale.

About NUPLAZID™ (pimavanserin)

NUPLAZID is ACADIA’s proprietary small molecule that is a selectiveserotonin inverse agonist preferentially targeting 5-HT_2A receptorsthat play an important role in psychosis. ACADIA has reported positivePhase III trial results with NUPLAZID, which has the potential to be thefirst drug approved in the United States for psychosis associated withParkinson’s disease. NUPLAZID is administered orally once-a-day. ACADIAdiscovered NUPLAZID and holds worldwide rights to this new chemicalentity. The trade name NUPLAZID has been provisionally accepted by theFDA.

About Parkinson’s Disease Psychosis

According to the National Parkinson Foundation, about one million peoplein the United States and from four to six million people worldwidesuffer from Parkinson’s disease. Parkinson’s disease psychosis (PDP) isa debilitating disorder that occurs in an estimated 40 percent ofParkinson’s patients. Currently, there is no FDA-approved therapy totreat PDP in the United States. PDP, which commonly consists of visualhallucinations and delusions, substantially contributes to the burden ofParkinson’s disease and deeply affects the quality of life of patients.PDP also is associated with increased caregiver stress and burden,nursing home placement, and increased morbidity and mortality. There isa large unmet medical need for new therapies that will effectively treatPDP without compromising motor control in patients with Parkinson’sdisease.

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin neurological and related central nervous system disorders. ACADIA hasa pipeline of product candidates led by NUPLAZID™ (pimavanserin), forwhich we have reported positive Phase III trial results in Parkinson’sdisease psychosis and which has the potential to be the first drugapproved in the United States for this disorder. Pimavanserin is also inPhase II development for Alzheimer’s disease psychosis and hassuccessfully completed a Phase II trial in schizophrenia. ACADIA alsohas clinical-stage programs for chronic pain and glaucoma incollaboration with Allergan, Inc. and two preclinical programs directedat Parkinson’s disease and other neurological disorders. All productcandidates are small molecules that emanate from internal discoveries.ACADIA maintains a website at www.acadia-pharm.comto which we regularly post copies of our press releases as well asadditional information and through which interested parties cansubscribe to receive e-mail alerts.

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, either alone or with a partner,including clinical trials, the benefits to be derived from ACADIA’sproduct candidates, in each case including NUPLAZID (pimavanserin), andwhether a reduction in caregiver burden would translate into a reducedor delayed nursing home admission for patients with Parkinson’s disease.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 andcommercialization, and collaborations with others, and the fact thatpast results of clinical trials may not be indicative of future trialresults. For a discussion of these and other factors, please refer toACADIA’s annual report on Form 10-K for the year ended December 31, 2013as well as ACADIA’s subsequent filings with the Securities and ExchangeCommission. 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 ACADIAundertakes no obligation to revise or update this press release toreflect events or circumstances after the date hereof, except asrequired by law.

Source: ACADIA Pharmaceuticals Inc.

Investor Contacts:
ACADIA Pharmaceuticals Inc.
SteveDavis, Executive Vice President,
Chief Financial Officer andChief Business Officer
Lisa Barthelemy, Director of InvestorRelations
(858) 558-2871
or
Media Contact:
ChandlerChicco Companies
David Polk
(310) 309-1029 or(805) 428-5775