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  • October 11, 2016
  • General

ACADIA Pharmaceuticals Receives California Life Sciences Association’s 2016 Pantheon DiNA Award for Outstanding Therapeutic Product for NUPLAZID™

SAN DIEGO—(BUSINESS WIRE)—Oct. 11, 2016—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesthat address unmet medical needs in central nervous system (CNS)disorders, has been awarded the California Life Sciences Association’s2016 Pantheon DiNA Award for Outstanding Therapeutic Product forNUPLAZID™ (pimavanserin), the first and only drug approved by the U.S.Food and Drug Administration for the treatment of hallucinations anddelusions associated with Parkinson’s disease psychosis.

The California Life Sciences Association’s (CLSA) DiNA Pantheon Awardsrecognize achievements and honor excellence in the life sciences sectorin California. The Outstanding Therapeutic Product award is given to themost promising or significant new life sciences product approved in the12 months preceding selection. The selection is made by a panel of lifesciences industry leaders, journalists and CLSA board members. Thisyear’s winners will be honored at the 2016Pantheon Awards ceremony on December 2 at the Westin St. Francis inSan Francisco.

“We are honored to be recognized for our team’s hard work and commitmentto discovering, developing and commercializing NUPLAZID,” said SteveDavis, ACADIA’s President and Chief Executive Officer. “NUPLAZIDrepresents the culmination of many years of work across our entireorganization, and we are gratified by the opportunity to improve thelives of people with Parkinson’s disease psychosis.”

“We are pleased to honor this first-in-class, first-in-diseasemedication with this year’s Pantheon DiNA Award for OutstandingTherapeutic Product,” said Sara Radcliffe, President and Chief ExecutiveOfficer of California Life Sciences Association. “NUPLAZID trulyrepresents the type of innovation and excellence for which theCalifornia life sciences sector is known.”

About NUPLAZID™ (pimavanserin)

NUPLAZID is the first FDA-approved treatment for hallucinations anddelusions associated with Parkinson’s disease psychosis. NUPLAZID is anon-dopaminergic, selective serotonin inverse agonist preferentiallytargeting 5-HT2A receptors that are thought to play animportant role in Parkinson’s disease psychosis. NUPLAZID is an oralmedicine taken once a day with a recommended dose of 34 mg (two 17-mgtablets). ACADIA discovered this new chemical entity and holds worldwiderights to develop and commercialize NUPLAZID.

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. An estimated 40 percent of thesepatients have Parkinson’s disease psychosis, which is characterized byhallucinations and delusions, is associated with significant caregiverburden, and is a major reason for nursing home placement amongParkinson’s patients.

About California Life Sciences Association (CLSA)

California Life Sciences Association (CLSA) is the state’s largest andmost influential life sciences advocacy and business leadershiporganization. With offices in Sacramento, San Diego, South SanFrancisco, Los Angeles and Washington DC, CLSA works closely withindustry, government, academia and others to shape public policy,improve access to innovative technologies and grow California’s lifesciences economy. CLSA serves biotechnology, pharmaceutical, medicaldevice and diagnostics companies, research universities and institutes,investors and service providers throughout the Golden State. CLSA wasfounded in 2015 when the Bay Area Bioscience Association (BayBio) andthe California Healthcare Institute (CHI) merged. Visit CLSA at www.califesciences.org,and follow us on Twitter @CALifeSciences,Facebook,Instagram,LinkedInand YouTube.

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 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 email 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, and the benefits to be derivedfrom NUPLAZID™ (pimavanserin), including the promise or significance ofNUPLAZID and whether it will improve the lives of people withParkinson’s disease psychosis, and ACADIA’s product candidates. 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 in 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, 2015as 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.

Important Safety Information and Indication forNUPLAZID (pimavanserin) tablets
WARNING: INCREASEDMORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderlypatients with dementia-related psychosis treated with antipsychoticdrugs are at an increased risk of death. NUPLAZID is not approved forthe treatment of patients with dementia-related psychosis unrelated tothe hallucinations and delusions associated with Parkinson’s diseasepsychosis.

NUPLAZID is an atypical antipsychotic indicated for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis.

QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use ofNUPLAZID should be avoided in patients with known QT prolongation or incombination with other drugs known to prolong QT interval includingClass 1A antiarrhythmics or Class 3 antiarrhythmics, certainantipsychotic medications, and certain antibiotics. NUPLAZID should alsobe avoided in patients with a history of cardiac arrhythmias, as well asother circumstances that may increase the risk of the occurrence oftorsade de pointes and/or sudden death, including symptomaticbradycardia, hypokalemia or hypomagnesemia, and presence of congenitalprolongation of the QT interval.

Adverse Reactions: The most common adverse reactions (≥2%for NUPLAZID and greater than placebo) were peripheral edema (7%vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination(5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).

Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole)increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half.Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reducedefficacy. Increase in NUPLAZID dosage may be needed.

Renal Impairment: No dosage adjustment for NUPLAZID is needed inpatients with mild to moderate renal impairment. Use of NUPLAZID is notrecommended in patients with severe renal impairment.

Hepatic Impairment: Use of NUPLAZID is not recommended in patients withhepatic impairment. NUPLAZID has not been evaluated in this patientpopulation.

Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated andshould therefore be used in pregnancy only if the potential benefitjustifies the potential risk to the mother and fetus.

Pediatric Use: Safety and efficacy have not been established inpediatric patients.

Dosage and Administration: Recommended dose: 34 mg per day, taken orallyas two 17-mg tablets once daily, without titration.

For additional Important Safety Information, including boxed warning,please see the full Prescribing Information for NUPLAZID at http://www.acadia-pharm.com/wp-content/uploads/2016/04/NUPLAZID-pimavanserin-Package-Insert.pdf.

Source: ACADIA Pharmaceuticals Inc.

Investor Contact:
ACADIA Pharmaceuticals Inc.
LisaBarthelemy, (858) 558-2871
ir@acadia-pharm.com
or
MediaContact:
Taft Communications
Ted Deutsch, (609)578-8765
ted@taftcommunications.com

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