Advisory Committee Meeting Scheduled for March 29, 2016
SAN DIEGO—(BUSINESS WIRE)—Jan. 29, 2016—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesto address unmet medical needs in central nervous system (CNS)disorders, today announced that the Psychopharmacologic Drugs AdvisoryCommittee of the U.S. Food and Drug Administration (FDA) will reviewdata included in ACADIA’s New Drug Application (NDA) for NUPLAZID™(pimavanserin) for the treatment of psychosis associated withParkinson’s disease. The Advisory Committee Meeting is scheduled forMarch 29, 2016.
“Parkinson’s disease psychosis is a debilitating condition for whichthere are no FDA-approved treatment options available to patients,” saidSteve Davis, ACADIA’s President and Chief Executive Officer. “We lookforward to discussing our data from the NUPLAZID clinical program withthe members of the Committee.”
The Prescription Drug User Fee Act (PDUFA) action date for completion ofFDA review of the NUPLAZID NDA is May 1, 2016. The FDA has granted theNUPLAZID NDA Priority Review status and designated NUPLAZID for thetreatment of psychosis associated with Parkinson’s disease as aBreakthrough Therapy.
About The Psychopharmacologic Drugs Advisory Committee
The Committee is an independent panel of experts that reviews andevaluates data regarding the safety and effectiveness of marketed andinvestigational human drug products for use in the practice ofpsychiatry and related fields and makes appropriate recommendations tothe FDA.
About NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a selectiveserotonin inverse agonist preferentially targeting 5-HT2A receptorsthat play an important role in psychosis. ACADIA has reported positivePhase III trial results with NUPLAZID in Parkinson’s disease psychosis.NUPLAZID is administered orally once-a-day. ACADIA discovered NUPLAZIDand holds worldwide rights to this new chemical entity. The trade nameNUPLAZID has been provisionally accepted by the FDA. The safety andefficacy of NUPLAZID have not been fully evaluated by any regulatoryauthority.
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, a diminished quality of life, andsignificant caregiver burden.
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 a pipeline of productcandidates led by NUPLAZID™ (pimavanserin), for which we have submitteda New Drug Application (NDA) in Parkinson’s disease psychosis to the FDAand which has the potential to be the first drug approved in the UnitedStates for this condition. The FDA has classified the NUPLAZID NDA ashaving Priority Review status. 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 potential for NUPLAZID(pimavanserin) to be the first drug approved in the United States forParkinson’s disease psychosis (PDP) and the potential timing of suchapproval, if approved at all, by the FDA; the timing or outcome of anydiscussion with the FDA or an advisory committee; and the benefits to bederived from ACADIA’s product candidates, including pimavanserin. 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 collaborations with others, and the fact thatpast results of clinical trials and past regulatory decisions may not beindicative of future trial results or future regulatory decisions,respectively. For a discussion of these and other factors, please referto ACADIA’s annual report on Form 10-K for the year ended December 31,2014 as well as ACADIA’s subsequent filings with the Securities andExchange Commission. You are cautioned not to place undue reliance onthese forward-looking statements, which speak only as of the datehereof. This caution is made under the safe harbor provisions of thePrivate Securities Litigation Reform Act of 1995. All forward-lookingstatements are qualified in their entirety by this cautionary statementand ACADIA undertakes no obligation to revise or update this pressrelease to reflect events or circumstances after the date hereof, exceptas required by law.
Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, SeniorDirector of Investor Relations
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