SAN DIEGO—(BUSINESS WIRE)—Mar. 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 U.S. Food and Drug Administration(FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2that the benefits of NUPLAZID™ (pimavanserin) for the treatment ofpsychosis associated with Parkinson’s disease outweigh the risks oftreatment.
The Prescription Drug User Fee Act (PDUFA) action date for completion ofFDA review of the NUPLAZID New Drug Application (NDA) is May 1, 2016.The FDA has granted the NUPLAZID NDA Priority Review status anddesignated NUPLAZID for the treatment of psychosis associated withParkinson’s disease as a Breakthrough Therapy.
“We are very encouraged by the Committee’s positive vote today and lookforward to working with the FDA as it completes its review of NUPLAZID,”said Steve Davis, ACADIA’s President and Chief Executive Officer. “Ifapproved by the FDA, NUPLAZID would be the first drug indicated to treatpsychosis associated with Parkinson’s disease.”
The Advisory Committee provides the FDA with independent expert adviceand recommendations on the safety and efficacy of potential newmedicines. The FDA is not bound by the Committee's recommendation, buttakes its advice into consideration when reviewing new drug applications.
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 NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a selectiveserotonin inverse agonist preferentially targeting 5-HT2Areceptors that play an important role in psychosis. The New DrugApplication for NUPLAZID for psychosis associated with Parkinson’sdisease is currently under review by the FDA. NUPLAZID is an oralmedicine that, if approved, would be taken once a day (34 mg). ACADIAdiscovered NUPLAZID and holds worldwide rights to this new chemicalentity. The trade name NUPLAZID has been provisionally accepted by theFDA. The safety and efficacy of NUPLAZID have not been fully evaluatedby any regulatory authority.
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) for psychosis associated with Parkinson’sdisease to the FDA and which has the potential to be the first drugapproved in the United States for this condition. The FDA has classifiedthe NUPLAZID NDA as having Priority Review status. ACADIA maintains awebsite 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 forpsychosis associated with Parkinson’s disease, if approved at all; thepotential timing of such approval; and whether the FDA will take intoconsideration the recommendation of the Advisory Committee of thebenefit-risk profile of NUPLAZID when reviewing the NDA for NUPLAZID.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, regulatoryapproval and commercialization, the fact that the FDA is not bound bythe vote of the Advisory Committee, and the fact that past results ofclinical trials may not be indicative of future 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, 2015 as well asACADIA’s subsequent filings with the Securities and Exchange Commission.You are cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. This caution is madeunder the safe harbor provisions of the Private Securities LitigationReform Act of 1995. All forward-looking statements are qualified intheir entirety by this cautionary statement and ACADIA undertakes noobligation to revise or update this press release to reflect events orcircumstances after the date hereof, except as required by law.
Source: ACADIA Pharmaceuticals Inc.
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