SAN DIEGO—(BUSINESS WIRE)—Sep. 3, 2015—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesto address unmet medical needs in central nervous system disorders,today announced it has submitted a New Drug Application (NDA) to theU.S. Food and Drug Administration (FDA) seeking approval for NUPLAZID™(pimavanserin) for the treatment of psychosis associated withParkinson’s disease.
NUPLAZID is an SSIA (selective serotonin inverse agonist) preferentiallytargeting 5-HT2A receptors. Through this novel mechanism,NUPLAZID has demonstrated significant efficacy in Parkinson’s diseasepsychosis (PDP) and has the potential to avoid many of the debilitatingside effects of existing antipsychotics, none of which are approved foruse in PDP patients. The FDA granted NUPLAZID Breakthrough Therapydesignation for PDP in 2014.
“NUPLAZID holds promise for patients with Parkinson’s disease psychosiswho currently have no FDA-approved treatment options,” said Steve Davis,ACADIA’s Chief Executive Officer. “Psychosis is the leading cause forParkinson’s patients moving from their homes to nursing homes or otherinstitutions and leads to an increased risk of mortality, a diminishedquality of life and significant caregiver burden. If approved, NUPLAZIDwould represent a new and distinctly different pharmacological approachto treating psychosis and would be the first drug approved in the UnitedStates for psychosis associated with Parkinson’s disease.”
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. Currently, there is no FDA-approvedtherapy to treat Parkinson’s disease psychosis.
ACADIA’s NDA submission is based on data from a comprehensivedevelopment program assessing the safety and efficacy of NUPLAZID forParkinson’s disease psychosis. The NDA includes data from the pivotalPhase III -020 Study, in which NUPLAZID met all primary and secondaryendpoints with statistical significance, along with supportive data fromother studies with NUPLAZID. The -020 Study demonstrated that NUPLAZIDsignificantly reduced psychosis compared to placebo in patients withParkinson’s disease psychosis with no worsening of motor function. Theseresults were further supported by significant improvements in allsecondary efficacy measures and by significant benefits in exploratoryefficacy measures of nighttime sleep, daytime wakefulness and caregiverburden. Consistent with previous studies, NUPLAZID was safe and welltolerated in the -020 Study. Detailed results of the -020 Study havebeen published in The Lancet.
ACADIA has requested a Priority Review of its NDA. If granted, PriorityReview status would accelerate the review timeline from ten months tosix months following the conclusion of the 60 calendar day filing reviewperiod that begins on the FDA’s receipt of the NDA. The FDA informs theapplicant of a Standard or Priority Review designation following theconclusion of this 60 calendar day period.
Separately, ACADIA issued a news release today announcing that its Boardof Directors has appointed Steve Davis as Chief Executive Officer.
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, 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 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 in Parkinson’s disease psychosis to the FDA andwhich has the potential to be the first drug approved in the UnitedStates for this condition. Pimavanserin is also in Phase II developmentfor Alzheimer’s disease psychosis and has successfully completed a PhaseII trial in schizophrenia. ACADIA also has clinical-stage programs forchronic pain and glaucoma in collaboration with Allergan, Inc. Allproduct candidates are small molecules that emanate from internaldiscoveries. 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 timing of the potentialapproval of an NDA for NUPLAZID (pimavanserin); the potential forNUPLAZID to be the first drug approved in the United States forParkinson’s disease psychosis; whether, if approved, NUPLAZID wouldrepresent a new and distinctly different pharmacological approach totreating psychosis; the potential for NUPLAZID to avoid many of thedebilitating side effects of existing antipsychotics; and the progress,timing and results of ACADIA’s drug discovery and development programs,either alone or with a partner, including the progress and expectedtiming of clinical trials. These statements are only predictions basedon current information and expectations and involve a number of risksand uncertainties. Actual events or results may differ materially fromthose projected in any of such statements due to various factors,including the risks and uncertainties inherent in drug discovery,development, approval and commercialization, and in collaborations withothers, and the fact that past results of clinical trials may not beindicative of future trial results. For a discussion of these and otherfactors, please refer to ACADIA’s annual report on Form 10-K for theyear ended December 31, 2014 as well as ACADIA’s subsequent filings withthe Securities and Exchange Commission. You are cautioned not to placeundue reliance on these forward-looking statements, which speak only asof 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.
Investors:
ACADIA Pharmaceuticals Inc.
Steve Davis,Chief Executive Officer
Lisa Barthelemy, Director ofInvestor Relations
858-558-2871
or
Media:
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David Schull
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david.schull@russopartnersllc.com