PDUFA Date Set for May 1, 2016
SAN DIEGO—(BUSINESS WIRE)—Nov. 2, 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 that the New Drug Application (NDA) for NUPLAZID™ (pimavanserin)has been accepted for review by the U.S. Food and Drug Administration(FDA) and the agency has granted it Priority Review. ACADIA is seekingFDA approval of NUPLAZID for the treatment of psychosis associated withParkinson’s disease. The FDA granted NUPLAZID Breakthrough Therapydesignation for this indication in 2014.
The FDA grants Priority Review to drugs that may offer major advances intreatment or may provide a treatment where no adequate therapy exists.Priority Review accelerates the review timeline from 10 months to sixmonths from the date of acceptance of filing. The FDA has set a targetaction date under the Prescription Drug User Fee Act (PDUFA) of May 1,2016.
“The FDA Priority Review designation underscores the potential forNUPLAZID to provide an important treatment to patients with Parkinson’sdisease psychosis, a condition for which there is no FDA-approvedtherapy,” said Steve Davis, ACADIA’s President and Chief ExecutiveOfficer. “We look forward to working with the FDA during the review.”
NUPLAZID is a new class of non-dopaminergic antipsychotic that acts asan SSIA (selective serotonin inverse agonist), preferentially targeting5-HT2A receptors. Through this novel mechanism, NUPLAZID hasdemonstrated significant efficacy in 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.
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 showed statistical improvementon all primary and secondary efficacy endpoints with no worsening ofmotor function. Detailed results of the -020 Study were published in TheLancet.
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. The NDA for NUPLAZID for thetreatment of psychosis associated with Parkinson’s disease is currentlyunder Priority Review with the FDA. NUPLAZID is administered orallyonce-a-day. ACADIA discovered NUPLAZID and holds worldwide rights tothis new chemical entity. The trade name NUPLAZID has been provisionallyaccepted by the FDA. The safety and efficacy of NUPLAZID have not beenfully evaluated by 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 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 forglaucoma and, in collaboration with Allergan, Inc., for chronic pain.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; the potential benefits to be derived fromACADIA’s product candidates, including NUPLAZID; 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 and pastregulatory decisions may not be indicative of future trial results orregulatory decisions, respectively. 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.
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