SAN DIEGO—(BUSINESS WIRE)—Aug. 6, 2015—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesthat address unmet medical needs in neurological and related centralnervous system disorders, today announced the publication of new datafrom its ongoing open-label safety extension study, the -015 Study, withNUPLAZID™ in patients with Parkinson’s disease psychosis (PDP) in theJuly 31 online issue of the Journal of the American Medical DirectorsAssociation (www.jamda.com).This is the first published report evaluating the long-term impact ofantipsychotics on mortality and serious adverse events in patients withPDP.
Currently marketed antipsychotics are not approved for PDP and have ablack box warning for use in elderly patients with dementia due toincreased mortality and morbidity. NUPLAZID was granted BreakthroughTherapy designation from the FDA in 2014 and has the potential to be thefirst drug approved for the treatment of PDP in the United States. Inthe -015 study, all patients received NUPLAZID (40 mg). Of 423 patientsassessed, 357 received NUPLAZID only, while 66 patients received acurrently marketed antipsychotic prescribed by their physician at somepoint during the study in addition to NUPLAZID. The two groups were wellmatched at baseline with regard to age (mean of 71-72 years) and otherdemographic and baseline variables. In a post-hoc analysis, there was asignificant increase in the mortality rate of patients who receivedconcurrent treatment with a currently marketed antipsychotic (18.8deaths per 100 person-years since the first concurrent antipsychoticdose) compared to those who received NUPLAZID only (4.5 deaths per 100person-years).
There also was a significant increase in treatment emergent seriousadverse events in patients who received concurrent treatment with acurrently marketed antipsychotic (52.5 first-occurrence events per 100person-years since the first concurrent antipsychotic dose) compared tothose who received NUPLAZID only (17.8 first-occurrence events per 100person-years).
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 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. Parkinson’s disease psychosis (PDP) isa debilitating disorder that occurs in an estimated 40 percent ofParkinson’s patients. Currently, there is no FDA-approved therapy totreat PDP in the United States. PDP, which commonly consists of visualhallucinations and delusions, substantially contributes to the burden ofParkinson’s disease and deeply affects the quality of life of patients.PDP also is associated with increased caregiver stress and burden,nursing home placement, and increased morbidity and mortality. There isa large unmet medical need for new therapies that will effectively treatPDP without compromising motor control in patients with Parkinson’sdisease.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin neurological and related central nervous system disorders. ACADIA hasa pipeline of product candidates led by NUPLAZID™ (pimavanserin), forwhich we have reported positive Phase III trial results in Parkinson’sdisease psychosis and which has the potential to be the first drugapproved in the United States for this disorder. Pimavanserin is also inPhase II development for Alzheimer’s disease psychosis and hassuccessfully completed a Phase II trial in schizophrenia. ACADIA alsohas clinical-stage programs for chronic pain and glaucoma incollaboration with Allergan, Inc. All product candidates are smallmolecules that emanate from internal discoveries. 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 pimavanserin tobe the first drug approved in the United States for PDP, if approved atall; the progress, timing and results of ACADIA’s drug discovery anddevelopment programs, either alone or with a partner; and the benefitsto be derived from ACADIA’s product candidates, including pimavanserin.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, approval andcommercialization, and 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, 2014as 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.
Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Steve Davis, Interim ChiefExecutive Officer
or
Lisa Barthelemy, Director ofInvestor Relations
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