Conference Call Scheduled for Today, March 11, at 5:00 p.m. EasternTime
SAN DIEGO—(BUSINESS WIRE)—Mar. 11, 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 provided an update on the planned timingof its NUPLAZIDTM (pimavanserin) New Drug Application (NDA)submission.
ACADIA plans to submit its NUPLAZID NDA for the treatment of Parkinson’sdisease psychosis in the second half of 2015. The company had previouslyplanned to submit the NDA in the first quarter of 2015. The decision tomove back the planned submission is based on additional time required tocomplete the preparation of systems to support commercial manufacturingand supply and, in turn, to support the U.S. Food and DrugAdministration’s (FDA) review of NUPLAZID. The change in submissiontiming is not a result of any change to NUPLAZID’s clinical or safetyprofile, nor is it a result of any interaction with or request forinformation from the FDA.
“We have concluded that additional time is needed to complete thereadiness of our commercial manufacturing systems,” said Steve Davis,Interim Chief Executive Officer of ACADIA. “While we are verydisappointed with the change in timing, we believe that this is theprudent course of action to take. We are working expeditiously to ensurethat our systems are robust and ready for FDA review and commerciallaunch. Importantly, we remain confident in the safety and efficacypackage supporting the NDA of NUPLAZID, which received BreakthroughTherapy designation from the FDA last year.”
Separately, ACADIA Pharmaceuticals issued a news release todayannouncing that Uli Hacksell, Ph.D., has retired as its Chief ExecutiveOfficer and resigned from its Board of Directors effective today. SteveDavis, Executive Vice President, Chief Financial Officer and ChiefBusiness Officer of ACADIA, has been appointed as Interim ChiefExecutive Officer.
Conference Call and Webcast Information
ACADIA management will hold a conference call and webcast today, March11, 2015, at 5:00 p.m. Eastern Time to discuss its planned NDAsubmission and the management change. The conference call may beaccessed by dialing 877-280-4954 for participants in the U.S. orCanada and 857-244-7311 for international callers (reference passcode18127460). A telephone replay of the conference call may be accessedthrough March 25, 2015 by dialing 888-286-8010 for callers in the U.S.or Canada and 617-801-6888 for international callers (reference passcode30031975). The conference call also will be webcast live on ACADIA’swebsite, www.acadia-pharm.com,under the investors section and will be archived there until March 25,2015.
About NUPLAZIDTM (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a selectiveserotonin inverse agonist preferentially targeting 5-HT2A receptorsbelieved to play an important role in psychosis. ACADIA has reportedpositive Phase III trial results with NUPLAZID, which has the potentialto be the first drug approved in the United States for psychosisassociated with Parkinson’s disease. 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.
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 planned timing of thesubmission of an NDA for NUPLAZID (pimavanserin) for the treatment ofParkinson’s disease psychosis (PDP); the potential for pimavanserin tobe the first drug approved in the United States for PDP, if approved atall; and the progress, timing and results of ACADIA’s drug discovery anddevelopment programs, either alone or with a partner, including theprogress and expected timing of clinical trials. These statements areonly predictions based on current information and expectations andinvolve a number of risks and uncertainties. Actual events or resultsmay differ materially from those projected in any of such statements dueto various factors, including the risks and uncertainties related to thecomplete implementation of ACADIA’s systems related to commercialmanufacturing that are needed to support the approval by the FDA of anNDA and the potential future commercial launch of NUPLAZID, and thoseinherent 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.
Investor Contacts:
ACADIA Pharmaceuticals Inc.
SteveDavis, Interim Chief Executive Officer
Lisa Barthelemy,Director of Investor Relations
(858) 558-2871
or
MediaContact:
Russo Partners
David Schull
(858)717-2310
david.schull@russopartnersllc.com