Conference Call Scheduled for Today, June 16, 2008, at 8:30a.m. Eastern Time —
SAN DIEGO—(BUSINESS WIRE)—June 16, 2008—ACADIA PharmaceuticalsInc. (Nasdaq:ACAD) today announced results from its Phase IIb trialwith ACP-104 for the treatment of schizophrenia. The study did notmeet its primary endpoint of antipsychotic efficacy or any of thesecondary endpoints. Neither dose of ACP-104 demonstrated improvedefficacy as compared to placebo. The most common adverse events in thetreatment arms relative to placebo were increased salivation,tachycardia, and dyspepsia, which were noted to be dose-related. Therewas no clinically significant decrease in neutrophil counts in thestudy drug arms.
"We clearly are disappointed in the results of this study," saidUli Hacksell, Ph.D., Chief Executive Officer of ACADIA. "While we willthoroughly analyze the data to understand the outcome, we currently donot anticipate conducting further studies with ACP-104. Meanwhile, weare advancing our broad pipeline of drug candidates, including ourlead Phase III program with pimavanserin for the treatment ofParkinson's disease psychosis. Our primary objective is to continue toaggressively advance this program toward registration while exploringopportunities to develop and commercialize pimavanserin across a rangeof central nervous system indications with large unmet medical needs."
ACADIA's development pipeline consists of five clinical programsand several earlier stage programs. In addition to its Phase IIIpimavanserin program for Parkinson's disease psychosis, ACADIA's otherclinical programs also address areas of large unmet medical needs suchas schizophrenia, sleep maintenance insomnia, chronic pain, andglaucoma.
Study Design
The ACP-104 trial was a multi-center, double-blind,placebo-controlled Phase II study designed to evaluate the safety andefficacy of ACP-104 in patients with schizophrenia who wereexperiencing an acute psychotic episode. A total of 247 patients wereenrolled at multiple sites in the United States. Patients wererandomized to one of three study arms, with patients receiving one oftwo doses of ACP-104 (100 mg or 200 mg, twice daily) or placebo forsix weeks. The primary endpoint of the trial was antipsychoticefficacy as measured by the mean change from baseline in the Positiveand Negative Syndrome Scale (PANSS) total score for ACP-104 versusplacebo. Secondary endpoints included the PANSS subscales and theClinical Global Impression Severity scale.
Conference Call and Webcast Information
ACADIA will host a conference call and webcast today, June 16,2008, at 8:30 a.m. Eastern Time to discuss the results from thisACP-104 schizophrenia trial. The conference call can be accessed bydialing 888-396-2384 for participants in the U.S. or Canada and617-847-8711 for international callers (reference passcode 23592505).A telephone replay of the conference call may be accessed through June30, 2008 by dialing 888-286-8010 for callers in the U.S. or Canada and617-801-6888 for international callers (reference passcode 44270497).The conference call also will be webcast live on ACADIA's website,www.acadia-pharm.com, under the investors section and will be archivedthere until June 30, 2008.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of noveltreatments for central nervous system disorders. ACADIA currently hasfive clinical programs as well as a portfolio of preclinical anddiscovery assets directed at diseases with large unmet medical needs,including Parkinson's disease psychosis, schizophrenia, sleepmaintenance insomnia, chronic pain, and glaucoma. All of the drugcandidates in ACADIA's product pipeline emanate from discoveries madeusing its proprietary drug discovery platform. ACADIA's corporateheadquarters is located in San Diego, California and it maintainsresearch and development operations in both San Diego and Malmo,Sweden.
Forward-Looking Statements
Statements in this press release that are not strictly historicalin nature are forward-looking statements. These statements include butare not limited to statements related to additional analysis of thetrial data, future ACP-104 development, the advancement of ACADIA'sdrug candidate pipeline, and the development and commercialization ofpimavanserin. These statements are only predictions based on currentinformation and expectations and involve a number of risks anduncertainties. 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 clinical trials, anddrug development and commercialization, including the uncertainty ofwhether results in testing of pimavanserin to date will be predictiveof results in later stages of development. For a discussion of theseand other factors, please refer to ACADIA's annual report on Form 10-Kfor the year ended December 31, 2007 as well as other subsequentfilings with the Securities and Exchange Commission. You are cautionednot to place undue reliance on these forward-looking statements, whichspeak only as of the date hereof. This caution is made under the safeharbor provisions of the Private Securities Litigation Reform Act of1995. All forward-looking statements are qualified in their entiretyby this cautionary statement and ACADIA undertakes no obligation torevise or update this press release to reflect events or circumstancesafter the date hereof.
CONTACT: ACADIA Pharmaceuticals Inc.Lisa Barthelemy, 858-558-2871 (Investors)Director, Investor RelationsorUli Hacksell, 858-558-2871 (Investors)Ph.D., Chief Executive OfficerorRusso PartnersDavid Schull, 212-845-4271 (Media)PresidentSOURCE: ACADIA Pharmaceuticals Inc.