SAN DIEGO—(BUSINESS WIRE)—Sept. 25, 2006—ACADIA PharmaceuticalsInc. (Nasdaq:ACAD), a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of noveltreatments for central nervous system disorders, today provided anupdate on the timing of its Phase II adjunctive therapy trial withACP-103 in patients with schizophrenia. ACADIA reported thatenrollment in the clinical trial is significantly ahead of schedule,which should enable the company to report top-line results for thecomplete 400-patient clinical trial during the first quarter of 2007,ahead of earlier expectations. Given the rapid enrollment andopportunity to expedite results for the complete study, ACADIA will nolonger perform an interim analysis based on the first 200 patients,which had been planned to be conducted by the end of 2006.
The Phase II clinical trial is a multi-center, double-blind,placebo-controlled study designed to evaluate the ability of ACP-103when used adjunctively with each of risperidone, an atypicalantipsychotic drug, and haloperidol, a typical antipsychotic drug, toprovide an improved therapy for patients with schizophrenia. The trialis designed to enroll a total of 400 patients with schizophrenia.ACADIA previously announced that it had enrolled 200 patients in thestudy by mid-2006, and over 350 patients have been enrolled to date.The primary endpoint of the study is antipsychotic efficacy asmeasured by the Positive and Negative Syndrome Scale (PANSS), anindustry standard rating scale used in schizophrenia trials.
"We are pleased with the rapid rate of enrollment in our ACP-103Phase II adjunctive therapy trial and now expect to completeenrollment early in the fourth quarter," said Roger G. Mills, M.D.,ACADIA's Executive Vice President, Development. "This enables us toexpedite the completion of the trial and makes the interim analysisunnecessary. We believe that adjunctive therapy with ACP-103 mayresult in both better efficacy and lower side effects than currenttreatments, thereby providing the potential to significantly improvethe therapy for patients suffering from schizophrenia and relatedneuropsychiatric disorders."
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 Phase II-stage clinical programs as well as a portfolio ofpreclinical and discovery assets directed at diseases with large unmetmedical needs, including schizophrenia, Parkinson's disease, sleepmaintenance insomnia, and neuropathic pain. All of the drug candidatesin ACADIA's product pipeline emanate from discoveries made using itsproprietary drug discovery platform. ACADIA's corporate headquartersis located in San Diego, California and it maintains research anddevelopment 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 the progress of and benefitsto be derived from ACADIA's drug development program for theadjunctive use of ACP-103 for schizophrenia and other neuropsychiatricdisorders and the anticipated schedule for ACADIA to release resultsfrom its current Phase II trial. These statements are only predictionsbased on current information and expectations and involve a number ofrisks and uncertainties. Actual events or results may differmaterially from those projected in any of such statements due tovarious factors, including the risks and uncertainties inherent inpatient enrollment in clinical trials, and drug development andcommercialization. For a discussion of these and other factors, pleaserefer to ACADIA's annual report on Form 10-K for the year endedDecember 31, 2005 as well as other subsequent filings with theSecurities and Exchange Commission. You are cautioned not to placeundue reliance on these forward-looking statements, which speak onlyas of the date hereof. This caution is made under the safe harborprovisions of the Private Securities Litigation Reform Act of 1995.All forward-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.
CONTACT: ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Uli Hacksell, Ph.D., Chief Executive Officer
858-558-2871