—Faster Onset of Action —
—Less Weight Gain —
—Conference Call Scheduled for Today, March 19, 2007, at 9:00 a.m. Eastern Time –
"These data clearly demonstrate the advantages of co-therapy withACP-103 and show the importance of 5-HT2A receptor antagonism inschizophrenia therapy," said Herbert Y. Meltzer, M.D., Professor ofPsychiatry and Pharmacology and Director of the Psychosis Program atthe Vanderbilt University School of Medicine. "Current antipsychoticagents used to treat schizophrenia and related neuropsychiatricdisorders have many dose-related limitations. The use of ACP-103 inco-therapy with risperidone or other modern atypical antipsychoticsmay result in enhanced efficacy and an improved side effect profile,suggesting a formula for a new and improved treatment paradigm forpatients with schizophrenia." Trial Design The Phase II clinical trial was a multi-center, randomized,double-blind, placebo-controlled, six-week study designed to evaluatethe ability of ACP-103, when used together with either risperidone orhaloperidol, to provide an improved therapy for patients withschizophrenia. The trial enrolled 423 patients across sites in boththe United States and Brazil. Patients were randomly assigned to oneof five study arms: ACP-103 plus low-dose risperidone(ACP-103/risperidone); low-dose risperidone plus placebo (risperidoneLD); high-dose risperidone plus placebo (risperidone HD); ACP-103 plushaloperidol (ACP-103/haloperidol); or haloperidol plus placebo(haloperidol arm). The primary endpoint of the study was antipsychoticefficacy as measured after day 42 compared to baseline in each of thetwo ACP-103 co-therapy arms using the PANSS. Trial Results The ACP-103/risperidone co-therapy arm showed a 23.0 point (27.4%)improvement in the PANSS as measured after day 42 compared to baseline(p less than 0.0001), a primary endpoint in the study. In addition tomeeting the primary endpoint, the ACP-103/risperidone arm demonstrateda statistically significant enhancement of antipsychotic efficacy ascompared to the risperidone LD arm (p=0.01), and similar efficacy tothe risperidone HD arm (p=NS). The significant efficacy enhancementover risperidone LD was observed for both positive and negativesymptoms. Co-therapy with ACP-103 also provided a significantly faster onsetof antipsychotic action. After only two weeks of therapy, about 50%more patients in the ACP-103/risperidone arm responded to treatmentcompared to each of the risperidone LD (p less than 0.008) andrisperidone HD (p less than 0.03) arms. A responder was defined as apatient showing at least a 20% reduction in the PANSS. Importantly, patients in the ACP-103/risperidone co-therapy armalso had 50% less gain in weight than patients in the risperidone HDarm. This difference trended to statistical significance (p=0.078). The study also evaluated ACP-103 as a co-therapy with haloperidol.The ACP-103/haloperidol arm showed a 21.6 point (25.6%) improvement inthe PANSS as measured after day 42 compared to baseline (p less than0.0001), a primary endpoint in the study. The haloperidol arm showed arobust antipsychotic effect and there was no statistical differencecompared to the ACP-103/haloperidol arm after day 42. However, theACP-103/haloperidol arm did appear to result in a faster onset ofantipsychotic action after only two weeks of treatment as compared tothe haloperidol arm. In addition, patients in the ACP-103/haloperidolco-therapy arm had less gain in weight compared to patients in thehaloperidol arm. Each of the treatments was generally safe and well tolerated.Adverse events were comparable among the five study arms and weregenerally characterized as mild to moderate. The most common adverseevents were sedation, headache, and agitation. There were threeserious adverse events (SAEs) in the study that were deemed to bedrug-related, each of which occurred in a risperidone plus placeboarm. Two of these SAEs were cardiovascular in nature and occurred inthe risperidone HD arm. No drug-related SAEs were observed in eitherof the ACP-103 co-therapy arms. "We are very excited about these top-line results, whichdemonstrate several key advantages of co-therapy with ACP-103," saidUli Hacksell, Ph.D., Chief Executive Officer of ACADIA. "Whileachieving effective antipsychotic treatment comparable to a standarddose of risperidone, ACP-103 when added to a three-fold lower dose ofrisperidone provided substantial advantages, including a faster onsetof antipsychotic action and 50% less weight gain. We believe thatco-therapy with ACP-103 may provide important clinical advantagescompared to current antipsychotic drug therapy." Conference Call and Webcast Information ACADIA will host a conference call and webcast with slides today,March 19, 2007, at 9:00 a.m. Eastern Time to discuss the results fromthis ACP-103 Phase II schizophrenia co-therapy trial. The conferencecall can be accessed by dialing 800-435-1261 for participants in theU.S. or Canada and 617-614-4076 for international callers (referencepasscode 63511928). A telephone replay of the conference call may beaccessed through April 2, 2007 by dialing 888-286-8010 for callers inthe U.S. or Canada and 617-801-6888 for international callers(reference passcode 33087234). The conference call also will bewebcast live on ACADIA's website, www.acadia-pharm.com, under theinvestors section and will be archived there until April 2, 2007. About ACP-103 ACP-103 is a small molecule drug candidate that ACADIA discoveredand is developing as a co-therapy to be used together with otherantipsychotic drugs to treat schizophrenia. ACP-103 can be takenorally and is a novel, potent, and selective 5-HT2A inverse agonist,meaning that it blocks the activity of the 5-HT2A receptor. By addingACP-103 to existing treatment regimens, ACADIA believes that theoptimal combination of 5-HT2A inverse agonism and dopamine receptorblockade can be achieved, thereby resulting in enhanced efficacy andfewer side effects relative to existing treatments. ACADIA also isdeveloping ACP-103 for the treatment of Parkinson's disease psychosisand sleep maintenance insomnia. About Schizophrenia Schizophrenia is a chronic, debilitating mental illnesscharacterized by disturbances in thinking, emotional reaction, andbehavior. These disturbances may include positive symptoms, such ashallucinations and delusions, and a range of negative symptoms,including loss of interest, emotional withdrawal and cognitivedisturbances. Approximately one percent of the population developsschizophrenia during their lifetime and more than two million peoplein the United States suffer from this disease. Worldwide sales ofdrugs used to treat schizophrenia and other psychoses exceeded $15billion in 2005. Despite their commercial success, current drugs usedto treat schizophrenia have substantial limitations, including severeside effects and a lack of efficacy on all symptoms of the disease. 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 large unmet medical needs, includingschizophrenia, Parkinson's disease psychosis, sleep maintenanceinsomnia, and neuropathic pain. All of the drug candidates in ACADIA'sproduct pipeline emanate from discoveries made using its proprietarydrug discovery platform. ACADIA's corporate headquarters is located inSan Diego, California and it maintains research and developmentoperations 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 benefits to be derived fromACADIA's drug development programs, including the potential advantagesof the use of ACP-103 as a co-therapy for schizophrenia. Thesestatements 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 clinical trials, and drug development andcommercialization, including the uncertainty of whether results intesting of ACP-103 to date will be predictive of results in laterstages of development. For a discussion of these and other factors,please refer to ACADIA's annual report on Form 10-K for the year endedDecember 31, 2006 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.Study Arms Baseline Mean PercentageMean Change Change———————————————————————————————————ACP-103 (20 mg) plus low-dose risperidone(2 mg) 84.8 -23.0 27.4%———————————————————————————————————Low-dose risperidone (2 mg) plus placebo 87.5 -16.6 19.0%———————————————————————————————————High-dose risperidone (6 mg) plus placebo 86.4 -23.2 26.4%———————————————————————————————————Data based on the PANSS using the Intent to Treat Population and LastObservation Carried Forward Methodology.
Study Arms Baseline Mean PercentageMean Change Change———————————————————————————————————ACP-103 (20 mg) plus haloperidol (2 mg) 85.6 -21.6 25.6%———————————————————————————————————Haloperidol (2 mg) plus placebo 86.4 -25.1 29.2%———————————————————————————————————Data based on the PANSS using the Intent to Treat Population and LastObservation Carried Forward Methodology.
ACADIA Pharmaceuticals Inc.Lisa Barthelemy, 858-558-2871Director, Investor RelationsUli Hacksell, Ph.D., 858-558-2871Chief Executive Officer