SAN DIEGO—(BUSINESS WIRE)—March 29, 2007—ACADIA PharmaceuticalsInc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of noveltreatments for central nervous system disorders, today announced thatthe company will present at the 2007 International Congress onSchizophrenia Research, held from March 28 through April 1, 2007, inColorado Springs, Colorado. Presentations will cover ACADIA's twoschizophrenia programs and will include previously announced top-lineclinical data from the recently completed ACP-103 Phase IIschizophrenia co-therapy trial, as well as preclinical and top-lineclinical data on ACP-104 for the treatment of schizophrenia.
ACP-103: Top-Line Data from Phase II Schizophrenia Co-TherapyTrial
Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA, will makean oral presentation on April 1 titled "ACP-103, a 5-HT2A InverseAgonist in Schizophrenia and Parkinson's Disease Psychosis." Thispresentation will include previously announced top-line results fromthe recently completed ACP-103 Phase II schizophrenia co-therapytrial, which highlighted several advantages of co-therapy withACP-103, including enhanced efficacy, a faster onset of antipsychoticaction, and an improved side effect profile. Dr. Hacksell also willpresent new data from this study showing that patients in theco-therapy arm combining ACP-103 with risperidone (2 mg) hadsignificantly lower prolactin levels after 42 days of treatmentcompared to patients in the risperidone (6 mg) plus placebo arm(p=0.0001). The condition of elevated prolactin is a commonly observedside effect of antipsychotic therapy and may adversely affectmenstrual and sexual function as well as bone formation.
ACP-104: Top-Line Data From Single Ascending-Dose and MultipleAscending-Dose Studies
Professor Carol Tamminga, M.D., from the University of TexasSouthwestern Medical School, will make on oral presentation on April 1titled "ACP-104 Novel Atypical Antipsychotic with Potential CognitiveEffects." During the presentation, Dr. Tamminga will review the uniquepreclinical properties of ACP-104 as well as top-line clinical resultsfrom the single ascending-dose and multiple ascending-dose studieswith ACP-104, which were announced in July 2006. Additionally, datafrom the single ascending-dose study will be presented in a postertitled "ACP-104 Safety and Pharmacokinetics in Psychosis."
ACP-104: Demonstrates Pro-Cognitive Actions in Experimental Models
In a poster presentation titled "N-Desmethylclozapine DemonstratesPro-Cognitive Actions in Experimental Models," ACADIA researchersdescribe preclinical data that indicate ACP-104, in addition to beingactive in models predictive of antipsychotic activity, has a superiorprofile in animal models of cognitive function. ACP-104 showed animproved performance in the Radial Arm Maze and no adverse effect inthe Novel Object Recognition assay. In contrast, clozapine impairedperformance in both these assays. The pro-cognitive effects of ACP-104were shown to be dependent upon M1 muscarinic activity. These findingssuggest that ACP-104 will have a superior clinical profile withactivity against all symptom domains (positive, negative, andcognitive) in schizophrenia.
ACP-104: Unique Receptor Profile for Treating Psychosis
In a poster presentation titled "Comparison of the In VitroPharmacology of N-Desmethylclozapine (ACP-104) with other AtypicalAntipsychotic Agents," ACADIA researchers describe experiments thatused cell based assays to characterize the functional interaction ofACP-104 and other antipsychotic drugs with a number of receptorsimplicated in the efficacy or adverse effects of antipsychotic drugs.The results demonstrated that ACP-104 has a receptor profile that isdistinct from and potentially advantageous to clozapine and otheratypical antipsychotic agents.
About ACP-103
ACP-103 is a small molecule drug candidate that ACADIA discoveredand is developing as a co-therapy for schizophrenia. ACP-103 can betaken orally and is a novel, potent, and selective 5-HT2A inverseagonist, meaning that it blocks the activity of the 5-HT2A receptor.By adding ACP-103 to existing schizophrenia treatment regimens, ACADIAbelieves the optimal combination of 5-HT2A inverse agonism anddopamine receptor blockade can be achieved, thereby resulting inenhanced efficacy and fewer side effects relative to existingtreatments. ACADIA also is entering Phase III development with ACP-103for the treatment of Parkinson's disease psychosis. In addition,ACADIA is developing ACP-103 for the treatment of sleep maintenanceinsomnia.
About ACP-104
ACP-104, or N-desmethylclozapine, is the major metabolite ofclozapine, and is in Phase II-stage development by ACADIA as a novelstand-alone therapy for schizophrenia. ACP-104 offers an atypicalantipsychotic efficacy profile with the added potential benefit ofenhanced cognition. ACP-104 combines M1 muscarinic agonism, 5-HT2Ainverse agonism, and D2 and D3 dopamine partial agonism in a singlecompound and, therefore, uniquely addresses what ACADIA believes arethe three most promising target mechanisms for treating schizophrenia.ACADIA's development program for ACP-104 is supported in part by theStanley Medical Research Center.
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 and the use ofACP-104 as a treatment for schizophrenia. These statements are onlypredictions based on current information and expectations and involvea number of risks and uncertainties. Actual events or results maydiffer materially from those projected in any of such statements dueto various factors, including the risks and uncertainties inherent inclinical trials, and drug development and commercialization, includingthe uncertainty of whether results in testing of ACP-103 and ACP-104to date will be predictive of results in later stages of development.For a discussion of these and other factors, please refer to ACADIA'sannual report on Form 10-K for the year ended December 31, 2006 aswell as other 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.This caution is made under the safe harbor provisions of the PrivateSecurities Litigation Reform Act of 1995. All forward-lookingstatements are qualified in their entirety by this cautionarystatement and ACADIA undertakes no obligation to revise or update thispress release to reflect events or circumstances after the datehereof.
CONTACT: ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen
Vice President and Chief Financial Officer
(858) 558-2871
SOURCE: ACADIA Pharmaceuticals Inc.