Data Demonstrate Cognitive Advantages of Co-Therapy withPimavanserin and Stand-alone Therapy with ACP-104
SAN DIEGO—(BUSINESS WIRE)—Nov. 2, 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 preclinical data on its two advancedschizophrenia programs at the 37th Annual Meeting of the Society forNeuroscience to be held in San Diego, California from November 2-5,2007.
Pimavanserin: Improves Antipsychotic Efficacy and CognitiveProperties of Atypical Antipsychotic Drugs in Experimental Models
In a poster presentation titled "Pimavanserin, a 5-HT2A ReceptorInverse Agonist, Improves Antipsychotic Efficacy and CognitiveProperties of Atypical Antipsychotic Drugs," ACADIA researcherspresent data showing pimavanserin improves the activity of a number ofthe most commonly used atypical antipsychotic agents in animal modelspredictive of antipsychotic efficacy. Pimavanserin also reversed theadverse effects of these antipsychotic agents on cognitive function,one of the untreated symptom domains of schizophrenia. These resultssuggest that the positive findings from ACADIA's co-therapy trialevaluating the use of pimavanserin with risperidone may be applicableto a wide range of antipsychotic drugs.
ACP-104: Demonstrates Positive Effects on Antipsychotic Activityand Cognition in Experimental Models
In poster presentations titled "Comparison of the In Vitro and InVivo Pharmacology of N-desmethylclozapine (ACP-104) with OtherAtypical Antipsychotic Agents" and "N-desmethylclozapine (ACP-104)Induces Cellular Trafficking of Muscarinic M1 Receptors," ACADIAresearchers present data showing that ACP-104, in addition to beingactive in animal models predictive of antipsychotic activity, has asuperior profile in animal models of cognitive function when comparedto clozapine and other antipsychotic agents. Additionally, ACP-104 hasa receptor profile that is distinct from and potentially advantageousto these antipsychotic agents. These findings suggest that ACP-104 mayhave a superior clinical profile with activity against all symptomdomains (positive, negative and cognitive) in schizophrenia.
About Schizophrenia
Schizophrenia is a chronic, debilitating mental illnesscharacterized by disturbances in thinking, emotional reaction, andbehavior. Approximately one percent of the population developsschizophrenia during their lifetime and more than two million peoplein the United States suffer from this disease. Disturbances inschizophrenia may include positive symptoms, such as hallucinationsand delusions, and a range of negative symptoms, including loss ofinterest, emotional withdrawal and cognitive disturbances.
About Pimavanserin
Pimavanserin is a novel, potent, and selective 5-HT2A inverseagonist that ACADIA discovered and is developing as a co-therapy forpatients with schizophrenia. ACADIA announced positive top-lineresults in March 2007 from its Phase II schizophrenia co-therapytrial, demonstrating several advantages of pimavanserin when combinedwith a sub-maximal dose of risperidone, including enhanced efficacy, afaster onset of antipsychotic action, and an improved side-effectprofile. ACADIA also is in Phase III development with pimavanserin forthe treatment of Parkinson's disease psychosis.
About ACP-104
ACP-104, or N-desmethylclozapine, is the major metabolite ofclozapine that ACADIA is developing as a novel stand-alone therapy forschizophrenia. ACP-104 provides the potential for a superior atypicalantipsychotic efficacy profile with enhanced cognition. ACP-104combines M1 muscarinic agonism, 5-HT2A inverse agonism, and D2 and D3dopamine partial agonism in a single compound and, therefore, uniquelyaddresses what ACADIA believes are the three most promising targetmechanisms for treating schizophrenia. ACADIA currently is conductinga Phase IIb trial to evaluate the safety and efficacy of ACP-104 inpatients with schizophrenia. ACADIA's development program for ACP-104has been supported in part by the Stanley 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 mid-to-late stage clinical programs as well as a portfolio ofpreclinical and discovery assets directed at diseases with large unmetmedical needs, including schizophrenia, Parkinson's disease psychosis,sleep maintenance insomnia, and neuropathic pain. 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 benefits to be derived fromACADIA's drug development programs, including the potential advantagesof the use of pimavanserin as a co-therapy for schizophrenia, withrisperidone or other antipsychotics, and the use of ACP-104 as astand-alone 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 pimavanserin andACP-104 to date will be predictive of results in later stages ofdevelopment. For a discussion of these and other factors, please referto ACADIA's annual report on Form 10-K for the year ended December 31,2006 as well as other subsequent filings with the Securities andExchange Commission. You are cautioned not to place undue reliance onthese forward-looking statements, which speak only as of the datehereof. This caution is made under the safe harbor provisions of thePrivate Securities 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 andChief Financial Officer
858-558-2871
SOURCE: ACADIA Pharmaceuticals Inc.