SAN DIEGO—(BUSINESS WIRE)—April 4, 2008—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 ACP-104 schizophreniaprogram, its ACP-105 Selective Androgen Receptor Modulator (SARM)program, and its muscarinic discovery program at the ExperimentalBiology 2008 Meeting to be held from April 5-9, 2008 in San Diego,California, and the related Satellite Symposium on Recent Advances inMuscarinic Receptor Pharmacology and Therapeutics to be held fromApril 4-5, 2008.
ACP-104's Pro-cognitive and Antipsychotic Actions in Animal Modelsare Based on Simultaneous Interactions with M1, 5-HT2A, and D2Receptors
In poster presentations titled, "ACP-104 is a Unique AtypicalAntipsychotic Agent with M1 Muscarinic Activity" and "In Vivo ReceptorOccupancy of ACP-104 and Clozapine," ACADIA researchers present newpreclinical data on ACP-104, its novel drug candidate currently inPhase II development for the treatment of schizophrenia. The data showthat ACP-104 demonstrates pro-cognitive actions in an animal model bya muscarinic M1 receptor dependent mechanism. ACADIA researchers alsoshow that ACP-104 interacts with M1, 5-HT2A, and D2 receptors in vivoat doses that are effective in animal models of psychosis andcognition. In addition, the combined antagonism at 5-HT2A and partialagonism at D2 receptors in vivo suggests ACP-104 may produceantipsychotic activity with reduced extrapyramidal side effects.Furthermore, the findings that ACP-104 binds to and activates M1receptors in vivo support the potential utility of ACP-104 as apro-cognitive antipsychotic in the treatment of schizophrenia.
ACP-105, a Novel Non-Steroidal SARM
In a poster presentation titled, "In Vitro and In Vivo Profile ofa Novel Tissue Selective, Orally Bioavailable Non-Steroidal AndrogenReceptor Modulator," ACADIA researchers present findings on ACP-105, anovel non-steroidal SARM. ACP-105 is shown to be as potent andefficacious as testosterone in in vitro assays without interaction atother hormone receptors. In addition, ACP-105 demonstrates potentanabolic effects on muscle and bone with minimal effect on prostratein preclinical models.
AC-260584, a Novel and Selective Muscarinic M1 Agonist
In poster presentations titled, "Characterization of the IntrinsicEfficacies of M1 Muscarinic Receptor Agonists" and "PharmacologicalCharacterization of AC-260584, a Potent and Selective M1 MuscarinicReceptor Agonist," ACADIA researchers describe the pharmacology of anovel, potent, and selective muscarinic M1 receptor subtype agonist.AC-260584 activates muscarinic M1 receptors in the brain and also haspro-cognitive actions in animal models. Further studies using a rangeof in vitro techniques reveal notable differences in the intrinsicactivities of muscarinic M1 receptor agonists and demonstrate thatallosteric agonists such as AC-260584 can have high intrinsic activityat muscarinic M1 receptors.
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 is designed to provide 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 has completed enrollment in a Phase IIb trial to evaluate thesafety and efficacy of ACP-104 in patients with schizophrenia.ACADIA's development program for ACP-104 has been supported in part bythe Stanley Medical Research Center.
About ACP-105
ACP-105 is a non-steroidal and selective androgen receptoragonist. ACP-105 is part of a class of molecules referred to asselective androgen receptor modulators (SARMs). SARMs may advance thestandard of treatment for a variety of disorders includingmuscle-wasting conditions and osteoporosis, with fewer side effects ascompared to current treatments based on testosterone replacement.ACP-105 has exhibited promising pharmacological properties and afavorable safety profile in preclinical testing.
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 preclinical and drug development programs, including thepotential advantages of the use of ACP-104 as a stand-alone treatmentfor schizophrenia, including pro-cognitive benefits, the use ofACP-105 as a treatment for bone and muscle wasting with minimal sideeffects, and the use of AC-260594 to activate M1 receptors and providecognitive benefits. These statements are only predictions based oncurrent information 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 clinical testing of ACP-104 to date will bepredictive of results in later stages of development and whetherpreclinical testing of ACP-104, ACP-105 and AC-260584 in animal modelswill be predictive of results in later stages of development. For adiscussion of these and other factors, please refer to ACADIA's annualreport on Form 10-K for the year ended December 31, 2007 as well asother subsequent filings with the Securities and Exchange Commission.You are cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. This caution ismade under the safe harbor provisions of the Private SecuritiesLitigation Reform Act of 1995. All forward-looking statements arequalified in their entirety by this cautionary statement and ACADIAundertakes no obligation to revise or update this press release toreflect events or circumstances after the date hereof.
CONTACT: ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President andChief Financial Officer
(858) 558-2871
SOURCE: ACADIA Pharmaceuticals Inc.