SAN DIEGO—(BUSINESS WIRE)—March 31, 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 thatit has initiated its second Phase III trial designed to evaluate thesafety and efficacy of pimavanserin as a treatment for Parkinson'sdisease psychosis (PDP).
"The start of our second Phase III pivotal trial representsanother important step forward toward our goal of providing afirst-in-class treatment for patients with PDP," said Uli Hacksell,Ph.D., Chief Executive Officer of ACADIA Pharmaceuticals. "We believepimavanserin may provide a unique combination of antipsychoticefficacy, motoric tolerability and safety and, therefore, provides thepotential for an important advance in therapy for patients sufferingfrom this debilitating disorder."
The Phase III trial is a multi-center, double-blind,placebo-controlled study designed to evaluate the safety and efficacyof pimavanserin in approximately 240 patients with PDP. Patients inthe trial will be randomized to three different study arms, which willinclude two different doses of pimavanserin and one placebo arm.Patients will receive oral doses of either pimavanserin or placeboonce daily for six weeks in addition to stable doses of their existingdopamine replacement therapy. The primary endpoint of the trial isantipsychotic efficacy as measured by the Scale for the Assessment ofPositive Symptoms, or SAPS. Motoric tolerability will be an importantsecondary endpoint in the trial and will be measured using the UnifiedParkinson's Disease Rating Scale, or UPDRS.
ACADIA is also currently conducting an open-label safety extensionstudy under which patients who have completed either of the Phase IIIPDP trials will have the opportunity to enroll if, in the opinion ofthe physician, the patient may benefit from continued treatment withpimavanserin.
About Pimavanserin
Pimavanserin tartrate is a novel, potent, and selective 5-HT2Ainverse agonist that ACADIA discovered and is developing as atreatment for PDP. ACADIA is currently conducting two Phase IIIpivotal trials in its program with pimavanserin as a treatment forPDP. ACADIA has also reported positive results from a Phase II trialin its program with pimavanserin as a co-therapy for schizophrenia.
About Parkinson's Disease Psychosis (PDP)
Parkinson's disease is a chronic neurological disorder thatresults from the degeneration of neurons in a region of the brain thatcontrols movement. According to the American Parkinson's DiseaseAssociation, over 1.5 million people in the United States suffer fromthis disease. Studies have suggested that up to 40 percent of patientswith Parkinson's disease will develop psychotic symptoms, commonlyconsisting of visual hallucinations and delusions. The development ofpsychosis in patients with Parkinson's disease often disrupts theirability to perform many of the activities of daily living that keepthem independent and active. As a result, Parkinson's diseasepsychosis is associated with increased caregiver burden, nursing homeplacement, and increased mortality.
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 largeunmet medical needs, including schizophrenia, Parkinson's diseasepsychosis, sleep maintenance insomnia, and neuropathic pain. All ofthe drug candidates in ACADIA's product pipeline emanate fromdiscoveries made using its proprietary drug discovery platform.ACADIA's corporate headquarters is located in San Diego, Californiaand it maintains research and development operations in both San Diegoand 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 ACADIA's drugdiscovery and development programs and the benefits to be derived fromACADIA's drug candidates, in each case, including pimavanserin. 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 drug discovery, development andcommercialization, and the fact that past results of clinical trialsmay not be indicative of future trial results. For a discussion ofthese and other factors, please refer to ACADIA's annual report onForm 10-K for the year ended December 31, 2007 as well as ACADIA'ssubsequent filings with the Securities and Exchange Commission. Youare 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.