Single Pivotal Phase III -020 Study and Other Supportive DataSufficient for Future NDA Filing for the Treatment of Parkinson’sDisease Psychosis
Conference Call and Webcast to Be Held Today, April 11, 2013, at 8:00am Eastern Time
SAN DIEGO—(BUSINESS WIRE)—Apr. 11, 2013—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on innovative treatments that address unmet medical needs inneurological and related central nervous system disorders, todayannounced that the U.S. Food and Drug Administration (FDA) has agreedthat the data from the pivotal Phase III -020 study, together withsupportive data from other studies with pimavanserin, are sufficient tosupport the filing of a New Drug Application (NDA) for the treatment ofParkinson’s disease psychosis (PDP). As a result, ACADIA will no longerconduct the Phase III -021 study that was planned as a confirmatorytrial and was scheduled to be initiated later this month.
ACADIA is currently focused on completing the remaining elements of itspimavanserin PDP development program that are needed for submission ofan NDA. These include customary supportive studies, such as drug-druginteraction studies, and CMC development, such as stability testing ofregistration batches. Subject to changes that could result from futureinteractions with the FDA or other developments, ACADIA is currentlytargeting an NDA submission near the end of 2014. While the FDA hasagreed to accept and review an NDA for pimavanserin on the basis ofACADIA’s positive pivotal -020 study, along with supportive efficacy andsafety data from other pimavanserin studies, the NDA will be subject toa standard FDA review to determine whether the filing package isadequate to support approval of pimavanserin for PDP.
“We are very pleased with the outcome of our meeting with the FDA, whichwe expect will reduce substantially both the time and cost of our PDPdevelopment program,” said Uli Hacksell, Ph.D., ACADIA’s Chief ExecutiveOfficer. “This represents another important step toward our goal ofbringing pimavanserin to the market as an innovative therapy forParkinson’s patients who suffer from the psychosis frequently associatedwith this disease.”
Conference Call and Webcast Information
ACADIA will host a conference call and webcast today, April 11, 2013 at8:00 a.m. Eastern Time to discuss its recent meeting with the FDA andthe impact on its pimavanserin program. The conference call can beaccessed by dialing 877-546-5019 for participants in the U.S. and Canadaand 857-244-7551 for international callers (reference passcode69249817). The conference call will be webcast live on ACADIA’s website, www.acadia-pharm.com,under the investors section and will be archived there until April 25,2013. A telephone replay also may be accessed through April 25, 2013 bydialing 888-286-8010 for participants in the U.S. and Canada and617-801-6888 for international callers (reference passcode 91970609).
About Pimavanserin
Pimavanserin is ACADIA’s proprietary small molecule that actsselectively as an antagonist/inverse agonist on serotonin 5-HT2Areceptors and is in Phase III development as a potential first-in-classtreatment for Parkinson’s disease psychosis. ACADIA previously hasannounced positive results from its pivotal Phase III -020 studyevaluating the efficacy, tolerability and safety of pimavanserin inpatients with Parkinson’s disease psychosis. In the -020 study,statistically significant and consistent efficacy was observed acrossmeasures and, as with prior studies, pimavanserin was safe and welltolerated in this study. Pimavanserin can be taken orally as a tabletonce-a-day. ACADIA discovered pimavanserin and holds worldwide rights tothis new chemical entity.
About Parkinson’s Disease Psychosis
According to the National Parkinson’s Foundation, about one millionpeople in the United States and from four to six million peopleworldwide suffer from Parkinson’s disease. Parkinson’s diseasepsychosis, or PDP, is a debilitating disorder that develops in up to 60percent of patients with Parkinson’s disease. Currently, there is noFDA-approved therapy to treat PDP in the United States. PDP, commonlyconsisting of visual hallucinations and delusions, substantiallycontributes to the burden of Parkinson’s disease and deeply affects thequality of life of patients. PDP is associated with increased caregiverstress and burden, nursing home placement, and increased morbidity andmortality. There is a large unmet medical need for new therapies thatwill effectively treat PDP without compromising motor control inpatients with Parkinson’s disease.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on innovative treatmentsthat address unmet medical needs in neurological and related centralnervous system disorders. ACADIA has a pipeline of product candidatesled by pimavanserin, which is in Phase III development as a potentialfirst-in-class treatment for Parkinson's disease psychosis. ACADIA alsohas clinical-stage programs for chronic pain and glaucoma incollaboration with Allergan, Inc. and two advanced preclinical programsdirected at Parkinson’s disease and other neurological disorders. Allproduct candidates are small molecules that emanate from discoveriesmade at ACADIA. ACADIA maintains a website at www.acadia-pharm.comto which ACADIA regularly posts copies of its press releases as well asadditional information and through which interested parties cansubscribe to receive email alerts.
Forward-Looking Statements
Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but arenot limited to statements related to the progress and timing of ACADIA’sdrug discovery and development programs, either alone or with a partner,including clinical trials, the benefits to be derived from ACADIA’sproduct candidates, in each case including pimavanserin, the potentialbenefit of pimavanserin to PDP sufferers, expectations of substantialreductions of the time and cost of developing pimavanserin, futureactivities in the pimavanserin development program, the expected timingof submitting an NDA for pimavanserin, and future acceptance for filingof a pimavanserin NDA by the FDA. These statements are only predictionsbased on current information and expectations and involve a number ofrisks and uncertainties. Actual events or results may differ materiallyfrom those projected in any of such statements due to various factors,including the risks and uncertainties inherent in drug discovery,development and commercialization, any future failure to reach agreementwith the FDA on the regulatory path for pimavanserin for PDP, any issuesthat may arise related to the planned supportive studies or CMCdevelopment related to pimavanserin, and the risk that an NDA forpimavanserin is not accepted or ultimately approved by the FDA. For adiscussion of these and other factors, please refer to ACADIA’s annualreport on Form 10-K for the year ended December 31, 2012 as well asACADIA’s 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 is madeunder the safe harbor provisions of the Private Securities LitigationReform Act of 1995. All forward-looking statements are qualified intheir entirety by this cautionary statement and ACADIA undertakes noobligation to revise or update this press release to reflect events orcircumstances after the date hereof, except as required by law.
Source: ACADIA Pharmaceuticals Inc.
Investor Contacts:
ACADIA Pharmaceuticals Inc.
UliHacksell, Ph.D., Chief Executive Officer
Lisa Barthelemy,Director of Investor Relations
(858) 558-2871
or
MediaContact:
Russo Partners
David Schull
(212)845-4271 or (858) 717-2310
david.schull@russopartnersllc.com