ACADIA Pharmaceuticals Announces Expedited Path to NDA Filing for Pimavanserin Following Meeting with FDA
Single Pivotal Phase III -020 Study and Other Supportive Data Sufficient for Future NDA Filing for the Treatment of Parkinson's Disease Psychosis
Conference Call and Webcast to Be Held Today, April 11, 2013, at 8:00 am Eastern Time
SAN DIEGO--ACADIA Pharmaceuticals Inc. (ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) has agreed that the data from the pivotal Phase III -020 study, together with supportive data from other studies with pimavanserin, are sufficient to support the filing of a New Drug Application (NDA) for the treatment of Parkinson's disease psychosis (PDP). As a result, ACADIA will no longer conduct the Phase III -021 study that was planned as a confirmatory trial and was scheduled to be initiated later this month.
ACADIA is currently focused on completing the remaining elements of its pimavanserin PDP development program that are needed for submission of an NDA. These include customary supportive studies, such as drug-drug interaction studies, and CMC development, such as stability testing of registration batches. Subject to changes that could result from future interactions with the FDA or other developments, ACADIA is currently targeting an NDA submission near the end of 2014. While the FDA has agreed to accept and review an NDA for pimavanserin on the basis of ACADIA's positive pivotal -020 study, along with supportive efficacy and safety data from other pimavanserin studies, the NDA will be subject to a standard FDA review to determine whether the filing package is adequate to support approval of pimavanserin for PDP.
"We are very pleased with the outcome of our meeting with the FDA, which we expect will reduce substantially both the time and cost of our PDP development program," said Uli Hacksell, Ph.D., ACADIA's Chief Executive Officer. "This represents another important step toward our goal of bringing pimavanserin to the market as an innovative therapy for Parkinson's patients who suffer from the psychosis frequently associated with this disease."
Conference Call and Webcast Information
ACADIA will host a conference call and webcast today, April 11, 2013 at 8:00 a.m. Eastern Time to discuss its recent meeting with the FDA and the impact on its pimavanserin program. The conference call can be accessed by dialing 877-546-5019 for participants in the U.S. and Canada and 857-244-7551 for international callers (reference passcode 69249817). 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 by dialing 888-286-8010 for participants in the U.S. and Canada and 617-801-6888 for international callers (reference passcode 91970609).
Pimavanserin is ACADIA's proprietary small molecule that acts selectively as an antagonist/inverse agonist on serotonin 5-HT2A receptors and is in Phase III development as a potential first-in-class treatment for Parkinson's disease psychosis. ACADIA previously has announced positive results from its pivotal Phase III -020 study evaluating the efficacy, tolerability and safety of pimavanserin in patients with Parkinson's disease psychosis. In the -020 study, statistically significant and consistent efficacy was observed across measures and, as with prior studies, pimavanserin was safe and well tolerated in this study. Pimavanserin can be taken orally as a tablet once-a-day. ACADIA discovered pimavanserin and holds worldwide rights to this new chemical entity.
About Parkinson's Disease Psychosis
According to the National Parkinson's Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson's disease. Parkinson's disease psychosis, or PDP, is a debilitating disorder that develops in up to 60 percent of patients with Parkinson's disease. Currently, there is no FDA-approved therapy to treat PDP in the United States. PDP, commonly consisting of visual hallucinations and delusions, substantially contributes to the burden of Parkinson's disease and deeply affects the quality of life of patients. PDP is associated with increased caregiver stress and burden, nursing home placement, and increased morbidity and mortality. There is a large unmet medical need for new therapies that will effectively treat PDP without compromising motor control in patients with Parkinson's disease.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders. ACADIA has a pipeline of product candidates led by pimavanserin, which is in Phase III development as a potential first-in-class treatment for Parkinson's disease psychosis. ACADIA also has clinical-stage programs for chronic pain and glaucoma in collaboration with Allergan, Inc. and two advanced preclinical programs directed at Parkinson's disease and other neurological disorders. All product candidates are small molecules that emanate from discoveries made at ACADIA. ACADIA maintains a website at www.acadia-pharm.com to which ACADIA regularly posts copies of its press releases as well as additional information and through which interested parties can subscribe to receive email alerts.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to the progress and timing of ACADIA's drug discovery and development programs, either alone or with a partner, including clinical trials, the benefits to be derived from ACADIA's product candidates, in each case including pimavanserin, the potential benefit of pimavanserin to PDP sufferers, expectations of substantial reductions of the time and cost of developing pimavanserin, future activities in the pimavanserin development program, the expected timing of submitting an NDA for pimavanserin, and future acceptance for filing of a pimavanserin NDA by the FDA. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from 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 agreement with the FDA on the regulatory path for pimavanserin for PDP, any issues that may arise related to the planned supportive studies or CMC development related to pimavanserin, and the risk that an NDA for pimavanserin is not accepted or ultimately approved by the FDA. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2012 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
ACADIA Pharmaceuticals Inc.
Uli Hacksell, Ph.D., Chief Executive Officer
Lisa Barthelemy, Director of Investor Relations
(212) 845-4271 or (858) 717-2310