SAN DIEGO—(BUSINESS WIRE)—Aug. 28, 2014—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesto address unmet medical needs in neurological and related centralnervous system disorders, today announced that the U.S. Food and DrugAdministration (FDA) has provisionally accepted the trade name“NUPLAZID”™ for pimavanserin. NUPLAZID is a selective serotonin inverseagonist and, if approved, will represent the first in a new class ofdrugs to treat psychosis. NUPLAZID has successfully completed a pivotalPhase III trial in Parkinson’s disease psychosis, which the FDA hasagreed can serve as the basis, together with supportive data from otherstudies, for a New Drug Application (NDA). ACADIA plans to submit theNUPLAZID NDA to the FDA near the end of this year.
About NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a selectiveserotonin inverse agonist preferentially targeting 5-HT2A receptorsbelieved to play an important role in psychosis. ACADIA has reportedpositive Phase III trial results with NUPLAZID, which has the potentialto be the first drug approved in the United States for psychosisassociated with Parkinson’s disease. NUPLAZID is administered orallyonce-a-day. ACADIA discovered NUPLAZID and holds worldwide rights tothis new chemical entity.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin neurological and related central nervous system disorders. ACADIA hasa pipeline of product candidates led by NUPLAZID (pimavanserin), forwhich we have reported positive Phase III trial results in Parkinson’sdisease psychosis and which has the potential to be the first drugapproved in the United States for this disorder. We are currentlycompleting NDA-enabling clinical and manufacturing activities forNUPLAZID and are planning to submit an NDA to the FDA near the end ofthis year. Pimavanserin is also in Phase II development for Alzheimer’sdisease psychosis and has successfully completed a Phase II trial inschizophrenia. ACADIA also has clinical-stage programs for chronic painand glaucoma in collaboration with Allergan, Inc. and two preclinicalprograms directed at Parkinson’s disease and other neurologicaldisorders. All product candidates are small molecules that emanate frominternal discoveries. ACADIA maintains a website at www.acadia-pharm.comto which we regularly post copies of our press releases as well asadditional information and through which interested parties cansubscribe to receive e-mail 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 planned timing of thesubmission of an NDA for NUPLAZID for the treatment of psychosisassociated with Parkinson’s disease; the potential for NUPLAZID to bethe first drug approved in the United States for psychosis associatedwith Parkinson’s disease, if approved at all; the potential for NUPLAZIDto represent the first in a new class of drugs to treat psychosis; theprogress, timing and results of ACADIA’s drug discovery and developmentprograms, either alone or with a partner, including the progress andexpected timing of clinical trials; and the progress of ACADIA’sNDA-enabling clinical and manufacturing activities. These statements areonly predictions based on current information and expectations andinvolve a number of risks and uncertainties. Actual events or resultsmay differ materially from those projected in any of such statements dueto various factors, including the risks and uncertainties inherent indrug discovery, development, approval, and commercialization, andcollaborations with others, and the fact that past results of clinicaltrials may not be indicative of future trial results. For a discussionof these and other factors, please refer to ACADIA’s annual report onForm 10-K for the year ended December 31, 2013 as well as ACADIA’ssubsequent filings with the Securities and Exchange Commission. You arecautioned 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.
ACADIA Pharmaceuticals Inc.
Steve Davis, Executive VicePresident,
Chief Financial Officer and Chief Business Officer
or
LisaBarthelemy, Director of Investor Relations
858-558-2871