SAN DIEGO—(BUSINESS WIRE)—Aug. 28, 2014—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
to address unmet medical needs in neurological and related central
nervous system disorders, today announced that the U.S. Food and Drug
Administration (FDA) has provisionally accepted the trade name
“NUPLAZID”™ for pimavanserin. NUPLAZID is a selective serotonin inverse
agonist and, if approved, will represent the first in a new class of
drugs to treat psychosis. NUPLAZID has successfully completed a pivotal
Phase III trial in Parkinson’s disease psychosis, which the FDA has
agreed can serve as the basis, together with supportive data from other
studies, for a New Drug Application (NDA). ACADIA plans to submit the
NUPLAZID NDA to the FDA near the end of this year.
About NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a selective
serotonin inverse agonist preferentially targeting 5-HT2A receptors
believed to play an important role in psychosis. ACADIA has reported
positive Phase III trial results with NUPLAZID, which has the potential
to be the first drug approved in the United States for psychosis
associated with Parkinson’s disease. NUPLAZID is administered orally
once-a-day. ACADIA discovered NUPLAZID and holds worldwide rights to
this new chemical entity.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development and
commercialization of innovative medicines to address unmet medical needs
in neurological and related central nervous system disorders. ACADIA has
a pipeline of product candidates led by NUPLAZID (pimavanserin), for
which we have reported positive Phase III trial results in Parkinson’s
disease psychosis and which has the potential to be the first drug
approved in the United States for this disorder. We are currently
completing NDA-enabling clinical and manufacturing activities for
NUPLAZID and are planning to submit an NDA to the FDA near the end of
this year. Pimavanserin is also in Phase II development for Alzheimer’s
disease psychosis and has successfully completed a Phase II trial in
schizophrenia. ACADIA also has clinical-stage programs for chronic pain
and glaucoma in collaboration with Allergan, Inc. and two preclinical
programs directed at Parkinson’s disease and other neurological
disorders. All product candidates are small molecules that emanate from
internal discoveries. ACADIA maintains a website at www.acadia-pharm.com
to which we regularly post copies of our press releases as well as
additional information and through which interested parties can
subscribe to receive e-mail alerts.
Forward-Looking Statements
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 planned timing of the
submission of an NDA for NUPLAZID for the treatment of psychosis
associated with Parkinson’s disease; the potential for NUPLAZID to be
the first drug approved in the United States for psychosis associated
with Parkinson’s disease, if approved at all; the potential for NUPLAZID
to represent the first in a new class of drugs to treat psychosis; the
progress, timing and results of ACADIA’s drug discovery and development
programs, either alone or with a partner, including the progress and
expected timing of clinical trials; and the progress of ACADIA’s
NDA-enabling clinical and manufacturing activities. 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, approval, and commercialization, and
collaborations with others, and the fact that past results of clinical
trials may not be indicative of future trial results. 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, 2013 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.
Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Steve Davis, Executive Vice
President,
Chief Financial Officer and Chief Business Officer
or
Lisa
Barthelemy, Director of Investor Relations
858-558-2871