Conference Call Scheduled for Today, March 11, at 5:00 p.m. Eastern
Time
SAN DIEGO—(BUSINESS WIRE)—Mar. 11, 2015—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
that address unmet medical needs in neurological and related central
nervous system disorders, today provided an update on the planned timing
of its NUPLAZIDTM (pimavanserin) New Drug Application (NDA)
submission.
ACADIA plans to submit its NUPLAZID NDA for the treatment of Parkinson’s
disease psychosis in the second half of 2015. The company had previously
planned to submit the NDA in the first quarter of 2015. The decision to
move back the planned submission is based on additional time required to
complete the preparation of systems to support commercial manufacturing
and supply and, in turn, to support the U.S. Food and Drug
Administration’s (FDA) review of NUPLAZID. The change in submission
timing is not a result of any change to NUPLAZID’s clinical or safety
profile, nor is it a result of any interaction with or request for
information from the FDA.
“We have concluded that additional time is needed to complete the
readiness of our commercial manufacturing systems,” said Steve Davis,
Interim Chief Executive Officer of ACADIA. “While we are very
disappointed with the change in timing, we believe that this is the
prudent course of action to take. We are working expeditiously to ensure
that our systems are robust and ready for FDA review and commercial
launch. Importantly, we remain confident in the safety and efficacy
package supporting the NDA of NUPLAZID, which received Breakthrough
Therapy designation from the FDA last year.”
Separately, ACADIA Pharmaceuticals issued a news release today
announcing that Uli Hacksell, Ph.D., has retired as its Chief Executive
Officer and resigned from its Board of Directors effective today. Steve
Davis, Executive Vice President, Chief Financial Officer and Chief
Business Officer of ACADIA, has been appointed as Interim Chief
Executive Officer.
Conference Call and Webcast Information
ACADIA management will hold a conference call and webcast today, March
11, 2015, at 5:00 p.m. Eastern Time to discuss its planned NDA
submission and the management change. The conference call may be
accessed by dialing 877-280-4954 for participants in the U.S. or
Canada and 857-244-7311 for international callers (reference passcode
18127460). A telephone replay of the conference call may be accessed
through March 25, 2015 by dialing 888-286-8010 for callers in the U.S.
or Canada and 617-801-6888 for international callers (reference passcode
30031975). The conference call also will be webcast live on ACADIA’s
website, www.acadia-pharm.com,
under the investors section and will be archived there until March 25,
2015.
About NUPLAZIDTM (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. The trade name NUPLAZID has been provisionally
accepted by the FDA.
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. 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. 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 (pimavanserin) for the treatment of
Parkinson’s disease psychosis (PDP); the potential for pimavanserin to
be the first drug approved in the United States for PDP, if approved at
all; and 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. 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 related to the
complete implementation of ACADIA’s systems related to commercial
manufacturing that are needed to support the approval by the FDA of an
NDA and the potential future commercial launch of NUPLAZID, and those
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, 2014
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.
Investor Contacts:
ACADIA Pharmaceuticals Inc.
Steve
Davis, Interim Chief Executive Officer
Lisa Barthelemy,
Director of Investor Relations
(858) 558-2871
or
Media
Contact:
Russo Partners
David Schull
(858)
717-2310
[email protected]