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—(BUSINESS WIRE)—Apr. 11, 2013—ACADIA Pharmaceuticals Inc. (NASDAQ: 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).
About Pimavanserin
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.
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 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.
Source: ACADIA Pharmaceuticals Inc.
Investor Contacts:
ACADIA Pharmaceuticals Inc.
Uli
Hacksell, Ph.D., Chief Executive Officer
Lisa Barthelemy,
Director of Investor Relations
(858) 558-2871
or
Media
Contact:
Russo Partners
David Schull
(212)
845-4271 or (858) 717-2310
[email protected]