ACADIA Pharmaceuticals Announces Expedited Path to NDA Filing for Pimavanserin Following Meeting with FDA

  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

Business Wire

SAN DIEGO -- April 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 PhaseIII -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-HT[2A] 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
December31, 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.

Contact:

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
david.schull@russopartnersllc.com
 
Press spacebar to pause and continue. Press esc to stop.