ACADIA Pharmaceuticals Announces NUPLAZID™ (pimavanserin) Is Now Available for the Treatment of Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis

NUPLAZID is the First and Only FDA-Approved Drug for this
Indication

An Estimated 40 Percent of Parkinson’s Disease Patients Have
Psychosis

SAN DIEGO–(BUSINESS WIRE)–ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
to address unmet medical needs in central nervous system (CNS)
disorders, today announced that NUPLAZID™ (pimavanserin) is now
available for prescription in the United States. NUPLAZID was approved
by the U.S. Food and Drug Administration (FDA) on April 29, 2016 for the
treatment of hallucinations and delusions associated with Parkinson’s
disease psychosis.

NUPLAZID is the first and only drug approved by the FDA for this
indication. NUPLAZID is also the only drug approved by the FDA that
preferentially targets 5-HT2A receptors. These receptors are
thought to play an important role in Parkinson’s disease psychosis. The
unique pharmacology of NUPLAZID establishes a new class of drug –
selective serotonin inverse agonists (SSIA) – by not only preferentially
targeting 5-HT2A receptors but also avoiding activity at
dopamine and other receptors commonly targeted by antipsychotics.
Typical Parkinson’s disease therapy consists of drugs that stimulate
dopamine to treat patients’ motor symptoms such as tremor, muscle
rigidity and difficulty with walking. NUPLAZID does not interfere with
patients’ dopaminergic therapy and therefore does not impair their motor
function.

“I am delighted that we now have an effective and FDA-approved therapy
for patients with hallucinations and delusions associated with
Parkinson’s disease psychosis,” said Neal Hermanowicz, M.D., Health
Sciences Clinical Professor, Neurology, UC Irvine School of Medicine and
Director, UC Irvine Movement Disorders Program. “In the pivotal Phase
III study of NUPLAZID, we observed significant reductions in the
severity and frequency of hallucinations and delusions in patients with
Parkinson’s disease psychosis. Importantly, these benefits were achieved
without impairing motor function.”

According to the National Parkinson Foundation, about one million people
in the United States and from four to six million people worldwide
suffer from Parkinson’s disease. An estimated 40 percent of these
patients have Parkinson’s disease psychosis, which is characterized by
hallucinations and delusions, is associated with significant caregiver
burden, and is a major reason for nursing home placement among
Parkinson’s patients.

“We believe NUPLAZID fills an important therapeutic gap as the first
FDA-approved treatment for patients afflicted with hallucinations and
delusions associated with Parkinson’s disease psychosis,” said Steve
Davis, ACADIA’s President and Chief Executive Officer. “We are excited
to bring this new treatment option to patients living with the
challenges of this debilitating condition.”

NUPLAZIDconnect™ Patient Access and Support Services

ACADIA is committed to ensuring that patients in the United States who
are prescribed NUPLAZID are able to access the medicine and receive the
ongoing support they may need. ACADIA has established NUPLAZIDconnect™,
a comprehensive program that provides access assistance to patients,
their caregivers, and physicians, as well as financial assistance to
those patients who qualify. NUPLAZID is available through a specialty
pharmacy network. Patients and physicians can access information about
NUPLAZID and NUPLAZIDconnect by visiting www.nuplazid.com
or calling 844-737-2223.

About NUPLAZID (pimavanserin)

NUPLAZID is the first FDA-approved treatment for hallucinations and
delusions associated with Parkinson’s disease psychosis. NUPLAZID is a
non-dopaminergic, selective serotonin inverse agonist preferentially
targeting 5-HT2A receptors that are thought to play an
important role in Parkinson’s disease psychosis. NUPLAZID is an oral
medicine taken once a day with a recommended dose of 34 mg (two 17 mg
tablets). ACADIA discovered this new chemical entity and holds worldwide
rights to develop and commercialize NUPLAZID. Please see full
prescribing information at www.nuplazid.com.
For additional information and multimedia assets on NUPLAZID, click here http://www.businesswire.com/news/home/20160429006144/en/

 
Important Safety Information and Indication for NUPLAZID
(pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death. NUPLAZID is
not approved for the treatment of patients with dementia-related
psychosis unrelated to the hallucinations and delusions associated
with Parkinson’s disease psychosis.
 

NUPLAZID is an atypical antipsychotic indicated for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis.

QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of
NUPLAZID should be avoided in patients with known QT prolongation or in
combination with other drugs known to prolong QT interval including
Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain
antipsychotic medications, and certain antibiotics. NUPLAZID should also
be avoided in patients with a history of cardiac arrhythmias, as well as
other circumstances that may increase the risk of the occurrence of
torsade de pointes and/or sudden death, including symptomatic
bradycardia, hypokalemia or hypomagnesemia, and presence of congenital
prolongation of the QT interval.

Adverse Reactions: The most common adverse reactions (≥2%
for NUPLAZID and greater than placebo) were peripheral edema (7%
vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination
(5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).

Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole)
increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half.

Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced
efficacy. Increase in NUPLAZID dosage may be needed.

Renal Impairment: No dosage adjustment for NUPLAZID is needed in
patients with mild to moderate renal impairment. Use of NUPLAZID is not
recommended in patients with severe renal impairment.

Hepatic Impairment: Use of NUPLAZID is not recommended in patients with
hepatic impairment. NUPLAZID has not been evaluated in this patient
population.

Pediatric Use: Safety and efficacy have not been established in
pediatric patients.

Dosage and Administration: Recommended dose: 34 mg per day, taken
orally as two 17 mg tablets once daily, without titration.

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company focused on the development and
commercialization of innovative medicines to address unmet medical needs
in central nervous system disorders. 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 benefits to be derived from
ACADIA’s product candidates and from NUPLAZID (pimavanserin); whether
NUPLAZID fills an important therapeutic gap as the first FDA-approved
treatment for patients afflicted with hallucinations and delusions
associated with Parkinson’s disease psychosis; whether NUPLAZID
establishes a new class of drug; whether ACADIA will be able to ensure
patients have access to NUPLAZID; and the assistance that will be
available to patients, their caregivers and physicians from ACADIA,
including through NUPLAZIDconnect. 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, whether NUPLAZID receives adequate
reimbursement from third-party payers, ACADIA’s ability to establish an
adequate specialty pharmacy network to distribute NUPLAZID, the degree
to which NUPLAZID receives acceptance from patients and physicians for
its approved indication, 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, 2015 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.

Contacts

Investor Contact:
ACADIA Pharmaceuticals Inc.
Lisa
Barthelemy

(858) 558-2871
ir@acadia-pharm.com
or
Media
Contact:
Taft and Partners
Ted Deutsch
(609)
578-8765

ted@taftandpartners.com