FDA Decision Highlights Significant Unmet Need in the Treatment of
Parkinson’s Disease Psychosis
SAN DIEGO—(BUSINESS WIRE)—Sep. 2, 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 granted Breakthrough Therapy designation to
NUPLAZID™ (pimavanserin) for the treatment of Parkinson’s disease
psychosis. NUPLAZID is a selective serotonin inverse agonist and, if
approved, will establish a new and distinctly different pharmacological
approach to treating 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.
“The hallucinations and delusions in Parkinson’s disease psychosis are
devastating to patients and contribute to a dramatic rise in caregiver
burden,” said Joyce Oberdorf, President and Chief Executive Officer of
the National Parkinson Foundation. “Parkinson’s disease psychosis is a
leading cause of nursing home placement for Parkinson’s patients and,
with no FDA-approved therapy for this serious condition, there is a
great unmet medical need for an effective, safe, and well-tolerated
treatment option for patients.”
“The Breakthrough Therapy designation for NUPLAZID reinforces the urgent
need for a treatment for patients with Parkinson’s disease psychosis,”
said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. “NUPLAZID
represents a potential new class of psychosis medication and could be
the first drug approved in the United States for patients with
Parkinson’s disease psychosis.”
The Breakthrough Therapy designation was created by the FDA to expedite
the development and review of drugs that are intended to treat serious
or life-threatening conditions. For indications without an approved
therapy, drugs qualifying for this designation must show a substantial
and clinically meaningful effect on an important outcome when compared
with placebo. The Breakthrough Therapy designation is distinct from
priority review, which can also be granted to the same drug if the
relevant criteria are met. The FDA informs the applicant of a standard
or priority review designation within 60 days of the receipt of the
original NDA.
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. The trade name NUPLAZID has been provisionally
accepted by the FDA.
About Parkinson’s Disease Psychosis
According to the National Parkinson Foundation (www.parkinson.org),
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 (PDP) is a debilitating disorder that occurs in an
estimated 40 percent of Parkinson’s patients. Currently, there is no
FDA-approved therapy to treat PDP in the United States. PDP, which
commonly consists of visual hallucinations and delusions, substantially
contributes to the burden of Parkinson’s disease and deeply affects the
quality of life of patients. PDP also 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 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 timing of the submission of an
NDA for NUPLAZID for PDP; the potential for NUPLAZID to be the first
drug approved in the United States for PDP, if approved at all; the
approval of NUPLAZID for PDP establishing a new and different
pharmacological approach to treating 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.
Investor Contacts:
ACADIA Pharmaceuticals Inc.
Uli
Hacksell, Ph.D., Chief Executive Officer
Lisa Barthelemy,
Director of Investor Relations
(858) 558-2871
or
Media
Contact:
Chandler Chicco Companies
David Polk
(310)
309-1029 or (805) 428-5775