ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical
company focused on the development and commercialization of
innovative medicines that address unmet medical needs in central
nervous system (CNS) disorders, has been awarded the California
Life Sciences Association’s 2016 Pantheon DiNA Award for
Outstanding Therapeutic Product for NUPLAZID™ (pimavanserin), the
first and only drug approved by the U.S. Food and Drug
Administration for the treatment of hallucinations and delusions
associated with Parkinson’s disease psychosis.
The California Life Sciences Association’s (CLSA) DiNA Pantheon
Awards recognize achievements and honor excellence in the life
sciences sector in California. The Outstanding Therapeutic Product
award is given to the most promising or significant new life
sciences product approved in the 12 months preceding selection. The
selection is made by a panel of life sciences industry leaders,
journalists and CLSA board members. This year’s winners will be
honored at the 2016 Pantheon Awards ceremony on December 2 at the
Westin St. Francis in San Francisco.
“We are honored to be recognized for our team’s hard work and
commitment to discovering, developing and commercializing
NUPLAZID,” said Steve Davis, ACADIA’s President and Chief Executive
Officer. “NUPLAZID represents the culmination of many years of work
across our entire organization, and we are gratified by the
opportunity to improve the lives of people with Parkinson’s disease
psychosis.”
“We are pleased to honor this first-in-class, first-in-disease
medication with this year’s Pantheon DiNA Award for Outstanding
Therapeutic Product,” said Sara Radcliffe, President and Chief
Executive Officer of California Life Sciences Association.
“NUPLAZID truly represents the type of innovation and excellence
for which the California life sciences sector is known.”
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.
About Parkinson’s Disease Psychosis
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.
About California Life Sciences Association (CLSA)
California Life Sciences Association (CLSA) is the state’s
largest and most influential life sciences advocacy and business
leadership organization. With offices in Sacramento, San Diego,
South San Francisco, Los Angeles and Washington DC, CLSA works
closely with industry, government, academia and others to shape
public policy, improve access to innovative technologies and grow
California’s life sciences economy. CLSA serves biotechnology,
pharmaceutical, medical device and diagnostics companies, research
universities and institutes, investors and service providers
throughout the Golden State. CLSA was founded in 2015 when the Bay
Area Bioscience Association (BayBio) and the California Healthcare
Institute (CHI) merged. Visit CLSA at www.califesciences.org, and
follow us on Twitter @CALifeSciences, Facebook, Instagram, LinkedIn
and YouTube.
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 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, and the benefits to be derived from NUPLAZID™
(pimavanserin), including the promise or significance of NUPLAZID
and whether it will improve the lives of people with Parkinson’s
disease psychosis, and ACADIA’s product candidates. 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 in 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, 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.
Important Safety Information and
Indication for NUPLAZID (pimavanserin)
tabletsWARNING: INCREASED MORTALITY IN ELDERLY
PATIENTS WITH DEMENTIA-RELATED PSYCHOSISElderly 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.
Pregnancy: Use of NUPLAZID in pregnant women has not been
evaluated and should therefore be used in pregnancy only if the
potential benefit justifies the potential risk to the mother and
fetus.
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.
For additional Important Safety Information, including boxed
warning, please see the full Prescribing Information for NUPLAZID
at
http://www.acadia-pharm.com/wp-content/uploads/2016/04/NUPLAZID-pimavanserin-Package-Insert.pdf.
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version on businesswire.com: http://www.businesswire.com/news/home/20161011005552/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Lisa Barthelemy,
(858) 558-2871ir@acadia-pharm.comorMedia Contact:Taft
CommunicationsTed Deutsch, (609)
578-8765ted@taftcommunications.com
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