-Robert Kaper, M.D., named Senior Vice
President, Global Head of Medical Affairs
-Eliseo Salinas, M.D., M.Sc., named Senior Vice
President, Chief Scientific Officer and Head of External
Innovation
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 two executive
appointments: Robert Kaper, M.D., has joined ACADIA as Senior Vice
President, Global Head of Medical Affairs, and Eliseo Salinas,
M.D., M.Sc., has joined the company as Senior Vice President, Chief
Scientific Officer and Head of External Innovation. In these newly
created roles, Dr. Kaper will report to Steve Davis, ACADIA’s
President and Chief Executive Officer, and Dr. Salinas will report
to Serge Stankovic, M.D., M.S.P.H., Executive Vice President and
Head of Research and Development.
“We are excited to welcome Rob Kaper and Eliseo Salinas to the
ACADIA team,” said Steve Davis. “Rob brings 25 years of experience
across all functions in global medical affairs and
pharmacovigilance. Eliseo has a stellar track record in leading
several R&D organizations and providing the strategic and
operational guidance to bring to market 15 pharmaceuticals in
various therapeutic areas, including CNS. Both Rob and Eliseo will
be of tremendous help to us as we continue to realize the
significant opportunities of NUPLAZID and deliver on our vision of
building a leading CNS company.”
Dr. Kaper most recently served as Senior Vice President of
Medical and Scientific Affairs for AMAG Pharmaceuticals where he
led medical affairs and pharmacovigilance for marketed products,
new indications and new assets. Throughout his career, Dr. Kaper
has built successful teams to support strategic planning and
execution of late stage development, new product launches and
lifecycle management. His previous leadership positions include
Vice President, Global Medical Affairs for Teva and Vice President,
Medical Affairs for Cephalon and Organon. Dr. Kaper received his
M.D. from the Free University of Amsterdam and completed his
post-graduate training in neurosurgery and orthopedic surgery at
Amsterdam-based hospitals.
Dr. Salinas joins ACADIA from New World Laboratories where he
was Chief Medical Officer and led pre-clinical, clinical and
regulatory activities for directly reprogrammed cell therapy
programs in neurodegeneration. Dr. Salinas has 27 years of
experience developing diverse therapeutic products for CNS and
other disorders and has been directly involved with 16
investigational new drug (IND) submissions and 15 regulatory
approvals. Prior to New World Laboratories, Dr. Salinas held
leadership positions in R&D at several companies including
Executive Vice President, R&D and Chief Scientific Officer at
Shire; Executive Vice President, Head of Development and Chief
Medical Officer at Elan Pharmaceuticals; Vice President, Head of
Worldwide CNS Product Development at Wyeth and Head of R&D at
several small pharmaceutical and biotechnology companies. Dr.
Salinas received his M.D. from the University of Buenos Aires,
completed his residency in Psychiatry at the Clinique des Maladies
Mentales et de l'Encéphale, Paris and obtained his Master’s degree
in Pharmacology from the Université Pierre et Marie Curie, Academie
de Paris.
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 has
developed and is commercializing the first and only medicine
approved for the treatment of hallucinations and delusions
associated with Parkinson’s disease psychosis. In addition, ACADIA
has ongoing clinical development efforts in additional areas with
significant unmet need, including dementia-related psychosis,
schizophrenia inadequate response, schizophrenia-negative symptoms,
major depressive disorder and Rett syndrome. This press release and
further information about ACADIA can be found at:
www.acadia-pharm.com.
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 NUPLAZID. 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. 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, 2017 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)
WARNING: 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.
Contraindication: NUPLAZID is contraindicated in patients with a
history of a hypersensitivity reaction to pimavanserin or any of
its components. Rash, urticaria, and reactions consistent with
angioedema (e.g., tongue swelling, circumoral edema, throat
tightness, and dyspnea) have been reported.
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: Coadministration with strong CYP3A4
inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce
NUPLAZID dose to 10 mg taken orally as one tablet once daily.
Coadministration with strong CYP3A4 inducers may reduce NUPLAZID
exposure. Monitor patients for reduced efficacy and an increase in
NUPLAZID dosage may be needed.
Pediatric Use: Safety and efficacy have not been established in
pediatric patients.
Dosage and Administration: Recommended dose: 34 mg taken orally
once daily, without titration.
NUPLAZID is available as 34 mg capsules, 17 mg tablets and 10 mg
tablets.
For additional Important Safety Information, including Boxed
WARNING, please see the full Prescribing Information for NUPLAZID
at
https://www.NUPLAZID.com/pdf/NUPLAZID_Prescribing_Information.pdf
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180926005228/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Elena Ridloff,
CFA(858) 558-2871ir@acadia-pharm.comorMedia Contact:Taft
CommunicationsBob Laverty(609)
558-5570bob@taftcommunications.com
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