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 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 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.
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
