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 Damien McDevitt, Ph.D., has joined ACADIA as Senior Vice President, Corporate Development, leading the company’s corporate development activities. He will report to Steve Davis, ACADIA’s President and Chief Executive Officer.
“We are thrilled to welcome Damien to the team,” said Steve Davis. “Damien has extensive experience in business development, licensing and strategic partnering, and he has completed dozens of value-creating transactions. This expertise, combined with his strong strategic and technical background, will be of great value as we continue to explore the potential for expanding our CNS portfolio.”
Dr. McDevitt joins ACADIA after more than two decades at GlaxoSmithKline plc, where he was at the forefront of the R&D externalization effort, and involved in more than 70 global business development transactions spanning a variety of therapeutic areas, including neuroscience. Most recently, he was Vice President, Head of Business Development for R&D Extended Therapy Areas, Head of Worldwide Business Development Asia, and head of the company’s R&D West Coast Satellite. Prior to that, Dr. McDevitt held positions with increasing responsibility within Worldwide Business Development, GSK Ventures and Anti-Infectives Discovery. Dr. McDevitt attended Trinity College in Dublin, Ireland, where he earned his Ph.D. and his undergraduate degree, both in Microbiology. He is an author of 70 scientific publications and published patents.
ACADIA also announced that Jim Nash, Senior Vice President, Technology Development and Operations, will be retiring from the company as of January 2018. Bob Mischler, formerly Senior Vice President, Strategy and Business Development, will assume responsibilities for technology development and operations in addition to continuing his strategy responsibilities in the new role of Senior Vice President, Strategy and Technology Operations.
“We thank Jim for his significant contributions over the past several years,” said Mr. Davis. “Under his leadership, ACADIA expanded its manufacturing, pharmaceutical development and GMP quality assurance operations, all of which were critical to the approval and commercialization of NUPLAZID. We wish Jim well in his retirement.”
About NUPLAZID® (pimavanserin)
NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis (PD Psychosis). NUPLAZID is a non-dopaminergic, selective serotonin inverse agonist preferentially targeting 5-HT2Areceptors that are thought to play an important role in PD 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.
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 (pimavanserin) and the potential expansion of ACADIA’s CNS portfolio. 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 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, 2016 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) 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.
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: 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 https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.
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