ACADIA Pharmaceuticals Reports First Quarter 2016 Financial Results
“We are very excited about the recent
ACADIA reported a net loss of
Research and development expenses increased to
General and administrative expenses increased to
Conference Call and Webcast Information
ACADIA management will review its first quarter financial results and
operations via conference call and webcast later today at
About NUPLAZID™ (pimavanserin)
NUPLAZID is the first
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 e-mail alerts.
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 ACADIA’s plans to make NUPLAZID
commercially available in
|ACADIA PHARMACEUTICALS INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
(in thousands, except per share amounts)
|Three Months Ended|
|Research and development||22,775||16,295|
|General and administrative||27,491||24,261|
|Total operating expenses||50,266||40,556|
|Loss from operations||(50,262||)||(40,552||)|
|Interest income, net||500||177|
|Net loss per common share, basic and diluted||$||(0.45||)||$||(0.40||)|
|Weighted average common shares outstanding, basic and diluted||111,346||100,197|
|ACADIA PHARMACEUTICALS INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash, cash equivalents and investment securities||$||457,243||$||215,132|
|Prepaid expenses, receivables and other current assets||5,109||3,857|
|Total current assets||462,352||218,989|
|Other non-current assets||3,863||2,532|
|Liabilities and stockholders’ equity|
|Total liabilities and stockholders’ equity||$||466,590||$||221,896|
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.
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.
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.
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ACADIA Pharmaceuticals Inc.
Taft and Partners