U.S. Commercial Launch Planned for June 2016
An Estimated 40 Percent of Parkinson’s Disease Patients HavePsychosis
Conference Call Scheduled on Monday, May 2 at 8:30 a.m. ET
SAN DIEGO—(BUSINESS WIRE)—Apr. 29, 2016—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesto address unmet medical needs in central nervous system (CNS)disorders, today announced that the U.S. Food and Drug Administration(FDA) has approved NUPLAZID (pimavanserin) for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis. In 2014, the FDA designated NUPLAZID as a BreakthroughTherapy for this condition.
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NUPLAZID™ (pimavanserin) bottle (Photo: Business Wire)
“Today’s approval of NUPLAZID represents a major paradigm shift in thetreatment of Parkinson’s disease psychosis,” said Michael S. Okun, M.D.,Medical Director of The National Parkinson Foundation. “Through itsnovel and selective mechanism of action, NUPLAZID is a breakthroughtreatment that works in a whole new way - treating hallucinations anddelusions without blocking dopamine receptors and, therefore, notimpairing motor function in Parkinson’s psychosis patients.”
NUPLAZID is the first and only medicine to be approved by the FDA forthis indication. NUPLAZID is also the only drug approved by the FDA thatpreferentially targets 5-HT2A receptors. These receptors arethought to play an important role in Parkinson’s disease psychosis. Theunique pharmacology of NUPLAZID establishes a new class of drug -selective serotonin inverse agonists (SSIA) - by not only preferentiallytargeting 5-HT2A receptors but also avoiding activity atdopamine and other receptors commonly targeted by antipsychotics.Typical Parkinson’s disease therapy consists of drugs that stimulatedopamine to treat patients’ motor symptoms such as tremor, musclerigidity and difficulty with walking. NUPLAZID does not interfere withpatients’ dopaminergic therapy and therefore does not impair their motorfunction.
According to the National Parkinson Foundation, about one million peoplein the United States and from four to six million people worldwidesuffer from Parkinson’s disease. An estimated 40 percent of thesepatients have Parkinson’s disease psychosis, which is characterized byhallucinations and delusions, is associated with significant caregiverburden, and is a major reason for nursing home placement amongParkinson’s patients.
“NUPLAZID represents a major medical advancement for patients withParkinson’s disease psychosis who suffer from hallucinations anddelusions,” said Steve Davis, ACADIA’s President and Chief ExecutiveOfficer. “We are grateful to the many patients and investigators whoparticipated in NUPLAZID’s clinical studies. NUPLAZID represents theculmination of many years of work across our entire organization tobring this novel medicine, discovered by our scientists, to patients inneed.”
“Parkinson’s disease psychosis is a debilitating condition that adds atremendous burden on the lives of patients already contending with motorissues such as slow movement, loss of balance, and muscle rigidity,”said Todd Sherer, Ph.D., Chief Executive Officer of the Michael J. FoxFoundation. “It also places an increased burden on caregivers and canlead to loss of independence and nursing home admittance for patients. Atherapy to treat the hallucinations and delusions associated withParkinson’s disease psychosis without worsening motor symptoms cansignificantly impact the lives of Parkinson’s patients and their lovedones.”
Clinical Data
The FDA approval of NUPLAZID was based on data from the pivotal PhaseIII Study -020 and other supportive studies, representing the largestresearch and development program in Parkinson’s disease psychosis todate. In Study -020, NUPLAZID significantly reduced the frequency andseverity of psychotic symptoms compared to placebo on the Scale forAssessment of Positive Symptoms – Parkinson’s Disease (SAPS-PD). Thisbenefit was achieved without impairing motor function. The most commonadverse reactions (≥5% and twice the rate of placebo) in this study wereperipheral edema (7% NUPLAZID vs 3% placebo) and confusional state (6%NUPLAZID vs 3% placebo). Results of Study -020 were published in TheLancet. Please see full prescribing information at www.nuplazid.com.
Introducing NUPLAZIDconnect™ Patient Access and Support Services
ACADIA plans to make NUPLAZID commercially available to patientssuffering from hallucinations and delusions associated with Parkinson’sdisease psychosis in the United States in June 2016. ACADIA is committedto ensuring that patients in the United States who are prescribedNUPLAZID are able to access the medicine and receive the ongoing supportthey may need. ACADIA will be introducing NUPLAZIDconnect, acomprehensive program that provides financial assistance and/or accessassistance to patients, their caregivers, and physicians. NUPLAZID willbe available through a specialty pharmacy network. Patients andphysicians can access information about NUPLAZID and NUPLAZIDconnect byvisiting www.nuplazid.comor calling 844-737-2223.
Important Safety Information and Indication for NUPLAZID(pimavanserin) tablets |
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITHDEMENTIA-RELATED PSYCHOSIS |
Elderly patients with dementia-related psychosis treated withantipsychotic drugs are at an increased risk of death. NUPLAZID isnot approved for the treatment of patients with dementia-relatedpsychosis unrelated to the hallucinations and delusions associatedwith Parkinson’s disease psychosis. |
NUPLAZID is an atypical antipsychotic indicated for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use ofNUPLAZID should be avoided in patients with known QT prolongation or incombination with other drugs known to prolong QT interval includingClass 1A antiarrhythmics or Class 3 antiarrhythmics, certainantipsychotic medications, and certain antibiotics. NUPLAZID should alsobe avoided in patients with a history of cardiac arrhythmias, as well asother circumstances that may increase the risk of the occurrence oftorsade de pointes and/or sudden death, including symptomaticbradycardia, hypokalemia or hypomagnesemia, and presence of congenitalprolongation 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 reducedefficacy. Increase in NUPLAZID dosage may be needed.
Renal Impairment: No dosage adjustment for NUPLAZID is needed inpatients with mild to moderate renal impairment. Use of NUPLAZID is notrecommended in patients with severe renal impairment.
Hepatic Impairment: Use of NUPLAZID is not recommended in patients withhepatic impairment. NUPLAZID has not been evaluated in this patientpopulation.
Pediatric Use: Safety and efficacy have not been established inpediatric patients.
Dosage and Administration: Recommended dose: 34 mg per day, takenorally as two 17 mg tablets once daily, without titration.
Conference Call
ACADIA will hold a conference call and webcast on Monday, May 2, 2016 at8:30 a.m. ET to discuss the FDA approval of NUPLAZID. The conferencecall may be accessed by dialing 844-821-1109 for participants inthe U.S. or Canada and 830-865-2550 for international callers (referencepasscode 3844233). A telephone replay of the conference call may beaccessed through May 16, 2016 by dialing 855-859-2056 for callers in theU.S. or Canada and 404-537-3406 for international callers (referencepasscode 3844233). The conference call also will be webcast live onACADIA’s website, www.acadia-pharm.com,under the investors section and will be archived there until May 16,2016.
About NUPLAZID™ (pimavanserin)
NUPLAZID is the first FDA-approved treatment for hallucinations anddelusions associated with Parkinson’s disease psychosis. NUPLAZID is anon-dopaminergic, selective serotonin inverse agonist preferentiallytargeting 5-HT2A receptors that are thought to play animportant role in Parkinson’s disease psychosis. NUPLAZID is an oralmedicine taken once a day with a recommended dose of 34 mg (two 17 mgtablets). ACADIA discovered this new chemical entity and holds worldwiderights to develop and commercialize NUPLAZID.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin central nervous system disorders. ACADIA maintains a website at www.acadia-pharm.comto which we regularly post copies of our press releases as well asadditional information and through which interested parties cansubscribe to receive e-mail alerts.
Forward-Looking Statements
Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but arenot limited to statements related to the benefits to be derived fromACADIA’s product candidates, including NUPLAZID (pimavanserin); whetherNUPLAZID represents a paradigm shift in the treatment of Parkinson’sdisease psychosis (PDP) patients; whether NUPLAZID is a breakthroughtreatment that works in a whole new way; whether NUPLAZID establishes anew class of drug; whether NUPLAZID represents a major medicaladvancement for PDP patients who suffer from hallucinations anddelusions; whether a therapy to treat the hallucinations and delusionsassociated with PDP without worsening motor symptoms can significantlyimpact the lives of Parkinson’s patients and their loved ones; ACADIA’splans to make NUPLAZID commercially available in the United States,including the timing thereof; whether ACADIA will be able to ensurepatients have access to NUPLAZID; and the assistance that will beavailable to patients, their caregivers and physicians from ACADIA,including through NUPLAZIDconnect. These statements are only predictionsbased on current information and expectations and involve a number ofrisks and uncertainties. Actual events or results may differ materiallyfrom those projected in any of such statements due to various factors,including the risks and uncertainties inherent in drug discovery,development, and commercialization, whether NUPLAZID receives adequatereimbursement from third-party payers, ACADIA’s ability to establish anadequate specialty pharmacy network to distribute NUPLAZID, the degreeto which NUPLAZID receives acceptance from patients and physicians forits approved indication, and the fact that past results of clinicaltrials may not be indicative of future trial results. For a discussionof these and other factors, please refer to ACADIA’s annual report onForm 10-K for the year ended December 31, 2015 as well as ACADIA’ssubsequent filings with the Securities and Exchange Commission. You arecautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. This caution is madeunder the safe harbor provisions of the Private Securities LitigationReform Act of 1995. All forward-looking statements are qualified intheir entirety by this cautionary statement and ACADIA undertakes noobligation to revise or update this press release to reflect events orcircumstances after the date hereof, except as required by law.
Source: ACADIA Pharmaceuticals Inc.
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