Serge Stankovic
Analyst · J.P. Morgan. Your line is now open
Thank you, Steve. It is always so gratifying to hear the impact NUPLAZID can have on the lives of patients and their caregivers. As we continue to evaluate the benefits of pimavanserin as a potential treatment in number of new indications, safety remains front and center and has always been a primary focus of our activities. NUPLAZID was approved by the FDA based on the pivotal Phase 3 study that demonstrated clinically robust and highly statistically significant efficacy, along with supportive data from other clinical studies. We are confident in NUPLAZID's efficacy and positive risk profile and stand firmly behind it. Since, approval and launch in 2016, ACADIA has monitored NUPLAZID’s safety throughout this period in robust of pharmacovigilance activities. We're also continuously evaluating the benefits and risks of pimavanserin treatment in our ongoing clinical studies, both in placebo-controlled and the open-label long-term safety trials. Based on this ongoing evaluations and the totality of currently available information, we maintain our assessment that the benefit risk profile for NUPLAZID remains unchanged and it is appropriately described in the product labeling. We base this on the following: first, placebo-controlled studies completed after NUPLAZID approval revealed no new or changed safety information. In addition, in controlled clinical studies in an aggregate of approximately 300 frail elderly patients with Alzheimer's disease, there was no difference in the number of deaths reported between NUPLAZID and placebo; second, our postmarketing safety reviews and signal-detection analysis of serious and fatal adverse events did not identify the presence of any common etiology or underlying pathophysiological mechanism that would lead to the conclusion of a causal relationship to NUPLAZID. The reported deaths remain consistent with the patient's advanced age, medical conditions and comorbidities; and third, the morbidity and mortality rates we observed in pimavanserin clinical studies and from the NUPLAZID postmarketing safety database are reassuring when put in context of comparable literature data and large insurance data sets of other PD Psychosis patients. Some recent media reports around NUPLAZID having correctly extrapolated a causal relationship between NUPLAZID and postmarketing adverse event information reported to the FDA, which is reflected in a database known as the FDA Adverse Event Report System, or FAERS, for short. The FAERS data alone is not an indicator of the safety profile of any drug or biologic. As the FDA explains on its website, while the FAERS database contains reports on adverse events that occur while a patient is on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Further, the FAERS database does not contain any information underlying exposure to a particular drug or about adverse events collection methodology. So it is not possible to understand, draw reliable inferences or make appropriate comparisons between products based on this information alone. For instance, number reported for NUPLAZID are better understood if we consider that NUPLAZID is distributed through a specialty distribution channel, through which there is a frequent and direct contact with patients and caregivers. Approximately 93% of reported adverse events associated with NUPLAZID are coming from this direct interaction and therefore are considered solicited. On the other hand, only approximately 7% of NUPLAZID adverse event reports are voluntary reports originating and prompted from consumers or health care professionals and therefore are considered spontaneous. In contrast, most other drugs are distributed through retail channel, which rely almost entirely on spontaneous reporting. Increased interaction with patients and caregivers results in a significantly higher number of adverse event reports compared to products not distributed this way. As a result, it is not appropriate to simply compare or otherwise draw conclusions based on a raw number of reports. In response to recent media reports, the FDA stated that based on the information to-date, it had not identified a specific safety issue that is not already adequately described in the product label. The FDA also indicated that they were performing an evaluation of emerging safety information. We have already and will continue to respond to all requests for additional information from the agency to facilitate their evaluation as part of their track safety issue process. To repeat what the FDA has stated in the response to press inquiries, this evaluation does not mean that FDA has concluded that the drug has a new risk and the FDA is not suggesting that healthcare providers should stop prescribing drug or that patients taking the drugs should stop taking the medication while the evaluation is being conducted. I would also like to remind you of the benefit that NUPLAZID offers to patients suffering from debilitating symptoms of Parkinson's disease psychosis. Our pivotal Phase 3 study showed approximately 74% of patients show some improvement on psychosis and 14% experienced complete response. Additionally, patient's overall show no negative impact on motor symptoms. Let's now turn to updates on new potential indications for pimavanserin. We're advancing four late-stage development programs in CNS areas, where there are either no approved treatments or there is a strong need for treatment options. As a selective serotonin inverse agonist, pimavanserin may provide a new approach to treating these debilitating conditions. I will now provide a brief update on each of these studies. First, dementia-related psychosis, a serious medical condition for which there is no FDA-approved treatment. Studies suggest that approximately 30% of patients with dementia have psychosis, commonly consisting of hallucinations and delusions. Serious consequences have been associated with severe or persistent psychosis in patients with dementia and medications that are currently used off-label to treat dementia related psychosis have been shown to impair cognition in this already impaired population. We initiated our Phase 3 HARMONY study in dementia-related psychosis in the fourth quarter of 2017 and continued to make excellent progress with respect to both opening global study sites and patient enrollment. Tremendous initial interest for the study by the investigator has translated in solid enrollment numbers in this first few months of the trial. We are very much on plan with this study and look forward to updating you on our continued progress. Second, schizophrenia inadequate response. According to American Psychiatric Association, about 30% of patients with schizophrenia have inadequate response to antipsychotic medications, meaning that they exhibit improvement, but continue to have residual hallucinations or delusions. We continue to make progress with this study and expect results to read out next year. Third, schizophrenia-negative symptoms. There is currently no drug approved to treat symptoms of schizophrenia. Studies show that about 40% to 50% of schizophrenia patients suffer from prominent negative symptoms. Because currently available antipsychotic treatments for schizophrenia target positive symptoms, most patients remain functionally impaired, because of negative symptoms, cognitive deficit and limited social functioning. We continue to make progress with this study and expect readout results next year. And fourth, major depressive disorder. MDD is a leading cause of disability for ages 15 to 44. The majority of people who suffer from MDD do not respond to initial antidepressant therapy. As Steve stated earlier, we plan to announce top-line results from our Phase II study in MDD in the second half of this year. I will now turn the call to Michael to discuss our commercial performance.