Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Corporate Update (December 2021)
18 slides from Acadia Pharmaceuticals's corporate update, Dec 21, 2021
Slide 1: Regulatory Update on sNDA for NUPLAZID (pimavanserin)
Exhibit 99.2 Regulatory Update on sNDA for ® NUPLAZID (pimavanserin) December 20, 2021
Slide 2: Call Agenda
Call Agenda Introduction Mark Johnson | Vice President, Investor Relations CEO Opening Remarks Steve Davis | Chief Executive Officer Regulatory Update Serge Stankovic, M.D., M.S.P.H | President CEO Closing Remarks Steve Davis | Chief Executive Officer Also available for Q&A: Mark Schneyer | Chief Fi
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future r
Slide 4: CEO Opening Remarks
CEO Opening Remarks Steve Davis CEO
Slide 5: sNDA Resubmission for Pimavanserin
sNDA Resubmission for Pimavanserin Resubmission focused on Alzheimer’s Disease Psychosis (ADP) • ADP represents the majority of DRP patients and is the largest dementia subgroup • Efficacy demonstrated across clinical studies and endpoints: • Improvement of psychosis symptoms and reduction of relaps
Slide 6: Timeline from CRL to Resubmission
Timeline from CRL to Resubmission 2Q21: Complete Response Letter (CRL) regarding the sNDA in dementia-related psychosis 3Q21: Type A, End of Review Meeting • FDA stated they would evaluate pimavanserin by individual subgroups of dementia • Acadia presented additional analyses to demonstrate consiste
Slide 7: Regulatory Update
Regulatory Update Serge Stankovic President
Slide 8: Alzheimer's Disease Psychosis
Alzheimer’s Disease Psychosis 1 Alzheimer’s Disease Psychosis (ADP) : • There are >6M Alzheimer’s patients in the U.S., representing 60 – 80% of all dementia patients • ~30% (>1.8M patients in the U.S.) experience psychosis • ~50% of ADP patients diagnosed • No approved treatments for ADP ADP repres
Slide 9: HARMONY Study: Alzheimer's Disease Subgroup
HARMONY Study: Alzheimer’s Disease Subgroup 1 HARMONY Study Pimavanserin showed consistent and clinically meaningful reduction in risk of psychosis relapse in AD subgroup (~40% reduction) Overall AD Subgroup Examples of analyses for HARMONY Open-label portion of study (12 weeks) supporting antipsych
Slide 10: HARMONY Study: Responder Analysis
HARMONY Study: Responder Analysis Worsening (point changes on SAPS) Worsening (point changes on SAPS) Worsening (point changes on SAPS) Worsening (point changes on SAPS) For subjects who never worsened from Baseline (i.e., improved during double-blind phase), their maximum worsening score was set to
Slide 11: HARMONY Study: Exposure-Response Relationship
HARMONY Study: Exposure-Response Relationship Relative Risk of Relapse • Exposure-Response relationship indicator of true drug effect vs. spurious finding ADP DRP (N=123) (N=194) • Higher pimavanserin exposure associated with decreased relapse rate • Very consistent improvement in ADP subgroup, simi
Slide 12: HARMONY Study: Consistent Efficacy Observed Across Dementia Subgroups
HARMONY Study: Consistent Efficacy Observed Across Dementia Subgroups • Similar levels of efficacy observed across subgroups in the open-label period • Observed consistently low relapse rates across subgroups in the double-blind randomized period • PDD response only different in response of patients
Slide 13: Study -019: Primary Efficacy and Responder Analyses
1,2 Study -019 : Primary Efficacy and Responder Analyses -5.72 -10.15 NPI – NH PS = Neuropsychiatric Inventory – Nursing Home Version Psychosis Score; LSM = least squares mean; MMRM = mixed – effect model repeated measures. *Nominal p-value (exploratory). 1 2 Ballard C, et al. Lancet Neurol. 2018;17
Slide 14: Study -019: Providing Independent Evidence of Efficacy in ADP
Study -019: Providing Independent Evidence of Efficacy in ADP In the resubmission Acadia plans to address FDA’s concerns outlined in CRL • Study -019 contributes to substantial evidence of efficacy Study -019 was a randomized, double-blind, placebo-controlled study that met its pre-specified, primar
Slide 15: CEO Closing Remarks
CEO Closing Remarks Steve Davis CEO
Slide 16: sNDA Resubmission for Pimavanserin
sNDA Resubmission for Pimavanserin Resubmission focused on Alzheimer’s Disease Psychosis (ADP) • ADP represents the majority of DRP patients and is the largest dementia subgroup • Efficacy demonstrated across clinical studies and endpoints: • Improvement of psychosis symptoms and reduction of relaps
Slide 17: Program Development Pipeline
Program Development Pipeline Program Indication Phase 1 Phase 2 Phase 3 Marketed ® NUPLAZID Parkinson’s Disease 1 Psychosis (pimavanserin) Alzheimer’s Disease 2 Pimavanserin Psychosis 3 Rett Syndrome Trofinetide Negative Symptoms of Pimavanserin Schizophrenia Postoperative Pain ACP-044 Osteoarthriti
Slide 18: Q&A Session
C) ACADIA Q&A Session
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