Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Day (May 2008)
64 slides from Vanda Pharmaceuticals's investor day presentation, May 7, 2008
Slide 1: Analyst and Investor Day
Vanda Pharmaceuticals Inc. Analyst and Investor Day American Psychiatric Association Annual Meeting May 6, 2008 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to our financial condition, results from operations and business, and our expectations and beliefs about future events. Actual resu
Slide 3: Introduction & Overview
Introduction & Overview Mihael H. Polymeropoulos, MD Chief Executive Officer 5
Slide 4: Agenda
Agenda 6:30 pm Introduction and Overview Mihael H. Polymeropoulos, MD - CEO 6:40 pm Physician Perspective Peter J. Weiden, MD Andrew J. Cutler, MD 7:15 pm Fanapta(tm) Commercialization Strategy Al W. Gianchetti, SVP and CCO 7:25 pm Tasimelteon Overview Paolo Baroldi, MD, PhD - CMO 7:35 pm Conclusion
Slide 5: Vanda Today
Vanda Today Two late-stage product candidates targeting large, unmet medical needs: Fanapta(tm) (iloperidone) - schizophrenia (NDA) Tasimelteon (VEC-162) - sleep and mood disorders (Phase III and II) Significant near-term milestones Fanapta(tm) PDUFA action date expected on or about July 27, 2008 Ta
Slide 6: Fanapta Overview
Fanapta(tm) Overview Significant commercial opportunity Substantial unmet treatment needs remain New Drug Application filed with FDA Data from 35 clinical trials More than 3,000 patients treated Unique pharmacogenetics opportunity PDUFA action date expected on or about July 27, 2008 11
Slide 7: Tasimelteon Overview
Tasimelteon Overview Novel mechanism of action for multiple indications Treatment for significant unmet medical need Demonstrated effect on circadian rhythm Phase III data for treatment of patients with chronic insomnia expected in June, 2008 13
Slide 8: Physician Perspective
Physician Perspective Peter J. Weiden, MD Center for Cognitive Medicine University of Illinois at Chicago Chicago, IL 15
Slide 9: Introduction
Introduction Efficacy and tolerability limitations of available antipsychotic agents are well known Additional safe and effective treatment options are needed for patients with schizophrenia ILP3101 represents the most recent Phase III study of iloperidone for the treatment of schizophrenia Ziprasid
Slide 10: NR4-078 Efficacy of Iloperidone in Placebo- and Ziprasidone-Controlled Trial
NR4-078 Efficacy of Iloperidone in a Placebo- and Ziprasidone-Controlled Clinical Trial for the Treatment of Schizophrenia Peter J. Weiden, MD1; Curt D. Wolfgang, PhD2 1Center for Cognitive Medicine, University of Illinois at Chicago, Chicago, IL; 2Vanda Pharmaceuticals Inc., Rockville, MD 19
Slide 11: NR4-046 Safety and Tolerability of Iloperidone
NR4-046 Safety and Tolerability of Iloperidone in a Placebo- and Ziprasidone-Controlled Clinical Trial for the Treatment of Schizophrenia Jennifer Hamilton, MS1; Leslie Citrome, MD, MPH2; Curt D. Wolfgang, PhD1; Paolo Baroldi, MD, MPH1 1 Vanda Pharmaceuticals Inc., Rockville, MD; 2 New York Universi
Slide 12: Study Objectives
Study Objectives To characterize the efficacy of iloperidone 24 mg/d (12 mg BID) and ziprasidone 160 mg/d (80 mg BID) compared with placebo over 28 days of treatment To evaluate and characterize the safety and tolerability of iloperidone in the treatment of acute schizophrenia compared with placebo
Slide 13: Methodology
Methodology Prospective, randomized, double-blind, placebo- and active comparator-controlled, multicenter in-patient study at 35 centers in the US and 9 in India Treatments: fixed BID doses for 4 weeks Target dose 7-day titration to target dose Iloperidone: 24 mg/d (12 mg BID) Ziprasidone: 160 mg/d
Slide 14: Efficacy
Efficacy APA Poster No. NR4-078 27
Slide 15: Efficacy
Efficacy Efficacy APA Poster No. NR4-078 29
Slide 16: Adverse Events
Adverse Events Adverse Events APA Poster No. NR4-046 31
Slide 17: Metabolics
Metabolics Metabolics APA Poster No. NR4-046 33
Slide 18: Akathisia (ESRS and BAS)
Akathisia (ESRS and BAS) APA Poster No. NR4-046 35
Slide 19: Conclusions - Efficacy
Conclusions - Efficacy Iloperidone 24 mg/d (12 mg BID) was more effective than placebo in the short term treatment of acute schizophrenia Iloperidone was effective for both positive and negative symptom domains Across parameters measured, the overall efficacy of iloperidone appears to be numerically
Slide 20: Conclusions - Safety and Tolerability
Conclusions - Safety and Tolerability Iloperidone 24 mg/d (12 mg BID) was well-tolerated and showed favorable extrapyramidal, akathisia, and metabolic profiles in this short-term, 28-day study Modest weight increase seen in iloperidone-treated patients was not associated with clinically meaningful i
Slide 21: Extrapyramidal Symptom and Akathisia Profile of Iloperidone
917 Extrapyramidal Symptom and Akathisia Profile of Iloperidone in Phase III Schizophrenia Clinical Trials Peter J. Weiden, MD1; Rosarelis Torres, PhD2 1Center for Cognitive Medicine, University of Illinois at Chicago, Chicago, IL; 2Vanda Pharmaceuticals Inc., Rockville, MD 41
Slide 22: Introduction and Methodology
Introduction and Methodology Antipsychotic-induced akathisia and EPS have been associated with: Morbidity Treatment nonadherence Lack of response Suicide EPS and akathisia assessed in a pooled analysis of iloperidone data from 4 short-term, Phase III, double- blind, placebo-controlled clinical trial
Slide 23: EPS Adverse Events
EPS Adverse Events SOBP Poster No. 917 45
Slide 24: Akathisia Adverse Events
Akathisia Adverse Events SOBP Poster No. 917 47
Slide 25: Akathisia (BAS)
Akathisia (BAS) Akathisia (BAS) SOBP Poster No. 917 49
Slide 26: Conclusions
Conclusions Iloperidone treatment demonstrated low rates of treatment emergent EPS and akathisia, comparable to placebo The movement disorders profile supports the use of iloperidone as a new therapeutic option in schizophrenia 51
Slide 27: Physician Perspective
Physician Perspective Andrew J. Cutler, MD Florida Clinical Research Center Maitland, FL 53
Slide 28: Introduction
Introduction Atypical antipsychotics are a significant advancement but nonetheless hampered by: Limited efficacy and tolerability The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study underscored the limitation of current treatment: 74% overall discontinuation at 18 months 15
Slide 29: The Metabolic Profile of Iloperidone: Summary of Phase III Trials
890 The Metabolic Profile of Iloperidone: Summary of Phase III Schizophrenia Trials Andrew J. Cutler, MD1; John Feeney, MD2 1 Florida Clinical Research Center, Maitland, FL; 2Vanda Pharmaceuticals Inc., Rockville, MD 57
Slide 30: NR4-102 Metabolic Profile of Iloperidone
NR4-102 The Metabolic Profile of Iloperidone: Summary of Phase II and Phase III Schizophrenia Trials Stephen M. Stahl, MD, PhD1; Paolo Baroldi, MD PhD2; John Feeney, MD2; Curt D. Wolgang, PhD2 1 University of California, San Diego, La Jolla, CA; 2Vanda Pharmaceuticals Inc., Rockville, MD 59
Slide 31: Iloperidone Trials Safety Database
Iloperidone Trials Safety Database Pooled data from 4,838 adults with schizophrenia in nine Phase II and III double-blind or open-label trials Mean changes between baseline and end of treatment summarized for: Body weight Blood glucose Total cholesterol Triglycerides Prolactin level 61
Slide 32: Weight Changes
Weight Changes APA Poster No. NR4-102 63
Slide 33: Metabolic Parameters
Metabolic Parameters APA Poster No. NR4-102 65
Slide 34: Conclusions
Conclusions Four to six weeks of treatment with iloperidone resulted in a modest increase in mean body weight Favorable short-term metabolic profile for iloperidone regarding blood glucose, cholesterol, and triglycerides No meaningful increase in prolactin levels 67
Slide 35: NR4-093 Iloperidone versus Haloperidol Long-Term Maintenance
NR4-093 Iloperidone versus Haloperidol as Long-Term Maintenance Treatment for Patients with Schizophrenia or Schizoaffective Disorder Rosarelis Torres, PhD1; Henry A. Nasrallah, MD2; Paolo Baroldi, MD, PhD1 1 Vanda Pharmaceuticals Inc., Rockville, MD; 2University of Cincinnati College of Medicine, D
Slide 36: NR4-024 Long-Term Safety of Iloperidone versus Haloperidol
NR4-024 Long-Term Safety of Iloperidone versus Haloperidol for Patients with Schizophrenia or Schizoaffective Disorder Curt D. Wolgang, PhD; Jennifer Hamilton, MS; Paolo Baroldi, MD, PhD Vanda Pharmaceuticals Inc., Rockville, MD 71
Slide 37: Pooled Iloperidone Studies
Data pooled from 3 iloperidone prospective, randomized, multicenter, double-blind, flexible-dose, parallel-group studies Prospectively designed to be pooled Initial 6-week double-blind phase followed by 46-week long-term double-blind phase Iloperidone dose range 4-16 mg once daily (median dose = 12
Slide 38: Pooled Iloperidone Studies (Cont'd)
Patients were included in efficacy analysis if they completed initial 6-week phase with: Reduction in PANSS-T score ^20% at weeks 4 & 6 vs. baseline CGI-C score <4 Took ^1 dose of long-term, double-blind study medication Had ^1 efficacy assessment during the long-term, double-blind phase Primary eff
Slide 39: Time to Relapse (TtR)
Time to Relapse (TtR) APA Poster No. NR4-093 77
Slide 40: PANSS and BPRS Scores at Weeks
PANSS and BPRS Scores at 52 Weeks APA Poster No. NR4-093 79
Slide 41: Adverse Events during Long-Term Maintenance
Adverse Events during Long-Term Maintenance APA Poster No. NR4-024 81
Slide 42: Efficacy and Safety
Efficacy and Safety Iloperidone was demonstrated to be non-inferior in Time to Relapse (TtR) as compared to haloperidol in this long- term maintenance study Treatment with iloperidone appeared safe and well- tolerated for long-term treatment Iloperidone has a favorable EPS and akathisia profile, whi
Slide 43: Fanapta Commercialization Strategy
Fanapta(tm) Commercialization Strategy Al W. Gianchetti Senior Vice President and Chief Commercialization Officer 85
Slide 44: Fanapta Status
Fanapta(tm) Status Key short-term milestones PDUFA action date expected on or about July 27, 2008 Currently targeting launch in Q1, 2009 Compelling clinical profile Commercialization efforts underway pre-PDUFA action 87
Slide 45: Approved Atypical Antipsychotics
Approved Atypical Antipsychotics Source: IMS HEALTH National Sales Perspectives (2007), Vanda calculations 1Reflects Moving Annual Target (Dec '06 - Dec '07) Approved Products Company US Launch Year 2007 US Revenue ($MM) 2007 US Y-o-Y Growth Seroquel(r) AstraZeneca 1997 3,256 13.2% Risperdal(r) J&J
Slide 46: Atypical Drug Selection Factors
Question. Please rate each of the statements using a scale of 1-10 on importance to you when selecting an antipsychotic therapy for your schizophrenia patients. (130 respondents) Risk of prolactin elevation Availability of long-acting formulation Risk of QT prolongation Somnolent effects QD dosing F
Slide 47: Perceptual Map: Driven by Movement and Metabolics
Adverse Lipid Effects Weight Gain Adverse Glucose Effects Onset of EPS Onset of Akathisia Efficacy Source: GfK V2 Qualitative Positioning Study, January 2008. Perceptual Map: Driven by Movement and Metabolics Physicians differentiate atypicals more on side effect profile than on efficacy 93
Slide 48: Compelling Clinical Profile of Fanapta
Compelling Clinical Profile of Fanapta(tm) Similar Efficacy Favorable Metabolic Profile Favorable Movement Disorder Profile Geodon(r) Abilify(r) Invega(r) Risperdal(r) Seroquel(r) Zyprexa(r) 95
Slide 49: Key Areas of Launch Preparation
Key Areas of Launch Preparation Launch Preparation Sales Force MSLs Managed Care Distribution Marketing 97
Slide 50: Marketing Efforts Underway
Marketing Efforts Underway Marketing team build-out Messaging and positioning Brand development Publication planning and execution Packaging design Psychiatric community outreach Conference attendance 99
Slide 51: Sales Force Development
Sales Force Development Hire VP of sales Territory mapping Plan sales force scenarios Managers/reps: if Vanda builds its own sales force CSO: if Vanda engages outside sales force Hire or engage sales force Source: Verispan Deciles Antipsychotic MDs Depression MDs Insomnia MDs 10 721 3,418 3,370 10-8
Slide 52: Managed Care Strategy
Managed Care Strategy IMS, Atypical managed care analysis, Q42006 Vanda believes a small managed care sales organization can effectively ensure Fanapta(tm) coverage Hire VP of managed care Payer profiling Develop pricing and contracting strategy Plan, engage managed care field force Execute on contr
Slide 53: Distribution Organization
Distribution Organization Engage 3rd party logistics agency Responsible for getting product to the trade Applying for state licenses Continue outsource strategy Contract manufacturer 3rd Party Logistics Contract packaging Role of 3rd Party Logistics Coordinator National wholesalers Regional wholesal
Slide 54: Tasimelteon Overview
Tasimelteon Overview Paolo Baroldi, MD, PhD Chief Medical Officer 107
Slide 55: Distinct MoA Demonstrated in Wide Range of Indications
Distinct MoA Demonstrated in Wide Range of Indications Balanced melatonin-1, melatonin-2 agonist Sleep induction Sleep maintenance Circadian rhythm advance Sleep onset insomnia Sleep maintenance insomnia Circadian rhythm sleep disorders Seasonal Affective Disorder Major Depression MoA Effect Potenti
Slide 56: Significant Unmet Medical Need
Significant Unmet Medical Need Sleep induction Sleep maintenance Circadian rhythm modulation Sleep onset insomnia Sleep maintenance insomnia Circadian rhythm sleep disorders US prevalence 54 million 18 million Approved drugs/drug classes NBZDs (Ambien(r) CR, Lunesta(r), etc.) BZDs (lorazepam, etc.)
Slide 57: Circadian Rhythm Sleep Disorders
CRSD Circadian Rhythm Sleep Disorders Shift Worker Sleep Disorder Delayed Sleep Phase Syndrome Jet Lag Non-24 Hour Sleep/Wake Cycle U.S. Prevalence (000) 1,500 3,000 13,500 50 Tasimelteon Potential Benefits Disease-modification (CR modulation) Demonstrated efficacy in sleep disorders Long-term safet
Slide 58: Mood Disorders
Mood Disorders Circadian Rhythm- Related Mood Disorders Seasonal Affective Disorder Major Depression U.S. Prevalence (000) 5,800 14,700 Disease-modification (CR modulation) Long-term safety Sleep benefits Source: LEK, 2005 Tasimelteon Potential Benefits 115
Slide 59: Pending Tasimelteon Phase III Milestone
Pending Tasimelteon Phase III Milestone Objective Safety and efficacy in treatment of patients with chronic insomnia Duration 35 days (including screening) Dosing 20, 50 mg QD Comparator Placebo # of Patients 324 Key Endpoints LPS, WASO, safety Results expected in June 2008 Tasimelteon previously de
Slide 60: Substantial Development Program Underway
Substantial Development Program Underway Phase III transient insomnia Completed Phase III chronic insomnia Process refinement Completion expected in 08 Carcinogenicity Clinical Preclinical Manufacturing Clinical pharmacology Clinical scale-up In planning stage Commercial scale-up Driving, DEA schedu
Slide 61: Conclusion
Conclusion 121
Slide 62: Summary
Summary Two late-stage product candidates with significant market opportunities Both products have significant milestones upcoming: Fanapta(tm) - PDUFA action date expected on or about July 27, 2008 Tasimelteon - Phase III data expected in June, 2008 Pre-launch commercial activities are ongoing 123
Slide 63: Q&A
Q&A 125
Slide 64: Analyst and Investor Day
Vanda Pharmaceuticals Inc. Analyst and Investor Day American Psychiatric Association Annual Meeting May 6, 2008 127