Pfizer, Inc. · NYSE:PFE
Pfizer — Technical Presentation (June 2020)
20 slides from Pfizer's technical presentation, Jun 18, 2020
Slide 1: Analyst and Investor Call to Review Presentations of Hemophilia A Gene Therapy at WFH and Oral GLP-1R Agonist at ADA
Analyst and Investor Call to Review Presentations of Hemophilia A Gene Therapy at WFH and Oral GLP-1R Agonist at ADA June 18, 2020 1
Slide 2: Disclaimer
Disclaimer This presentation includes forward-looking statements about, among other things, Pfizer’s Rare Disease and Internal Medicine products and product candidates, including, among others, Giroctocogene fitelparvovec (SB-525), Marstacimab and our investigational oral GLP-1RA agonist (PF-0688296
Slide 3: Introductory Remarks
Introductory Remarks Mikael Dolsten, M.D., Ph.D. Chief Scientific Officer and President, Worldwide Research, Development, and Medical 3
Slide 4: Hemophilia A Gene Therapy Presentation at WFH
Hemophilia A Gene Therapy Presentation at WFH Seng Cheng, Ph.D. Chief Scientific Officer and Senior Vice President, Rare Disease 4
Slide 5: Multiple Pathways to Treat the Spectrum of Hemophilia Patients
Multiple Pathways to Treat the Spectrum of Hemophilia Patients Transformative Periods in Hemophilia Treatment Targeting Multiple Pathways 1960’s 1990’s 2000’s 2014 2020’s Transformative Incremental Transformative Plasma- Extended Half Life Bleeding Recombinant Factor (Short Half Life) Non-Factor Age
Slide 6: Marstacimab: Promising Ph2 and Long-Term Results With Weekly Subcutaneous Flat Dose
PF-06741086 PF-06741086: Marstacimab Promising Ph2 and Long-Term Results With Weekly Subcutaneous Flat Dose in Both Hemophilia A and B Patients +/- Inhibitors Ph2 and Long Term Extension Study 30 Pre-treatment On Study 25 ABR (80% CI) 20 15 10 5 0 150mg (n=14) 300mg (n=12) Exposure days Median (min,
Slide 7: Giroctocogene fitelparvovec (SB-525) Gene Therapy for Hemophilia A
Giroctocogene fitelparvovec (SB-525) Gene Therapy for Hemophilia A • Alta is a phase 1/2 dose-ranging, single-dose, Key exclusion criteria multicenter study to assess the safety and tolerability of giroctocogene fitelparvovec (SB-525) • Neutralizing activity to AAV6 capsid and/or inhibitor in adult
Slide 8: Safety Summary: Cohort (3x10^13 vg/kg)
Safety Summary: Cohort 4 (3x1013 vg/kg) • 1 subject had a treatment-related serious adverse event (SAE) of grade 3 hypotension and grade 2 fever, with symptoms of headache and tachycardia occurring ≈6 hours after completion of the vector infusion, with resolution ≈12 hours postinfusion • No addition
Slide 9: Efficacy: Cohort (3E13 vg/kg)
Efficacy: Cohort 4 (3E13 vg/kg) FVIII Activity as measured at Central Laboratory with Chromogenic Assay 200 – 175 – SUBJECT Factor VIII Activity (% normal) 150 – 7 8 125 – 9 100 – 10 11 75 – 50 – 25 – 0– 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56 58 60 62 64 St
Slide 10: Efficacy: Cohort (3E13 vg/kg) Box-Whisker Plot
Efficacy: Cohort 4 (3E13 vg/kg) Box-Whisker Plot of Factor VIII Activity for Cohort 4 (3E13 vg/kg) CHROMOGENIC 300 – 50% Factor VIII activity (Lower bound of Normal) N=5 Patients N=4 250 – (Up to Wk 36) (Up to Wk 28) Mean Factor VIII activity value Factor VIII Activity from Week 9 to Week 36 200 – (
Slide 11: Conclusions
Conclusions • Cohort 4 (3e1013 vg/kg): • With follow-up ranging 30 to 61 weeks, data continues to show that giroctocogene fitelparvovec (SB- 525) is generally well tolerated • Sustained FVIII activity levels • No use of exogenous FVIII beyond week 3 post infusion • No bleeding events • 1 treatment r
Slide 12: Oral GLP-1R Agonist PF-06882961 Presentation at ADA
Oral GLP-1R Agonist PF-06882961 Presentation at ADA Morris Birnbaum, M.D., Ph.D. Chief Scientific Officer, Internal Medicine 12
Slide 13: Our Internal Medicine R&D Strategy Seeks to Address the Increasing Global Impact of the Dysmetabolic State
Our Internal Medicine R&D Strategy Seeks to Address the Increasing Global Impact of the Dysmetabolic State We are driving innovation for cardiometabolic patients who often suffer from multiple diseases that share common origins in dysregulated metabolism NASH emerging as #1 indication for liver tran
Slide 14: Emerging Pipeline with Multiple Novel MOAs Addressing Cardiometabolic Conditions
Emerging Pipeline with Multiple Novel MOAs Addressing Cardiometabolic Conditions NASH Cardiovascular T2DM/Obesity Cachexia Additional In line Phase 3 Tanezumab DGAT2 Inhibitor Oral GLP1R Agonist Vupanorsen PF-06885571 PF-06882961 KHK Inhibitor KHK Inhibitor Phase 2 PF-06835919 PF-06835919 ACC / DGAT
Slide 15: Diabetes and Obesity are Highly Prevalent and Drive Global Healthcare Burden
Diabetes and Obesity are Highly Prevalent and Drive Global Healthcare Burden: Significant Potential Opportunity to Bring Benefits of GLP-1RA Class to More Patients in Need Carry Significant Global Epidemics GLP-1RA Class is Currently Underutilized Health that Continue to Rise Consequences US Dollar
Slide 16: Oral Small Molecule GLP-1RA (PF-06882961) Evaluated in Phase 1 Study of Adults with Type 2 Diabetes
Oral Small Molecule GLP-1RA (PF-06882961) Evaluated in Phase 1 Study of Adults with Type 2 Diabetes Mellitus for 4 Weeks Study Objectives & Study Design Overview Endpoints Randomized, double-blind, placebo- controlled, multiple ascending dose Phase 1 study (NCT03538743) Primary Endpoint: • Safety an
Slide 17: PF-06882961 Safety and Tolerability Profile in Study NCT03538743
PF-06882961 Safety and Tolerability Profile in Study NCT03538743 (Primary Endpoint) • Overall safety profile was consistent with the GLP-1RA class • The most frequently reported all-causality adverse events were nausea (49.0%), dyspepsia (32.7%), vomiting (26.5%), diarrhea (24.5%), headache (23.5%)
Slide 18: Study NCT03538743 Demonstrated Substantial Reductions in Glucose, HbA1c and Body Weight
Why We Are Encouraged: Study NCT03538743 Demonstrated Substantial Reductions in Glucose, HbA1c and Body Weight in T2DM Patients Receiving PF-06882961 for 28 Days Observed change from baseline at Day 28 Parameter Baseline PF-06882961 dose BID Placebo 10 mg 15 mg 50 mg 70 mg 120 mg FPG, mg/dL, mean (S
Slide 19: Our Oral Small Molecule GLP-1RA Has the Potential to Improve Treatment of T2DM and Obesity
Our Oral Small Molecule GLP-1RA Has the Potential to Improve Treatment of T2DM and Obesity Promising Early Key Next Steps Future Opportunity Clinical Profile • Robust glycemic efficacy and • Concurrent Phase 2 studies in T2DM & • Oral GLP-1RA may offer more encouraging reductions in HbA1c at Obesity
Slide 20: Q&A Speakers
Mikael Dolsten – Chief Scientific Officer and President, Pfizer Worldwide Research, Development, and Medical Morris Birnbaum – Chief Scientific Officer and Senior Vice President, Internal Medicine Q&A Seng Cheng – Chief Scientific Officer and Senior Vice President, Rare Disease Brenda Cooperstone –