Altria Group, Inc. · NYSE:MO
Altria — Technical Presentation (September 2019)
18 slides from Altria's technical presentation, September 2019
Slide 1: 12 Week e-Vapor Switching Study: Biomarkers of Exposure and Potential Harm
An Open-label, Randomized, Parallel Group, Controlled Study to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to Using e-Vapor Products for 12 Weeks Jeff Edmiston, Douglas Oliveri, Qiwei Liang, Mohamadi Sarkar Tobacc
Slide 2: Primary Objective
Primary Objective Compare absolute changes in selected biomarkers from Baseline to End of Study between adult smokers who continue to smoke conventional cigarettes and adult smokers who have completely switched to the test e-vapor products for 12 weeks J. Edmiston | Regulatory Affairs | Altria Clien
Slide 3: Study Products
Study Products Battery Assembly Cartridge Product Nicotine Nicotinea (% by weight) (mg/puff) Classic Bold 4.0 0.20 Menthol Bold 4.0 0.23 a Based on 5s puff duration, 50mL puff volume and 30s inter-puff-interval J. Edmiston | Regulatory Affairs | Altria Client Services | TSRC Sept 15-18th 2019 | FINA
Slide 4: 12 Week e-Vapor Switching Study
12 Week e-Vapor Switching Study J. Edmiston | Regulatory Affairs | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 4
Slide 5: Key Measurements
Key Measurements Biomarkers of Exposure FDA Biomarker Constituent Classification Total NNAL NNK Carcinogen Reproductive or Carboxyhemoglobin (COHb) Carbon Monoxide Developmental Toxicant Reproductive or Nicotine Equivalents Nicotine Developmental Toxicant, (nicotine and 5 metabolites) Addictive Biom
Slide 6: Demographics
Demographics Classic Bold Menthol Bold Control Overall Trait Category/Statistics (n=151) (n=150) (n=149) (n=450) Female 74 (49%) 75 (50%) 73 (49%) 222 (49%) Gender Male 77 (51%) 75 (50%) 76 (51%) 228 (51%) White/Caucasian 103 (68%) 111 (74%) 106 (71%) 320 (71%) Race Black or African American 44 (29%
Slide 7: Tobacco History
Tobacco History Classic Bold Menthol Bold Control Overall n 151 150 149 450 Cigarettes per Day mean 18.2 (SD±5.7) 17 (SD±5.2) 17.4 (SD±5.8) 17.5 (SD±5.6) Years Smoked mean 24.1 (SD±8.3) 25 (SD±9.5) 24.5 (SD±9.8) 24.5 (SD±9.2) J. Edmiston | Regulatory Affairs | Altria Client Services | TSRC Sept 15-1
Slide 8: Study Product Use
Study Product Use 30 Cigarettes per Day 25 Average Cartridges per Day 20 Group Week 12 N 120 15 Classic Bold Mean 1.44 10 SD 0.979 N 122 5 Menthol Bold Mean 1.31 0 SD 0.831 Baseline Week 3 Week 6 Week 9 Week 12 -5 Arithmetic Means ±SD J. Edmiston | Regulatory Affairs | Altria Client Services | TSRC
Slide 9: Compliance With Test Product Use
Compliance With Test Product Use eCO Category n (%) Group Week N ≤5 >5 - ≤8 >8 Baseline 146 10% 4% 86% 3 136 63% 13% 24% Classic 6 124 75% 10% 15% Bold 9 116 68% 15% 17% 12 112 68% 12% 21% Baseline 147 4% 12% 84% 3 134 60% 14% 25% Menthol 6 126 71% 13% 16% Bold 9 123 67% 10% 24% 12 121 64% 17% 19% B
Slide 10: Biomarkers of Exposure
Biomarkers of Exposure 700 NNAL 600 500 400 ng/g Cr 300 200 27 Nicotine Equivalents 100 22 0 Baseline Week 6 Week 12 -100 17 mg/g Cr 10 COHb 12 9 8 7 Percent saturation 7 6 2 5 Baseline Week 6 Week 12 4 3 2 1 0 Baseline Week 6 Week 12 Arithmetic Means ±SD J. Edmiston | Regulatory Affairs | Altria Cl
Slide 11: Biomarkers of Exposure
Biomarkers of Exposure Absolute Change from Baseline to 12 Weeks LS Means LS Mean Difference Biomarker Group Test (n) Control (n) (Test - Control) p-value^ Classic Bold -184.391 (112) -7.764 (128) -176.627 <.0001 Urine Total NNAL -161.576 (120) -7.764 (128) -153.812 <.0001 Menthol Bold (ng/g Cr) Cla
Slide 12: Biomarkers of Potential Harm
Biomarkers of Potential Harm WBC 70 HDL-C 10 65 9 60 55 Count (x 10^3/uL) 8 mg/dL 50 7 45 6 40 35 5 30 4 25 Baseline Week 6 Week 12 Baseline Week 6 Week 12 375 sICAM-1 325 ng/ml 275 225 175 125 Baseline Week 6 Week 12 Arithmetic Means ±SD J. Edmiston | Regulatory Affairs | Altria Client Services | T
Slide 13: Biomarkers of Potential Harm
Biomarkers of Potential Harm Urine 8-epi-PG F2α 1600 Urine 11-DTX B2 800 1400 700 1200 600 1000 500 ng/g Cr ng/g Cr 800 400 600 300 200 400 100 200 0 0 Baseline Week 6 Week 12 Baseline Week 6 Week 12 Arithmetic Means ±SD J. Edmiston | Regulatory Affairs | Altria Client Services | TSRC Sept 15-18th 2
Slide 14: Biomarkers of Potential Harm
Biomarkers of Potential Harm Absolute Change from Baseline to 12 Weeks LS Means LS Mean Difference p- Biomarker Group Test (n) Control (n) (Test - Control) value^ Whole Blood WBC Classic Bold -0.686 (110) 0.111 (128) -0.797 0.0002 Count Menthol Bold -0.342 (119) 0.111 (128) -0.453 0.0639 (x 10^3/uL)
Slide 15: Spirometry (percent predicted)
Spirometry (percent predicted) 110 FEV1 110 FVC 105 105 100 100 95 95 90 90 85 85 80 80 75 75 Baseline Week 12 Baseline Week 12 110 FEV1/FVC 105 100 95 90 85 80 75 Baseline Week 12 Arithmetic Means ±SD J. Edmiston | Regulatory Affairs | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 15
Slide 16: Spirometry (percent predicted)
Spirometry (percent predicted) Absolute Change from Baseline to 12 Weeks LS Means LS Mean Pulmonary Function Difference Parameter Comparison Test (n) Reference (n) (Test - Reference) p-value Classic Bold -1.04 (100) -2.46 (115) 1.42 0.0839 Percentage of Predicted Menthol Bold -0.37 (112) -2.46 (115)
Slide 17: Overall Summary
Overall Summary Subjects switching to MarkTen® products demonstrated: - Reduction in cigarette consumption by ~98% - Significant reduction in BOE (NNAL & COHb) Nicotine exposure remained the same as for cigarettes - Favorable changes in BOPH WBC and sICAM significantly reduced (p<0.001) HDL, 1
Slide 18: Conclusions
Conclusions Complete switching from cigarettes to MarkTen® should reduce the risks of smoking related diseases Flavor does not appear to have an impact on the risk reduction potential. A 12-week study with the currently available biomarkers along with exclusive use should be sufficient enough
Altria Group — Technical Presentation (September 2019) on 6ix