Altria Group, Inc. · NYSE:MO
Altria — Next Generation Nicotine Delivery Conference 2018
40 slides from Altria's conference presentation, Apr 24, 2018
Slide 1: Tobacco Harm Reduction: E-Vapor Products
Tobacco Harm Reduction E-Vapor Products Maria Gogova, M.D., Ph.D. April 24, 2018 Next Generation Nicotine Delivery Conference Altria Client Services l Regulatory Affairs l Next Generation Nicotine Delivery l 4/24/2018 l Final | 1
Slide 2: Cigarette Smoking: A Significant Public Health Problem
Cigarette Smoking: A Significant Public Health Problem Cigarette smoking Cigarette Smokers’ life causes about smoking causes expectancy one of every an estimated is about five deaths 480,000 deaths 10 years shorter annually annually. than nonsmokers’ in the U.S Source: http://www.cdc.gov/tobacco/dat
Slide 3: Diseases Caused by Cigarette Smoking
Diseases Caused by Cigarette Smoking Other Diagnoses 21,500 Lung Cancer § The most hazardous form of COPD 127,700 tobacco consumption is burning 100,600 tobacco and inhaling the smoke. § There is overwhelming evidence that cigarette smoking is addictive and causes serious diseases such Other as: Cir
Slide 4: Cigarette Smoking Trends Among U.S. Adults
Cigarette Smoking Trends Among U.S. Adults 1965 – 20151 45 A Healthy People 2020 objective is 40 12% smoking 35 prevalence.2 Adult Smoking Rate (%) 30 25 20 ~40 15 million 10 5 0 1965 1967 1969 1971 1973 1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007 2009 2011 2
Slide 5: FDA Recognizes Continuum of Risk
FDA Recognizes Continuum of Risk “We must recognize the potential for innovation to lead to less harmful products, which, under FDA’s oversight, could be part of a solution. While there’s still much research to be done on these products and the risks that they may pose, they may also present benefit
Slide 6: Tobacco Harm Reduction at Altria
Tobacco Harm Reduction at Altria Our long-term goal at Altria is to achieve a leadership position in innovative and reduced risk tobacco products. Continuum of Risk Combusted Tobacco Products Non-combusted Tobacco Products MOST LEAST HARMFUL HARMFUL July 28, 2017: Protecting American Families: Compr
Slide 7: Altria Supports Harm Reduction in a Variety of Ways
Altria Supports Harm Reduction in a Variety of Ways Developing & Supporting Help Reduce Communicating Marketing Cessation Underage about the health Lower-Risk Tobacco Use effects of Tobacco tobacco use Products Altria Client Services l Regulatory Affairs l Next Generation Nicotine Delivery l 4/24/20
Slide 8: Harm Reduction Opportunities
Harm Reduction Opportunities ~5 MM Adult Smokeless Consumers ~40 MM Adult Cigarette Smokers ~10 MM Adult E-Vapor Consumers *Source: 18+ATCT 12MM ending December 2017 Numbers may not foot due to rounding Altria Client Services l Regulatory Affairs l Next Generation Nicotine Delivery l 4/24/2018 l Fin
Slide 9: Tobacco Harm Reduction Product Platforms
Tobacco Harm Reduction Product Platforms Oral Tobacco/ Heated Tobacco E-Vapor Nicotine Products Products Altria Client Services l Regulatory Affairs l Next Generation Nicotine Delivery l 4/24/2018 l Final | 9
Slide 10: Diverse E-vapor Product Portfolio
Diverse E-vapor Product Portfolio Altria Client Services l Regulatory Affairs l Next Generation Nicotine Delivery l 4/24/2018 l Final | 10
Slide 11: FDA Market Pathways
FDA Market Pathways Product Pathway Reduced Exposure or Reduced Risk Claim Substantial Modified Risk Equivalence Substantial Premarket Tobacco Application Tobacco Product Exemption Request Equivalence “PMTA” or “910” Application “905(j)(3)” “SE” or “905” “MRTPA” or “911” Altria Client Services l Reg
Slide 12: MarkTen E-Vapor Products Portfolio
MarkTen® E-Vapor Products Portfolio Altria Client Services l Regulatory Affairs l Next Generation Nicotine Delivery l 4/24/2018 l Final | 12
Slide 13: ALCS Framework for Reduced Harm Tobacco Products
ALCS Framework for Reduced Harm Tobacco Products Constituent Risk Reduction Harm Reduction Reduction Individual Population Product Chemical Toxicology Studies in Perception Risks and Design and and Physical and Risk Adult Human and Behavior Benefits to the Control Characterization Assessment Subject
Slide 14: ALCS Framework for Reduced Harm Tobacco Products
ALCS Framework for Reduced Harm Tobacco Products Constituent Risk Reduction Harm Reduction Reduction Individual Population Product Chemical Toxicology Studies in Perception Risks and Design and and Physical and Risk Adult Human and Behavior Benefits to the Control Characterization Assessment Subject
Slide 15: MarkTen Designed to Eliminate or Significantly Reduce HPHC Generation
MarkTen® Product was Designed to Product Design and Control Eliminate or Significantly Reduce Chemical HPHC1 Generation and Physical Characterization Cartridge Puff sensor Heated coil Battery Vent holes Mouth piece • Selection and evaluation of individual components and ingredients Product Design an
Slide 16: HPHCs in MarkTen Aerosol Substantially Lower Than Reference Cigarettes
Harmful and Potentially Harmful Constituents in Chemical and Physical Characterization MarkTen® Aerosol Are Substantially Lower Than Reference Cigarettes Volatile Aromatic Organic Percentage Carbonyls Carbonyls B(a)P B(a)P Aromatic AminesAmines VOCs Compounds TSNAs TSNAs Change 100% 0 Compared to Re
Slide 17: ALCS Framework for Reduced Harm Tobacco Products
ALCS Framework for Reduced Harm Tobacco Products Constituent Risk Reduction Harm Reduction Reduction Individual Population Product Chemical Toxicology Studies in Perception Risks and Design and and Physical and Risk Adult Human and Behavior Benefits to the Control Characterization Assessment Subject
Slide 18: Reduced Risk Assessment: Pre-Clinical Studies
Reduced Risk Assessment: Toxicology and Risk Pre-Clinical Studies Assessment Toxicological literature review Ingredients risk assessment Flavors and carriers are: § Generally recognized as safe (GRAS) for use in foods § Food or pharmaceutical grade Carrier assessment 90 day in-vivo studies Flavor as
Slide 19: No Cytotoxicity Observed from MarkTen Aerosol Condensates
No Cytotoxicity Observed from MarkTen® Toxicology and Risk Aerosol Condensates in Neutral Red Uptake Assessment Assays1 8 MarkTen® Variants Reference Cigarette 3R4F • The 3R4F condensate: Positive response(IC50 of 0.048 ±0.004 mg/mL TPM) • E-vapor condensates: Viability > 80% (IC50 could not be esti
Slide 20: No Mutagenicity Response Observed in Ames Test
Toxicology No Mutagenicity Response Observed from and Risk Assessment MarkTen® Aerosol Condensates in Ames Test1 Ames Assay - TA98 +S9 Reference Cigarette 3R4F 8 MarkTen® Variants 1 Data shared at Society of Toxicology 2018 Annual Meeting. Doshi et al., Comparison of in vitro Cytotoxicity and Genoto
Slide 21: Reduced Risk Assessment: Pre-Clinical Studies Key Takeaways
Reduced Risk Assessment: Toxicology and Risk Pre-Clinical Studies Assessment Key Takeaways: Ingredients risk assessment No treatment related effects Carrier assessment § Survival § Body weight Flavor assessment § Clinical observations & chemistry parameters § Histopathology E-liquid and aerosol cond
Slide 22: ALCS Framework for Reduced Harm Tobacco Products
ALCS Framework for Reduced Harm Tobacco Products Constituent Risk Reduction Harm Reduction Reduction Individual Population Product Chemical Toxicology Studies in Perception Risks and Design and and Physical and Risk Adult Human and Behavior Benefits to the Control Characterization Assessment Subject
Slide 23: MarkTen Users Have Lower Levels of Biomarkers of Exposure and Potential Harm
MarkTen® Users Have Lower Levels of Studies in Adult Human Subjects Biomarkers of Exposure and Potential Harm Pharmacokinetics/ Nicotine delivery and satisfaction Pharmacodynamics Reduced Exposure 3-months Exposure reduction assessment (in progress) Reduced Risk 6-months Biomarkers of potential harm
Slide 24: MarkTen Nicotine Pharmacokinetic Studies Demonstrate a Range of Deliveries
MarkTen® Nicotine Pharmacokinetic Studies Studies in Adult Human Subjects Demonstrate a Range of Nicotine Deliveries1 14 Plasma Nicotine Concentration (ng/mL) 12 10 8 6 4 Cigarette 2 MarkTen® (3 products) Nicotine Gum (4mg) 0 0 20 40 60 80 100 120 140 160 180 Minutes ALCS | Regulatory Affairs | 10/1
Slide 25: Significant Differences in BoE and BoPH Between E-vapor Users and Smokers
Significant Differences in BOE and BOPH Studies in Adult Human Subjects Between E-vapor Users and Cigarette Smokers1 120% Biomarkers of Biomarkers of Potential Exposure (BoE) Harm (BoPH) Percent of cigarette exposure 100% Cig. smoker exposure level 80% Total sample EVP 60% Tank users Tank Cartridge
Slide 26: Clinical Studies Support Lower Biomarker Levels in MarkTen Users
Clinical Studies Support MarkTen® Users Studies in Adult Human Subjects Have Lower Levels of Biomarkers of Exposure and Potential Harm Key Takeaways: Pharmacokinetics/ MarkTen® portfolio offers a range of nicotine Pharmacodynamics deliveries Reduced Exposure 3-months Reduced exposure and risk biomar
Slide 27: ALCS Framework for Reduced Harm Tobacco Products
ALCS Framework for Reduced Harm Tobacco Products Constituent Risk Reduction Harm Reduction Reduction Individual Population Product Chemical Toxicology Studies in Perception Risks and Design and and Physical and Risk Adult Human and Behavior Benefits to the Control Characterization Assessment Subject
Slide 28: Consumer Perception and Behavioral Assessment
Consumer Perception and Perception and Behavior Behavioral Assessment Assessment Perception and Risk perceptions and likelihood of use behavioral intentions Actual use studies Use patterns, likelihood of switching In market study Market data on use behavior, likelihood of initiation and quitting Pro
Slide 29: Risk Perceptions of MarkTen E-vapor Products Compared to Cigarettes
Risk Perceptions of MarkTen® E-vapor Perception and Behavior Products Compared to Cigarettes Assessment Risk perception of MarkTen® relative to smoking cigarettes: Based on participant exposure to MarkTen® promotional materials 100% 12% 8% 8% 6% 8% 10% 10% % of Participants 80% 18% 28% 34% 23% 27% 3
Slide 30: Flavor Portfolio Maximizes Appeal Among Adult Smokers and Vapers
Perception Flavor Portfolio Maximizes Appeal of and Behavior Assessment MarkTen® Products Among Adult Smokers and Vapers Which of the following Adult smokers Adult smokers NOT E-vapor users products are most planning to quit planning to quit (N = 426) appealing to you? (N = 415) (N = 423) (select up
Slide 31: Adult Non-tobacco Users Do Not Find MarkTen Flavors Appealing
Adult Non-tobacco Users Do Not Find Perception and Behavior MarkTen® Flavors Appealing Assessment Which of the following products are most Former users Never users LA-24 Non-users appealing to you? (N = 417) (N = 425) (N = 410) (select up to 3) Smooth Menthol MarkTen® Smooth Menthol… 8% MarkTen® Smo
Slide 32: Flavor Varieties Play an Important Role in Switching
Flavor Varieties Play an Perception and Behavior Important Role in Switching Assessment Proportion of participants using one or more flavor varieties by cigarette consumption at Week 6 # Flavor Total Sample Switched Decreased No Change in varieties used (0 CPD*) CPD CPD n=526 n=208 n=257 n=61 1 1.8
Slide 33: Every Day MarkTen Users More Likely to be Exclusive Users
Every Day MarkTen® Users are More Likely Perception and Behavior to be Exclusive Users1 Assessment Current Every day Some days Users E-cigarettes only 25% 42% 12% E-cigarettes + 1 other tobacco product 45% 36% 52% E-cigarettes + 2 or more other tobacco products 31% 22% 37% 1 Data shared at Society f
Slide 34: Larger Proportion of Switchers Report Every Day MarkTen Use
Larger Proportion of Switchers Report Perception and Behavior Every Day MarkTen® Use1 Assessment Switchers Dual Users (n=349) (n=1,465) Some day users Every day users 26% Some day 32% Every day users users 68% 74% 1 Data shared at Society for Research on Nicotine and Tobacco 2018 Annual Meeting. Lar
Slide 35: Reasons for MarkTen Use Vary by Users
Beyond “satisfying nicotine cravings” Perception and Behavior Reasons for MarkTen® Use Vary by Users1 Assessment Switchers Dual Users Reasons (n=349) (n=1,465) To satisfy my nicotine cravings 81% 71% To help prevent relapse 63% 15% To not smell like smoke/not bother other people with smoke 60% 43% I
Slide 36: Consumer Perception and Behavioral Assessment Key Takeaways
Consumer Perception and Perception and Behavior Behavioral Assessment Assessment Key Takeaways: Sizable portion of AS perceive MarkTen® as Perception and equally or more harmful than cigarettes behavioral intentions MarkTen® flavor portfolio appeals primarily to current tobacco users Actual use stud
Slide 37: ALCS Framework for Reduced Harm Tobacco Products
ALCS Framework for Reduced Harm Tobacco Products Constituent Risk Reduction Harm Reduction Reduction Individual Population Product Chemical Toxicology Studies in Perception Risks and Design and and Physical and Risk Adult Human and Behavior Benefits to the Control Characterization Assessment Subject
Slide 38: Population Assessment
Population Assessment1 Risks and Benefits to the Population Population Modeling Projection of likely impact on the population Base Case Modified Case Never Never Tobacco Tobacco User User Cigarette Cigarette Dual E-vapor Smoker Smoker User User Former Former Former Former Cigarette Cigarette Dual E-
Slide 39: Population Assessment: Post-Market Surveillance
Population Assessment Risks and Benefits to the Population Post-Market Surveillance Passive and active monitoring the impact of the introduction of the new product into the market Active Surveillance Passive Surveillance Consumer Health Consumer Behavior Consumer Perception Adverse Events In-market
Slide 40: Overall Conclusions
Overall Conclusions § E-vapor products present an opportunity to reduce the harm from cigarette smoking § We have a rigorous process to develop and evaluate our e-vapor products to demonstrate harm reduction opportunity § To advance harm reduction § Generate sound science § Reframe debate about nico
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