Reduced-risk* Potential of Velo as Cigarette Alternative Reinforced by Innovative Real-world Study
New results from an innovative cross-sectional clinical study of Velo i, BAT’s flagship modern oral nicotine pouch product, have been published today in Biomarkers Journal. In the study, consumers exclusively using Velo for over six months had significant favourable differences in several biomarkers of exposure and biomarkers of potential harm relevant to smoking-related diseases compared to the adults who smoked.
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A Velo modern oral product tested in BAT laboratory, Southampton UK (Photo: Business Wire)
The results showed that the levels for the biomarkers of exposure, based on priority toxicants as defined by the WHO ii, were substantially lower in Velo consumers compared with smokers. The data also showed favourable differences between the Velo consumers and smokers in the majority of the biomarkers of potential harm, with four achieving statistical significance, and the others having similar levels across the Velo consumers, former and never smoker groups.
The study provides important new data and insights into the real-world health impact in Velo consumers compared to smokers, former smokers and never smokers. A single set of samples of blood, urine and other clinical measurements was tested for certain toxicants and a range of biomarkers thought to be linked to the development of diseases such as cancer and cardiovascular disease (CVD).
Dr David O’Reilly, Director, Scientific Research at BAT, said: “These results are very important for Velo and the modern oral nicotine product category. They build on the extensive scientific evidence, including epidemiological data, that already exists for oral tobacco and add to the weight of evidence that supports our belief that Velo is a reduced-risk*† product for smokers who completely switch from cigarettes as compared to continued smoking. We have already generated data that shows Velo has a toxicant profile better than snus and comparable to Nicotine Replacement Therapy (NRT)iii. These results add further evidence that supports the important contribution Velo can make to Tobacco Harm Reduction.
“I’d like to thank everyone who participated and helped deliver this study. It is another important step forward in our journey to building A Better Tomorrow.”
Based on the biomarkers measured, compared to smokers, Velo consumers who had been using the product exclusively showed:
- Significantly lower levels in biomarkers of exposure to priority tobacco toxicants
- Significant favourable differences in a biomarker of potential harm relevant to lung cancer risk
- Significant favourable differences in a number of biomarkers of potential harm relevant to cardiovascular disease
- Significant favourable differences in a biomarker of potential harm relevant to general inflammation
For the biomarkers that showed no significant difference between the Velo consumers and smokers, similar levels were observed between the Velo and former and never smoker groups.
About the study
The study included participants who had been using Velo exclusively for over six months, as well as current smokers, former smokers and never smokers. For the Velo consumers and current cigarette smokers, usage patterns and overall consumption were not controlled under the study protocol as the aim was to assess the impact among people using the products in their ‘normal’ way rather than in a controlled way. Four different groups were enrolled and studied.
- Current smokers who had been smoking for at least one year prior to screening
- Exclusive Velo consumers for at least six months
- Former smokers who had quit for at least six months
- Never smokers
Participants were based in Denmark and Sweden, aged between 19-55 years old, and in good general health.
Unlike longitudinal studies where participants attend multiple clinic visits over an extended period of time, participants in this study made a single clinic visit where samples of blood, urine and breath were collected, and other clinical measurements were performed. These samples and measurements were then assessed for biomarkers of exposure (to selected toxicants) and biomarkers of potential harm. Differences in the biomarker levels between the groups were compared and analysed.
In addition, to ensure compliance with reported product usage, the Velo and former smoker groups were tested for the biomarker, CEVal, to indicate whether or not they had smoked cigarettes during the preceding six months.
BAT is a leading, multi-category consumer goods business with a purpose to build A Better Tomorrow™ by reducing the health impact of its business through offering a greater choice of enjoyable and less risky products for adult consumers.
The company continues to be clear that combustible cigarettes pose serious health risks, and the only way to avoid these risks is not to start or to quit. BAT encourages those who would otherwise continue to smoke to switch completely to scientifically-substantiated, reduced-risk alternatives*†. In order to deliver this, BAT is transforming into a truly consumer-centric multi-category consumer products business.
BAT’s ambition is to have 50 million consumers of its non-combustible products by 2030 and to generate £5billion of New Categories revenue by 2025. BAT has set stretching ESG targets including achieving carbon neutrality for Scopes 1 & 2 by 2030 and eliminating unnecessary single-use plastic and making all plastic packaging reusable, recyclable or compostable by 2025.
BAT employs over 52,000 people and operates in over 175 countries. The BAT Group generated revenue of £25.68 billion in 2021 and profit from operations of £10.2 billion.
The company’s Strategic Portfolio is made up of its global cigarette brands and a growing range of reduced-risk*† New Category tobacco and nicotine products and traditional non-combustible tobacco products. These include vapour, tobacco heating products, modern oral products including tobacco-free nicotine pouches, as well as traditional oral products such as snus and moist snuff. In the first half of 2022, we had 20.4 million consumers of our non-combustible products, a rise of 2.1 million on full year 2021.
* Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk free and are addictive.
† Our products as sold in the US, including Vuse, Velo, Grizzly, Kodiak, and Camel Snus, are subject to Food and Drug Administration (FDA) regulation and no reduced-risk claims will be made as to these products without agency clearance.
This press release is not intended as a piece of promotional material for any products, very notably in the US where claims of a certain type are subject to FDA clearance. This update relates to new scientific data and is not aimed at a specific market. It is intended to provide further scientific evidence to underpin our products.
This release contains certain forward-looking statements, including "forward-looking" statements made within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "believe," "anticipate," "could," "may," "would," "should," "intend," "plan," "potential," "predict," "will," "expect," "estimate," "project," "positioned," "strategy," "outlook", "target" and similar expressions. These include statements regarding our customer target ambition, New Categories revenue targets and our ESG targets.
All such forward-looking statements involve estimates and assumptions that are subject to risks, uncertainties and other factors. It is believed that the expectations reflected in this release are reasonable but they may be affected by a wide range of variables that could cause actual results to differ materially from those currently anticipated. A review of the reasons why actual results and developments may differ materially from the expectations disclosed or implied within forward-looking statements can be found by referring to the information contained under the headings “Cautionary Statement” and "Group Principal Risks " in the 2021 Annual Report and Form 20-F of British American Tobacco p.l.c. (BAT).
Additional information concerning these and other factors can be found in BAT's filings with the U.S. Securities and Exchange Commission ("SEC"), including the Annual Report on Form 20-F and Current Reports on Form 6-K, which may be obtained free of charge at the SEC's website, http://www.sec.gov and BAT’s Annual Reports, which may be obtained free of charge from the BAT website www.bat.com.
Past performance is no guide to future performance and persons needing advice should consult an independent financial adviser. The forward-looking statements reflect knowledge and information available at the date of preparation of this release and BAT undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Readers are cautioned not to place undue reliance on such forward-looking statements.
i The study was conducted using Lyft, since re-branded as Velo.
ii WHO Study Group on Tobacco Regulation. Report on the Scientific Basis of Tobacco Product Regulation: Fifth Report of a WHO Study Group. 2015.
iii David Azzopardi, Chuan Liu & James Murphy (2021) Chemical characterization of tobacco-free “modern” oral nicotine pouches and their position on the toxicant and risk continuums, Drug and Chemical Toxicology, DOI: 10.1080/01480545.2021.1925691
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