British American Tobacco - Innovative new study to compare the health impact of Velo modern oral nicotine pouches to smoking

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News Release

Innovative new study to compare the health impact of Velo modern oral nicotine pouches to smoking

13 October 2022

  • New study designed to identify differences in important early indicators associated with smoking-related disease between Velo users and smokers
  • Results will provide important new data and insights about Velo and its role in facilitating tobacco harm reduction
  • Demonstrates BAT’s focus on science and innovation to deliver A Better Tomorrow™ and reduce the health impact of its business

BAT has conducted an innovative cross-sectional clinical study of Veloi, which is designed to provide new insights into the real-world health impact of its modern oral nicotine pouch product compared to smoking. Protocol details explaining the design have been published in the journal JMIR Research Protocols .

The study evaluates exposure to certain toxicants and early indicators associated with smoking-related disease in people who have been exclusively using Velo for over six months and compares them with groups of smokers, former smokers, and never-smokers.

The biomarkers selected are important indicators that include:

  • Biomarkers of Exposure: a person’s exposure to certain toxicants or chemicalsii
  • Biomarkers of Potential Harm: indicators of potential harm related to several smoking-related diseases, such as respiratory or cardiovascular disease

It is hoped that the results, which are currently being analysed and will be published by the end of the year, will provide further supportive evidence that using Velo may reduce relative risk for certain diseases among adult consumers compared to smoking. These data would add to the growing body of evidence demonstrating Velo’s potential as a reduced-risk product.*†

Dr Sharon Goodall, BAT’s Group Head of Regulatory Sciences, said: “Modern oral nicotine pouches are an exciting product category, which build upon the extensive scientific evidence available for snus, but are designed to offer adult consumers an improved, tobacco-free reduced-risk alternative. We have already generated data that shows Velo has a toxicant profile better than snus and is comparable to Nicotine Replacement Therapy (NRT)iii. However, we wanted to generate further evidence to demonstrate the important contribution it can make to tobacco harm reduction. I believe the results of this study will provide important new information and we look forward to sharing them once available.”

About the study

The study includes participants who have been using Velo exclusively for over six months, as well as current smokers, former smokers and never-smokers. For the Velo users and current cigarette smokers, usage patterns and overall consumption were not controlled whilst in the clinic as the aim was to assess the impact among people using the products in their ‘normal’ way rather than in a controlled manner. Four different groups were enrolled and studied.

These comprised:

  1. Current smokers who had been smoking at least 10 cigarettes per day for at least one year prior to screening
  2. Exclusive Velo consumers for at least six months
  3. Former smokers who had quit for at least six months
  4. 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, and the exploratory biomarkers anatabine and anabasine, to indicate whether or not they had smoked cigarettes during the preceding six months.

Results from the completed study will be published by the end of the year.

Enquiries

Media Centre
+44 (0) 20 7845 2888 (24 hours)  | @BATplc 

Investor Relations
Victoria Buxton: +44 (0)20 7845 2012
William Houston: +44 (0)20 7845 1138
John Harney: +44 (0)20 7845 1263

* 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 FDA clearance.

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 

Forward-looking statements

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.

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