What scientific evidence is available on the risk profile of our smoke-free products?

The best option for smokers concerned about their health is to quit tobacco and nicotine use altogether. Our portfolio of smoke-free products is designed for smokers who would otherwise continue to smoke.  For these smokers, the primary aim is to reduce their risk of developing smoking-related diseases compared with what it would be if they continued smoking.

However, smoke-free products are not risk-free and they contain nicotine, which is addictive. In order to identify the extent of reduction in risk compared to continued smoking, we are evaluating the risk profile of all our smoke-free products using a robust scientific assessment program. All of our products are at different stages of this assessment program.

The Tobacco Heating System (THS) is the most advanced in terms of scientific assessment. Starting with the aerosol, we have shown that by eliminating combustion, the levels of HPHCs are reduced on average by 90-95% compared to those measured in the smoke of a standard reference cigarette (3R4F) designed for research purposes.

We have also conducted regulatory toxicological assessment of the aerosol from THS. Toxicity is a measurement of the degree of biological damage that a chemical or mixture of chemicals causes. This may or may not result in the development of disease. We have shown that in a laboratory setting, there is, on average, a 90-95% reduction in toxicity of the aerosol of THS compared to smoke from the 3R4F reference cigarette.

The likely impact on the development of smoking-related diseases has also been explored using sophisticated systems toxicology approaches. By using benchmarks representing the maximum risk (continued smoking) and the least risk for smokers (smoking cessation), we have been able to study the biology of how the exposure to cigarette smoke results in changes that lead to the development of smoking related diseases, and how these changes revert upon smoking cessation. In this context, we have observed that changes resulting from complete switching to THS are close to what is observed upon smoking cessation.

These results provided us with the confidence to conduct clinical studies to understand the changes in exposure to HPHCs and changes in disease risk when smokers switch to THS.

In our first batch of clinical studies, we observed that when smokers switch to THS, the reduction in their exposure to a number of HPHCs approaches the reduction seen in smokers who quit for the duration of the study. In our most recent clinical studies, which will last for 12 months, we are investigating if changes associated with disease development also change in a similar way. We aim to have the results related to the first 6 months of this study available in the first half of 2018. In our three-month Reduced Exposure studies, we have already observed that biological and functional risk markers that are linked to cardiovascular and respiratory disease changed in the same direction in the group that switched to THS and in the smoking cessation group.

To date, all the data we have collected is extremely encouraging and tells us that switching completely to THS can reduce the risk of developing smoking-related diseases compared to continued smoking. The existing body of scientific evidence will be complemented by the incoming results of our clinical and long-term studies.