Our Global Harm ReductionProgrammeTMA 2009

David O’Reilly, PhD

Head of Public Health & Scientific Affairs

© British-American Tobacco (Holdings) Limited 2009. All rights reserved. No part of these materials may be reproduced in any form or by any means without the prior written consent of British American Tobacco Holdings Limited, and no responsibility or liability is accepted for any third party reliance on any data contained herein. The data and information used in these materials has been compiled from a number of sources.

A long-term commitment

Our pivotal question

What do we need to do to bring commercially viable,

consumer acceptable reduced risk products to

market?

The Product/Risk Continuum

Risk to user

High

LowHigh LowToxicants:nicotine

Con

vent

iona

l Cig

aret

tes

Hea

t-no

t-B

urn

Cig

aret

te-li

ke D

evic

es

Low

Tox

ican

t S

mok

eles

s T

obac

co

Non

-tob

acco

Nic

otin

e P

rodu

cts

Com

bust

ible

PR

EP

s

Consumer acceptance of

smokeless

PREP development &

assessment

Public Health, Scientific &

Regulatory support

Our Global Harm Reduction Programme- Progress over the last year

Snus test market expansion in South Africawith new products

First clinical studies on modified combustible prototypes underway in Germany

http://www.controlled-trials.com/ISRCTN72157335

To compare the exposure levels of selected smoke constituents as determined by biomarkers of exposure, filter analysis, sensory perception and other parameters when smokers using commercial cigarettes are switched to novel cigarettes

Tobacco diluent Treated tobacco

Opti cal Mi crograph (× 73)

Opti cal Mi crograph (× 73)

Selective filter

‘Alternative’ Nicotine Products

E-cigarettes

0

0.002

0.004

0.006

0.008

0.01

0.012

(0mg) (6mg) (11mg) (16mg)

Claimed Nicotine Loading of Cartridge

Nic

oti

ne

/ p

uff

(m

g)

ISO (E-Cigarette) Intense (E-Cigarette)

ISO regime = 35mL puff/ 2secs duration / 60 secs interval

Intense regime = 55 mL puff/ 2secs duration / 30 secs interval

Analysis of Ruyan Classic E-Cigarette

•The cartridge nicotine loadings claimed by Ruyan were similar to that measured by BAT, with the exception of the 0mg cartridge which was measured in the range of 0.4-2.9mg nicotine

•Nicotine yields per puff were similar irrespective of the cartridge nicotine loading or puffing regime

•All Hoffmann analyte yields were below the BAT analytical Limit of Quantification (LOQ)

•The E-Cigarette does not generate Carbon Monoxide

•The vapour & particulate phases from the e-cigarette contained less compounds than those from conventional cigarettes, however the presence of plasticisers, PG derivatives, flavour compounds and nicotine derivatives was confirmed

Figure 1. Nicotine yields per puff

Electronic cigarettes are currently the biggest business in ANP

~20

N/a<0.5~2 <0.50.5 - 1

>100Yearly worldwide sales volume

2007, USD millions

ESTIMATES

ANP category Electronic cigarettes

Nicotine / tobacco gum

Nicotine / tobacco pills

Nicotine / tobacco inhalators

Nicotine / tobacco gel

Nicotine drinks and food

Nicotine film and others

Number of brands 20+ 1 2 2 2 1 0

Number of manufacturers

50+ 1 1 2 2 1 0

Major markets • China

• USA

• EU states

• Japan

• Sweden

• USA • USA

• UK

• USA

• EU states

• Worldwide online

• USA • Not available yet (some brands failed)

The biggest worldwide ANP market is for electronic cigarettes, which only started up

less than 3-4 years ago. Other ANP categories, although being longer on the market

don’t show signs of rapid expansion

The traditional boundaries of tobacco / nicotine products are starting to blur

* Or nicotine substitute** Pfizer, Johnson & Johnson, GSK, Novartis

Tobacco (and nicotine) Nicotine only*

Combustion (or heat) Smoke-free

•Cigarettes• Machine made• Hand made (roll-your-own)

•Cigars• Large• Little

•Pipe tobacco

•Nasal tobacco• Moist• Dry

•Oral tobacco• Loose leaf• Plug• Twist, roll• Other traditional (e.g. Guthka, Toombak, Ipco Creamy Snuff, etc.)

• “Smokeless” inhalation (Heat-not-burn)

•Nicotine gums•Nicotine lozenges•Nicotine aerosols (sprays, inhalators, etc.)

•Nicotine patches

•Nicotine gel (with tobacco)•Nicotine film (with tobacco) •Nicotine pills/lozenges (with tobacco)

•Nicotine gums (with tobacco)•Nicotine water (with tobacco)

•Electronic cigarettes •Nicotine drinks•Nicotine food •Nicotine snus (tobacco free)•Nicotine film•Nicotine water (tobacco free)

Traditional tobacco space

• Big tobacco companies (BAT, PMI, IT, JT, etc.)

• Long-standing smokeless tobacco companies (Swedish Match, UST, etc.)

• Small producers of traditional local tobacco products

Nicotine replacement therapies (NRT)

• Regulated as pharma-ceuticals or medical devices

• Marketed by big pharmaceutical companies** often with the involvement of generic producers

• On the market for 10+ years (in different shapes and forms)

Alternative nicotine products (ANP)

• Newly emerging small companies with one or few products

• Alternative, non-traditional nicotine delivery technologies

‘Quit or Die’ continues to dominate public health policy for tobacco….

The answer to our pivotal question….?

POLICY

SCIENCE

CONSUMER

PRODUCT

Integrated approach

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