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Some of the statistics for smoking-related health problems
are staggering. According to the American Cancer Society and
the World Health Organization:
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Tobacco causes 16% of all cancer cases in the developed
world |
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Almost
half of all smokers aged 35-69 die prematurely |
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Smokers
could lose 20-25 years of life |
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500
million people alive today will eventually die from
smoking |
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Four
million died from the effects of smoking in 1998 - this
will rise to 10 million in 2030, 70% of which will be
in the developing world |
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By
2020, smoking will cause one in three of all adult deaths |
Unfortunately, smokers can also affect others - non-smoking
spouses of smokers have a 30% greater risk of developing lung
cancer, while children born to women who smoked whilst pregnant
are prone to low birth weight and respiratory disease amongst
other ill effects.
Although lung cancer is the most commonly thought of consequence
of cigarette smoking, the habit is also linked to ischaemic
heart disease, chronic bronchitis and emphysema, and a number
of other cancers, including oropharyngeal, bladder and cervical.
While smoking is on the rise in developing countries as the
tobacco industry seeks out new markets, and more women appear
to be taking up the extremely addictive habit, the number
of smokers is gradually falling in the West.
Perhaps most importantly, the news is positive for those who
do find the determination to kick smoking. Health benefits
are seen relatively quickly, and even stopping in old age
can prolong life.
The public is encouraged to stop smoking by events like the
Great American Smokeout in the US (organized by the ACS) on
November 16 in 2000, the WHO's World No-Tobacco Day on May
31, and No Smoking Day in the UK. The pharmaceutical industry
has also developed a number of products to assist smokers
trying to quit the habit.
Most are based on nicotine replacement, and are designed to
gradually wean smokers off their addiction to the 'active
ingredient' in tobacco. First used in the 1980s, the gums
and transdermal patches were originally prescription-only,
but since the 1990s many have been sold over-the-counter.
Nasal sprays, inhalers and sub-lingual tablets are also available.
The dominant player in the smoking cessation market is SmithKline
Beecham, with 36% of the N7B therapy area according to IMS
HEALTH's Monthly
MIDAS. Its predominant brand is Nicorette (gum), supported
by Nicoderm and Niquitin (patches).
Pharmacia licensed the US rights for Nicorette to SB, and
Nicotrol to Johnson & Johnson, but has recently regained the
rights to the latter. Novartis, Aventis, Pierre Fabre, and
various generic manufacturers all have similar products.
*Retail pharmacy markets in the US, Canada,
Germany, Italy, France, Spain, UK, Brazil, Mexico, Argentina,
New Zealand and Japan - approximately 80% of global pharmaceutical
sales
Source: Monthly MIDAS
One generic specialist, Watson, has been involved in protracted
litigation with SB since it tried to launch its own version
of nicotine polacrilex gum (equivalent to Nicorette). The
US FDA approved the 2mg and 4mg formulations of Watson's gum
in March 1999. The products were launched in August 1999,
upon which SB immediately served Watson with a lawsuit - alleging
copyright infringement of its user guide and audiocassette
support material.
At the beginning of September 1999, a US District Court refused
to grant SB a temporary restraining order against Watson,
but a week later the same Court issued a preliminary injunction
enjoining Watson from selling its nicotine gum during the
pendency of the lawsuit.
The case progressed to an Appeals Court, which in April 2000
ordered the District Court to dismiss SB's case: Watson reintroduced
its nicotine gum shortly afterwards. SB appealed to the US
Supreme Court, but at the beginning of October 2000 its case
was rejected. Nevertheless, SB is committed to its brand,
and at the beginning of November launched a new orange-flavoured
Nicorette gum.
The main impact on the smoking cessation market in recent
times, however, has come from the launch of Glaxo Wellcome's
Zyban. A sustained-release version of the antidepressant
bupropion/amfebutamone (also sold as Wellbutrin SR), Zyban
was the first nicotine-free prescription medicine for smoking
cessation.
Launched in the US in mid-1997, it was approved in the European
Union in April 2000. According to IMS HEALTH's Monthly MIDAS,
Zyban has captured 25% of the N7B market, second only to Nicorette.
Ironically, it is perhaps Zyban's very success that has caused
a delay to Glaxo Wellcome's merger with SmithKline Beecham:
the US Federal Trade Commission is allegedly examining the
impact of their combined products on the smoking cessation
market - though the companies say that the merger is still
on course to close by the end of 2000. Pharmacia is involved
in the FTC research: it is rumoured to be interested in reacquiring
the US rights to Nicorette.
Meanwhile a number of other companies are researching new
antismoking products. IMS HEALTH's R&Dfocus
has details on over 15 such compounds in development, ranging
from the more traditional nicotine replacement products, through
psychiatrically active drugs (including two from Eli Lilly),
to newer ideas, such as Cantab/ImmuLogic's and Nabi's nicotine
vaccines.
Perhaps unfortunately, it seems that there will be plenty
of takers when these products reach the market in the next
few years.
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