WILMINGTON, Del. & LONDON–(BUSINESS WIRE)–Extab Corporation (“Extab”) a clinical stage biopharmaceutical company
with a focus on smoking cessation, today announced the results of a cost
effectiveness study published in the peer reviewed journal, Nicotine
and Tobacco Research. These data are based on the results of the
Tabex Smoking Cessation (“TASC”) 740-patient pivotal trial, which were
published in the New England Journal of Medicine on September 29,
The primary endpoint of the TASC trial was the Russell Standard criteria
for smoking cessation measured at 12 months from the end of treatment.
Quit rates were confirmed by exhaled carbon monoxide levels. The trial
showed a strongly statistically significant result with a Risk Ratio of
3.4 (p<0.001) indicating that smokers treated with Tabex were 3.4 times
more likely to quit than those on placebo. The pivotal trial met all its
primary and secondary efficacy endpoints.
Rick Stewart, Chairman of Extab, said “We were delighted with the
highly positive and statistically significant results from the TASC
trial, especially as they compare most favourably with the current
market-leading prescription smoking cessation treatments. Moreover,
extensive evaluation of the Tabex safety database shows no evidence of
significant neuropsychiatric or behavioural side-effects as seen with
some currently marketed smoking cessation drugs. These positive
data confirm the outcomes from previous clinical trials and corroborate
the in-market experience of Tabex with the approximately 20 million
patients who have received the drug to date. The addition of
behavioural support in future clinical trials should further enhance
Tabex’s efficacy and safety profile, which we expect will accelerate our
route to approval for Tabex.”
According to a new study published today in the peer reviewed journal, Nicotine
and Tobacco Research, health care systems globally could gain
substantial cost savings by offering an alternative to currently
marketed nicotine replacement products, varenicline and bupropion.
According to the study, Tabex (cytisine), which has been used in Central
and Eastern European countries for many years, would increase each year
of life at a cost of about $300, compared to current National Health
Service (United Kingdom) medicines’ cost which are approximately $3,0001.
The study, conducted at the Cancer Research UK Health Behaviour Research
Centre at University College London by John Stapleton and Robert West,
describes a standard methodology and gives tables to enable the
immediate calculation of the cost-effectiveness of all effective smoking
cessation interventions. It follows recent publication of a trial
showing Tabex to be effective in helping people stop smoking2.
Professor Robert West, Department of Epidemiology and Public Health at
University College London and Principal Investigator on the TASC trial,
concluded, “With more than a billion smokers worldwide and lung
cancer still as one of the top killers, the results of the TASC trial
and these cost effectiveness data show that not only is Tabex comparable
with market leading smoking cessation treatments, but that its cost
effectiveness has the capacity to save millions of lives globally, by
providing an affordable and effective treatment to help people stop
John Stapleton, another Principal Investigator on the TASC trial, said: “The
new Cancer Research UK report shows that more than 40% of cancers are
avoidable, and that smoking is still by far the leading cause of these
preventable cancers.3 “Smoking related diseases
remain the single biggest killer globally. The TASC trial and these new
cost effectiveness results show that Tabex has a greater potential than
existing treatments to save millions of lives globally.”
Tabex has been marketed in Central and Eastern Europe for many years by
Sopharma as a comparatively safe and effective treatment for smoking
cessation. Over 20 million patients have been treated with Tabex and the
latest Periodic Safety Update Reports (PSUR) submitted to the European
Medicines Evaluation Agency (EMEA) was based on approximately 8 million
cases. Numerous Tabex clinical studies have demonstrated positive
efficacy and safety. There have been over 7,000 subjects in clinical
trials to date. The TASC study was the first major study to be performed
to Good Clinical Practice (GCP). The adverse effects associated with
Tabex treatment were generally mild and self-limiting; the benefit-risk
for Tabex treatment was excellent.
Extab Corporation, a Delaware corporation, is a clinical stage
pharmaceutical company focused on the development of efficacious and
cost effective smoking cessation drugs. Extab is dedicated to seeking
regulatory approvals for Tabex in the US, EU and Japan as well as in
Sopharma is the largest Bulgarian pharmaceutical company currently
selling its products in 30+ countries with Group annual turnover of €300
M. The largest export markets are Russia, Ukraine, Kazakhstan and
Poland. The company has developed and manufactures more than 190
pharmaceutical Rx and OTC products in various therapy areas. Sopharma is
the manufacturer and marketing authorization holder for Tabex® in a
number of countries in Central and Eastern Europe. Sopharma is currently
the main partner of Extab for the global development and
commercialization of Tabex®. More information is available on www.sopharma.bg
1 Stapleton JA, West R. A direct method and ICER tables for
the cost-effectiveness of smoking cessation interventions in general
populations: application to a new cytisine trial and other examples.
Nicotine & Tobacco Research 2011 online Dec 7 2011.
2 West R, Zatonski W, Cedzynska M, Lewandowska D, Pazik J,
Aveyard P, Stapleton JA. Randomised placebo-controlled trial of cytisine
for smoking cessation. NEJM 2011; 365(13): 1193-1200.
3 Parkin DH, Boyd L, Walker LC.. The Fraction of Cancer
Attributable to Lifestyle and Environmental Factors in the UK in 2010.
Brit. Journal of Cancer 2011; 105: S77 – S81.