Mathematical Model Based on Clinical Findings From Cervarix(TM), GSK's Cervical Cancer Candidate Vaccine, Suggests Vaccination Could Reduce Cervical Cancers by up to 80%

Mathematical Model Based on Clinical Findings From Cervarix(TM), GSK's Cervical Cancer Candidate Vaccine, Suggests Vaccination Could Reduce Cervical Cancers by up to 80%

October 30, 2006

    LONDON and RIXENSART, Belgium, Oct. 30
/Xinhua-PRNewswire/ -- Mathematical model projections
predict that vaccinating all 11-13 year old girls with
Cervarix(TM), GSK's cervical cancer candidate vaccine, has
the potential to reduce the incidence of cervical cancer by
up to 80%, based on available clinical data.(1) The
projections model was constructed in two stages. In the
first, vaccination with GSK's cervical cancer candidate
vaccine -- which has shown excellent protection against the
two most cancer-causing HPV types, 16 and 18(2) -- accounted
for a projected 74% reduction of cervical cancer in France.
This constituted the base-case analysis of this model.(1)

    In a further analysis, the model incorporated
preliminary evidence that GSK's cervical cancer candidate
vaccine has been shown to provide substantial protection
against pre-cancerous lesions beyond that expected from HPV
vaccine-types 16 and 18.2 When this additional protection is
added to the model, a further 6% reduction is predicted,
making a total reduction of 80% of cervical cancers.(1)
These findings were presented today at the International
Society of Pharmacoeconomics and Outcomes Research 9th
Annual European Congress (ISPOR) in Copenhagen, Denmark.

    Further data presented at ISPOR underscore not only the
major health burden(3),(1) that cervical cancer represents
for all women, but also the substantial cost for
society(4), particularly considering the costs of the
organisation and implementation of screening against
cervical cancer.(5),(6) Indeed, the data presented at ISPOR
suggest that vaccination will reduce cervical cancer
specific mortality, the number of cervical cancer cases,
pre-clinical cancer cases, as well as their related costs.

    "The potential to reduce cervical cancer cases and
mortality by up to 80 per cent, as suggested by the outcome
of the model is very encouraging," noted Prof. Lieven
Annemans, the former president of ISPOR. "Vaccination
that provides the broadest possible protection against
cancer-causing HPV types is a desirable strategy to reduce
the significant health burden of cervical cancer. In doing
so, we can save lives of women as well as expect to save
our healthcare systems the associated high costs of
intervention," he said.

    The mathematical model presented at ISPOR adds to the
growing body of collected analyses -- which have
demonstrated similar cervical cancer case reduction figures
projected using GSK's cervical cancer candidate vaccine --
including those for Spain(7), the UK(8) and the USA(9).

    Notes to editors:

    The projection of reduction in cervical cancers is
calculated based on the clinically demonstrated efficacy of
the cervical cancer candidate vaccine, within the existing
screening and disease management environment, assuming 100%
vaccination of the age group.

    About the mathematical model(1)

    To investigate the clinical benefit of the candidate
vaccine, researchers used a Markov model to simulate the
long term prevention effects against cervical cancer of
GSK's cervical cancer candidate vaccine. The Markov model
was built in Microsoft(R) Excel software and replicates the
natural history of HPV infection to cervical cancer over the
lifetime of an age-cohort of 11-13 year old girls. The model
simulates the effect of adding 100% vaccination of the age
cohort to the current screening program in terms of number
of cervical cancer cases and cervical cancer deaths
avoided. All transition probabilities of the natural
history of HPV-infection to cervical cancer and the
screening patterns were obtained from literature review,
expert opinion and official French statistics.

    About GSK's cervical cancer candidate vaccine

    GSK's cervical cancer candidate vaccine was developed
to prevent infection and lesions from the two most
prevalent cancer-causing types of HPV, specifically HPV 16
and 18.

    In previous clinical trials performed in 15-25 year old
women, the vaccine demonstrated excellent protection from
persistent infection against both HPV 16 and 18, associated
precancerous lesions and excellent antibody response up to
4.5 years. GSK's cervical cancer candidate vaccine is
formulated with the proprietary adjuvant AS04 selected to
ensure that it confers high and sustained antibody levels.
In addition, preliminary data regarding GSK's cervical
cancer candidate vaccine has been shown to provide
substantial protection against infection with the third and
fourth most prevalent cancer-causing types of HPV, namely
types 45 and 31. HPV types 16, 18, 45 and 31 are
collectively responsible for 80 per cent of cervical
cancers globally.

    The overall safety profile from the completed
controlled trials indicates that the vaccine is generally
safe and well tolerated with a very good compliance to the
3 dose schedule.

    Over 16,000 women worldwide have been vaccinated with
GSK's cervical cancer candidate vaccine as part of
completed and ongoing clinical trials. It is currently
undergoing extended Phase III clinical trials.

    GSK's submitted a marketing application review for its
cervical cancer candidate vaccine to the European Agency
for the Evaluation of Medicinal Products (EMEA) in March
2006. Other international regulatory filings followed in
Australia, parts of Asia and Latin America from March 2006,
with submission to the US Food and Drug Administration (FDA)
by April of 2007.

    About HPV and cervical cancer

    HPV infection is very common; every sexually active
woman is at risk of contracting a type of HPV, which may
cause cervical cancer. While there are many different types
of HPV that may cause cancer, HPV types 16, 18, 45 and 31
are collectively responsible for 80 per cent of cervical
cancers globally.

    Cervical cancer is a major global health problem, with
nearly 500,000 new cases occurring each year worldwide. It
is the second most common cancer -- and the third leading
cause of cancer deaths -- in women worldwide. Each year an
estimated 270,000 women die from the disease, and it is the
leading cancer killer of women in the developing world.

    References:

    (1) Demarteau N et al. Long term clinical effect of an
HPV-vaccine
        for the prevention of cervical cancer in France in
relation to
        age of vaccination: results from a Markov Model.
Poster to be
        presented at ISPOR, 28-31 October 2006.

    (2) Harper DM, et al. Sustained efficacy up to 4-5
years of a
        bivalent L1 virus-like particle vaccine against
human
        papillomavirus types 16 and 18: follow-up from a
randomised
        control trial. Lancet 2006; 367:1247-1255.

    (3) Rogozza R, Estimating the clinical benefits of HPV-
16/18
        vaccination: challenges of modeling predicted cases
of cervical
        cancer in Poland and Mexico, two countries with
differing
        degrees of cervical disease and population
stability. Poster to
        be presented at ISPOR, 28-31 October 2006.

    (4) Rash B, Comparing Management Patterns And
Associated Costs Women
        With Abnormal Cervical Cytology In 5 Different
Countries. Poster
        to be presented at ISPOR, 28-31 October 2006.

    (5) Helms LJ, Melnikow J, Determing costs of health
care services
        for cost-effectiveness analyses: the case of
cervical cancer
        prevention and treatment. Med Care 1999;
37:652-66.

    (6) Insinga RP, Glass AG, Rush BB. The health care
costs of cervical
        human papillomarvirus-related disease. Am J Obstet
Gynecol 2004; 
        191:114-20.

    (7) De San Jose S et al. Adaptation of a Health
Economic Model of
        the Natural History of HPV Infection and Cervical
Cancer for
        Spain. Presented at International Papillomavirus
Conference,
        Prague, 3-7 September 2006.

    (8) Kohli M et al. Estimating the Long-term Impact of a
Prophylactic
        Human Papillomavirus (HPV) 16/18 Vaccine on the
Burden of
        Cervical Disease in the UK. Presented at
International
        Papillomavirus Conference, Prague, 3-7 September
2006.

    (9) Juday TR et al. Clinical Benefits Associated with
Vaccination
        Against Human Papillomavirus: The Contribution of
        Cross-Protection. Presented at Interscience
Conference on
        Antimicrobial Agents and Chemotherapy in San
Francisco (USA)
        (ICAAC), 27-30 September 2006.

    For more information, please contact:

     GSK Biologicals: 

     Chris Hunter-Ward
     Tel: [phone]

     Stella Gu
     Tel: [phone]

SOURCE  GlaxoSmithKline