Healthcare Industry News:  GSK 

Biopharmaceuticals Oncology

 News Release - October 30, 2006

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%

LONDON, England and RIXENSART, Belgium, October 30 (HSMN NewsFeed) -- Mathematical model projections predict that vaccinating all 11-13 year old girls with Cervarix(TM), GSK's (NYSE:GSK ) 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 model1

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® 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.


[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 José 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.

Source: GlaxoSmithKline

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