Healthcare Industry News:   cervical cancer vaccine 

Biopharmaceuticals Oncology

 News Release - September 29, 2006

Mathematical Model Predicts That CERVARIX May Prevent Nearly 80 Percent of Cervical Cancers

Model Shows the Potential Impact of a Vaccine Candidate that May Offer More Protection Against Cancer-Causing HPV Types

SAN FRANCISCO, Sept. 29 (HSMN NewsFeed) -- New mathematical modeling data show that assuming total vaccine coverage of all 12-year-old girls in the United States, cervical cancer vaccination against HPV types 16 and 18 may prevent 70 percent of cervical cancer cases and deaths. When the model factors in potential additional protection against other cancer-causing HPV types, it estimates that vaccination may prevent nearly 80 percent of cervical cancer cases and deaths in the U.S.

The mathematical model was designed to evaluate the lifetime clinical benefit of three cervical cancer prevention strategies. This analysis was undertaken to investigate the potential incremental benefit of broader oncogenic protection against other cancer-causing HPV types beyond HPV types 16 and 18. The hypothetical model is based in part on published clinical data that demonstrated that GlaxoSmithKline's (GSK) (NYSE: GSK ) cervical cancer vaccine candidate, CERVARIX(TM), may provide broader protection.

These data were presented today at The American Society for Microbiology's 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC(TM)) in San Francisco, California [Session 163, Paper O-1472].

"The findings of this mathematical model are very encouraging, particularly in the context of our clinical findings which suggest a broader oncogenic protection with this vaccine candidate against infection with HPV types other than HPV 16 and HPV 18. Ultimately, a vaccine with broader oncogenic protection may provide women with enhanced protection against cervical cancer," said Gary Dubin, Vice President, HPV Vaccines, GlaxoSmithKline. "Additionally, this vaccine candidate is formulated with an advanced adjuvant system which was specifically selected to induce sustained immune responses against HPV which may provide women with durable protection against cervical cancer."

One hundred percent vaccination coverage is likely not feasible in the U.S., therefore the mathematical model also examined the impact of vaccinating 70 percent of 12-year-old U.S. females against HPV 16 and 18 -- a percentage based on previous immunization adherence findings within the population. The model showed that a cervical cancer vaccine which targets HPV types 16 and 18 could cut the number of cases and deaths from cervical cancer by nearly half in the U.S. The model also evaluated the benefit of protection against other oncogenic HPV types, projecting that additional protection against other cancer-causing HPV types may result in a close to ten percent improvement in cervical cancer prevention when compared with vaccination against HPV 16 and 18 alone.

"With this model, we wanted to determine whether the clinical data for a cervical cancer vaccine candidate, which targets HPV 16 and 18, but has been reported to provide enhanced protection against infection with other cancer- causing HPV types, would in the long-term greatly reduce the number of cases and deaths from cervical cancer," said Dr. Tim Juday, study author and clinical health outcomes expert with i3 Innovus, based in Medford, Massachusetts.

Because other cancer-causing HPV types beyond 16 and 18 can cause up to 40-50 percent of precancerous disease (low-grade CIN 1 and high-grade lesions CIN 2 and 3), broader protection may be particularly important in preventing early stages of the disease. Early (precancerous) disease can drive the economic burden of HPV-related cervical disease, with the total annual cost of follow-up of abnormal pap smears and treatment of precancerous lesions estimated at $3.6 billion (90 percent of total HPV-related costs).

Notes to editors:

Study Design

To investigate the lifetime clinical benefit of the vaccine candidate, researchers examined three separate cervical cancer prevention strategies. To achieve a baseline, researchers simulated the natural history of HPV over a lifetime (including screening and disease progression) among a Census-based cohort of non-vaccinated, 12-year-old U.S. females based on the strategies of (1) screening only, with no vaccination; (2) screening and vaccination against HPV 16 and 18 only and (3) screening and vaccination against HPV 16 and 18 and other oncogenic HPV types.

Calibrated model estimates were validated against U.S. epidemiologic data, based on screening only and assuming no vaccination. Calibration endpoints included age-specific HPV prevalence, HPV type distribution in normal cytology and cervical disease, prevalence of CIN 1 to CIN 3 lesions, and cervical cancer incidence and mortality.

Next, researchers included GSK's cervical cancer vaccine candidate clinical trial data into the model based on two vaccination strategies. The model assumed both 70 and 100 percent vaccination of females by age 13 and that vaccination conferred lifetime protection. HPV 16 and 18 vaccine efficacy was simulated in the model to match results reported for HPV 16/18 bivalent vaccine clinical trials.

About GlaxoSmithKline'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. It is formulated with the proprietary adjuvant system, AS04, selected to ensure this vaccine confers strong and sustained antibody levels over time.

More than 16,000 women worldwide have been vaccinated with GSK's cervical cancer candidate vaccine as part of completed and ongoing clinical trials. Phase III studies are under way in more than 25 countries with more than 35,000 subjects enrolled in ongoing trials.

GSK intends to file a biologics license application with the U.S. Food and Drug Administration by the end of 2006 for its cervical cancer candidate vaccine. The company submitted a marketing application review to the European Agency for the Evaluation of Medicinal Products in March 2006. Other international regulatory filings followed in Australia, parts of Asia and parts of Latin America in March 2006.

About GlaxoSmithKline

In the next two to five years, GSK expects to launch more major new vaccines in the United States, for example, a vaccine against rotavirus, an improved flu vaccine for the elderly and a meningitis combination vaccines for various ages, including infants.

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit http://www.gsk.com.

GSK Biologicals (GSK Bio), one of the world's leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline's activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2005, GSK Bio distributed more than 1.2 billion doses of vaccines to 165 countries in both the developed and the developing world, an average of more than 3 million doses per day.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under "Risk Factors" in the "Operating and Financial Review and Prospects" in the company's Annual Report 2005.


Source: GlaxoSmithKline

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