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FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline's Candidate Cervical Cancer Vaccine
Date:9/9/2009

data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 participants receiving CERVARIX, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women.

About CERVARIX((R))

GSK designed CERVARIX with its ASO4 adjuvant system to deliver high and sustained levels of antibodies aimed at providing long-term protection against cancer-causing HPV types, although the exact level of antibodies that confer protection is not known. Protection has been shown through 6.4 years and ongoing clinical studies continue to assess duration of protection. ASO4 enhances the body's immune response to the antigens contained in the vaccine. This response provides protection at the cervix, where natural antibody response to infection may not adequately protect against future infections with the same virus type.

To date, CERVARIX has been approved in nearly 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries, including Japan and the United States. GSK also received World Health Organization (WHO) prequalification in July 2009.

CERVARIX((R)) (Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) is a registered trademark of the GlaxoSmithKline group of companies.

About Cervical Cancer

Women are at risk of HPV infection and cervical cancer throughout their sexually active lives. Approximately 100 types of HPV have been identified to date and, of these, approximately 15 virus types are known to cause cervical cancer. HPV ty
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SOURCE GlaxoSmithKline
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