Issued: 24 September 2007

 

GlaxoSmithKline (GSK) today announced that the European Commission has granted a marketing authorisation for its cervical cancer vaccine, Cervarix ^TM for all 27 European member states*. Cervarix, with its innovative AS04 adjuvant system, is indicated for the prevention of precancerous cervical lesions (high-grade cervical intraepithelial neoplasia [CIN] grades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18. The indication is based on data generated in girls and women aged between 10 and 25.^1,2

“The decision to approve Cervarix for the European Union represents a great step forward for European women. Physicians across Europe will now have access to this important vaccine to help protect women against cervical cancer, the second most common cancer in women,” said JP Garnier, Chief Executive Officer of GSK.

The approval follows Positive Opinion of the Committee for Medicinal Products for Human Use (CHMP) in July 2007, based on a review of data from clinical trials which involved almost 30,000 females and which demonstrated excellent efficacy and immunogenicity data. The file included:

• Data from the largest Phase III cervical cancer vaccine efficacy trial to date³, which demonstrated that – based on a post hoc analysis** - Cervarix provides 100 percent protection against precancerous lesions (CIN2+) causally related to human papillomavirus types 16 and 18. These virus types are responsible for 70 per cent of all cervical cancer cases worldwide.⁴ The trial also indicated that Cervarix is generally well tolerated.
• Long-term trial data showing Cervarix provides 100 per cent sustained protection for up to 5.5 years after vaccination.¹ Duration of protection is particularly important as women may acquire infections throughout their lifetimes
• Data from immunogenicity trials, which indicate that Cervarix is highly immunogenic in a broad age range, inducing high antibody levels in women aged 10-55 years old.^1,2,5

Novel adjuvant system

Cervarix is formulated with a novel proprietary adjuvant system called AS04, which is designed to enhance the immune response and increase the duration of protection against cancer-causing virus types.

Published data have shown that Cervarix, formulated with this adjuvant system, induces an immune response of higher magnitude and persistence compared to the same vaccine composition, formulated with conventional aluminium hydroxide adjuvant alone.⁶

About Cervarix regulatory progress

Cervarix is indicated in the EU for the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18.⁷

In May 2007, Cervarix was granted its first license in a major market by the Therapeutic Goods Administration (TGA) of Australia for the prevention of cervical cancer and precancerous lesions caused by human papillomavirus types 16 and 18 for use in females ages 10 to 45 years.⁸ This is the first time that a cervical cancer vaccine has been approved with an explicit indication anywhere in the world for women over the age of 26. Subsequent licenses have been granted in other international markets.

GSK submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its cervical cancer candidate vaccine in March 2007, following earlier regulatory filings with the European Medicines Agency (EMEA) and regulatory filings in Africa, Asiaand Latin America.

* The EU marketing authorisation granted today will also have consequent effect in Iceland, Norway and Liechtenstein

** In this study of women including those with other oncogenic HPV infections and low-grade abnormal cytology at entry there was 90% efficacy against CIN2+ associated with HPV 16/18 DNA in the lesion. Many of the CIN2+ lesions were associated with multiple HPV types. There was 100% efficacy against CIN2+ considered causally related to HPV 16/18 in an additional analysis taking account of the likely causal role of persistence of oncogenic HPV infection prior to lesion development).³

Notes to editors

About cervical cancer

Cervical cancer is the second leading cause of cancer in women, and causes over 270,000 deaths worldwide per year.⁹ It occurs when infection with the human papillomavirus becomes persistent and progresses to cancer. Up to 80 per cent of sexually active women will acquire a human papillomavirus infection in their lifetime, with the risk of persistence increasing with age.^10,11 Approximately 100 types of human papillomavirus have been identified to date¹² and, of these, approximately 15 virus types are considered to cause cervical cancer.⁴ Virus types 16 and 18 are responsible for approximately 71.5 per cent of cervical cancers in Europe.⁴

About GlaxoSmithKline and GlaxoSmithKline Biologicals

In the next five years, GSK expects to launch a number of significant new vaccines to protect against a range of serious diseases.

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 www.gsk.com/media.

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 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination paediatric vaccines which protect the world’s children from up to six diseases in one vaccine.

Cervarix is a trademark of the GlaxoSmithKline group of companies.

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 on Form 20-F for 2006.

Enquiries:

UK Media enquiries:	Philip Thomson Alice Hunt Joss Mathieson Claire Brough	(020) 8047 5502 (020) 8047 5502 (020) 8047 5502 (020) 8047 5502
US Media enquiries:	Nancy Pekarek Mary Anne Rhyne	(215) 751 7709 (919) 483 2839
European Analyst/ Investor enquiries:	David Mawdsley Sally Ferguson	(020) 8047 5564 (020) 8047 5543
US Analyst/ Investor enquiries:	Frank Murdolo Tom Curry	(215) 751 7002 (215) 751 5419

References

¹ Gall SA, et al. Substantial impact on precancerous lesions and HPV infections through 5.5 years in women vaccinated with the HPV-16/18 L1 VLP AS04 candidate vaccine. Presented at the American Association for Cancer Research (AACR) annual meeting, 14-16 April 2007 (abstract no. 4900)

² Rombo L, Dubin G. Long-term safety and immunogenicity of a cervical cancer candidate vaccine in 10-14-year-old adolescent girls. Presented at the European Society of Paediatric Infectious Diseases (ESPID) annual meeting on 2-5 May 2007

³ Paavonen, J., Jenkins, D., Bosch, X., et al. Efficacy of a human papillomavirus (HPV)-16/18 L1 virus-like particle (VLP) AS04 vaccine: a phase III randomized, controlled trial in young women. The Lancet2007; 369: 2161-2170

⁴ Muñoz N, Bosch FX, Castellsagué X, Diaz M, de Sanjose S, Hammouda D, Shah KV, Meijer CJLM. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int J Can 2004; 111: 278-285

⁵ Schwarz T, Dubin G, et al. Human Papillomavirus (HPV) 16/18 L1 AS04 Virus-Like Particle (VLP) Cervical Cancer Vaccine is Immunogenic and Well-Tolerated 18 Months After Vaccination in Women up to Age 55 Years. Presented at ASCO Annual Clinical Meeting, 1-5 June 2007(abstract no. 3007)

⁶ Giannini SL, et al. Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminum salt combination (AS04) compared to aluminium salt only. Vaccine 2006 24: 5937–5949

⁷ Approved European Cervarix Product Information – September 2007

⁸ Approved Australian Cervarix Product Information – May 2007

⁹ Ferlay J, Bray P, Pizani P, Parkin DM. Cancer incidence, mortality and prevalence worldwide. Available at: GLOBOCAN 2002. Accessed September 20, 2005

¹⁰ Gravitt PE, Jamshidi R. Diagnosis and management of oncogenic cervical human papillomavirus infection. Infect Dis Clin North Am, 2005; 19:439-458

¹¹ Castle PE, Schiffman M et al. A prospective study of age trends in cervical human papillomavirus acquisition and persistence in Guanacaste, Costa Rica. J of Infect Diseases 2005; 191; 1808-1816

¹² de Villiers E, Fauquet C, Broker T, Bernard H, zur Hausen H. Classification of papillomavirus. Virology 2004; 324: 17-27