GSK seeks prequalification for Cervarix™ from the World Health Organization

GlaxoSmithKlineGlaxoSmithKline (GSK) announced that it has submitted a file on its cervical cancer vaccine, Cervarix™, to the World Health Organization (WHO) for pre-qualification, following the granting of a marketing authorisation approval by regulatory authorities in Europe on 20 September.

WHO designed the pre-qualification mechanism to speed the delivery of new vaccines to developing countries (and where they are needed most), once the vaccines have received approval from a recognised national regulatory authority. With three opportunities for submission a year, prequalification functions as a public health endorsement of a vaccine's efficacy, safety and quality and confirms the manufacturer's ability to fulfil large-scale UN tenders. Products with prequalification status may be used by UN agencies and the GAVI Alliance, as well as mass vaccination programmes across the developing world.

"GSK believes that people in developing countries should have rapid access to life-saving vaccines once they are approved," said Jean Stéphenne, President and General Manager of GSK Biologicals. "By submitting Cervarix for prequalification as early as possible, we are working to eliminate the historical 15-20 year delay for new vaccines to become available in developing countries. This move is the latest example of GSK's longstanding partnership with UNICEF and the GAVI Alliance, including our tiered pricing programme, which we pioneered more than 20 years ago."

Worldwide a woman dies of cervical cancer every two minutes resulting in more than 270,000 deaths each year.1 85 per cent of deaths from cervical cancer occur in the developing world where, in the absence of regular screening and treatment programmes, it is the leading cause of cancer deaths in women.[1]

"Cervical cancer vaccines represent a major medical breakthrough and have the potential to transform women's health, particularly in resource-poor countries," said Dr. Nono Simelela from the International Planned Parenthood Federation. "Prequalification would help speed access to this important new tool for girls and women across the world at risk for cervical cancer. Along with increased awareness and improvements in screening and treatment, cervical cancer vaccines will help save and improve the lives of millions of women."

GSK Biologicals has a long-standing commitment to preventing diseases prevalent in the developing world. As with its other vaccines, GSK will provide its cervical cancer vaccine at preferential prices to low income countries. GSK's unique business model is designed to ensure availability of its vaccines regardless of where people live. Under tiered pricing, GSK offers low-cost vaccines to major purchasers like UNICEF and the GAVI Alliance as well as individual countries based on their national income, the volume of doses ordered and the length of the contract.

About Cervarix™
GSK developed Cervarix™ to protect women from cervical cancer by guarding against the most common cancer-causing forms of the human papillomavirus (HPV). Clinical trials involving almost 30,000 females demonstrated excellent efficacy and immunogenicity data, including:

  • Interim data from the largest Phase III cervical cancer vaccine efficacy trial to date[2], which demonstrated that — based on a post hoc analysis* - the vaccine 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.[3] The interim analysis also indicated that the vaccine is generally well tolerated
  • Long-term trial data showing 100 per cent sustained protection for up to 5.5 years after vaccination.[4] Duration of protection is particularly important as women may acquire infections throughout their lifetimes
  • Data from immunogenicity trials, which indicate that the vaccine is highly immunogenic in a broad age range, inducing high antibody levels in women aged 10-55 years old[4,5,6]
* In this study of women, including those with other oncogenic HPV infections and low-grade abnormal cytology at entry, there was 90 per cent 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 per cent efficacy against CIN2+ considered causally related to HPV 16/18 in an additional, post hoc, analysis taking account of the likely causal role of persistence of oncogenic HPV infection prior to lesion development.[2]

Novel adjuvant system
Cervarix™ is formulated with a novel proprietary adjuvant system called AS04, which is designed to enhance the immune response against cancer-causing virus types.

Published data have shown that the vaccine, 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.[8]

About cervical cancer
Cervical cancer is the second leading cause of cancer in women. 9 500,000 new cases of cervical cancer are reported in women each year and projections indicate that, without a dramatic improvement in cervical cancer prevention, there could be over a million new cases each year by 2050.[9]

Cervical cancer 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 date[12] and, of these, approximately 15 virus types are considered to cause cervical cancer.3 Virus types 16 and 18 are responsible for approximately 71.5 per cent of cervical cancers in Europe.[3]

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 has one of the largest development pipelines in the vaccine industry. Of the more than 25 vaccine projects in the pipeline, approximately one-third are focused on diseases prevalent in the developing world. These include vaccines for pneumococcal diseases, meningitis, and dengue. GSK Bio is the only company with vaccine development programmes for each of the "big three" global infectious diseases: HIV/AIDS, malaria, and TB.

In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries. Of these doses, seventy-five percent of these went to the developing world. 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.

References
[1] Ferlay J, Bray P, Pizani P, Parkin DM. Cancer incidence, mortality and prevalence worldwide. Available at: GLOBOCAN 2002. Accessed September 20, 2005
[2] Paavonen
[3] 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. International Journal of Cancer 2004; 111: 278-285
[4] 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)
[5] 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
[6] 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)
[7] Harper DM, Franco EL, Wheeler CM, MoscickiAB, Romanowski B, Roteli-Martins CM 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. The Lancet 2006; 367:1247-1255
[8] 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
[9] Ferlay J, Bray F, Pisani P, Parkin DM. GLOBOCAN 2002: Cancer incidence, mortality and prevalence worldwide. IARC CAncerBase No.5, version 2.0. IARC Press 2004
[10] GravittPE, 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. Journal of Infectious 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

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