Cervarix™, GSK's cervical cancer vaccine, wins tender for UK national immunisation programme

GlaxoSmithKlineGlaxoSmithKline's (GSK) cervical cancer vaccine, Cervarix TM, was confirmed as the UK Department of Health's vaccine of choice for its national human papillomavirus (HPV) immunisation programme. The programme, which aims to protect against the two types of HPV that are responsible for approximately 70% of cervical cancers[1], will start in September 2008 and will vaccinate girls aged 12 to 13 each year. There will also be a catch up programme for girls aged 14 up to 18 years, which will be implemented over the next 2-3 years.

"This is great news for girls and women across the UK and reflects the growing confidence in Cervarix, which provides cervical cancer protection with a strong and sustained immune response," said Eddie Gray, President of Pharmaceuticals Europe for GSK. "We are delighted to be working with the UK Department of Health to help reduce the burden of cervical cancer and believe the benefits of this programme will be felt by women and their families for generations to come."

In the UK, an average of 3,000 women are diagnosed with cervical cancer and approximately 1,000 die from the disease each year.[2] Cervical cancer is the third leading cause of cancer death among women globally, killing one woman every two minutes.[3,4] As well as the deaths associated with the disease, cervical cancer and pre-cancerous lesions are also a significant cause of emotional and physical distress in women.[5] Alongside screening and a healthy lifestyle, vaccination is expected to significantly reduce the lifetime risk of cervical cancer.[6]

GSK's cervical cancer vaccine is already approved in 64 countries worldwide. As the first major national tender for which GSK has bid, the UK win marks another important milestone. This represents one of the largest human papillomavirus national immunisation programmes in the world to date and GSK looks forward to working with more governments around the world to ensure that as many girls and women as possible can benefit from cervical cancer vaccination with Cervarix.

GSK will now work with the UK Department of Health to support the successful implementation of the cervical cancer vaccination programme.

About the UK vaccination programme
From September 2008, HPV vaccination will be routinely recommended for all girls at 12 to 13 years of age (school year 8 or S2 in Scotland or school year 9 in Northern Ireland). Initially, there will be a catch-up campaign where girls aged 14 to under 18 years will be offered the vaccine.

From September 2009, girls in England, Wales and Northern Ireland aged 16 to 18 (school years 12 and 13 or school years 13 and 14 in Northern Ireland) will be offered the vaccine. From September 2010, girls aged 15 to 17 (school years 11 and 12 or school years 12 and 13 in Northern Ireland) will be offered the vaccine.

In Scotland, the catch up programme will begin on 1 September 2008 with girls aged 16 to 17 (school years S5 and S6). Scottish girls aged 14 to 16 (school years S4 and S5) will be vaccinated from September 2009, and girls who have incomplete or no immunisation will be offered vaccination from September 2010.

About cervical cancer and its progression
Approximately 100 types of human papillomavirus have been identified to date[7] and, of these, approximately 15 virus types are known to cause cervical cancer.[1] Virus types 16 and 18 are responsible for approximately 70% of cervical cancers.[1] Persistent infection with cancer-causing virus types can lead to the formation of abnormal cells in the cervix, which, over time, may become precancerous or cancerous.[8] Throughout their sexually active lifetime, women may be exposed to cancer-causing virus types. The majority of women will clear an infection spontaneously. However, if the infection persists it can lead to precancerous lesions or cervical cancer.[9]

Experts believe that neutralising antibodies – so-called because they have the ability to neutralise cancer-causing virus types and prevent them from infecting cells in the cervix – are essential for cervical cancer protection, post-vaccination.[10-12] The World Health Organization has stated that neutralising antibodies are "considered to be the major basis" of vaccine-induced protection from infection.[11,12]

Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.[4]

About the GSK cervical cancer vaccine
Cervarix TM has been specifically designed by GSK to provide women with protection against cervical cancer, targeting the two human papillomavirus (HPV) types, 16 and 18, that are responsible for over 70% of cervical cancer.1

To date, GSK's cervical cancer vaccine has been approved in 64 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 35 additional countries including Japan. In September 2007, GSK also submitted Cervarix to the World Health Organization for prequalification, towards distribution across the developing world via the United Nations and the GAVI Alliance.

GSK submitted a Biologics Licence Application (BLA) to the U.S. Food and Drug Administration (FDA) for its cervical cancer vaccine in March 2007.

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

GlaxoSmithKline Biologicals (GSK Biologicals) is a global vaccine company which has shown itself to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world – an average of 3 million doses a day.

GSK Biologicals employs over 9,000 people worldwide including more than 1,600 passionate scientists engaged in research aimed at discovering innovative vaccines that contribute to the health and well-being of people of all generations around the world.

Cervarix TM is a trademark of the GlaxoSmithKline group of companies.

References
[1] Munoz N, Bosch X, Castellasague X. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int J Cancer 2004; 111: 278-85
[2] Cancer Research UK cancer statistics – Incidence and mortality UK. info.cancerresearchuk.org/cancerstats/?a=5441. Assessed May 2008
[3] Ferlay J, Bray P, Pisani P, et al. GLOBOCAN 2002: Cancer incidence, mortality and prevalence worldwide. IARC CancerBase No. 5, version 2.0. IARCPress, Lyon, 2004
[4] World Health Organization. Initiative for Vaccine Research. www.who.int/vaccine_research/diseases/hpv/en/ Accessed on 29 April 2008
[5] Basen-Engquist K, Paskett ED, Buzaglo J et al. Cervical cancer. Behavioral Factors Related to Screening, Diagnosis, and Survivors’ Quality of Life Cancer 2003; 98: 2009-2014
[6] Goldie SJ, Kohli M, Grima D, Weinstein MC, Wright TC, Bosch FX, Franco E. Projected clinical benefits and cost-effectiveness of a human papillomavirus 16/18 vaccine. J Natl Cancer Inst 2004b; 96: 604-615. 13
[7] De Villiers EM. Heterogeneity of the human papillomavirus group. J Virology 1989; 63: 4898-903. 4. 796-802
[8] Bosch FX, Lorincz A, Munoz N et al. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol 2002; 55: 244-65
[9] GravittPE, Jamshidi R. Diagnosis and management of oncogenic cervical human papillomavirus infection. Infect Dis Clin North Am, 2005; 19:439-458
[10] Villa L. Vaccines against papillomavirus infections and disease. Revista Chilena de Infectologia. 2006; 23(2): 160-163
[11] World Health Organization Human papillomavirus and HPV vaccines: technical information for policy-makers and health professionals. Retrieved from www.who.int/reproductive-health/publications/hpvvaccines_techinfo/hpvtechinfo_nocover.pdf on 8 February 2008
[12] World Health Organization. Guidelines to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines. Expert committee on biological standardization, Oct 2006

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