GlaxoSmithKline: Cervarix is approved in Australia for females 10-45 years old

CervarixTM, the cervical cancer vaccine from GSK, has been granted a licence by the Therapeutic Goods Administration (TGA) of Australia for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types. CervarixTM is now approved in Australia for use in females aged 10 to 45 years old. This is the first major market licence for CervarixTM, GSK’s cervical cancer vaccine.


“The approval of CervarixTM in Australia is a key milestone towards eradicating the burden of cervical cancer for all women, especially as this is the first cervical cancer vaccine that is explicitly indicated anywhere in the world for women over the age of 26. This vaccine heralds a major scientific breakthrough in cervical cancer prevention and demonstrates GSK’s commitment to developing innovative vaccines. It is great news for us and this vaccine will be a key driver in GSK’s future growth,” said Jean Stephenne, President of GlaxoSmithKline Biologicals.


CervarixTM is formulated with a novel proprietary adjuvant system called AS04 which is designed to enhance immune response and increase the duration of protection. Published data have shown that this adjuvant formulation provides a stronger and longer-lasting immune response compared to the same vaccine composition formulated with conventional aluminum hydroxide adjuvant alone5. Jean Stephenne added, “We are especially excited about CervarixTM, the first cervical cancer vaccine to feature one of our novel adjuvant systems. Our goal is to provide the best possible protection for women against cervical cancer.”


CervarixTM has been tested in over 40,000 females in clinical trials and, in these trials, CervarixTM showed consistently high levels of efficacy in preventing precancerous lesions due to cancer-causing virus types 16 and 181. In findings from these clinical trials, CervarixTM has been shown to have a good safety profile and to be generally well-tolerated in women6,7,8. Data also showed preliminary evidence of additional protection against infection with cancer-causing virus types other than virus types 16 and 181.


GSK submitted a Biologics Licence Application (BLA) for CervarixTM to the U.S. Food and Drug Administration (FDA) in March 2007, following earlier regulatory filings with the European Medicines Agency(EMEA) and regulatory filings in Africa, Asia and Latin America.


Cervical cancer is the second leading cause of cancer in women under 45, and causes over 270,000 deaths worldwide per year2. It occurs when infection with the human papillomavirus becomes persistent, and progresses to cancer. Up to 50-80 per cent of women will acquire an infection in their lifetime, with the risk of persistence increasing with age3. This is why it is so important to ensure that women over 26 are also protected against cancer-causing virus types, to reduce the risk of infection becoming persistent and progressing to cervical cancer. In humans, approximately 100 types of HPV have been identified to date and, of these, approximately 15 virus types are considered to cause cervical cancer. Virus types 16 and 18 are responsible for approximately 70 percent of cervical cancers globally4.



About CervarixTM
CervarixTM is a trade mark of the GlaxoSmithKline group of companies.

CervarixTM, GSK’s cervical cancer vaccine, was developed to prevent infection and lesions from the two most prevalent cancer-causing human papillomavirus types, specifically types 16 and 18. It is formulated with the proprietary adjuvant system, AS04, selected to ensure that this vaccine confers strong and sustained antibody levels over time.


About GlaxoSmithKline
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 pediatric vaccines which protect the world’s children with up to six diseases in one vaccine.




References

1 Harper 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. Lancet 2006; 367: 1247-1255

2 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. Available at: http://www-dep.iarc.fr. Accessed 30 March, 2007

3 Bosch FX, de Sanjose S. Chapter 1 : Human papillomavirus and cervical cancer – burden and assessment of causality. J Natl Cancer Inst Monogr, 2003; 3-13

4 Muñoz N, Bosch FX, de Sanjose S, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 2003; 348: 518-527

5 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

6 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 on 14-16 April 2007 (abstract no. 4900)

7 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. June 2007.

8 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