Cervical Cancer Vaccine Submitted for Regulatory Approval in Australia

Cervical Cancer Vaccine Submitted for Regulatory Approval in Australia

Melbourne, Australia — 20/12/2005

CSL Limited announced today that the cervical cancer vaccine GARDASIL® (Quadrivalent Human Papillomavirus Types 6, 11, 16, 18 Recombinant Vaccine) was one step closer to being made available to Australians, after being submitted today for regulatory review to the Therapeutic Goods Administration (TGA). An application requesting priority review of GARDASIL has also been submitted to the TGA.

Once GARDASIL has been granted registration, the world's first vaccine specifically developed to prevent a cancer, will be made available to the Australian public.

Part of the submission to TGA  included clinical trial data from Australian women. Phase III data showed that GARDASIL prevented 100 per cent of high-grade cervical pre-cancers and non-invasive cervical cancers (CIN 2/3 and AIS) associated with human papillomavirus (HPV) types 16 and 18.  The Human papillomavirus types 6, 11, 16 and 18 in the vaccine are the most common types affecting women's health, and cause 70% of cervical cancer and account for a significant proportion of abnormal pap tests.

Dr Andrew Cuthbertson, Chief Scientific Officer at CSL Limited, said today that he was keen to see the vaccine made available to Australian women as soon as possible.

"A preventative vaccine complimented by regular pap tests will be a major leap forward in eradicating this disease", Dr Cuthbertson said.

In Australia there are approximately 15,000 women each year who are detected with high-grade cervical abnormalities (on histology).  These abnormalities require surgical treatment to remove part of the cervix, causing much anxiety for the women and their families.

"Being part of the solution to reduce the burden from this disease is very exciting,' he said, "the beneficial impact of the vaccine will be appreciated by millions of women worldwide".

GARDASIL, based on technology licensed by CSL to Merck in 1995, has been developed as a result of a collaboration in the early 1990s between CSL and Professor Ian Frazer of the University of Queensland. Development of the vaccine followed Dr Ian Frazer's discovery of HPV recombinant virus-like particles (VLPs) circumventing the need to grow HPV in the laboratory.  Merck has conducted world-wide pre-clinical and clinical trials in support of GARDASIL development.

For further information please contact:

Dr Rachel David, Director of Public Affairs
CSL Limited
0401 775 779


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