Investigational Vaccine Prevents 100% High Grade Cervical Pre-Cancers, and Non-Invasive Cervical Cancers in Phase III Study

Investigational Vaccine Prevents 100% High Grade Cervical Pre-Cancers, and Non-Invasive Cervical Cancers in Phase III Study

Melbourne, Australia — 07/10/2005

CSL Limited announced today that GARDASIL™, an investigational vaccine developed by Merck & Co., Inc., based on technology licensed from CSL, prevented 100 percent 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 which account for 70 percent of all cervical cancers.

The Company advised that the trial compared GARDASIL™ to placebo in women who were not infected with HPV 16 and 18 at enrolment and who remained free of infection through the completion of the vaccination regimen.

A secondary analysis of the trial data demonstrated that even trial women who may have become infected with HPV16 or 18  during the vaccination period or who violated the protocol in significant ways were at a reduced risk of developing high grade pre-cancer and non-invasive cervical cancer.

The Company noted that Merck remained on track to submit a Biologics Licence Application for GARDASIL™  to the Food and Drug Administration (FDA) in the fourth quarter of 2005, with the Australian regulatory file being submitted to the Therapeutic Goods Administration (TGA) soon thereafter.

 ‘These results could not be better’, Dr Brian McNamee Managing Director of CSL Limited said today.

‘They show that prophylactic vaccination with GARDASIL™ comprehensively eliminates HPV 16 and 18 related cervical pre-cancer and non-invasive cervical cancer. 

‘CSL  is proud of the development of this investigational vaccine from discovery of the fundamental technology by Professor Ian Frazer of the University of Queensland in 1991 to its potential filing for approval for international marketing by Merck & Co., Inc.

‘The success of this phase III trial validates CSL’s commitment to realizing the potential of Australia’s first class scientific base, and represents a further step in recognising the value of our R&D portfolio’, Dr McNamee said.

The Company advised that more than 12,000 women from 13 countries worldwide participated in the trial. Women received three doses of either the investigational vaccine or placebo over a six month period, and were subsequently tested for signs of cervical cancer or pre-cancerous lesions over a two year period.

The Company commented that the technology licensed by CSL to Merck in 1995 had been developed as a result of a collaboration in the early 90s between CSL and Professor Ian Frazer of the University of Queensland, following Dr Ian Frazer’s discovery of HPV recombinant virus-like particles (VLPs) circumventing the need to grow HPV in the laboratory.

“Before Professor Frazer’s achievement, a vaccine for cervical cancer had been inconceivable because of the very significant challenges of being able to grow this particular virus”, Dr Andrew Cuthbertson Chief Scientific Officer at CSL said today.

“This breakthrough has far-reaching implications for both vaccine and cancer research, and is a triumph for Australian science”, he said.

The Company advised that GARDASIL™ will be marketed in Australia and New Zealand by CSL, pending assessment by the TGA and Medsafe.

For further information please contact:

General
Dr Rachel David
Director of Public Affairs
CSL Limited
Mobile: 0401 775 779

Investors
Mark Dehring
Head of Investor Relations
CSL Limited
Telephone: +613 9389 2818
Email: mark.dehring@csl.com.au

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