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Cervical Cancer Vaccine Shows 100% Prevention

Media Release

Investigational Vaccine Prevented 100% High Grade Cervical Pre-Cancers, And Non-Invasive Cervical Cancers (*) in Phase III Study

MELBOURNE Oct. 7 2005 – CSL Limited announced today that GARDASIL™ (Quadrivalent Human Papillomavirus Types 16, 18 6, 11 Recombinant Vaccine), 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 trial 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 a regulatory file being submitted to the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand, soon thereafter.

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

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

‘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 the next two years.

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.

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About CSL Limited

CSL Limited is a global, speciality biopharmaceutical company that develops, manufactures and markets products to treat and prevent serious human medical conditions.

Innovation and new product development for unmet medical needs continue to drive CSL’s growth.


About the F.U.T.U.R.E. II Clinical Trial

This phase III study, titled FUTURE II (Females United To Unilaterally Reduce Endo/Ectocervical disease) is a prospective, randomised, double-blind, placebo-controlled study with two vaccination groups. Women aged 16 to 26 years were randomised to receive a three-dose regimen of either GARDASIL or placebo at Day 1, Month 2, and Month 6. A total of 12,167 women were enrolled from 90 study centres in Europe, South America, Asia and the USA, and were equally allocated between the two groups. A group of 6,082 females received GARDASIL and another group of 6,075 received placebo.

FUTURE II evaluated the incidence of HPV 16/18-related cervical pre-cancers known as CIN (cervical intraepithelial neoplasia) 2/3 and non-invasive cancers. CIN 2 is a moderate-grade lesion of the cervix. CIN 3 represents both high-grade lesions and CIS (carcinoma in situ), the immediate pre-cursor to invasive squamous cell cervical cancer. AIS (adenocarcinoma in situ) is the early development of adenocarcinoma (or glandular cancer) of the cervix. CIN 3 and AIS are defined as Stage 0 cancer according to the International Federation of Gynecology and Obstetrics (FIGO) classification.

The primary analysis of this trial evaluated the incidence of CIN 2/3 and AIS in women who received three doses of GARDASIL, had no major protocol violations and remained free of HPV 16 and/or HPV 18 infection through month 7; this analysis started 30 days after completion of the vaccination regimen, and followed women for an average of 17 months after completion of the regimen. In this group, GARDASIL prevented 100 percent of cases of high-grade pre-cancer and non-invasive cancer (CIN 2/3 or AIS) associated with HPV types 16 and 18 (p < 0.001); no cases of CIN 2/3 or AIS were observed in the vaccine group (n=5,301) compared to 21 cases in the placebo group (n=5,258).

A secondary analysis, also being presented, evaluated the incidence of CIN 2/3 and AIS in a broader group of women. This analysis started 30 days after administration of the first dose of GARDASIL or placebo, and included all of the women in the primary analysis group, as well as women who may have become infected with HPV 16 or HPV 18 during the vaccination period and women who may have violated the protocol in significant ways (for example, by missing certain protocol visits). On average, these women were followed for approximately two years. In this group, GARDASIL reduced the risk of developing high-grade pre-cancer and
non-invasive cancer (CIN 2/CIN 3, or AIS) associated with HPV types 16 and 18 by 97 percent (n=5,736); one case was observed in the vaccine group compared to 36 in the placebo group (n=5,766).

There were no discontinuations due to serious vaccine-related adverse events. Adverse events were higher among those who received GARDASIL compared with placebo recipients. The most common vaccine-related adverse event reported was local discomfort at the injection site.

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