In June 2006, the US Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration granted approval to sell Gardasil – the world’s first vaccine against cervical cancer.

Merck & Co. Inc., CSL’s licensee for this novel quadrivalent recombinant vaccine, has also applied for licensing approval to regulatory authorities in a number of other countries.

The powerful result of more than 15 years collaborative work, Gardasil has potential to benefit millions of women. Cervical cancer is the second most prevalent cancer in women, typically affecting those aged 35 to 55, and causing close to 240,000 deaths globally each year. Gardasil is designed to prevent 70% of cervical cancers.

Cervical cancers are caused by human papillomavirus (HPV) infections. Professor Ian Frazer and his team at the University of Queensland made the crucial first breakthrough in 1991 by discovering that the HPV capsid recombinant protein could self-assemble into virus-like particles (VLPs) which made production of a vaccine possible. Research continued in collaboration with CSL scientists from the early 1990s and with the support of Merck from 1995.

Extensive clinical trials carried out by Merck demonstrated Gardasil prevented 100% of all high-grade cervical pre-cancers and non-invasive cervical cancers associated with HPV types 16 and 18.

HPV types 6, 11, 16 and 18 in the vaccine are the most common types affecting the health of women, accounting for a significant proportion of abnormal pap tests. HPV types 16 and 18 account for close to 70 percent of cervical cancer cases and are linked to most deaths from this disease. HPV types 6 and 11 cause about 90 percent of genital warts infections.

	Our Future Research and Development Focus CSL is investing in the development of new protein-based medicines that can be purified from human plasma, made from traditional sources (as with our influenza vaccines), or be produced using recombinant biotechnology. The common feature is that all these approaches lead to powerful biological medicines for treating serious human diseases. As the company has grown, CSL has continued to strengthen the focus of research and development activities on developing products that match our commercial capabilities. CSL’s research and development programs show our strong commitment to products made from human plasma, as with our range of liquid intravenous and subcutaneous immunoglobulins. We are also engaged in broadening both regulatory jurisdictions and clinical indications for specialty plasma products such as Zemaira® (alpha-1 antitrypsin inhibitor) and Berinert® P (C1-esterase inhibitor). We continue to support market expansion for our Australian-manufactured influenza vaccines by seeking new international registrations. Another goal for us is to improve influenza vaccine efficacy, particularly in older people. An increasing proportion of our research and development investment is being allocated to biotechnology projects, particularly for recombinant antibody medicines. A key longer-term objective is to build the skills and facilities that ensure we are capable of carrying out the clinical development of recombinant antibody candidates and following this through all the way to commercialisation.

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