CSL Ltd. — Regulatory Filings 2002

Nov 20, 2002

21 November 2002

"THE BEGINNING OF THE END FOR CERVICAL CANCER?"

CSL Limited announced today that an investigational monovalent vaccine evaluated in a proof-of-principle study by Merck & Co., Inc. and incorporating a breakthrough technology licensed from CSL to Merck & Co., Inc. demonstrated 100% protection against human papillomavirus (HPV) 16 - one type of HPV commonly associated with cervical cancer.

The results of the Proof of Principal study, undertaken by Merck & Co, Inc., were published today in the prestigious The New England Journal of Medicine (NEJM).

In 1995, as part of the development by Merck of the HPV vaccine, Merck exclusively licensed from CSL technology developed by CSL and Professor Ian Frazer of the University of Queensland.

In addition to worldwide royalties, CSL has the exclusive right to market any Merck HPV vaccine developed using this technology in Australia and New Zealand.

Currently, Merck is developing an investigational multivalent vaccine that is targeted against four common types of HPV-types 16,18, 6 and 11. Studies to evaluate this multivalent investigational vaccine are under way including the Australian arm of a multinational Phase III study being conducted at the Royal Women's Hospital in Melbourne.

Principal investigator in the Australian arm of the trial Professor Suzanne Garland from Royal Women's Hospital in Melbourne said, "This is an exciting result as it could potentially represent a major breakthrough in the reduction of incidence of HPV 16 infection and related cervical disease. The technology behind the vaccine is potentially one of Australia's most important medical discoveries."

In an accompanying editorial in the NEJM, Professor Christopher Crum MD from the Harvard Medical School said, "This study puts to rest the recurring question posed by immunologists as to whether this type of vaccine can protect the highly vulnerable cervical epithelium (lining) from cancer-causing HPV.

"The study demonstrates that the vaccine not only prevents the disease from developing, but also prevents the causative agent from residing in the genital tract."

Cervical cancer is the second leading cause of cancer amongst women, with 450,000 women diagnosed with the disease worldwide every year. In Australia, despite a highly successful cervical screening program, cervical cancer claims a significant number of Australian lives.

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For further information please contact:
Louis Reginato	Ph: 02 9928 1570 or 0402 447 111
Lisa Jervis	Ph: 02 9928 1506 or 0419 432 239

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