CSL Announces Application for Licensure of Gardasil® by Merck & Co., Inc.

CSL Announces Application for Licensure of Gardasil® by Merck & Co., Inc.

Melbourne, Australia — 06/12/2005

CSL Limited announced today that its licensee, Merck & Co., Inc., has submitted a Biologics License Application (BLA) for GARDASIL (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) to the U.S. Food and Drug Administration (FDA) on December 1, 2005.

CSL noted that within 60 days following submission, the FDA will determine whether it will accept the BLA for review.  Merck has advised that it is seeking priority review designation for GARDASIL which means that it is possible that the FDA could register GARDASIL within six months of receipt.

CSL also confirmed plans to file`` for the registration of GARDASIL with the Australian Therapeutic Goods Administration in December 2005, with applications for registration being filed in Europe and other countries by Merck in December 2005 and early 2006.

CSL announced in October 2005 that, in Phase III clinical trials, GARDASIL had prevented 100% of high-grade cervical pre-cancers and non-invasive cervical cancers associated with human papillomavirus types 16 and 18 in women aged 16-26 who were naïve to these types throughout the trial.  HPV 16 and 18  account for 70% of all cervical cancers.


For further information please contact:

Investors: Mark Dehring 03-9389 2818
Media: Dr Rachel David 0401 775 779.

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