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CSL Ltd. Regulatory Filings 2007
17854_rns_2007-04-17_2138b042-dfc7-4243-aaf3-fd1a8ed26ef7.pdf
Regulatory Filings
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CSL Limited 45 Poplar Road Parkville Victoria 3052 Australia
T +613 9389 1911 F +613 9389 1434 www.csl.com.au
ASX Announcement
For immediate release
GARDASIL® CROSS-PROTECTION DATA SUBMITTED TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)
April 18, 2007 - CSL Limited announced today that its partner, Merck & Co., Inc., has submitted a supplemental Biologics License Application (sBLA) for GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] to the U.S. FDA to include efficacy data on additional cervical cancer causing HPV types responsible for more than 10 percent of cervical cancers, additional data on protection against vaginal and vulvar cancers and data on immune memory.
CSL advises that GARDASIL has now demonstrated some cross-protection against additional cervical cancer causing HPV types responsible for greater than 10 percent of cervical cancers.
Dr Gerard Wain, Director of Gynaecological Oncology at Westmead Hospital said today that: "the vaccine GARDASIL has been hailed as a medical breakthrough with data to demonstrate protection against the HPV types that account for 70% of cervical cancer cases, and to now have data showing some cross-protection against HPV types that cause an additional 10% of cervical cancer cases is even more impressive. This data is exciting news as Gardasil can further reduce the burden of cervical cancer and cervical abnormalities in Australian women".
CSL notes that the new data will be submitted to the Australian Therapeutic Goods Administration (TGA) as soon as practicable with complete results of the cross-protection data being presented at scientific conferences later this year.
Media Contact:
Australia and New Zealand Maria Pikos Phone: 61 3 9389 1414
Investor Contact:
Mark Dehring Director of Investor Relations Phone: 61 3 9389 2818 Email: [email protected]
For more information about CSL Limited, visit www.csl.com.au
GARDASIL® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.