CSL Limited to Apply for License to Market Influenza Vaccine in the U.S.

CSL Limited to Apply for License to Market Influenza Vaccine in the U.S.

Melbourne, Australia — 08/02/2006

CSL Limited (ASX: CSL), Australia’s leading biopharmaceutical company today announced plans to introduce its influenza vaccine into the U.S. market.

Speaking at Merrill Lynch’s Global Pharmaceutical and Biotechnology Conference in New York, CSL Chief Executive Officer and Managing Director Dr. Brian McNamee said,

“CSL is the leading producer of influenza vaccine in the Southern Hemisphere and has a long heritage in biological research and manufacture. With the planned expansion of our influenza vaccine production capabilities, we look forward to working with the Food and Drug Administration (FDA) on the licensing of our vaccine in the U.S.”

Dr. McNamee announced a $80 million investment in plant and equipment to double capacity at its Melbourne facility to approximately 40 million doses per season, making it one of the largest vaccine manufacturing plants in the world.

“This will increase the diversity of supply in the U.S., helping to meet the public health need for vaccinations identified by the Centres for Disease Control and Prevention and other policy makers,” Dr. McNamee added.

CSL plans to initiate a human clinical study of the vaccine in the US later this year, and submit a Biologics License Application (BLA) to the FDA within 12 months, for both multi dose vial and thiomersal-free single-dose syringe products. Contingent upon regulatory approval, the company intends to have vaccine available for the 2007-2008 season. The company plans to supply up to 20 million doses to the U.S. as the expanded plant comes online in 2008.

CSL’s plan to double its manufacturing capacity will enhance Australia’s ability to respond to influenza vaccine demand.

Media Contacts:

Australia and New Zealand

Dr. Rachel David
Director of Public Affairs
Phone: 0401 775 779
Email: rachel.david@csl.com.au

Investor Contact:
Mark Dehring
Director of Investor Relations
Phone: 61 3 9389 2818
Email: mark.dehring@csl.com.au
© 2017 CSL Limited