CSL

This has been a milestone year for our influenza vaccines with Afluria® approved for the US market, Panvax® approved in Australia and CSL’s expanded influenza vaccine facility ready to provide extra capacity for continuing business growth.

The US Food and Drug Administration (FDA) approval of our Afluria® seasonal influenza vaccine in September 2007 and the October product launch marked CSL’s first entry into the US vaccine market.

This outstanding achievement is the result of close cooperation between many people in our manufacturing, quality, regulatory and supply chain groups. Afluria® is manufactured and formulated into bulk vaccine in our Melbourne facility, flown to Marburg in Germany to be dispensed into single use syringes or multi-dose vials, then packaged and sent to CSL’s Kankakee site for distribution across the US.

New dispensing and packaging facilities are being built at our Kankakee site to help meet projected US sales growth. We anticipate dispensing and packaging operations will commence at this new facility in 2009.

International expansion of CSL’s influenza vaccine business and entry to the US market are underpinned by the extra capacity now available at our Melbourne influenza vaccine manufacturing facility. Designed to increase potential influenza vaccine production to 80 million doses per annum, the plant expansion program took only eighteen months to complete.

During the year, the Therapeutic Goods Administration (TGA) approved Panvax®, CSL’s avian influenza vaccine developed in collaboration with the Australian Government. Should a pandemic occur, CSL is well placed to manufacture the vaccine required to protect the Australian population.

CSL is Australia’s only manufacturer of influenza vaccine which is now registered and marketed as a finished product in twenty-six countries, and as a bulk vaccine in South Korea.