U.S. Food and Drug Administration approves CSL influenza virus vaccine, for marketing in the U.S.

U.S. Food and Drug Administration approves CSL influenza virus vaccine, for marketing in the U.S.

Melbourne, Australia — 01/10/2007

CSL Limited, one of the world’s leading manufacturers of influenza vaccine, announced today that the U.S. Food and Drug Administration (FDA) has approved its influenza virus vaccine, to be known as Afluria® in the U.S., for active immunisation to prevent influenza disease caused by influenza virus types A and B present in the vaccine in adults 18 years and older. Today’s approval marks CSL’s first entry into the U.S. influenza vaccine market. Afluria® will be made available in both single-dose, thiomersal-free, pre-filled syringes and in multidose vials to provide choice and convenience to caregivers who administer it. CSL plans to begin delivering shipments to the U.S. during the 2007-2008 flu season, through its subsidiary CSL Biotherapies.

‘CSL Biotherapies is the leading producer of influenza vaccine in the Southern Hemisphere, and is proud to bring a 40-year heritage in influenza vaccines to the U.S. market, where boosting the supply of available flu vaccine and increasing vaccination rates is a priority public health goal. Commencing export of our flu vaccine to the U.S. will be the next step for us in becoming a significant global player in the supply of this life-saving product.’ General Manager of CSL Biotherapies Mary Sontrop said today.

‘The World Health Organisation and the Centres for Disease Control and Prevention in the U.S. agree that globally, the need for influenza vaccines greatly exceeds the available supply. Although our entry into the U.S. will initially be modest, we aim to have a significant role providing much-needed diversity of supply in the next four years.’ she said.

About CSL Limited

Headquartered in Melbourne, CSL Limited (ASX: CSL) is a global, specialty biopharmaceutical company that develops, manufactures and markets products to treat and prevent serious human medical conditions.

CSL has manufactured influenza vaccine in its Melbourne facility since 1968. CSL-branded influenza vaccines are approved and marketed in 16 countries worldwide. The company also provides bulk influenza vaccine for sale in 24 countries. In the last two seasons one in four influenza vaccine recipients in the UK, were vaccinated with a CSL product.

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