United States

CSL Biotherapies Announces FDA Marketing Approval of its Monovalent Pandemic (H1N1) 2009 Influenza A Vaccine


King of Prussia, PA — 09/16/2009

CSL Biotherapies, a subsidiary of CSL Limited (ASX: CSL), one of the world’s leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental biologics licensing application for licensure of its monovalent pandemic (H1N1) 2009 influenza A vaccine for active immunization of persons age 18 years and older against influenza disease caused by the H1N1 virus.

"The FDA's licensure of our H1N1 vaccine is a significant milestone in CSL's efforts to bring an effective pandemic influenza vaccine to the U.S. and Southern hemisphere markets," said Paul Perreault, President, CSL Biotherapies. "We're pleased to have contributed important clinical trial data on this vaccine to regulatory authorities in the United States and Australia. CSL Biotherapies will continue to work closely with the U.S. government to supply pandemic H1N1 vaccine as quickly as possible in order to assist in national efforts to protect the health of Americans."

CSL Biotherapies has an initial contract worth $180 million to deliver bulk H1N1 vaccine antigen to the U.S. Health and Human Services Department (HHS), with an option for filling and packaging services out of CSL’s Kankakee, Illinois and Marburg, Germany facilities. These facilities have the capability to produce influenza vaccine in thimerosal-free, prefilled, single-use syringes and in multi-dose vials containing preservative. CSL will supply bulk H1N1 antigen to the U.S. and will formulate that bulk as directed by the federal government. CSL expects to begin delivery of bulk H1N1 antigen to HHS in October, 2009.

About CSL Biotherapies

The United States headquarters of CSL Biotherapies are located in King of Prussia, PA. Its parent company, CSL Limited, in Melbourne, Australia, has made a $60 million (U.S.D.) investment in plant and equipment to double the manufacturing capacity of the company’s Melbourne facility to 40 million doses per season; it is now one of the world's largest influenza vaccine facilities for global markets. CSL Biotherapies, which shares its United States headquarters with its sister company, CSL Behring, is commercializing influenza vaccine products globally.

The CSL Group, which includes CSL Biotherapies, CSL Research & Development, CSL Bioplasma, and CSL Behring, has more than 10,000 employees and operates in 27 countries worldwide. For more information, visit us at www.cslbiotherapies-us.com, or call 1-888-435-8633.

Media Contacts:

Sheila A. Burke
Director, Public Relations & Communications
Worldwide Commercial Operations
CSL Biotherapies
484-919-2618 (mobile)

Elizabeth Fisher-Au

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