United States

CSL Biotherapies Announces Afluria® Pre-Booking Open

Newest entrant into U.S. market plans to deliver 6 million doses, largely thimerosal-free, pre-filled syringes

King of Prussia, PA — 04/03/2008

CSL Biotherapies announced today that healthcare providers now have the opportunity to pre-book Afluria® (influenza virus vaccine) through either www.afluria.com or at the company’s toll-free number 1-888-435-8633. CSL Biotherapies, which entered the U.S. market last season, plans to produce approximately 6 million doses of Afluria for delivery in time for the upcoming season. The majority of the Afluria supply for the upcoming season will be in single-dose, thimerosal-free, pre-filled syringes.

“CSL has a 40-year track record of producing and delivering flu vaccines, beginning in the Southern Hemisphere and now, expanding into the Northern Hemisphere,” said Paul Perreault, Executive Vice President of CSL Biotherapies Worldwide Commercial Operations. “We are proud to further our commitment to providing US communities with an increasing and steady supply of thimerosal-free and latex-free flu vaccine. We encourage providers who wish to take advantage of a timely delivery of Afluria to pre-book as soon as possible.”

About Afluria
Afluria received US Food and Drug Administration (FDA) approval for active immunization of persons age 18 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine in September 2007. The indication is based on the immune response elicited by Afluria; no controlled clinical studies have demonstrated a decrease in influenza disease after vaccination with Afluria.

While the Afluria US approval represented CSL's first entry into the US vaccine market, CSL-branded influenza vaccines are approved and marketed in 17 countries worldwide. The company also provides bulk antigen for influenza vaccine sold in 24 countries.

CSL’s influenza vaccine is a purified, inactivated, trivalent influenza vaccine propagated in embryonated chicken eggs. Each dose contains the required dose of influenza virus hemagglutinin antigens from the influenza strains recommended and prioritized by FDA’s Vaccine and Related Biological Products Advisory Committee for the 2008-2009 flu season.

Previous international flu vaccine studies sponsored by CSL Limited, and a clinical trial conducted by the National Institutes of Health (NIH), formed the basis for CSL Biotherapies’ biologics licensing application submission to the FDA.

The NIH-supported clinical trial that led to U.S. licensure enrolled 1,357 volunteers at nine clinical sites in the U.S. in a pivotal, Phase III, randomized, double-blind, placebo-controlled study. The study evaluated the safety, tolerability and immunogenicity of thimerosal-free and thimerosal-containing formulations of influenza vaccine in healthy adults aged 18 to < 65 years.

Important Safety Information
Afluria is indicated for active immunization of persons age 18 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. The indication is based on the immune response elicited by Afluria; no controlled clinical studies have demonstrated a decrease in influenza disease after vaccination with Afluria.

Afluria should not be administered to individuals with hypersensitivity to eggs or chicken protein or other components of Afluria, and in anyone who has had a life-threatening reaction to previous influenza vaccination. The most common injection-site adverse reactions were tenderness, pain, redness and swelling. The most common systemic adverse reactions were headache, malaise and muscle aches. Vaccination with Afluria may not protect all individuals. Immunocompromised persons may have a diminished immune response. If Guillain-Barrė syndrome has occurred within six weeks of receipt of prior influenza vaccine, the decision to give Afluria should be based on careful consideration of the potential benefits and risks. Full prescribing information on Afluria can be found at www.Afluria.com.

About CSL Biotherapies
The U.S. headquarters of CSL Biotherapies are located in King of Prussia, Pa. Its parent company, CSL Limited, in Melbourne, Australia, operates one of the world’s largest influenza vaccine facilities for global markets. CSL Biotherapies, which shares its U.S. headquarters with its sister company, CSL Behring, is commercializing influenza vaccine products globally.

Last year, CSL, parent company to CSL Biotherapies, announced 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, making it one of the largest vaccine manufacturing plants in the world. Recently, CSL also announced its intention to expand its fill and finish activities with installation of a new facility in Illinois.

At CSL Biotherapies, delivering vaccines is our mission, protecting lives our passion. The CSL Group, which also includes CSL Research & Development, CSL Bioplasma, and CSL Behring, has more than 8,500 employees and operates in 21 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
610-290-7403
484-919-2618 (mobile)
Sheila.Burke@cslbiotherapies.com

Punnie Donohue
Weber Shandwick
212-445-8163
pdonohue@webershandwick.com

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