CSL Biotherapies to supply Afluria influenza vaccines from newly licensed packaging facility

CSL Biotherapies, a subsidiary of CSL Limited, one of the world's leading manufacturers of influenza vaccine, announced today that the U.S. Food and Drug Administration (FDA) has licensed the company’s newest vaccine filling and packaging facility, located in Kankakee, Ill. The facility, part of an investment to expand CSL’s U.S. influenza vaccine production capabilities, includes a high-speed, single-dose vaccine syringe filling line.

The primary function of the Kankakee facility is to provide filling and packaging services for CSL Biotherapies’ influenza vaccine supply to the U.S. market. That supply is manufactured in Australia. CSL Biotherapies completed production of its seasonal influenza vaccine, Afluria^®, in early July and will deliver more than 8 million doses of Afluria for the upcoming influenza season. The majority of that delivery will be in thimerosal-free, prefilled syringes.

CSL Biotherapies recently signed an initial contract for at least $180 million to supply the U.S. Department of Health & Human Services (HHS) with Novel Influenza A (H1N1) antigen. Licensure of the new facility in Kankakee provides CSL Biotherapies with the ability to fill and package that antigen if requested to do so by HHS.

“The licensure of this facility enables CSL Biotherapies to rapidly deliver quality, ready-to-administer, flu vaccines to U.S. healthcare providers,” said Wally Casey, Senior Vice President and General Manager of Kankakee Operations. “This milestone demonstrates once more CSL’s expertise and commitment to addressing pressing U.S. public health needs. It also underscores our support to enhance vaccine administration safety through the use of ready-to-use prefilled syringes.”

Upon opening, the Kankakee site will have the capacity to fill and package 10 million doses of Afluria (influenza virus vaccine). At full capacity, 20 million doses in thimerosal-free prefilled syringes will be filled and packaged at the Illinois-based site.

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 U.S. approval represented CSL's first entry into the U.S. vaccine market, CSL-branded influenza vaccines are licensed in 27 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.

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.

www.cslbiotherapies-us.com