Phase III U.S. Pivotal Study Results on CSL Biotherapies' Afluria Published in Vaccine
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Sept. 3, 2008 - Phase III pivotal study findings in the journal Vaccine showed that two formulations of CSL Biotherapies' influenza virus vaccine Afluria(R) elicited an immune response (also known as immunogenicity) in healthy adults aged 18 - less than 65 years. The results, from a study performed at nine centers affiliated with the National Institutes of Health (NIH), met the U.S. Food and Drug Administration's (FDA) requirements for influenza vaccine immunogenicity. These data formed the basis of CSL Biotherapies' US biologics licensing application for Afluria that was approved through priority review by the FDA in September 2007.
Afluria is indicated for the active immunization of persons age 18 years and older against influenza disease (commonly referred to as the "flu") 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 is available in both single-dose, thimerosal-free, pre-filled syringes and in multi-dose vials.
"The flu remains a serious health threat that impacts thousands of Americans every year," said Kathryn M. Edwards, MD, of Vanderbilt University School of Medicine and Pediatrics and principal study investigator. "An ample supply of flu vaccine is critical, particularly as the Centers for Disease Control's Advisory Committee on Immunization Practices has expanded its recommendations for influenza vaccination in the U.S. population. Having on hand additional safe and effective doses of influenza vaccines, such as Afluria, offers healthcare providers a greater ability to protect more Americans from this preventable disease."
"CSL Biotherapies has a long heritage in influenza vaccines and a track record of producing vaccines for Europe and the Southern Hemisphere," said Paul Perreault, Executive Vice President of CSL Biotherapies Worldwide Commercial Operations. "The published study results on Afluria reinforce CSL's commitment to addressing unmet needs, enlarging the supply of influenza vaccine in the United States and to providing consumers and doctors with diverse options, including thimerosal-free Afluria."
CSL recently announced completion of a $75 million (U.S.D.) investment in plant and equipment to double the manufacturing capacity of the company's Melbourne facility to 40 million doses a year, making it one of the largest vaccine manufacturing plants in the world. CSL has also commenced construction of additional flu vaccine fill and finish capabilities in the United States.
About the Phase III Study
The pivotal study was a National Institutes of Health (NIH)-supported clinical study that enrolled 1,359 volunteers at nine clinical sites in the U.S. A randomized, double-blind, placebo-controlled study, its primary objective was to evaluate the immunogenicity of the thimerosal-free and thimerosal-containing formulations of Afluria influenza vaccine in healthy adults aged 18 to less than 65 years. Secondary objectives included the clinical consistency of the vaccine across formulations and age groups, as well as the safety and tolerability of Afluria.
Administration of Afluria resulted in seroprotection (the presence of a significant level of antibodies) for the three antigens included in the vaccine in over 90% of those studied - a result that exceeded the FDA's benchmarks for the approval of an influenza vaccine. Study investigators also noted in the publication that this immunogenic response was consistent between the formulations and age groups studied. Afluria was well-tolerated, with few local or systemic adverse events.
Afluria 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 Ltd., and a clinical trial conducted by the NIH, formed the basis for CSL Biotherapies' biologics licensing application submission.
Important Safety Information
Afluria should not be administered to individuals with hypersensitivity to eggs or chicken protein or other components of Afluria, and to 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-Barre - 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 http://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. 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 http://www.cslbiotherapies-us.com, or call 1-888-435-8633.
Sheila A. Burke, 610-290-7403
Director, Public Relations & Communications
Worldwide Commercial Operations
Abenaa (Abby) Hayes, 212-445-8337
Posted: September 2008