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Press Release Archive

12/21/2009
Findings of Australian trial of CSL’s Pandemic (H1N1) 2009 ‘swine’ flu vaccine in children published in Journal of the American Medical Association (JAMA)
CSL Limited, Australia's leading biopharmaceutical company, announced the Journal of the American Medical Association (JAMA) has published data from a clinical trial conducted in Australia to study CSL’s pandemic H1N1 2009 'swine' flu vaccine. Results of the trial demonstrate a robust immune response after a single dose in children as young as 6 months of age, which is further enhanced by the administration of a second dose given three weeks later. More.

11/12/2009
CSL Biotherapies obtains FDA licensure for use of its thimerosal-free pandemic Influenza A (H1N1) 2009 Monovalent Vaccine in children
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 application for accelerated approval of its seasonal flu vaccine, Afluria® (Influenza Virus Vaccine) for use in the pediatric population aged 6 months and older. More.

09/28/2009
CSL Biotherapies reaches agreement with Merck & Co. on rights to market and distribute Afluria® in the U.S.
CSL Biotherapies and its parent company, CSL Limited (ASX: CSL), one of the world's leading manufacturers of influenza vaccine, have reached an agreement with Merck & Co., Inc. on rights to market and distribute Afluria® in the United States under an exclusive, six-year agreement effective September 3, 2009. Afluria, a CSL product, is a non-adjuvanted trivalent seasonal influenza vaccine sold in two different formulations: thimerosal-free, pre-filled syringes, and in multi-dose vials. More.

09/16/2009
CSL Biotherapies Announces FDA Marketing Approval of its Monovalent Pandemic (H1N1) 2009 Influenza A Vaccine
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. More.

09/10/2009
CSL Demonstrates Robust Immune Response from Single (15mcg) Dose of Monovalent Pandemic (H1N1) 2009 Influenza Vaccine in Healthy Adults
CSL Limited, Australia’s leading biopharmaceutical company, announced today that preliminary data from the first study of its candidate pandemic H1N1 vaccine demonstrated a robust immune response in healthy adults after a single unadjuvanted15mcg dose. More.

08/24/2009
CSL Biotherapies Announces Start of U.S. H1N1 Vaccine Clinical Trials
CSL Biotherapies has announced the initiation of the company’s first U.S. clinical trials of its candidate Influenza A/H1N1 2009 vaccine. Study investigators will administer vaccinations to the first U.S. study volunteers today, August 24. More.

08/18/2009
U.S. FDA Licenses CSL Biotherapies’ New U.S. Influenza Vaccine Filling and Packaging Facility in Illinois
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. More.

07/27/2009
CSL Biotherapies Starts Shipment of Seasonal Influenza Vaccine for the 2009-2010 Flu Season
CSL Biotherapies, a subsidiary of one of the world's leading manufacturers of thimerosal-free seasonal influenza vaccine, announced today that it has begun shipment of its seasonal influenza virus vaccine to a national network of U.S. distributors for the 2009-2010 season. CSL Biotherapies plans to deliver more than eight million doses of the vaccine, the majority of which will be in single-dose, thimerosal-free, pre-filled syringes. More.

07/09/2009
CDC, AWHONN and CSL Biotherapies Partner to Educate Healthcare Providers on the Impact of Novel H1N1 Pandemic on Influenza Management in Pregnant Women
To address public health concerns about the novel influenza A pandemic virus – H1N1 -- and the implications of it on the upcoming influenza (flu) season, the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) hosted a late-breaking educational session for healthcare providers who are on the front-lines of care for pregnant women at the AWHONN 2009 annual convention. Funded by CSL Biotherapies, “A Tale of Two Flus: A Focus on Seasonal and Novel H1N1 During Pregnancy” featured speakers from the Centers for Disease Control (CDC) and provided valuable insights and recommendations in the months leading up to the Fall flu season. More.

05/29/2009
CSL Biotherapies contracts with U.S. Department of Health and Human Services (HHS) to provide Novel A (H1N1) influenza vaccine antigen
King of Prussia, PA—CSL Biotherapies, Inc. announced today that it has signed a contract with the U.S. Department of Health and Human Services (HHS) to provide Novel A (H1N1) influenza vaccine antigen in bulk form to support HHS’ pandemic influenza preparedness efforts. The initial order under contract will be for an amount of at least $180 million. CSL Biotherapies anticipates initial delivery of the antigen by September, subject to regulatory approval. The new vaccine antigen will be tested in clinical trials funded by HHS. More.

03/23/2009
National Influenza Vaccine Summit Announces Recipients of the 2009 Immunization Excellence Award Winners
The National Influenza Vaccine Summit announces the recipients of the Annual National Influenza Vaccine Summit (NIVS) Immunization Excellence Awards: Overall 2008-09 Season Activity: Sickness Prevention Achieved Through Regional Collaboration (SPARC), Lakeville, CT and Newton, MA; Healthcare Personnel Campaign: Children’s Hospitals and Clinics of Minnesota, Saint Paul, MN;18 years and younger Campaign: The Wellness Company, Providence, RI; Coalition Campaign: Maryland Partnership for Prevention, Owings Mills, MD; and Corporate Campaign: MinuteClinic CVS/pharmacy, Minneapolis, MN, and National Women’s Health Resource Center, Red Bank, NJ. More.

12/22/2008
CSL Biotherapies Announces Influenza Vaccine Pre-Booking Open for the 2009-2010 Flu Season
CSL Biotherapies, a subsidiary of one of the world’s leading manufacturers of influenza vaccine, today announced that healthcare providers now have the opportunity to pre-book the company’s influenza virus vaccine through either www.mercuryfreefluvaccine.com or the toll-free number, 1-888-435-8633. The majority of CSL Biotherapies’ vaccine supply for the 2009-2010 flu season will be offered as thimerosal-free, single-dose, pre-filled syringes. To help increase access to the thimerosal-free vaccine, CSL Biotherapies will offer value programs for a limited time to healthcare providers who pre-book through authorized distributors. More.

11/14/2008
Jesse Palmer Throws a "Season Pass" at Influenza Awareness to College Students Nationwide
To increase flu vaccination rates among college students, CSL Biotherapies is partnering on Season Pass© with Jesse Palmer, ESPN co-host of "College Football Live" and former pro football player. Season Pass is a novel program designed to immunize as many college students as possible during the 2008-2009 influenza (flu) season. College students are at risk for contracting the flu due to their close living quarters and frequent contact with other students. Season Pass aims to educate college students about influenza prevention and motivate them to visit their on-campus health center to get vaccinated. More.

10/16/2008
CSL Biotherapies Launches www.mercuryfreefluvaccine.com, An Online, Order-As-You-Go Service for Thimerosal-Free Influenza Vaccine
CSL Biotherapies, a subsidiary of one of the world's leading manufacturers of influenza vaccine, today announced an innovative online quick-ship ordering system, enabling healthcare providers and other purchasers to buy CSL Biotherapies' thimerosal-free flu vaccine for adults directly from the company. This new purchasing platform (accessible at www.mercuryfreefluvaccine.com) offers customers enhanced access to a thimerosal-free product in the quantity they need, whenever they need it. More.

09/04/2008
CSL Biotherapies Announces First Shipments of Afluria® Thimerosal-Free Influenza Vaccine for the 2008-2009 Flu Season
CSL Biotherapies, a subsidiary of one of the world's leading manufacturers of influenza vaccine, announced today that it has begun shipment of its influenza virus vaccine in the U.S. for the 2008-2009 season. CSL plans to deliver more than six million doses of Afluria and the majority of the supply will be in single-dose, thimerosal-free, pre-filled syringes. More.

05/13/2008
CSL Marks 40 Years in the Influenza Vaccine Market
CSL Limited today celebrated its 40th year as a leading manufacturer of influenza (flu) vaccine.  The company’s vaccine, Fluvax®, is a Thiomersal-free influenza vaccine that is approved for use in adults and children in Australia and New Zealand.  This vaccine is known as Afluria™, Enzira™, Nilgrip™, and X-Flu™ in 17 different countries, including the US and European markets.  Additionally, CSL supplies the antigen used to manufacture the flu vaccine in 24 countries.  More.

04/03/2008
CSL Biotherapies Announces Afluria® Pre-Booking Open
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. More.

10/17/2007
CSL Biotherapies Starts U.S. Shipments of Influenza Vaccine
CSL Biotherapies, a subsidiary of one of the world's leading manufacturers of influenza vaccine, announced today that it has begun shipment of its influenza virus vaccine in the United States for the 2007-2008 season. More.

09/28/2007
CSL Biotherapies announces FDA marketing approval of Afluria®
Global biopharmaceutical company with strong vaccine heritage affirms commitment to help address critical U.S. public health need More.

04/02/2007
CSL Biotherapies Submits BLA to Introduce Flu Vaccine to U.S. Market
CSL Biotherapies Submits BLA to Introduce Flu Vaccine to U.S. Market. More.

06/05/2006
CSL Biotherapies, A New Entrant Into U.S. Flu Market, Starts Influenza Vaccine Biological Licensure Trial
Enrollment will begin for a pivotal influenza vaccine clinical trial sponsored by the National Institutes of Health (NIH), CSL Biotherapies announced today. The study will assess the safety and immunogenicity of single-dose and multi-dose formulations of influenza vaccine and has been designed to meet U.S. Food & Drug Administration (FDA) requirements. More.

02/07/2006
CSL Limited to Apply for License to Market Influenza Vaccine in the U.S.
CSL Limited (ASX: CSL), a global, specialty biopharmaceutical company headquartered in Melbourne, Australia, today announced plans to introduce its influenza vaccine into the U.S. market. More.