United States

CSL Biotherapies obtains FDA licensure for use of its thimerosal-free pandemic Influenza A (H1N1) 2009 Monovalent Vaccine in children

Expanded label marks CSL’s ongoing support to US Health and Human Services’ pandemic influenza mitigation plan

King of Prussia, PA — 11/12/2009

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 application for accelerated approval of its seasonal flu vaccine, Afluria® (Influenza Virus Vaccine) for use in the pediatric population aged 6 months and older. This approval also included labeling for CSL Biotherapies' Influenza A (H1N1) 2009 Monovalent Vaccine which is an inactivated influenza virus vaccine now indicated for active immunization of persons ages 6 months and older against influenza disease caused by pandemic (H1N1) 2009 virus. This indication is based on the immune response elicited by the seasonal trivalent Influenza Virus Vaccines manufactured by CSL (Afluria®). CSL's Influenza A (H1N1) 2009 monovalent vaccine and Afluria are manufactured by the same process. There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Afluria.

"The FDA's licensure of CSL Biotherapies' thimerosal-free monovalent pandemic H1N1 vaccine for use in children aged 6 months and older is a critically important milestone," said Paul Perreault, President, CSL Biotherapies. "The U.S. Centers for Disease Control has identified young children as a priority group for pandemic H1N1 vaccine administration. CSL Biotherapies is proud to now be in a position to help in protecting this most vulnerable population of Americans."

CSL's pandemic H1N1 vaccine is available in both thimerosal-free (i.e., preservative-free), single-dose, pre-filled syringes and multi-dose vial (thimerosal containing) formulations, as directed by the U.S. government. The thimerosal-free formulation is available in two dosages:

  • A 0.25 mL single-dose, pre-filled syringe for use in children 6-35 months of age;
  • A 0.5 mL single-dose, pre-filled syringe for use in persons 36 months of age and older

About CSL's Influenza A (H1N1) 2009 Monovalent Vaccine
CSL's pandemic H1N1 vaccine was licensed by the FDA for active immunization of adults on September 15, 2009. CSL's Influenza A/H1N1 2009 vaccine is manufactured by a process identical to the one used in manufacturing CSL's FDA-licensed trivalent seasonal influenza vaccine. CSL's pandemic H1N1 influenza vaccine is a purified, inactivated, monovalent influenza virus propagated in embryonated chicken eggs.

CSL Biotherapies is conducting clinical trials in the U.S. of its monovalent H1N1 vaccine in children using a thimerosal-free (i.e., preservative-free) formulation. The studies were designed to determine the safety of CSL's vaccine and its ability to elicit an immune response (also referred to as immunogenicity) in children. The studies will also evaluate the incidence of adverse events up to six months after first injection. The clinical studies are sponsored by CSL Biotherapies and funded in whole or in part with Federal funds from the U.S. Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority.

Important Safety Information
CSL's Influenza A (H1N1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 6 months of age and older against influenza disease caused by the pandemic (H1N1) 2009 virus. The indication is based on the immune response elicited by the seasonal trivalent influenza virus vaccine manufactured by CSL (Afluria). CSL's Influenza A (H1N1) 2009 monovalent vaccine and Afluria are manufactured by the same process. CSL's H1N1 vaccine should not be administered to individuals with hypersensitivity to eggs, neomycin, polymyxin or anyone who has had a life-threatening reaction to previous influenza vaccination. Vaccination with the H1N1 vaccine 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 the H1N1 vaccine should be based on careful consideration of the potential benefits and risks. In adults, the most common injection-site reactions were tenderness, pain, redness and swelling. The most common systemic adverse reactions were headache, malaise and muscle aches. In children, the most common local (injection-site) adverse reactions observed in a clinical study with Afluria were pain, redness and swelling. The most common systemic adverse reactions observed were irritability, rhinitis, fever, cough, loss of appetite, vomiting/diarrhea, headache, muscle aches and sore throat. Full prescribing information can be found at www.cslbiotherapies-us.com.

About Influenza and the Novel Influenza A/H1N1 Virus
The emergence of the novel H1N1 flu, which was first detected in humans in April 2009, has proven to be very contagious, spreading worldwide, and has led to the World Health Organization declaring a pandemic on June 11, 2009.

CSL Biotherapies has developed and produced its monovalent Influenza A/H1N1 2009 vaccine drawing on four decades of experience with its proven vaccine production processes.

About CSL Biotherapies
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 seasonal and pandemic influenza vaccines in thimerosal-free, pre-filled, single-use syringes and in multi-dose vials containing preservative.

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
610-290-7403
484-919-2618 (mobile)
Sheila.Burke@cslbiotherapies.com

Elizabeth Fisher-Au
Weber-Shandwick
212-445-8111
efisherau@webershandwick.com

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