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bioCSL Inc. Launches AFLURIA® Shipping Campaign For 2014-2015 Seasonal Influenza



8/5/2014 9:22:33 AM

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• bioCSL Inc. to supply U.S. Market with 16.5 Million Doses
• Historical reliability, coupled with dedicated commercial and production efforts, drive strong customer prebook order demand
• Early season deliveries will support U.S. providers’ 2014-15 vaccination needs


KING OF PRUSSIA, Pa., August 5, 2014 – bioCSL Inc. announced today it has commenced shipping its seasonal influenza vaccine AFLURIA (Influenza Vaccine) for the 2014-2015 flu season. U.S. providers who ordered AFLURIA may be able to begin vaccinating as early as this month.

Reflecting bioCSL’s longstanding commitment to public health and improving seasonal influenza vaccination rates, bioCSL Inc. will deliver about 16.5 million doses of the 2014-2015 formulation of AFLURIA, with approximately 75 percent of doses in thimerosal-free pre-filled syringes.

“Our historical operational focus on early and consistent delivery has resulted in a strong customer prebook order demand for the coming season,” said Dr. Marie Mazur, President of bioCSL Inc. “We are committed to continuing to serve the needs of providers in the United States, and want to ensure that they are prepared to help prevent influenza in their communities.”

The impact of the 2013-14 influenza season was especially detrimental to the health of 18-64 year old adults. Approximately 60 percent of the reported influenza-associated hospitalizations were among people between the ages of 18 and 64. While the Centers for Disease Control and Prevention (CDC) recommends that everyone between the ages of 18-64 be vaccinated against the flu, this age group lags behind the national average. Based on early season estimates of people between the ages of 18 and 64, only 44 percent who were at high risk and only 30 percent who were not at high risk were vaccinated in the 2013/2014 season.

“With each influenza season comes new challenges,” said Dr. Mazur. “The flu is a significant public health threat. bioCSL Inc. strives to deliver vaccines to providers as early as possible to give them ample time to vaccinate against the flu.”

About AFLURIA®
AFLURIA is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older.

Select Safety Information
AFLURIA is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.

Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly younger than 5 years of age, as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 to less than 9 years of age. If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks.

If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished. AFLURIA should be given to pregnant women only if necessary. AFLURIA has not been evaluated in nursing mothers. It is not known whether AFLURIA can be excreted in human milk following immunization. Because many drugs are excreted in human milk, caution should be exercised when AFLURIA is administered to a nursing woman.

Antibody responses in persons 65 years of age and older were lower after administration of AFLURIA as compared to younger adult subjects. In children 5 through 17 years of age, the most common injection-site reactions observed in clinical studies with AFLURIA were pain, redness and swelling. The most common systemic adverse events were headache, myalgia, malaise and fever. In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness and pain. The most common systemic adverse reactions observed were headache, malaise and muscle aches.

In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness and pain. Vaccination with AFLURIA may not protect all individuals. Before administering AFLURIA, please read the Prescribing Information.

About bioCSL Inc.
bioCSL Inc. is the United States subsidiary of bioCSL and is headquartered in King of Prussia, Pennsylvania. bioCSL is part of the CSL Group (ASX:CSL), which employs more than 12,000 employees in 27 countries. It is headquartered in Melbourne, Australia.

bioCSL is a leading provider of essential vaccines, pharmaceuticals and diagnostic reagents. For over 50 years, bioCSL has manufactured seasonal and pandemic influenza vaccines. It operates one of the world’s largest influenza vaccine manufacturing facilities in Australia, and maintains fill and finish facilities in the United States and Germany for the timely, reliable supply of influenza vaccines to global markets. Today, bioCSL’s influenza vaccine is registered in 27 countries. bioCSL also specializes in the production of antivenoms and is the world’s only producer of Q Fever vaccine.

Visit bioCSL Inc. at www.biocsl-us.com

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