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FluLaval Quadrivalent

Generic name: influenza virus vaccine, inactivated
Treatment for: Influenza Prophylaxis

Update: FluLaval Now FDA Approved - October 5, 2006

GlaxoSmithKline Submits Biologics License Application for FDA Approval of FluLaval

Filing of New Vaccine Candidate Further Demonstrates Company's Commitment to Ensuring Adequate Supply of Flu Vaccine in the U.S.

PHILADELPHIA, March 23, 2006 -- GlaxoSmithKline today announced it has submitted a Biologics License Application (BLA) for FluLaval (Influenza Virus Vaccine) to the U.S. Food and Drug Administration (FDA). If licensed, FluLaval will be used for the active immunization of adults 18 years of age and older against influenza disease caused by influenza virus types A and B, which are contained in the vaccine.

"GSK is committed to increasing the supply of seasonal flu vaccine to help keep Americans healthy during the flu season," said Christopher Viehbacher, President, U.S. Pharmaceuticals, GSK. "Influenza is a serious threat to public health and the U.S. has faced recent shortages of vaccine to prevent it. Following last year's approval of Fluarix, today's announcement is another important step toward ensuring adequate availability of a critical weapon to fight the flu."

Fluarix (Influenza Virus Vaccine) was approved by the U.S. FDA on August 31, 2005. GSK added FluLaval to its portfolio of flu products when it acquired the Canadian vaccine manufacturer ID Biomedical Corporation in December 2005. FluLaval was granted fast-track status by the U.S. FDA in July 2005 and is marketed in Canada under the name Fluviral. If granted U.S. marketing approval for FluLaval, GlaxoSmithKline expects to provide up to 30 million doses of seasonal influenza vaccine (FluLaval and Fluarix) to the U.S. market for the 2006/2007 flu season.

About Influenza

Influenza is a highly contagious and potentially fatal virus that affects five to 20 percent of the total U.S. population during each influenza season. Between 1990 and 1999, approximately 36,000 people died in the United States each year from complications of influenza infection; more than 90 percent of these deaths occurred in persons 65 years of age and older. Influenza can reach epidemic levels and poses a significant threat to public health, particularly among the nation's oldest and youngest citizens.

Influenza vaccination is the primary method for preventing influenza and its severe complications. Influenza is easily passed from one person to another through the air by tiny droplets and particles released when an infected individual coughs or sneezes. Most people recover fully within a week or two.

The risk of complications is elevated in very young, very old and chronically ill persons. The genetic makeup of the influenza virus and the rapid mutations that can occur make annual vaccination necessary.

Source: GlaxoSmithKline

Posted: March 2006

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