GlaxoSmithKline's Application for Rotarix(R) is Accepted for Review by the FDA

Wednesday, August 15, 2007 General News
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PHILADELPHIA, Aug. 14 GlaxoSmithKline(NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA)has accepted for review its Biologics License Application (BLA) forRotarix(R), an oral candidate vaccine for infants to prevent rotavirusgastroenteritis. Severe, dehydrating gastroenteritis occurs primarily amongchildren aged three to 35 months. Of children hospitalized with rotavirus,approximately 17 percent are younger than six months old. If approved, theGSK candidate vaccine could offer completion of the rotavirus vaccinationseries by four months of age. The rotavirus candidate vaccine is a live-attenuated vaccine derived from the most common human rotavirus strain.Published data show that immunity resulting from natural human rotavirusinfection provides significant protection against moderate to severe disease,regardless of rotavirus strain.

The BLA for the GSK rotavirus candidate vaccine is based on one of thelargest clinical development plans undertaken by a vaccine manufacturer andincludes data from nearly 75,000 infants. These clinical trials wereconducted in the Americas, Europe, Asia and Africa and reflect an ethnicallydiverse population.

"This vaccine, which is designed to protect in a manner similar to naturalhuman infection, could make a considerable contribution in protecting veryyoung infants from rotavirus disease, a significant burden on families and thehealthcare system in the U.S.," said Barbara Howe, M.D., Vice President, NorthAmerican Vaccine Development, GlaxoSmithKline. "We also believe it isimportant to immunize infants against rotavirus as early as possible."

The Centers for Disease Control and Prevention's (CDC) Advisory Committeeon Immunization Practices (ACIP), the American Academy of Pediatrics (AAP),and the American Academy of Family Physicians (AAFP) recommend that infantsreceive routine vaccination against rotavirus to prevent rotavirusgastroenteritis with the vaccine currently licensed by the FDA at two, four,and six months of age.

About Rotarix(R)

The GSK rotavirus candidate vaccine is a live-attenuated oral rotavirusvaccine licensed in 99 countries around the world. The vaccine is designed toprevent rotavirus gastroenteritis by mimicking natural rotavirus infection.Studies have shown that natural rotavirus infection provides significantprotection from moderate to severe disease, regardless of rotavirus strain.In the file under review by the FDA, it is proposed that the vaccine would begiven in two oral doses beginning at six weeks of age and completed by 24weeks of age, with a minimum four-week interval between the doses. Ifapproved, the vaccine would typically be administered at the two and fourmonth immunization visits.

About Rotavirus

Rotavirus infects virtually every child worldwide by age five and is theleading cause of severe acute gastroenteritis in infants and young children inthe U.S. and worldwide. Severe diarrhea and dehydration occurs from as youngas three months of age. In the U.S. each year, 2.7 million children youngerthan five years of age suffer from rotavirus disease, resulting in 410,000clinic visits and up to 272,000 emergency room visits. In addition, between55,000 and 70,000 children are hospitalized each year and 20-60 die.

GlaxoSmithKline: A Leader in Vaccines

GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and ResearchTriangle Park, NC, is one of the world's leading research-based pharmaceuticaland healthcare companies and is committed to improving the quality of humanlife by enabling people to do more, feel better and live longer.

GSK Biologicals (GSK Bio), one of the world's leading vaccinemanufacturers, is headquartered in Rixensart, Belgium, where the majority ofGlaxoSmithKline's activities in the field of vaccine research, development andproduction are conducted. GSK Bio employs more

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