Rotarix is an oral, two-dose, live attenuated vaccine against rotavirus disease in infants that was licensed in 1997 by Avant Immunotherapeutics to GSK for worldwide commercialization.
Rotavirus infection is the leading cause of severe diarrhea and vomiting in infants and young children between three and 24 months worldwide. Rotarix is designed to provide broad protection against multiple rotavirus strains and to provide early protection before the onset of rotavirus illness.
The vaccine works by stimulating the body to mimic the immune response to natural rotavirus infection, which protects against the subsequent development of moderate to severe rotavirus disease.
More than 70,000 infants have been enrolled in the global clinical development program, with studies conducted in Europe, the US, Latin America and Asia to evaluate the safety and efficacy of Rotarix. These studies demonstrate that Rotarix is an effective, safe and well-tolerated vaccine.
“We are very gratified to receive this milestone payment, which marks a key event in the worldwide commercialization of Rotarix,” said Dr Una Ryan, Avant president and CEO. “Last year, we saw the first commercial approval for Rotarix in Mexico, and over the course of the next several years, we expect GSK to extend the marketing approvals for this product on a global basis.”