GSK SET TO LAUNCH VACCINE WITHOUT FDA APPROVAL

UK-based drug manufacturer GlaxoSmithKline (GSK) is set to become the first pharmaceutical firm to bypass the US FDA with the launch of a vaccine against rotavirus in Mexico, which does not have FDA approval. GSK is due to launch its product, Rotarix, in January 2005 and the process could signal a new method for vaccine approval and distribution where the US and Western Europe are not the first countries to receive vaccines against illnesses which rarely affect them, such as malaria. Rotavirus causes severe diarrhoea and dehydration, which is rarely fatal in developed countries but which causes the deaths of more than 500,000 children in emerging markets worldwide every year.

GSK invested US$500mn in the development of Rotarix and conducted some of the largest ever clinical trials for the product. The Mexican drug authority approved the vaccine in October 2004 and GSK plans to seek FDA approval only after it has launched the vaccine in all Latin American countries and selected Asian markets. Rotarix has been designed to fit in with a country's existing infant vaccination schedules with both doses given before six months of age and has been in development at GSK Biologicals since 1997, when it was in-licensed from Avant Immunotherapeutics.

GSK is among the leading drug companies in Mexico, with annual sales of around US$150mn, claiming a market share of 8.1% in value terms and 6% in volume terms. The company operates in Mexico through its wholly owned subsidiary GSK Mexico.