MEXICO SPEARHEADS GLAXOSMITHKLINE ROTAVIRUS DRUG LAUNCH

UK-based pharmaceuticals major GlaxoSmithKline (GSK) has launched rotavirus treatment Rotarix in Mexico, ahead of the drug's worldwide launch. The drug is a novel, orally administered two-dose treatment for rotavirus, which causes severe diarrhoea and vomiting in children, and is estimated to kill some 440,000 sufferers annually, mainly in the developing world. Reports suggest the treatment could earn GSK annual sales of up to US$1.8bn.

Notably, Mexico was the first country to grant the drug initial approval in July, and was a leading centre in Phase III clinical trials for the drug, which is now expected to be integrated to the government's infant immunisation programs. Rotarix's approval in Mexico effectively allowed the company to bypass the US FDA and roll out the treatment in less developed countries, where the infection is more likely to prove fatal. Meanwhile, the European Medicines Agency has already accepted GSK's marketing approval application for review, with some 20 countries already considering similar applications.

Rotarix was originally developed in Cincinnati, US, and was in-licensed from Avant Immunotherapeutics in 1997. Last week's European review approval triggered a US$2mn milestone payment to the US company.