GlaxoSmithKline submits Cervarix application

The pursuit to become the top-selling cervical cancer vaccine intensified last week as GlaxoSmithKline submitted its Biologics License Application (BLA) for Cervarix with the FDA. Cervarix is being developed to prevent strains of the sexually transmitted human papillomavirus (HPV), which can cause cervical cancer. The vaccine could reach the market by the end of 2007, if the FDA grants it “fast-track” status and then approves it, GlaxoSmithKline CEO Jean-Pierre Garnier said in a recent interview with Cervarix faces tough competition from Merck’s Gardasil. Launched in 2006, Gardasil has gained an early advantage as the only cervical cancer vaccine on the market. Analysts are giving Gardasil the edge. Gbola Amusa, analyst for Sanford C. Bernstein, projects $2.5 billion in peak annual sales for Gardasil and $1.5 billion for Cervarix. But GlaxoSmithKline counters that Cervarix is more powerful. The drugmaker is funding an unusual head-to-head study to try to prove that Cervarix is more potent than Gardasil. Results of the study are anticipated by January 2008.