Gilead submits NDA to FDA for tenofovir DF

Gilead Sciences has submitted marketing applications for tenofovirdisoproxil fumarate, an investigational reverse transcriptase inhibitor, for the treatment of HIV infection to the US Food and Drug Administration and the European Medicines Evaluation Agency. The company's shares gained 5.7% to $50.54 on the announcement, as commentators suggested that tenofovir could achieve sales of more than $100 million and bring Gilead into profitability next year.

Gilead is hoping to get FDA approval for tenofovir DF, dosed as a once-daily 300mg tablet, within six months under the agency's fast-track procedure. The firm has previously announced compassionate-use programs in the USA, France, Spain and the UK to provide access to tenofovir DF, and also expects to start similar programs in Germany, Italy, Canada and other countries.