Gilead Sciences applies for EU approval of new HIV treatment

Gilead Sciences has submitted an application for European marketing approval of a new combination therapy for adult HIV sufferers.

The marketing authorisation application submitted to the European Medicines Agency pertains to a fixed-dose combination of Gilead's Truvada and Tibotec Pharmaceuticals' TMC278, an investigational non-nucleoside reverse transcriptase inhibitor.

Gilead is applying for approval of the therapy based on positive findings from recent phase III clinical trials, which illustrated the safety and efficacy of the combination.

Should the application meet with success, it would become the second product on the market to offer a complete antiretroviral treatment regimen in a single once-daily tablet.

Dr John Martin, chairman and chief executive officer of Gilead Sciences, said: "We are pleased to work with Tibotec in contributing another potentially important new once-daily, fixed-dose treatment option."

In July 2010 Gilead published its fiscal report for the second quarter of the year, a period which saw the firm experience double-digit revenue growth thanks to strong sales of HIV drugs including Truvada and Atripla.