EMA Validates Gilead's Drug

Recently, Gilead Sciences, Inc. ( GILD - Analyst Report ) announced that its marketing application seeking approval for its HIV candidate elvitegravir in the EU has been validated by the European Medicines Agency (EMA).

The marketing authorization application (MAA) was submitted by Gilead on May 22, 2012. The application was submitted on the basis of encouraging 96-week data from a late-stage study. Data from the study revealed that elvitegravir once daily (150 mg or 85 mg) was non-inferior to Merck’s ( MRK - Analyst Report ) HIV therapy Isentress (400 mg) twice daily.

We note that last month the marketing application of another candidate in Gilead’s pipeline, cobicistat, was validated by the EMA. Cobicistat acts as a “boosting” agent whose addition causes blood levels of protease inhibitors -- such as Bristol-Myers’ ( BMY - Analyst Report ) HIV drug Reyataz and Johnson & Johnson’s ( JNJ - Analyst Report ) Prezista -- to increase, thereby enabling the HIV therapy to be dosed once daily. We note that cobicistat only acts as a boosting agent without any antiviral activity. Gilead intends to seek approval from the US Food and Drug Administration (FDA) for cobicistat in the third quarter of 2012.

In May 2012, Gilead received further good news when an advisory panel of the FDA recommended the approval of the company’s HIV combination pill Quad. A final decision from the FDA regarding the matter is expected by August 27, 2012 (target date).

We note that the Quad pill is a combination of elvitegravir, cobicistat and Truvada. Gilead is looking to get the pill (once daily) approved as a first-line therapy for treating adults infected with the HIV virus.

Positive news from the FDA in August would further boost the top line at Gilead and