Gilead Sciences, Inc.
) 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
) 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
) HIV drug Reyataz and
Johnson & Johnson
) 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
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