Gilead Sciences, Inc.
) announced that it has filed a marketing application seeking
approval for its HIV candidate, elvitegravir, in the US.
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The application was submitted to the US Food and Drug
Administration (FDA) on the basis of encouraging 96-week data from
a phase III study (145). Data from the study revealed that
elvitegravir once daily (150 mg or 85 mg) was non-inferior to
) HIV therapy Isentress (400 mg) twice daily.
We note that the US filing for elvitegravir comes close on the
heels of the validation of the candidate's marketing application by
the EMA.Positive news from the FDA and the European Medicines
Agency (EMA) on elvitegravir would further boost Gilead's HIV
portfolio. We remind investors that Gilead has a licensing
agreement with Japan Tobacco since March 2005, under which it
acquired the worldwide rights (excepting Japan) for elvitegravir.
Elvitegravir is one of the components of Gilead's potential
blockbuster HIV combination pill Quad. The other components of the
pill are cobicistat and Truvada. Gilead is looking to get the Quad
pill (once daily) approved as a first-line therapy for treating
adults infected with the HIV virus. The pill is under review in the
US with a final decision expected by August 27, 2012. The Quad pill
is also under review in the EU, Australia and Canada.
Apart from elvitegravir, another component of the Quad pill -
cobicistat- was also in the news recently. Last month, the
marketing application of cobicistat was validated by the EMA.
Cobicistat acts as a "boosting" agent whose addition causes blood
levels of protease inhibitors -- such as
Bristol-Myers Squibb Company
) 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 FDA for cobicistat in the third quarter of 2012.
We have a Neutral recommendation on Gilead. Our long-term stance is
in line with the Zacks #3 Rank (Hold rating) carried by the company
in the short run.