The US Food and Drug Administration (FDA) recently approved
Gilead Sciences, Inc
) once-daily oral Truvada (combination of Viread and Emtriva) in
combination with safer sex practices for the reduction of the risk
of sexually acquired HIV-1 infection in uninfected adults.
The FDA approval for the pre-exposure prophylaxis (PrEP)
indication did not come as a surprise as in May 2012, Truvada
received a favorable recommendation from the FDA's advisory
With the FDA approval, Truvada became the first agent to be
approved for preventing HIV in uninfected adults or pre-exposure
prophylaxis (PrEP). Previously, it was approved in the US in
combination with other antiretroviral agents as a treatment of
HIV-1 infection in adults. The company believes that the approval
will help to reduce the rate of new HIV infections and curb the
The company, along with the FDA, developed a risk evaluation and
mitigation strategy (REMS) for the safe use of Truvada. Gilead
stated that 1.2 million people in the US are living with HIV.
Despite increasing awareness, around 50,000 people are being
infected each year since the last two decades.
Presently, Gilead's strong HIV product portfolio consists of
Truvada, Viread, Atripla and the newly launched Complera/Eviplera.
Gilead recorded Truvada sales of $758.3 million in the first
quarter of 2012.
Gilead is looking to expand its HIV portfolio. In May 2012 the
FDA's advisory panel gave another favorable recommendation on
Gilead's HIV combination pill Quad. A final decision from the FDA
regarding the matter is expected by August 27, 2012 (target date).
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
We remind investors that recently Gilead announced filing of a
marketing application seeking approval for its HIV candidate,
cobicistat, in the US. 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. In June 2012, Gilead filed another marketing
application seeking approval for its HIV candidate, elvitegravir,
in the US.
We have a Neutral recommendation on Gilead. We expect the sales
potential of Truvada will increase with the label expansion. We
also believe that Quad (if approved) together with
Complera/Eviplera, will further fortify Gilead's HIV franchise.
The stock carries a Zacks #4 Rank (Sell rating) in the short
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