Gilead Sciences, Inc.
(
GILD
) recently gained US Food and Drug Administration (FDA) approval
for its HIV combination pill, Stribild (formerly known as Quad).
Stribild (once-daily) was approved as a first-line therapy for
treating adults with HIV-1 infection.
Stribild is a combination of elvitegravir, cobicistat and Truvada.
We note that Truvada itself is a combination of Viread and Emtriva.
The FDA approval did not come as a surprise, as in May 2012, an FDA
advisory panel had voted overwhelmingly (13-1) in favor of clearing
the combination pill in the US.
Approval was based on encouraging data from two late-stage studies
-- 102, which compared Stribild to Atripla and 103, which compared
Stribild to Norvir (ritonavir)-boosted Reyataz plus Truvada. While
Norvir is marketed by
Abbott Labs
(
ABT
), Reyataz is marketed by
Bristol-Myers Squibb
(
BMY
).
Last month, the FDA approved Truvada (once-daily) in combination
with safer sex practices for bringing down the risk of uninfected
adults getting infected by HIV. The approval makes Truvada the
first drug to be approved for preventing HIV in uninfected adults
or pre-exposure prophylaxis (PrEP).
Truvada is also approved in combination with other
antiretroviral agents as a treatment for HIV-1 infection in adults.
The other two components of Stribild, elvitegravir and cobicistat,
are currently under regulatory review.
Neutral on Gilead
We currently have a Neutral recommendation on Gilead. The stock
carries a Zacks #3 Rank (Hold rating) in the short run. We remain
optimistic on the growth prospects of Gilead's HIV drugs, Truvada
and Atripla. We are also encouraged by the sales ramp of the newly
launched Complera/Eviplera, which together with Stribild, will
further fortify the HIV franchise and help mitigate the impact of
upcoming patent expirations.
Gilead is looking to combat the threat of genericization by inking
deals, making acquisitions and introducing new products. To further
strengthen its hepatitis C virus portfolio, Gilead purchased
Pharmasset earlier in the year, for approximately $11.1
billion.
ABBOTT LABS (ABT): Free Stock Analysis Report
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