) received some encouraging news recently when an advisory panel of
the U.S. Food and Drug Administration (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.
The FDA's advisory panel met to review the new drug application
(NDA) submitted by Gilead in October 2011 for getting Quad approved
in the U.S. The NDA included positive data from two late-stage
studies - 102 which compared Quad to Atripla and 103 which compared
Quad to Norvir (ritonavir)-boosted Reyataz plus Truvada. While
Norvir is marketed by
), Reyataz is marketed by
While reviewing the application, the panel voted overwhelmingly
(13-1) in favor of clearing the combination pill (a single tablet
regimen) in the U.S. Even though the U.S. agency is not bound to
follow the advice of its advisory committee, the recommendation of
the panel is usually considered by the agency while deciding the
fate of a candidate.
Positive news from the FDA in August would further boost the top
line at Gilead and strengthen its already established HIV
portfolio. The Quad pill is also under review in the E.U, Australia
and Canada. Approval in additional territories would increase the
drug's sales potential.
Neutral on Gilead
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. We remain optimistic on the growth
prospects of Gilead's HIV drugs, Truvada and Atripla. We are also
encouraged by the approval of Complera/Eviplera, which together
with Quad, once approved, will further fortify the HIV franchise
and help mitigate the impact of the upcoming patent
Gilead is looking to combat the threat of genericization by
inking deals and making acquisitions and introducing new products.
To further strengthen its hepatitis C virus (HCV) portfolio, Gilead
purchased Pharmasset in January 2012, for approximately $11.1
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