Gilead Sciences, Inc.
) announced that it has filed 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.
The new drug application (NDA) included data from a phase III
study (114) which showed that cobicistat was non-inferior to
) HIV therapy Norvir over 48 weeks. The application also included
pharmacokinetic data which revealed that the addition of cobicistat
boosted the exposure of HIV therapies Reyataz and Prezista similar
to Norvir. We note that Gilead is also seeking approval of
cobicistat in the EU.
Gilead has partnerships with Janssen R&D Ireland (a unit of
Johnson & Johnson) and Bristol-Myers for developing cobicistat
as a fixed-dose combination therapy. While the deal with Johnson
& Johnson pertains to the development of cobicistat with
Prezista, the deal with Bristol-Myers pertains to the development
of cobicistat in combination with Reyataz.
Moreover, cobicistat is one of the components of Gilead's
potential blockbuster HIV combination pill Quad. The other
components of the pill are elvitegravir 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. 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 EU, Australia and Canada.
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.
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