Gilead Sciences, Inc.
) announced that its marketing application seeking approval for its
candidate cobicistat in the EU has been validated by the European
Medicines Agency (EMA).
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. We note that cobicistat only acts as a boosting
agent without any antiviral activity.
The marketing authorization application (MAA) was filed by
Gilead on April 26, 2012, the day the company disclosed its first
quarter 2012 earnings results. The MAA was filed on the basis of
pharmacokinetic data from a study which revealed that the addition
of cobicistat boosted the exposure of HIV therapies Reyataz and
Prezista similar to
) HIV therapy Norvir.
Currently, Norvir is the only boosting agent available for
treating HIV. The MAA also contained data from a phase III study
which showed that cobicistat was non-inferior to Norvir over 48
weeks. Gilead intends to seek approval from the U.S. Food and Drug
Administration (FDA) for cobicistat in the third quarter of 2012.
Positive news from the FDA and EMA regarding cobicistat would boost
the HIV portfolio at Gilead further.
We note that 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.
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 expirations.
Gilead is looking to combat the threat of genericization by
inking deals and making acquisitions and introducing new
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