Gilead Presents Elvitegravir Data - Analyst Blog
December 12 2011 - 4:45AM
Zacks
Gilead Sciences, Inc. (GILD) recently announced
positive long-term data from a late-stage pivotal trial (study 145)
evaluating its HIV pipeline candidate elvitegravir.
The study assessed the non-inferiority of ritonavir-boosted
elvitegravir dosed once daily, as compared to
Merck’s (MRK) Isentress dosed twice daily in
treatment-experienced HIV patients. Earlier this year in March, the
study met the primary endpoint, when Gilead had announced 48 week
data. In January 2011, the company had extended the period of the
study to 96 weeks to gain longer-term efficacy and safety data to
support the regulatory filing of elvitegravir.
The latest data showed that elvitegravir continued to be
non-inferior to Isentress after two years in viral load reduction
(HIV RNA levels under 50 copies/mL). It was observed that after 96
weeks, 48% of the patients who were dosed with elvitegravir
achieved and maintained viral load reduction as compared to 45% of
the patients who were given Isentress. At 48 weeks this proportion
was 59% for Elvitegravir and 58% for Isentress. Gilead hopes to
file the new drug application (NDA) for elvitegravir in the second
quarter of 2012. The long-term data now hugely increases the chance
of elvitegravir’s approval.
We note that elvitegravir is an important component of Gilead’s
most anticipated HIV pipeline candidate Quad pill (a combination of
Gilead elvitegravir and another HIV pipeline candidate cobicistat
and its marketed HIV drug Truvada). Two late-stage trials (study
102 and study 103) evaluating Quad pill have already met the
primary endpoint. Gilead filed the NDA for approval of Quad in late
October 2011.
Last week Gilead announced that its investigational boosting
agent cobicistat met the primary endpoint in a late-stage study
(study 114), which was comparing cobicistat−boosted Reyataz plus
Truvada with ritonavir−boosted Reyataz plus Truvada.
Bristol-Myers Squibb’s (BMY) drug Reyataz is
indicated to be used in combination with other drugs for the
treatment of HIV. Since elvitegravir and cobicistat are key
components of Quad, positive elvitegravir and cobicistat data
greatly reduce the risk for approval of Quad.
Our Recommendation
We currently have a Neutral recommendation on Gilead. The stock
carries a Zacks #3 Rank (short-term Hold rating).
We are optimistic about the growth potential of Gilead’s HIV
franchise drugs, Truvada and Atripla. Moreover, Gilead’s strategy
of creating fixed-dose combinations of existing HIV drugs has
yielded enormous success. We believe the positive outcomes of two
late stage trials of Quad pill will lead to its approval.
Subsequent to regulatory clearance, Quad has the potential to reach
blockbuster status and become a market leading HIV medicine. 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. We are nonetheless concerned about patent challenges
against its key HIV drugs. We maintain a cautious stance until
Complera/ Eviplera along with the current pipeline proves its
worth, compensating for lost revenues from patent lapses.
BRISTOL-MYERS (BMY): Free Stock Analysis Report
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