Fate on Gilead Quad Set for Aug '12 - Analyst Blog
December 28 2011 - 10:15AM
Zacks
Gilead Sciences, Inc. (GILD) recently announced
that the US Food and Drug Administration (FDA) will give its
decision regarding approvability of its most anticipated HIV
pipeline candidate, the Quad pill, on August 27, 2012. Quad is a
combination of Gilead pipeline candidates elvitegravir and
cobicistat and its marketed HIV drug Truvada. Gilead had filed the
new drug application (NDA) for approval of Quad on October 27,
2011. This means the review will take the standard time of 10
months rather than the six-month priority review which the company
had requested.
Last week, Gilead filed a Marketing Authorisation Application
(MAA) for Quad in the European Union. Both the MAA as well as the
NDA were based on positive data from two late stage studies of
Quad, study 102 and 103.
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 upcoming patent
expirations. We are, nonetheless, concerned about patent challenges
against Gilead’s key HIV drugs. We maintain a cautious stance until
Complera/ Eviplera and the current pipeline proves their worth,
compensating for lost revenues from patent expiries.
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