Gilead's Eviplera Cleared in EU - Analyst Blog
November 29 2011 - 10:00AM
Zacks
Gilead Sciences, Inc (GILD), the world’s
largest HIV drug maker, received marketing authorization from the
European Medicines Agency (EMA) for the single tablet regimen
(STR), Eviplera, for the treatment of HIV in previously untreated
adults. The STR combines Gilead’s marketed HIV drug Truvada (a
fixed-dose, once-daily tablet containing Gilead's Viread and
Emtriva) and Johnson and Johnson’s (JNJ) new HIV
drug Edurant. The STR is already marketed as Complera in the US.
The EMA however limited the use of Eviplera only in patients with
low viral load (below 100,000 HIV RNA copies/mL). Complera/
Eviplera is the second STR approved in the EU for the treatment of
HIV, the first being Atripla, which is marketed by Gilead and
Bristol Myers Squibb (BMY).
Gilead has a license and collaboration agreement with Tibotec
Pharmaceuticals (a subsidiary of Johnson & Johnson) for the
development and commercialization of Complera/Eviplera. Gilead will
be responsible for manufacturing, registration, distribution and
commercialization of Complera in the US, EU, Canada, Brazil,
Australia and New Zealand. Johnson and Johnson can co-market the
drugs in these territories. The agreement has been expanded to
include certain European countries, Latin America and the
Caribbean. Johnson and Johnson will be responsible for other
territories, particularly Asia Pacific, including Japan, the Middle
East, Eastern Europe and all of Africa.
Our Recommendation
We currently have a Neutral recommendation on Gilead. The stock
carries a Zacks #3 Rank (short-term Hold recommendation).
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 the pipeline candidate Quad pill (a
combination of elvitegravir, cobicistat and Truvada) will lead to
its approval. On approval, 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
GILEAD SCIENCES (GILD): Free Stock Analysis Report
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
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