) recently announced that ViiV Healthcare's HIV candidate,
dolutegravir, will be reviewed by the US Food and Drug
Administration (FDA) on a priority basis. A decision from the US
regulatory body is expected by Aug 17, 2013 (target date).
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ViiV Healthcare is looking to get dolutegravir approved for the
treatment of adults and adolescents suffering from HIV infection
as an add-on therapy to other antiretroviral agents. The company
had submitted the new drug application (NDA) for dolutegravir in
The regulatory filing included encouraging data from the VIKING-3
phase III study. The study evaluated the efficacy and safety of
dolutegravir in HIV-1 infected patients adults with multiple
class antiretroviral resistance, including resistance to
integrase inhibitors. The company is also seeking to get
dolutegravir approved for HIV in the EU and has submitted a
marketing authorization application (MAA) in Dec 2012 for the
We remind investors that ViiV Healthcare and Shionogi & Co.
revised their agreement effective Oct 31, 2012. As per the
amended agreement, ViiV Healthcare acquired exclusive worldwide
rights to all Shionogi-ViiV Healthcare LLC joint venture assets
which include dolutegravir, in exchange of Shionogi gaining 10%
ownership in ViiV Healthcare.
ViiV Healthcare was originally established by Glaxo and
) in 2009. Glaxo, Pfizer and Shionogi now own 76.5%, 13.5% and
10% of ViiV Healthcare, respectively.
Glaxo carries a Zacks Rank #4 (Sell) in the short run. Large-cap
pharma companies that currently look better-positioned include
Eli Lilly and Company
). Both carry a Zacks Rank #2 (Buy).