) 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).
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).
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