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GSK's HIV Drug Gets Priority Review

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GlaxoSmithKline (GSK - Free Report) 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 Dec 2012.

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 same.

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 Pfizer (PFE - Free Report) 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 (LLY - Free Report) and Bayer (BAYRY - Free Report) . Both carry a Zacks Rank #2 (Buy).

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