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GlaxoSmithKline ( GSK - Analyst Report ) recently announced that ViiV Healthcare’s HIV candidate, dolutegravir, has demonstrated encouraging efficacy at 24 weeks in a phase III study. ViiV Healthcare was established by Glaxo and Pfizer ( PFE - Analyst Report ) in 2009.
The phase III SAILING (ING111762: n = 715) study is evaluating dolutegravir in treatment experienced patients suffering from HIV-1, who have not been treated with an integrase inhibitor.
The double-blind, double-dummy, 48-week,study is comparing the use of once-daily dolutegravir versus Merck & Co. ( MRK - Analyst Report ) Isentress (raltegravir). At 24 weeks, dolutegravir and Isentress demonstrated virologic suppression (HIV-1 RNA <50 c/mL) in 79% and 70% of the patients, respectively.
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.
We note that dolutegravir will be reviewed by the US Food and Drug Administration (FDA) on a priority basis (a six- month review period). A decision from the US regulatory body is expected by Aug 17, 2013 (target date). The candidate is also under review in the EU for the same indication.
We remind investors that ViiV Healthcare and Shionogi & Co. had 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. Glaxo, Pfizer and Shionogi now own 76.5%, 13.5% and 10% of ViiV Healthcare, respectively.
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