GlaxoSmithKline
(
GSK
) 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
) 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
) 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.
Glaxo carries a Zacks Rank #4 (Sell). Large-cap pharma
companies that currently look better-positioned include
Eli Lilly and Company
(
LLY
) carrying a Zacks Rank #2 (Buy).
