) announced that ViiV Healthcare has submitted a Marketing
Authorisation Application (MAA) to the European Medicines Agency
(EMA) for its HIV combination therapy in the form of a single
tablet. The candidate is a combination of Tivicay, abacavir and
lamivudine. The company is also looking to get the drug approved
in the U.S. and has submitted a New Drug Application to the U.S.
Food and Drug Administration (FDA) for the same indication.
The regulatory application was submitted on the basis of data
from a pivotal phase III study on Tivicay and three phase
III/IIIb studies evaluating the combination therapy. The
application also includes pivotal data from a bioequivalence
study evaluating combination of Tivicay, abacavir and lamivudine
in the form of a single tablet versus Tivicay and abacavir and
lamivudine separately. Additionally, a 48-week phase IIIb/IV ARIA
study evaluating the combination of Tivicay, abacavir and
lamivudine is ongoing
We note that ViiV Healthcare, a company focused on the treatment
of HIV, was established by Glaxo and
) in 2009. After certain amendments in Oct 2012, Glaxo, Pfizer
and Shionogi now own 76.5%, 13.5% and 10% of ViiV Healthcare,
We remind investors that in Aug 2013, Glaxo received a major
boost when its HIV drug, Tivicay, was cleared by the FDA as an
add-on therapy to other antiretroviral agents for the treatment
of patients suffering from HIV-1, who are above 12 years and
weigh at least 88 lbs (40 kg). ViiV Healthcare is also looking to
get the HIV drug approved in the EU and has submitted a MAA to
the European Medicines Agency for the same in Dec 2012.
A combination tablet of abacavir and lamivudine is also approved
in the U.S. and EU under the trade names Epzicom and Kivexa,
We note that sales at ViiV Healthcare have been on the decline
over the past few quarters due to generic erosion of Combivir,
Epivir and several other products in the U.S. However, the
approval of new HIV drugs with multi-million dollar potential
should help in the top-line rebound.
Currently prescribed therapies for HIV include
Johnson and Johnson
) Intelence and
Gilead Sciences Inc.
) Stribild and Complera.
Glaxo currently holds a Zacks Rank #3 (Hold). Currently, stocks
such as Johnson and Johnson look more attractive in the pharma
space with a Zacks Rank #2 (Buy).
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