GlaxoSmithKline (GSK) recently announced that ViiV Healthcare’s HIV drug, Tivicay, has been cleared by the U.S. Food and Drug Administration (:FDA). The FDA approved Tivicay 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).
We note that ViiV Healthcare, a company focused on the treatment of HIV, was established by Glaxo and Pfizer (PFE) in 2009. After certain amendments in Oct 2012, Glaxo, Pfizer and Shionogi now own 76.5%, 13.5% and 10% of ViiV Healthcare, respectively.
The FDA approved Tivicay on the basis of encouraging data from four pivotal phase III trials (n ~ 2,557). Tivicay is an integrase inhibitor. ViiV Healthcare is also looking to get the HIV drug approved in the EU and has submitted a marketing authorisation application to the European Medicines Agency for the same in Dec 2012.
A fixed dose combination of Tivicay and abacavir/lamivudine is also being evaluated. ViiV Healthcare expects to submit regulatory applications for the drug later in the year.
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 other several products in the U.S. Tivicay, with multi-million dollar potential, should help the top line rebound.
Currently prescribed therapies for HIV include Johnson and Johnson’s (JNJ) Intelence and Gilead Sciences Inc.’s (GILD) Stribild and Complera.
Glaxo currently holds a Zacks Rank #3 (Hold). Currently, stocks such as Gilead Sciences look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).
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