GlaxoSmithKline (GSK) shares rose following the positive opinion rendered by the European Medicines Agency’s (:EMA) Committee for Medicinal Products for Human Use (CHMP) on the marketing application of ViiV Healthcare’s HIV drug, Tivicay. A response from the European Commission is expected in early 2014.
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 positive CHMP recommendation came on the basis of encouraging data from four pivotal phase III trials (n > 2,500).
We remind investors that Tivicay has been already cleared by the FDA in Aug 2013 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 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. We believe approval of new HIV drugs with multi-million dollar potential will help in 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). Some better-ranked stocks in the pharma sector include Johnson and Johnson which carries a Zacks Rank #2 (Buy).
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