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Glaxo Seeks EU Approval for HIV Drug

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GlaxoSmithKline (GSK - Free Report) 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 Pfizer (PFE - Free Report) in 2009. After certain amendments in Oct 2012, Glaxo, Pfizer and Shionogi now own 76.5%, 13.5% and 10% of ViiV Healthcare, respectively.


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, respectively.

Our Take

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’s (JNJ - Free Report) Intelence and Gilead Sciences Inc.’s (GILD - Free Report) 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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