Tuesday 13 August 2013

GlaxoSmithKline FDA approval

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A global healthcare company that develops, manufactures and markets pharmaceutical products, including vaccines, over-the-counter (OTC) medicines and health-related consumer products.  I have a holding in my income portfolio (epic code: GSK). 



ViiV Healthcare (majority owned by GSK) announced today that the U.S. Food and Drug Administration has approved Tivicay (dolutegravir) 50-mg tablets. Tivicay is an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1.   GSK own 76.5% of the JV ViiV Healthcare, with Pfizer owning 13.5% and Shionogi 10%.

The main competition for this drug is Gilead's Atripla, but in a recent competitive study Tivicay blocked all signs of the HIV virus in 88% of patients compared to 81% for Atripla after 48 weeks of use.

Atripla sales are about $3bn a year and JP Morgan have stated that they expect Tivicay to exceed this getting close to $5bn of annual sales.

This is GSK's fourth new drug approval this year and should be just the start, as GSK have stated that  over the next three years, they have the potential to launch around 15 new products globally.  This will mark the start of what should be a series of growth years for the company, following the last three disappointing years.






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