Gilead's Stribild Backed by CHMP - Analyst Blog

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Gilead Sciences, Inc. ( GILD ) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recently rendered a positive opinion on its HIV combination pill, Stribild (formerly known as Quad). Stribild is a combination of elvitegravir, cobicistat and Truvada. We note that Truvada itself is a combination of Viread and Emtriva.

The CHMP recommended the approval of Stribild for treating HIV infected adults who are either antiretroviral-naïve or are HIV infected without known mutations associated with resistance to any of the components of Stribild.

Management at Gilead stated that it expects a final decision on its Marketing Authorisation Application (MAA) for Stribild in the coming months. Gilead filed the MAA last year on the basis of encouraging data from two phase III studies -- 102, which compared Stribild to Atripla and 103, which compared Stribild to Norvir (ritonavir)-boosted Reyataz plus Truvada. While Norvir is marketed by AbbVie Inc. ( ABBV ), Reyataz is marketed by Bristol-Myers Squibb ( BMY ).

We note that Stribild was approved in the US in Aug 2012 for treating HIV infected treatment-naïve adults. The drug is also approved in Canada, South Korea and Australia. European approval will further boost the sales potential of the drug.

We note that elvitegravir and cobicistat (2 of the components of Stribild) are under review in the US. A final decision from the US Food and Drug Administration (FDA) on elvitegravir is expected by Apr 27, 2013. The FDA is expected to decide on cobicistat, as a standalone agent, by Apr 28, 2013.

Gilead carries a Zacks Rank #3 (Hold). Osiris Therapeutics, Inc. ( OSIR ) looks more attractive in the pharma space. The stock carries a Zacks Rank #1 (Strong Buy).



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This article appears in: Investing , Business , Stocks

Referenced Stocks: ABBV , BMY , CHMP , GILD , MAA

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