Gilead Sciences, Inc.
) 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.
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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
), Reyataz is marketed by
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.
) looks more attractive in the pharma space. The stock carries a
Zacks Rank #1 (Strong Buy).