Biotech Values

[DewDiligence]

GILD Elvitegravir update (from today’s CC):

As impressive as GILD has been on the commercial front, they are equally impressive on the clinical front. Case in point: GILD persuaded the FDA to allow only one phase-3 study of Elvitegravir vs Isentress in support of an Elvitegravir NDA in treatment-experienced HIV by substituting two planned phase-3 studies of Quadro* in treatment-naïve HIV for what would’ve been the second phase-3 study of Elvitegravir vs Isentress. Insofar as the substituted Quadro studies are not even in the same clinical setting, this is quite a coup for GILD!

The phase-3 trial of Elvitegravir vs Isentress (#msg-30900183), which started in July, has already enrolled 40% of the 700 patients.

The planned phase-3 Quadro studies will have 600 patients each and will seek to show non-inferiority of Quadro vs Atripla. GILD will run one or more phase-2 trials before embarking on phase-3.

If Quadro can be shown to be non-inferior to Atripla on efficacy, it could eventually become the standard of care treatment in first-line HIV due to a Elvitegravir’s having a lower incidence of CNS side effects and a superior safety profile for pregnant patients relative to Sustiva.

*Quadro = Elvitegravir + Viread + Emtriva + GS9350 (a PK booster)