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mcbio

09/21/13 1:05 AM

#166807 RE: oc631 #166806

Even with simeprevir we don't have the visibility on any oral offering to do comparisons.

I'm not sure why you say this but I guess that depends on your definition of "visibility." There are of course no guarantees, and plenty of data that remains to be generated, but I see several possibilities. The nearest-term may well be with BMY in a simeprevir+daclatasvir combo. We will have the Phase 2 data later this year and, if it delivers, do you see BMY open to collaborating on a potent QD combo in GT1b with JNJ? Do their in-house offerings suffice here? If not, there's the collaboration with IDIX on IDX719 which also has a shot to be a potent QD combo in GT1b. And IDIX seems like they are likely going to be open to formal collaborations down the road given their nuke issues and likely lack of their own in-house combo. There's also the potential for this combo with the addition of the JNJ non-nuke in other GTs (though the JNJ non-nuke includes ritonavir boosting). Furthermore, there's still the potential in combo with a nuke in a formal collaboration with VX-135 at a lower dose. I don't think we can completely write off VX-135 just yet. Phase 2 trials are still apparently on track to begin this year. And finally, although it's very early and well behind, there's still the potential for simeprevir in combo with their own nukes that are set to enter the clinic shortly.

While there's no reason to expect GILD to be open to any formal licensing arrangement involving simeprevir and sofosbuvir, it sounds like you still expect there to be at least some off-label use of this combo.