Replies to post #198675 on Biotech Values

[willyw]

I’m pretty sure the design of ENDURANCE-3 is a business decision by ABBV/ENTA rather than a requirement imposed by regulators.

To which I might add, marketing....

Abbvie has been battling the notion that Gild is just best, even perhaps where it wasn't (G-1b's)

Gilead may have massaged the numbers a little; they provided blended SVR rates; combining G-1a and g-1b rates.

One REALLY had to look hard to find SVR rates for g-1b's.

It may be that Abbvie is out to upset the mindset first by toppling the Sovaldi/Daclatasvir best treatment for G-3, and then perhaps..... challenging SOV/VEL.

When the results are so close in SVR rates, it is conceivable that the Abbvie program could be better in some ways; Cure rates, tolerability, or cure rates on certain patient sub-sets.

It may even be that undermining the the concept may work on getting more acceptance of the upcoming 2nd gen program, but even a bit more consideration for the 1st gen.

It would seem to me, that if this were a purely optional exercise, Abbvie would avoid direct comparison it it knew it was inferior. I think it seems almost implicit that the SVR rates will be compared with SOV/VEL.

I am also wondering if they are gathering data on adding a 3rd component to the ABBVIE 2nd gen; nuke or cyclophillin?

[caravon]

The purpose of any registration trial is to get the best possible marketing label.

As for ABBV/ANTA HCV products, they are considered/perceived to be inferior to GILD's HCV products. Consequently, ABBV has realized that no marketing (including price discounts) would substantially change the situation. This is why the ABBV head-on trial will make or break HCV GT3 marketing.

It is interesting that ABBV decided stay away from other HCV GT group. A success (the head-on superiority results) will lock GT3 for ABBV and also will spill a positive perception into other GT groups. A failure will not be a big deal for GT1 marketing.