Aurinia Pharmaceuticals Inc (AUPH)

[moosedogger]

"Are FSGS and potential SLE foray fully baked..."

Not even half baked. I don't believe we'll see any value for SLE because:

1. The composition of matter patent for Voclosporin will likely expire or leave so little time it would be a financial loser even if it was effective for SLE, which I don't believe is likely because:

2. I referenced an analysis of the AURA results in msg. #8321 that points out that "when extrarenal elements were assessed alone, the VCS groups tended to have a similar or greater reduction in activity than did the control group (Supplementary Figure S4). For example, the extrarenal SELENA-SLEDAI scores fell 53%, 51%, and 67% in placebo, low-dose VCS, and high-dose VCS patients at week 48,
respectively."

In other words, once Voclosporin has improved the patient's kidney function, the SLEDAI scores are virtually the same as placebo for low dose VCS. So why even bother with expensive and time consuming trials where there is likely no discernible benefit?

3. The SELENA-SLEDAI scoring is subjective anyway, while the great benefit of Aurinia's LN results is they are objective and thus real.

4. The method of use 10 year patent extension won't apply to SLE as it's designed to be added to the label for LN use and treatment.

5. Even if in the unlikely event VCS became approved for SLE, how could the problematic pricing issue be overcome? I see zero possibility an SLE patient would pay $70K annually for VCS.

Re FSGS projected revenues, I didn't figure any value so consider that a bonus.