Biotech Values

[iwfal]

XOMA - Comments on their IL-1B program:

1) I would suggest that the biggest ultimate risk to Gevokizumab is that the FDA is likely to be extremely tough on safety. Two other IL-1 antagonists were recently rejected by the FDA for gout due to safety concerns.

1a) Ilaris, which is most similar to Gevokizumab since it too is an IL-1B antagonist, probably really did have safety issues (excess infections)

1b) Rilonacept, which is different from Ilaris and Gevokizumab in that it is a trap for both IL-1a and IL-1b, too was rejected for safety (excess cancers). Unlike Ilaris, which probably really does have issues with infections, the safety risk of Rilonacept is debatable IMO. But regardless clearly the FDA is ultra-safety conscious with regard to this class of drug.

Note that I would guess that given Gevokizumab's similarity to Ilaris it too probably has infection risk. So the question is whether the FDA considers the need greater than the excess risk. Clearly they do not believe so for gout. Which makes XOMA's pursuit of osteoarthritis questionable imo. But perhaps posterior uveitis will be treated differently because Gevokizumab works soo much better than the SOC - and the SOC has significant hazards of its own. ?

PS the pursuit of acne seems like an odd waste of time given the FDA's stance and the ilaris results?

Comments welcome of course.