Replies to post #147097 on Biotech Values

[biomaven0]

ARRY's prior 797 trial in ankylosing spondylitis tested the drug out to, and showed durability on pain to, 85 days

I didn't know that - reduces my concern considerably. Much more likely the CRP tachyphylaxis issue was specific to inflammation in RA then.

If they don't have new safety issues and the QTc issue isn't too serious, then this has the potential to be a very big drug. But as I said before, safety trials will need to be very big and multi-year. After Vioxx, the FDA is likely going to want a cardiac outcomes study prior to approval. (I really wonder if NSAIDs could get approved in today's environment).

Peter

[bladerunner1717]

re: ARRY 797

Hey guys, these discussions about the side effect issues with 797 are really enlightening, but really miss the main issue from an investor's point of view. The real question for investors is whether ARRY can partner the drug. On this issue, it was very unfortunate that no one forced Squarer to more specifically define what he meant by "significant interest" in the drug from potential partners. You'd have thought that at least one of the analysts might have tried to pin Squarer down on a timetable for a partnership.

The thing that i think jq1234 and Peter are missing in their discussion is how much time ARRY management spent on the CC talking about the drug and trying to dispel negative inferences about the QTc prolongation issues. I don't think ARRY management would have spent so much time talking about 797, if they didn't consider a partnership to be a strong possibility. (The very first question on the CC was from Jeffries asking about the QTc prolongation issue. ARRY was prepared for that and knew it was coming, IMO.)

McBio, you didn't mention that Genentech has taken an ARRY molecule into Phase I testing.

Nor did you mention Squarer talking about "additional discovery deals" coming soon.

And did you notice how--I don't want to use the term "dismissive," because it is too strong--seemingly disinterested Squarer was in what AZN was doing with Selumetinib. Squarer's attitude seemed to be "Ok, AZN has the drug, we're not exactly sure what they're going to do with it, check with clinicaltrials.gov., because that's the only way we or you are going to find out anything; now let's talk about Novartis and MEK-162, because these are the guys we really like (and have a much better financial relationship with--Bladerunner))and we have this really cool joint committee with NVS and we're taking MEK-162 on our own into a clinical trial with MEK-162 in combo with a chemotherapeutic and let's not talk about Selumetinib anymore." "Oh yeah, and we expect NVS to move MEK-162 into a Phase III in melanoma, because the Phase II data was 'remarkable'."

By the way, the Phase III that McBio mentioned with carfilzomib will be tested in patients refractory to bortezomib.


Bladerunner