Replies to post #146345 on Biotech Values

[exwannabe]

arry 797 data out

Anybody have a clue if the point value on pain reduction is decent (2.4 vs. 1.6 ; p = .027 vs placebo) is "decent"?

They left out the Oxy value (just said comparable), so I assume Oxy did better, but I don't see why that would be a major issue.

[bladerunner1717]

re: ARRY

In this trial, ARRY-797 was considered overall to be well-tolerated at the selected dose of 400 mg twice-daily. The most common adverse events observed in patients treated with ARRY-797 were dizziness, diarrhea and nausea, which were mainly mild in severity. ARRY-797 treatment was associated with sporadic, transient increases in creatine kinase and aspartate aminotransferase. Mild prolongations of the QTc interval and sustained decreases in systolic and diastolic blood pressure were also observed.

Isn't the QTc issue a huge red flag? I have osteoarthritis and I'm not sure I'd want to take this drug and ARRY is my second biggest holding. LOLOL The SP is down 12% in AH. (I really think this might be overdone; no one that I know had this drug factored into their valuation models.) Would any BP want to take on this drug?


Bladerunner

[mcbio]

Re: ARRY-797 data

As I've posted before (item 8 of #msg-71567015), ARRY guided for 797 having efficacy comparable to, or slightly less than, oxycontin with a much better side-effect profile. I think efficacy is right in-line with expectations given that the PR states that reduction in pain was "comparable to that seen with oxycodone ER." Safety is presumably where it's open to interpretation. On the one hand, 34% of oxycodone ER patients withdrew due to AEs compared to just 6% for 797 group (even placebo group was higher than 797 at 8%). That's quite a large difference. However, what do we make of the "mild prolongations of the QTc interval and sustained decreases in systolic and diastolic blood pressure"?

As pcrutch noted, ARRY further states in the PR that "no subject in either trial exhibited an absolute QTc interval >500 msec or a change from baseline >60 msec, two values cited by regulatory authorities, including the FDA, as thresholds of particular concern for cardiac arrhythmia." So, how does this compare to oxycodone and is the effect small enough to not be worrisome because it's within the given threshold? And with chronic treatment, would this interval stay the same or is it likely that the QTc interval gets worse as treatment time lengthens? I don't know the answer to these questions and would love to hear from the board. If these are issues, then I imagine the only likely path is in an acute setting, which is a much smaller market and one a big pharma presumably isn't interested in.

I've never really assigned any value to 797 and I'll continue to err on the conservative side and still not do so. Guess we'll have to see if they ink a deal. I still believe it's the MEKs and ARRY-614 that are the key potential value drivers for ARRY. As long as those programs continue to progress, I plan to continue to hold on to my shares.