ARRY - 4Q12/FY12 CC notes
1. Squarer called the prior Phase 1 results for the old formulation of ARRY-614 for MDS "striking" given nearly 40% response rate at highest dose, poor prognosis for targeted patient population, and lack of treatment options following HMA failure.
2. Regarding ARRY-797:
A. There is a huge market for new drugs to treat both acute and chronic pain and there have been no approved novel agents for a very long time. There is a sense of urgency for new pain treatments.
B. At ~24:30 mark of CC, Squarer claims ARRY has "already received significant interest" in a potential 797 partnership.
C. Koch claims the sustained decrease in blood pressure with 797 treatment may actually be beneficial to the drug's profile. In pre-clinical animal models, ARRY has increased OS in CHF animal models with 797.
D. Koch believes QTc interval is in an acceptable range. Given that the focus is on patients who are resistant to NSAIDs (and may not tolerate opioids), there is a different safety bar where QTc prolongation may be more acceptable than otherwise.
E. ARRY has seen efficacy at a 200mg BID dose for 797 so they implied they could go lower if needed, but it wasn't clear that ARRY thought they had to go lower with 797.
F. ARRY doesn't know that they need to conduct an additional QTc study to partner 797.
3. For ARRY-520, ARRY expects a P3 trial would compare 520+carfilzomib to carfilzomib alone and ARRY would hope to show a 50% improvement over carfilzomib alone. (Not sure what "improvement" was in regards to but otherwise sounds like a very high bar for 520.)
4. ARRY expects AZN to report P2 selumetinib+DTIC data in BRAF melanoma patients at an upcoming scientific meeting.
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