ARRY @ JMP (7/12/12)
1. ARRY-797 pain results will be out by mid-August.
2. ARRY has the potential to have 5 P3 trials under way by the end of 2013.
3. ARRY is "particularly excited" about ARRY-614 and believes it is a "potential blockbuster." 150,000 MDS patients total and 614 targets low-risk/intermediate-1 population, which is 100,000 patients. The only option for the bulk of HMA failures in this patient population is supportive care, which consists of EPO, growth factor, transfusions, and iron chelators. 614 is a potential billion dollar opportunity in MDS (slide 9).
4. ARRY will meet with the FDA on 614 by the end of the year and will discuss hematologic improvement as a potential endpoint for accelerated approval.
5. The improved formulation of 614, for which results should be available at ASH, is significantly more potent than the prior formulation and gets 3X the exposure.
6. Regarding ARRY-520 for MM, someone noted the prior failures of KSP inhibitors (e.g., CYTK) but management indicated that prior KSP inhibitors were not tested in MM. The rationale for a KSP inhibitor in MM is to inhibit the MCL-1 pathway, which MM depends on.
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