Biotech Values

[mcbio]

ARRY @ JPM (1/8/13)

1. ARRY's first official Phase 3 trial started today with NVS' opening of the Phase 3 trial for MEK162 against NRAS melanoma. ARRY expects the trial to complete in October 2014 and believes they could begin receiving revenues from the drug in 2015.

2. ARRY spoke with the FDA in December regarding path forward for ARRY-614 and came to agreement on measures of hematologic improvement (HI) as primary endpoint (slide 20). There was concern that OS might be only path forward. ARRY believes they can "hit" on HI based on the numbers from the prior formulation and is comfortable they have a path forward for 614. [Seems to be a pretty important point to me here as a primary endpoint of HI would seem to be a much lower bar than OS.]

3. In combo trial of ARRY-520 + carfilzomib, there was a CR in one of the first three patients. Carfilzomib itself only resulted in 1 CR in its entire registrational trial.