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NP1986

11/15/12 10:15 PM

#152505 RE: mcbio #152497

ARRY expects this to be another data point showing that selumetinib is active but seems to question if AZN will push forward in BRAF melanoma given that they are behind the competition here.



It makes sense given that AZN don't have a BRAF inhibitor (AFAIK), whereas GSK, Roche, and Novartis all have BRAF and MEK inhibitor combinations in the clinic.

I'm still hoping that AZN will commence a phase III trial in KRAS mutant NSCLC soon, as that would be a fairly substantial market. I haven't had a chance to listen to ARRY presentations lately - has there been any talk of the new formulation of selumetinib? I saw on clinicaltrials.gov that the pharmacokinetic study comparing it with the old formulation has been completed.

mcbio

11/27/12 7:01 PM

#153081 RE: mcbio #152497

ARRY @ Piper (11/27/12)

1. ARRY believes that by utilizing the biomarker and targeting MM patients with low levels of AAG (70-80% of MM patients have low to medium AAG per ARRY), they can attain a response rate for 520+dex in the "30s" (i.e. 30% or greater).

2. ARRY has seen a CR in the 520+carfilzomib combo at "relatively low doses." ARRY envisions a pivotal 520+carfilzomib trial as having 400-450 patients with PFS as primary endpoint and OS as a secondary endpoint.

3. With the recent financing, ARRY's existing cash takes them out nearly three years given anticipated net annual burn going forward of $55M (including anticipated milestones).

4. Deerfield debt due in 2015/2016 is $93M.