Biotech Values

[mcbio]

ARRY - 3Q12 CC notes

1. Reference to hiring Holden to assist with formulating regulatory strategy around ARRY-614. ARRY later indicated that they expect to start a registration study for 614 in 2013.

2. ARRY expects to start Phase 1 trials for ARRY-981 (targets GPR119 in type 2 diabetes) in last quarter of this year (not sure if fiscal or calendar). ARRY expects to begin partnering discussions very soon and expects any deal to have "significant value." (ARRY pointed to the $60M up-front deal it inked with AMGN for ARRY-403 after that drug's Phase 1 results.)

3. Kevin Koch pointed to the pending Phase 2 selumetinib KRAS NSCLC data as the real value driver for ARRY. He noted that KRAS NSCLC has very poor prognosis and is in dire need of new medical treatments. Koch also said ARRY is "very pleased" with the data and looks forward to the disclosure at ASCO. (FWIW, and perhaps absolutely nothing, Koch seemed more anxious than normal during planned remarks.)

4. Koch confirmed that we will have top-line Phase 2 data for selumetinib against BRAF melanoma this quarter (I was unsure by the vague wording in the quarterly results PR.)

5. ARRY included a milestone from AZN for commencing Phase 3 trials with selumetinib in its milestone guidance. ARRY thinks a Phase 3 trial for selumetinib against KRAS NSCLC would at least replicate the Phase 2 trial design but could also be more expansive. ARRY expects a formal announcement from AZN on whether or not it will commence Phase 3 trials with selumetinib either at ASCO or during the summer.

6. ARRY is looking for a 25% response rate from 520+dex and PFS around the 4 month mark in the ongoing trials.