INSM UPGRADE-Canaccord July 1 upgrade after phase 3 on INSM below, all other analysts reiterated or upgraded I believe
Ritu Baral of Canaccord Life Sciences -- Biotechnology (viewable from Canaccord or first call, etc...
ARIKACE ACTIVE, APPROVABLE IN CF:
WE VIEW NTM AS MAIN DRIVER AND
SELL-OFF AS OVERDONE
Reiterate BUY, raising our pNPV-based target to $18 from $17 on Arikace
potential in CF P. aeruginosa and nontuberculous mycobacteria (NTM) lung
infections. Arikace is a liposomal formulation of potent, FDA-approved
antibiotic amikacin. We are encouraged by EU Ph3 CF trial and looking
forward to US NTM Ph2 trial data (Q1/14).
• Incremental positive for main value driver NTM: top-line Ph2 now likely
Q1/14. We see Arikace’s activity in Ph3 CF as supportive of good drug
localization to deep lung. In vitro data also suggests better potency of
amikacin against NTM vs. tobra.
• We see Arikace as eminently approvable with good safety. While there
are optical imbalances in Arikace’s severe adverse events, INSM indicated
there is no kidney or ototox signal, our main concern. We look forward to
reviewing more details at medical meetings/in publication later this year.
• Once-daily delivery, “off-month” Tx may be underappreciated commercial
opportunities for Arikace in EU. Continuous Tx for CF pseudomonas is
pretty much SOC in EU, and given there is no evidence of amikacin/tobra
cross-resistance, Tobi/Arikace alternation Tx may have significant
commercial potential. Further, experts on INSM’s call today reiterated
what ATS experts told us: that qd delivery in CF is vastly underrated.
• QIDP, Fast Track for NTM in US; between that and orphan, we think FDA
will be more adaptive in Arikace for NTM review. QIDP already confers
priority review, as well as the ability to have very regular, less structured
talks with FDA around NTM.