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Insmed Incorporated Message Board

  • terryjones694@rocketmail.com terryjones694 Jul 2, 2013 12:29 PM Flag

    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

    Investment recommendation
    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).
    Investment highlights
    • 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.

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INSM
13.73+0.23(+1.70%)Aug 19 4:00 PMEDT

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