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Pharmacyclics Inc. Message Board

  • myownstimulusplan myownstimulusplan Apr 8, 2013 5:41 PM Flag

    upgrade credit suisse

    CP: US$ 75.55
    TP: US$ 90
    CAP: US$ 5.5b
    Third breakthrough designation for ibrutinib

    C/JNJ received a breakthrough therapeutics designation for ibrutinib as a monotherapy for the treatment of CLL/SLL
    patients with the 17p chromosome deletion, a high risk subset that responds well to ibrutinib. PCYC/JNJ is conducting a
    patient study in
    CLL patients with the 17p deletion (RESONATE). The designation provides a potential faster to market
    regulatory path. This is the third indication to receive this designation; the other two were Waldenstrom's macroglobulinemia
    (WM) and relapsed/refractory
    mantle cell lymphoma (MCL).

    Regulatory update expected at ASCO in June. We anticipate that PCYC will provide more specific guidance regarding
    timing of regulatory filings and clinical trial implications of the breakthrough designation at ASCO.

    MCL trial
    ongoing: The ongoing SPARK trial is in patients that have failed Velcade. We expect this will support a broader
    label including both Velcade failures and Velcade naïve patients based on the breakthrough designation.

    Catalysts: WM data at 2013 ASCO, potent
    ial 17p CLL data (RESONATE) and MCL data likely at 2013 ASH.

    Valuation. Our $90 target assumes a launch in MCL in Q3:14, off
    label use in CLL, and modest value for the Waldenstrom's
    opportunity. Our valuation could go higher if the fNHL opportunity is bet
    ter defined or if PCYC demonstrates efficacy in
    myeloma. Longer treatment duration or substantial penetration of prevalence markets could drive higher estimates

    Sentiment: Strong Buy

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