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Celgene Corporation Message Board

  • rob_cos rob_cos Nov 30, 2012 3:40 PM Flag

    CELG Select Late-Stage Pipeline Milestones by Drug.

    Still more catalysts coming....CELG Select Late-Stage Pipeline Milestones by Drug....a must read....

    (Easier to read version of this on Investor Village CELG board with colors/bold )

    Revlimid Indication/Setting Comment Next Update
    MAA strategy update MM newly diagnosed/maintenance CELG will provide an update on its filing stategy for newly diagnosed and maintenance settings1Q13

    sNDA strategy update MM newly diagnosed/ maintenance Rev to treat newly diagnosed patients who have not progressed on melphalan, prior Rev or ASCT1Q2012

    Phase 3 MM-020 MM newly diagnosed Rev/dex (18 cycles or to progression) vs MPT (12 cycles); N=1623; ASH 2012

    Phase 2 SPRINT (MCL 002) NHL relapsed refractory MCL Rev v s inv stgr choice in relapse refractory ; N=152 (EU); ASH 2012

    Phase 2 EMERGE (MCL 001) NHL relapsed refractory MCL Rev in Velcade failures; single arm study ; N=133 (US); SPA; enrolling 1Q09 ASH 2012

    Phase 2/3 DLC-001 DLBCL - GCB Rev in GCB vs non-GCB patients ASH 2012

    Phase 1/2 CLL 009 CLL relapse refractory Rev multiple dose (3); N=120; enrolling since 3Q09 ASH 2012

    Phase 3 ORIGIN (CLL 008) CLL newly diagnosed elderly Rev vs chlorambucil; N=428; SPA; enrolling since 2Q09 1Q2013

    Phase 3 CONTINUUM (CLL 002) CLL relapse refractory B-cell Rev maint. After 2nd line; N=680; SPA; enrollment began 1/2009 YE2013

    Pomalidomide (CC-4047) Indication/Setting Comment Next Update

    NDA MM relapsed refractory ODAC panel meeting scheduled for Nov. 8, 2012 has been cancelled 10-Feb-13

    MAA MM relapsed refractory Filed in May 2011 1H13

    Phase 3 MM-003 MM relapsed refractory Pom 4mg daily single agent until progressive disease; N=85 ASH 2012

    Phase 3 NIMBUS relapsed or RRMM Low v s. High dose dexamethasone + Pom 4mg (21day s/28day cy cle); Rev failures + Vel failurs; N=426; began enrollingmid-2103

    Phase 3 RESUME meylofibrosis Pom 0.5mg v s Pbo; 1º=proportion of patients reaching RBC transfusion independence; N=210; fully enrolled 2014

    Vidaza Indication/Setting Comment Next Update

    Phase 3 AML AML elderly pts Vidaza v s iv stgr choice; N=480; 1º=OS; 2º=1-y r OS, PFS, duration of remission 1Q2013

    Oral Azacitidine Indication/Setting Comment Next Update

    Phase 2 CL 005 MDS Low/Intermediate-1 risk More details pending YE2012

    Abraxane Indication/Setting Comment Next Update

    Phase 3 pancreatic Abraxane + gemcitabine vs gemcitabine; 1º=OS; 2º=PFS; N=630; PhII showed 2x improvement in OS ASCO GI (jan-13)

    sBLA filing pancreatic Expect label to reflect front-line combination with gemcitabine 1Q13

    sBLA filing melanoma PFS = 4.8mths v s 2.5mths for DTIC. Interim for 2° OS shows trend 12.8mths v s 10.7mths 2013

    Apremilast oral PDE-4 inhibitor Indication/Setting Comment Next Update

    Phase 3 ESTEEM 1 psoriasis mod/severe Apremilast 30mg bid; includes biologic failures; N=825; began enrolling 2H10 YE12

    Phase 3 ESTEEM 2 psoriasis mod/severe Apremilast 30mg bid; includes biologic failures; N=405; To begin enrolling 2011 1Q13

    Phase 3 PALACE 4 psoriatic arthritis - DMARD naïve Apremilast: 20mg v s 30mg BID (no adjustment) DMARD naiv e; 1º=signs and sypmptoms at 24wks; N=496 1Q13 (MONOTHERAPY IN DMARD naive - Will confirm ACR 20 as good as biologics - being underestimated)

    NDA psoriatic arthritis Based on success of PALACE 1, 2 & 3 studies filing in US and Canada 1H13

    NDA psoriasis Anticipating successful completion of ESTEEM program 2H13

    MAA psoriatic arthritis/psoriasis European filing on basis of PALACE and ESTEEM programs YE13

    Phase 3 POSTURE Ankylosing Spondylitis Apremilast: 20mg or 30mg BID v s pbo; 1º=ASAS 20 at 16 and 24wks; N=456 1Q14

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