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Celgene Corporation Message Board

  • rob_cos rob_cos Dec 28, 2012 2:34 PM Flag

    CELG Select Late-Stage Pipeline Milestones by Drug....a must read....

    A MUCH easier to read color read version of this list is posted on the CELG investor village board post number 174033. Also go to the main list and click on my name and see multiple compelling CELG analyst reports
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    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
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    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
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    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
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    Oral Azacitidine Indication/Setting Comment Next Update

    Phase 2 CL 005 MDS Low/Intermediate-1 risk More details pending YE2012
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    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
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    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 naive; 1º=signs and symptoms at 24wks; N=496 1Q13

    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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    Abbreviations

    RR=relapsed ref ractory,

    MM=mult1ple myeloma,

    NHL=non-Hodgk1ns lymphoma,

    MCL=mantle cell lymphoma,

    DLBCL=d1f fuse large B-cell lymphoma,

    CLL= chronic lymphocytic leukemia,

    MDS=myelodysplastic syndrome,

    SCLC=small cell lung cancer,

    Pbo=placebo,

    SPA=special protocol assessment,

 
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