Recent Advances In The Development Of Innovative Therapies The Celgene Pipeline

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  • Slide 70 and 71 from Board Presentation
  • Recent Advances In The Development Of Innovative Therapies The Celgene Pipeline

    1. 1. Recent Advances In The Development Of Innovative Therapies. The Celgene Pipeline Jean Caraux, MD PhD BTG, Hong Kong - February 23th 2013
    2. 2. 2 Targeting Unmet Medical Needs Hematologic Malignancies • Myeloma • CLL • NHL • MDS • AML • MF B-Cell Malignancies T-Cell Malignancies MDS and Myeloproliferative disorders REVLIMID POMALYST ISTODAX REVLIMID VIDAZA POMALYST • CTCL • PTCL
    3. 3. 3 Targeting Unmet Medical Needs Solid tumors • Metastatic Breast Cancer • NSCLC High Medical Need Malignancies • Pancreatic Cancer • Melanoma Abraxane
    4. 4. 4 Major Recent Accomplishments Multiple Myeloma • Lenalidomide (REVLIMID ®) • Approved in China for RRMM, • Reimbursed in Taiwan • Pomalidomide (POMALYST®) • Achieved an overall survival benefit in a Ph III trial for RRMM after failure of prior options • Approved in the US • Access for Asian patients being set up
    5. 5. 55 Pomalidomide-dex vs dex (phase III) Improved Overall Survival n= 455 HR=0.53
    6. 6. 6 •Global phase III trial fully accrued; Data expected H1:13 •Combination of pomalidomide and prednisone is active in myelofibrosis •62% of patients achieved transfusion independence Pomalidomide : Myelofibrosis
    7. 7. 7 Major Recent Accomplishments Lymphomas • MCL : Lenalidomide filed for approval in US • FL : R2 highly active in first-line, phase III ongoing • DLBCL : R2-CHOP21 is active and well tolerated. MDS and AML • CC-486 (oral aza) : Initiated Ph III program, Chronic hypomethylation
    8. 8. 8 Major Recent Accomplishments Nab-paclitaxel (ABRAXANE®) • NSCLC : approved (US) • Pancreatic Cancer : Demonstrated an overall survival benefit in Ph III trial • Melanoma : Achieved the primary endpoint of PFS with OS trend in Ph III trial
    9. 9. 9 Metastatic Melanoma : Abraxane Improved PFS in phase III vs dacarbazine • 529 pts • nab-Paclitaxel superior to standard DTIC chemotherapy • PFS (primary endpoint) : – significantly improved vs dacarbazine – 4.8 vs 2.5 months (P = 0.044) • OS : – Interim OS analysis : trend in favor of the nab- paclitaxel arm – Observed early and maintained throughout the study
    10. 10. 10 Pancreatic : Abraxane + Gemcitabine Improved Overall Survival in phase III Variable ABI- 007/Gemcitabine (N=431) Gemcitabine (N=430) Hazard Ratio HR A+G/Ga P-value b Deaths 333 (77%) 359 (83%) Censored 98 (23%) 71 (17%) Median (months) 8.5 6.7 0.72 0.0000152 95% Confidence Interval 7.89 - 9.53 6.01 - 7.23 0.617 – 0.835 Survival Rate (%) at 6 month 67% 55% 9 month 48% 36% 12 month 35% 22% 18 month 16% 9% 24 month 9% 4% a95% CI from stratified Cox model bStratified log-rank using IVRS strata of region, KPS, and presence of liver mets Confidential – for internal use only
    11. 11. 11 Near-term Milestones Apremilast Advantages  Targets high unmet need  Clinical activity in several inflammatory diseases  Safe and well tolerated  Convenient – oral Psoriatic Arthritis Large Underserved Patient Populations ~ 6M patients in US / EU only • Ph III ESTEEM data in psoriasis expected in Q1 • Ph III PALACE-4 data in treatment- naïve PsA expected in Q1 • Submit NDA for PsA in H1 ~1M ~2.5M~2.5M Ankylosing Spondylitis Psoriasis (moderate to severe) PsA Apremilast Adressing Frequent Unmet Needs
    12. 12. 12 CC-292 (Avila) Potential of BTK Inhibition Osteoclasts RA, IBD Leukemia, Lymphoma SLE, ITP Vasculitides Allergy, MS Asthma, RARA, Multiple Myeloma, Osteolytic Bone Disease Monocytes B Cells Mast Cells
    13. 13. 13 Focused Research and Early-Stage Development Highlights Leverage Strategic Collaborations & Disruptive Technologies • Advanced 7 programs into Ph I over last 2 yrs • Expanded biologics program • Enhanced platforms to accelerate discovery ARRY-111 ARRY-382 ACE-011 ACE-536 Cancer Metabolism Cancer Stem Cell Targets Genetic Lesion DOT1L + HMTs Novel Antibody Targets Ca ImmunoRx Target Exploit Our Unique Advantages • IMiD technology platform • Epigenetics • Kinase inh. (TORKi, DNAPKi) • Tumor progenitors • Avilomics – protein silencing Antibody Conjugates
    14. 14. Thank you February 3013

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