bristol myerd squibb Cowen and Company Health Care Conference

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    bristol myerd squibb Cowen and Company Health Care Conference - Presentation Transcript

    1. Research & Development Update Cowen Healthcare Conference March 17, 2008 Brian Daniels, MD Senior Vice President, Global Development This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 1
    2. During this meeting, we will make statements about the Company’s future plans and prospects, including statements about our financial position, business strategy, research pipeline concerning product development and product potential, that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward- looking statements as a result of various important factors, including those discussed in the company’s most recent annual report on Form 10-K, periodic reports on Form 10-Q and current reports on Form 8-K. These documents are available from the SEC, the Bristol-Myers Squibb website or from Bristol-Myers Squibb Investor Relations. In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our estimates change. This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 2
    3. Track Record of Success: Nine New Drug Approvals in Less Than Five Years Cancer HIV / AIDS Depression Cancer Cancer Schizophrenia, Depression Rheumatoid Arthritis HIV / AIDS Hepatitis B 2007 2003 2004 2005 2006 Somerset Otsuka America ImClone Systems PHARMACEUTICALS INC. Incorporated Pharmaceutical, Inc. This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 3
    4. Next Generation BioPharma Model Best of Pharma Best of Biotech Next Generation BioPharma Selectively Innovative Continuous Integrated Portfolio Improvement Business Model Agile, Entrepreneurial and Accountable Culture This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 4
    5. BMS Disease Areas and Unmet Medical Need Therapeutic Area Disease Area Unmet Medical Need Athero/Thrombosis • Improved therapeutic window Cardio- vascular • Prevention of complications Diabetes and • Slowing or halting of disease progression Metabolics Obesity • Increased efficacy and high degree of safety HIV • Overcoming resistance Virology • Targeted antivirals that improve cure rates Hepatitis • Overcoming resistance • Increasing survival • Less toxicity Oncology Oncology • Improved quality of life • Personalized therapy • Onset of action • Improved efficacy and tolerability Psychiatric Disorders • Enhanced compliance Neuroscience • Delay disease onset • Disease modification Alzheimer’s • Better symptom relief • Oral agents • Disease modification RA and Related Diseases • Improved tolerability and safety Immunology Solid Organ Transplant • Increased long-term efficacy with improved safety This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 5
    6. Development Portfolio Life Cycle Full Development Exploratory Development Management (Registrational, Filed) • Androgen Receptor Antagonists (Cancer) • Ixempra (Ixabepilone) • Sprycel (Cancer) • IGF-1R Antagonist (Cancer) (Cancer) • VEGF R-2 Inhibitor (Cancer) • Erbitux (Cancer) • Brivanib-VEGFR/FGFR Inhibitor (Cancer) • Ipilimumab • ErbB/VEGF Receptor Inhibitor (Cancer) • Orencia (Cancer) • Anti-CD137 Antibody (Cancer) (Rheumatoid Arthritis) • Epothilone-Folate (Cancer) • Belatacept • Met Kinase Inhibitor (Cancer) • Plavix • SMO Inhibitor (Cancer) (Solid Organ Transplant) (Atherothrombosis) • Hsp90 Inhibitor (Cancer) • p38 Kinase Inhibitors (Rheumatoid Arthritis) • Saxagliptin • Avapro / Avalide • CCR2/CCR5 Dual Antagonist (Immunology) (Diabetes) (Hypertension) • CCR2 Antagonist (CV / Met) • 11βHSD Inhibitor (Diabetes) • Abilify • Dapagliflozin • DPP4 Inhibitor Backup (Diabetes) (Psychiatric Disorders) (Diabetes) • CB1 Antagonist (Obesity) • DGAT Inhibitors (CV / Met) • Baraclude • Apixaban • LXR Agonist (Atherosclerosis) (Hepatitis B) • CRF Antagonists (Affective Disorders) (Thrombosis) • Triple Reuptake Inhibitor (Depression) • Reyataz (HIV/AIDS) • Gamma Secretase Inhibitor (Alzheimer’s) • HCV Inhibitor Target 1 (Hepatitis C) • Sustiva / ATRIPLA • HCV Inhibitor Target 2 (Hepatitis C) (HIV/AIDS) • HCV Inhibitor Target 3 (Hepatitis C) • HIV Attachment Inhibitor (HIV/AIDS) • HIV Integrase Inhibitor (HIV/AIDS) As of December 2007 This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 6
    7. Building Pipelines Within Products: Full Development Program Target Profiles Ipilimumab Belatacept Novel co-stimulation blocker Establishing a new developed to replace immunotherapy paradigm cornerstone therapy in solid for the treatment of cancer A new cytotoxic designed to organ transplantation overcome resistance Dapagliflozin Apixaban Saxagliptin Providing a new insulin- Predictable and reliable Bringing a new choice independent mechanism for anticoagulant with a wider to the management of diabetes improved outcomes in therapeutic window than – driven by the partnership of overweight and obese diabetes current standard of care – Bristol-Myers Squibb patients – driven by the driven by the partnership of and AstraZeneca partnership of Bristol-Myers Bristol-Myers Squibb and Squibb and AstraZeneca Pfizer This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 7
    8. Current Therapies for Kidney Transplant Significant gains in one-year graft survival rates with current therapy Less progress on five-year patient and graft survival – 34% graft loss for deceased donors – 21% graft loss for living related donors Calcineurin inhibitors (CNIs) are associated with long-term complications – Increased risk of chronic allograft nephropathy leading to graft loss – Increased risk factors for cardiovascular disease – Increased risk of diabetes This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 8
    9. Belatacept Showed Comparable Efficacy and Improved Safety Over Cyclosporine at 1 Year Immunosuppressive Efficacy Low rates of acute rejection, comparable across arms Comparable patient and graft survival Safety Profile Low rates of serious infections and malignancies, comparable across arms Addressing Key Areas of Unmet Need Protection of renal function Lower rates of chronic allograft nephropathy Favorable trends in CV and metabolic parameters Phase II Study IM103-100, 12 month results, NEJM, 353:770, August 25, 2005 IM103- IM103-100, This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 9
    10. Belatacept Showed Stable Kidney Function Over Four Years Belatacept (N = 102) Calculated GFR (Glomerular Filtration Rate) Cyclosporine (N = 26) 90 (ml/min/1.73m2) 80 70 60 12 18 24 30 36 42 48 Months After Transplant Oral Presentations: 2007 ATC, San Francisco; 2007 ESOT, Prague This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 10
    11. Belatacept: Initial Registrational Program in Renal Transplant Study Study Design Endpoints N Broad-criteria belatacept vs. • Death/Graft Loss 660 donor cyclosporine • Renal function (GFR) • Acute rejection Extended- belatacept vs. 540 • Chronic allograft criteria donor cyclosporine nephropathy Planning for BLA submission in 1H 09 This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 11
    12. Building Pipelines Within Products: Full Development Program Target Profiles Ipilimumab Belatacept Novel co-stimulation blocker Establishing a new developed to replace immunotherapy paradigm cornerstone therapy in solid for the treatment of cancer A new cytotoxic designed to organ transplantation overcome resistance Dapagliflozin Apixaban Saxagliptin Providing a new insulin- Predictable and reliable Bringing a new choice independent mechanism for anticoagulant with a wider to the management of diabetes improved outcomes in therapeutic window than – driven by the partnership of overweight and obese diabetes current standard of care – Bristol-Myers Squibb patients – driven by the driven by the partnership of and AstraZeneca partnership of Bristol-Myers Bristol-Myers Squibb and Squibb and AstraZeneca Pfizer This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 12
    13. Saxagliptin: DPP4 Inhibition – An Emerging Mechanism for Diabetes Treatment Once a day, oral route of administration Weight neutral and low incidence of hypoglycemia In clinical trials, safety profile comparable to placebo Prolonged glycemic control at low dose due to: – Highly potent inhibition of DPP4 – Sustained binding to DPP4 active site Fixed-dose combinations facilitated by: – Unique formulation – Efficacy at low dose This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 13
    14. Saxagliptin + Metformin Show Improved HbA1c Reductions at Week 24 Adjusted Change From Baseline Difference in Adjusted Change from Baseline vs Placebo + Metformin 0.4 0.2 % Change in HbA1c 0 -0.2 -0.83 -0.72 -0.73 -0.4 -0.6 * -0.8 * * -1 SAXA 10mg SAXA 5mg SAXA 2.5mg PBO + MET + MET + MET + MET (N = 180) (N = 186) (N = 186) (N = 175) * p<0.0001 Bars indicate 95% two-sided confidence interval two- Phase III Study -014, ADA, June 2007 This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 14
    15. Saxagliptin Registrational Program NDA submission targeted for mid-2008 Target indications – Monotherapy – Add-on combination therapy (metformin, TZD, sulfonylurea) – Initial combination therapy with metformin Phase III data presentations – ADA, June 2008 – EASD, Sept 2008 This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 15
    16. Building Pipelines Within Products: Full Development Program Target Profiles Ipilimumab Belatacept Novel co-stimulation blocker Establishing a new developed to replace immunotherapy paradigm cornerstone therapy in solid for the treatment of cancer A new cytotoxic designed to organ transplantation overcome resistance Dapagliflozin Apixaban Saxagliptin Providing a new insulin- Predictable and reliable Bringing a new choice independent mechanism for anticoagulant with a wider to the management of diabetes improved outcomes in therapeutic window than – driven by the partnership of overweight and obese diabetes current standard of care – Bristol-Myers Squibb patients – driven by the driven by the partnership of and AstraZeneca partnership of Bristol-Myers Bristol-Myers Squibb and Squibb and AstraZeneca Pfizer This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 16
    17. Dapagliflozin: Unique Insulin Independent Mechanism of Action Indirect Glucose Management Direct Glucose Management Insulin Action Insulin-independent • Kidney • Muscle TZDs • Fat cells glucose reabsorption Metformin • Liver inhibition SGLT2 Insulin Release 1. Complementary to any other Sulfonylureas mechanisms to treat diabetes • ß-cells GLP-1 analogues • Pancreas DPP4 inhibitors 2. Directly reduces hyperglycemia 3. Promotes calorie loss through glucosuria Enhanced glucose utilization, Glucose elimination / caloric loss Increased storage This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 17
    18. Dapagliflozin Demonstrated Efficacy in Reducing Fasting Serum Glucose 15 Change in Serum Glucose (mg/dl) Day 2 10 Day 13 5 1.3 3.1 0 from Day -2 (%) -6.3 -5 -9.3 -9.8 -10 -14.5 -15 -17.3 † -20 -21.9 -25 -30 * † * -35 Placebo 5 mg 25 mg 100 mg N = 47 Dapagliflozin dose * p<0.05 † p<0.001 Phase IIa study, ADA, June 2007 This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 18
    19. Dapagliflozin: Increased Urinary Glucose Excretion Leading to Increased Calorie Loss 120 Day -1 Day 14 urinary glucose (g/day) Mean (SD) Cumulative 100 80 68g/ 60 66g/ day day 40 35g/ 20 day 4g/ 2g/ 2g/ 2g/ 1 g/ day day day day day 0 Placebo 5 mg 25 mg 100 mg Dapagliflozin dose Phase IIa study, ADA, June 2007 This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 19
    20. Dapagliflozin Registrational Program Patient Population Treatment Types Treatment Naïve Monotherapy vs. Initial combination placebo with metformin Treatment Add-on Therapy Experienced (previous failure) Versus placebo: Active control: • metformin • sulfonylurea • sulfonylurea • others under consideration • TZD • insulin This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 20
    21. Building Pipelines Within Products: Full Development Program Target Profiles Ipilimumab Belatacept Novel co-stimulation blocker Establishing a new developed to replace immunotherapy paradigm cornerstone therapy in solid for the treatment of cancer A new cytotoxic designed to organ transplantation overcome resistance Dapagliflozin Apixaban Saxagliptin Providing a new insulin- Predictable and reliable Bringing a new choice independent mechanism for anticoagulant with a wider to the management of diabetes improved outcomes in therapeutic window than – driven by the partnership of overweight and obese diabetes current standard of care – Bristol-Myers Squibb patients – driven by the driven by the partnership of and AstraZeneca partnership of Bristol-Myers Bristol-Myers Squibb and Squibb and AstraZeneca Pfizer This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 21
    22. Properties of an Ideal Anticoagulant Apixaban target profile Properties Benefits Orally active Ease of administration Obviates need for overlap with Rapid onset of action a parenteral anticoagulant No significant food or drug Simplified dosing interactions No routine coagulation Predictable anticoagulant effect monitoring Safe in patients with renal Renal and extra-renal clearance insufficiency Simplifies management in case Rapid offset of action of bleed or need for intervention Treatment benefit outweighs Optimal benefit/risk profile risk This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 22
    23. Apixaban Demonstrated Greater Efficacy in Preventing VTE / Death Than Standard of Care (Phase II Study) 40 Venous 35 Thromboembolism (VTE) / Total Bleeding Death 30 % of Patients 25 20 15 10 5 0 Enox Warf Enox Warf QD BID QD BID QD BID QD BID QD BID QD BID Daily Dose: 5 10 20 5 10 20 (mg) Apixaban Apixaban BID dosing consistently produced lower rates of VTE/death compared with QD dosing with comparable bleeding rates Phase II VTE Prevention Study: APROPOS (CV185010), ASH December 2006 This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 23
    24. Apixaban Clinical Development: Pursuing Multiple Indications Simultaneously Indication Phase Trial N VTE prevention (knee replacement) III ADVANCE-1 3,000 VTE prevention (knee replacement) III ADVANCE-2 3,000 VTE prevention (hip replacement) III ADVANCE-3 4,000 VTE prevention (medical) III ADOPT 6,500 Stroke prevention in AF (vs. warfarin) III ARISTOTLE 15,000 Stroke prevention in AF (vs. aspirin) III AVERROES 5,600 VTE treatment III To start 2Q 08 Acute Coronary Syndrome II APPRAISE-1 1,700 VTE prevention in cancer II Pilot Trial 160 VTE – venous thromboembolism This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 24
    25. 2008 Key Data Flow Lupus: ACR, Oct 2008 Orencia Early RA: ACR, Oct 2008 RA Prevention: EULAR, June 2008 Sprycel Prostate cancer: ASCO, June 2008 Erbitux Lung cancer: ASCO, June 2008 ACTIVE-A data available: 2H 2008 Plavix CURRENT data available: 2H 2008 MBC -046 survival data: ASCO Breast, Sept 2008 Ixempra MBC -048 survival data: SABCS, Dec 2008 Ipilimumab Metastatic melanoma: ASCO, June 2008 Belatacept Ph III data available: 4Q 2008 Ph III data: ADA, June 2008 Saxagliptin Ph III data: EASD, Sept 2008 Dapagliflozin Ph IIb data: ADA, June 2008 Ph II ACS data: ESC, Aug/Sept 2008 Apixaban Ph III VTE prevention data: ASH, Dec 2008 This presentation is intended solely for an investment community/industry audience-not for promotional use community/industry audience- 25

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