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                ADA 2008 Highlights
                           Investor Teleconference
                                J...
Comments will be about the Company’s future plans and
prospects that may be forward-looking statements under
the Private S...
Diabetes: A Growing, Global Problem
                  Type 2 Diabetes prevalence expected to grow
                  from 1...
Majority of Patients Are Not Optimally
Controlled
      Lack of involvement / motivation / compliance / knowledge leads to...
The Progressive Nature of Type 2 Diabetes
  Ultimately Overwhelms Medications
                          Glycemic Control i...
Pharmacologic Intervention in Diabetes
  Several different classes of oral antidiabetic agents are
  available

  Most age...
Site of Action of Oral Antidiabetic Agents
                                  Carbohydrate
                                ...
Unmet Medical Needs Still Remain

  Optimal glycemic control on treatment
  Sustainable A1c reduction/glycemic
  efficacy
...
ADA Highlights: Bristol-Myers Squibb

Key data presented for two-late stage pipeline
compounds in collaboration with Astra...
Saxagliptin Overview

   Highly potent and selective DPP-4 inhibitor

   Completed Phase 3 registrational program

   Well...
Patient Exposures Throughout
Saxagliptin Program
Phase 1 and 2
   ~110 subjects exposed to saxagliptin at 20-80x the
   5 ...
Previously Disclosed Saxagliptin Data
Pharmacokinetics and safety
   2.5 to 400 mg
   No identified clinically meaningful ...
Saxagliptin Add-On to Metformin:
 Significant HbA1c Reductions From Baseline
                                             ...
Saxagliptin Monotherapy Study Design:
  ADA 2008
       2 Week          24 Weeks                                          ...
Significant Reductions in HbA1c, FPG, PPG
 From Baseline at Week 24

                A1c                                 F...
Most Common (≥5%) Adverse Events
 Reported In The Main Cohort
                                                            ...
Saxagliptin: What’s Next?

  NDA submission by mid-year

  Additional Phase 3 data planned for disclosure
  at EASD in Sep...
Dapagliflozin Overview

  First in a new class that inhibits renal glucose
  reabsorption
  Stable C-glucoside molecule th...
Effects of SGLT2 Inhibition on Renal
Glucose Reabsorption
                 Intestine                                      ...
ADA 2008: Dapagliflozin
At the ADA, data on dapagliflozin was presented from the
largest and longest (12 weeks) trial of a...
Dapagliflozin Registrational Program

 Patient Population             Treatment Types
 Treatment-Naïve      Monotherapy vs...
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                ADA 2008 Highlights
                           Investor Teleconference
                                J...
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bristol myerd squibb American Diabetes Association (ADA) Highlights

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bristol myerd squibb American Diabetes Association (ADA) Highlights

  1. 1. * ADA 2008 Highlights Investor Teleconference June 11, 2008 Fred Fiedorek, MD Vice President, Global Clinical Research Roland Chen, MD Group Director, Global Clinical Research *American Diabetes Association June 6 – June 10, 2008 Not For Promotional Use 1
  2. 2. Comments will be about the Company’s future plans and prospects that may be forward-looking statements under the Private Securities Litigation Reform Act of 1995. We caution that 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 web site or from Bristol-Myers Squibb Investor Relations. 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. Not For Promotional Use 2
  3. 3. Diabetes: A Growing, Global Problem Type 2 Diabetes prevalence expected to grow from 190 million to 330 million by 2030 50-70% of patients are not controlled Europe prevalence is Diabetes growing rapidly lower (~4.6%), but in U.S. – current increasing, especially in prevalence rate 6.7% the southern countries Mexico – highest India and China will make up prevalence rates in nearly 50% of the total the world: 12.4% number of patients with diabetes in 2030 Not For Promotional Use Source: WHO NOT FOR PROMOTIONAL USE 3 3
  4. 4. Majority of Patients Are Not Optimally Controlled Lack of involvement / motivation / compliance / knowledge leads to progression of disease, with nearly 2/3 of patients not controlled Percentage of patients not controlled, by market (relative to HbA1c target of 7.0%) 100 60% of 80 US diabetic 69 64 patients 62 Patients (%) 58 57 60 do not know 51 their A1c or 40 FPG values 20 0 UK FR GER ITL SPN US Source: Adelphi, 2006 Disease Specific Not For Promotional Use Programmes, NHWS 2006 4
  5. 5. The Progressive Nature of Type 2 Diabetes Ultimately Overwhelms Medications Glycemic Control in an Illustrative Patient Potential = Slope 5 treatment p er 0.75% change yrs. First 5yr s Agent Goal* HbA1c A1c=<7 Goal** A1c=<6.5 Normal*** A1c=5% ~30 Years Sources: ADOPT, UKPDS (*) According to the ADA; (**) according to the AACE/ACE; (***) according to the NIH Not For Promotional Use 5
  6. 6. Pharmacologic Intervention in Diabetes Several different classes of oral antidiabetic agents are available Most agents fail after 3-5 years; the current paradigm is one of adding a new treatment to an existing regimen Some patients do not even reach the 3-5 year time to fail point because of adverse events or poor tolerance The market is and continues to be an add-on market New classes have an important place in overall management There remains a need for new therapies Not For Promotional Use 6
  7. 7. Site of Action of Oral Antidiabetic Agents Carbohydrate Skeletal Load Muscle Pancreas Reduced glucose uptake Impaired Insulin Secretion and utilization Sulfonylureas Metformin Hyperglycemia DPP-4 inhibitors Thiazolidinediones Increased glucose Glucose production reabsorption Kidney Liver Metformin Thiazolidinediones SGLT2 inhibitors DPP-4 inhibitors Not For Promotional Use 7
  8. 8. Unmet Medical Needs Still Remain Optimal glycemic control on treatment Sustainable A1c reduction/glycemic efficacy Concurrent weight management Delaying or halting disease progression Improving patient compliance Finding additional therapies that are efficacious, well tolerated and safe Not For Promotional Use 8
  9. 9. ADA Highlights: Bristol-Myers Squibb Key data presented for two-late stage pipeline compounds in collaboration with AstraZeneca: Saxagliptin Phase 3 monotherapy study: Produced significant reductions in HbA1c, FPG, PPG Dapagliflozin Phase 2B study: Reductions in all measures of glycemic control with addition of weight loss Not For Promotional Use 9
  10. 10. Saxagliptin Overview Highly potent and selective DPP-4 inhibitor Completed Phase 3 registrational program Well tolerated Produced significant reductions in all key measures of glucose control On track for mid-year submission Not For Promotional Use 10
  11. 11. Patient Exposures Throughout Saxagliptin Program Phase 1 and 2 ~110 subjects exposed to saxagliptin at 20-80x the 5 mg dose for up to 6 weeks ~670 subjects exposed to saxagliptin at 2-10x the 5 mg dose for up to 12 weeks Phase 3 ~1000 patients treated at 10 mg dose for up to 2 years >3000 patients treated at any dose in Phase 3 Clinical correlates to the skin lesions in monkeys have not been identified in human clinical trials of saxagliptin Not For Promotional Use 11
  12. 12. Previously Disclosed Saxagliptin Data Pharmacokinetics and safety 2.5 to 400 mg No identified clinically meaningful drug interactions No dose adjustment required with hepatic impairment May be administered without regard to age or gender Phase 2 data recently published Diabetes Obesity Metabolism 2008; 10: 376-386 Phase 3 add-on to metformin study presented at ADA 2007 Not For Promotional Use 12
  13. 13. Saxagliptin Add-On to Metformin: Significant HbA1c Reductions From Baseline Adjusted Change From Baseline Difference in Adjusted Change From Baseline vs Placebo + MET 0.4 0.2 0 -0.2 -0.83 -0.72 -0.73 % -0.4 -0.6 -0.8 * * * -1 PBO + MET SAXA 2.5 mg SAXA 5 mg SAXA 10 mg (N = 175) + MET + MET + MET (N = 186) (N = 186) (N = 180) Bars indicate 95% two-sided confidence interval. *P values vs placebo + MET: P<0.0001. Not For Promotional Use Phase 3 Study -014, ADA June 2007 13
  14. 14. Saxagliptin Monotherapy Study Design: ADA 2008 2 Week 24 Weeks 42 Months PBO Metformin 500 mg QD* (PBO if enter LT via rescue) PBO* Lead In Superiority N = 401 2.5 mg Saxa QD* 2.5 mg Saxa QD* Treatment- Naïve T2DM Superiority A1c 5 mg Saxa QD* 5 mg Saxa QD* 7.0-10.0% to Enroll Superiority 10 mg Saxa QD* 10 mg Saxa QD* N = 66 Treatment- Naïve T2DM 10 mg Saxa QD* 10 mg Saxa QD* A1c 10.0-12.0% *If rescue criteria met in ST, add Metformin 500-2000 mg total daily dose, enter LT phase; Metformin rescue also available in LT extension (42 weeks) Not For Promotional Use Phase 3 Study -011, ADA June 2008 14
  15. 15. Significant Reductions in HbA1c, FPG, PPG From Baseline at Week 24 A1c Fasting Plasma Glucose Postprandial Glucose 2000 0.6 20.0 (%) (mg/dL) (mg min/dL) 15.0 0.4 0 0.19 10.0 -646.6 0.2 6.06 -2000 5.0 0.0 -4000 0.0 -0.2 -5.0 -6000 -0.4 -10.0 -6896 -8.67 -6868 -0.43 -0.46 -8000 -0.6 -0.54 -8084 -15.0 -14.53 -16.75 -10000 -0.8 -20.0 -1.0 -25.0 -12000 Saxagliptin + Met 2.5 mg 5 mg 10 mg PBO + Met Not For Promotional Use Phase 3 Study -011, ADA June 2008 15
  16. 16. Most Common (≥5%) Adverse Events Reported In The Main Cohort Saxagliptin Open-Label PBO Saxagliptin Cohort Main Cohort Main Cohort N=66 N=95 N=306 Total patients with AEs (%) 68 (71.6) 231 (75.5) 40 (60.6) Upper respiratory tract 11 (11.6) 27 (8.8) 6 (9.1) infection Headache 7 (7.4) 25 (8.2) 5 (7.6) Urinary tract infection 4 (4.2) 21 (6.9) 3 (4.5) Nasopharyngitis 6 (6.3) 18 (5.9) 3 (4.5) Sinusitis 3 (3.2) 17 (5.6) 1 (1.5) Not For Promotional Use Phase 3 Study -011, ADA June 2008 16
  17. 17. Saxagliptin: What’s Next? NDA submission by mid-year Additional Phase 3 data planned for disclosure at EASD in September – Combination studies with SU, TZD – Initial combination therapy with metformin Life cycle program underway Not For Promotional Use 17
  18. 18. Dapagliflozin Overview First in a new class that inhibits renal glucose reabsorption Stable C-glucoside molecule that allows once-daily dosing In Phase 3 development – Monotherapy – Combination Not For Promotional Use 18
  19. 19. Effects of SGLT2 Inhibition on Renal Glucose Reabsorption Intestine Kidney SGLT1 Plasma Urine Diet Glucose Glucose Glucose Glucose Glucose SGLT1 SGLT2 Dapagliflozin Potential benefits of selective SGLT2 inhibition: Insulin-independent glucose lowering Loss of calories in urine, with potential for weight control Not For Promotional Use 19
  20. 20. ADA 2008: Dapagliflozin At the ADA, data on dapagliflozin was presented from the largest and longest (12 weeks) trial of an SGLT2 Renal Glucose Reabsorption Inhibitor to date. Results demonstrated that dapagliflozin: Induced controlled glucosuria Improved glycemic control - Reduced fasting glucose - Reduced postprandial glucose - Reduced HbA1c Lowered weight Showed little propensity to cause hypoglycemia Demonstrated no clear adverse safety or tolerability signals over 12 weeks Not For Promotional Use 20
  21. 21. Dapagliflozin Registrational Program Patient Population Treatment Types Treatment-Naïve Monotherapy vs. Initial combination placebo with metformin Treatment- Add-on Therapy Experienced (previous treatment Versus placebo: Active control: failure) • Metformin • Sulfonylurea Sulfonylurea Others under • • consideration TZD • Insulin • Not For Promotional Use 21
  22. 22. * ADA 2008 Highlights Investor Teleconference June 11, 2008 Fred Fiedorek, MD Vice President, Global Clinical Research Roland Chen, MD Group Director, Global Clinical Research *American Diabetes Association June 6 – June 10, 2008 Not For Promotional Use 22

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