Sanofi Sa · EURONEXT:SAN
Sanofi Sa — Technical Presentation (March 2014)
28 slides from Sanofi Sa's technical presentation, Mar 31, 2014
Slide 1: IR Thematic Call on Alirocumab
IR Thematic Call on Alirocumab March 31st, 2014
Slide 2: Sanofi Forward Looking Statements
Sanofi Forward Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and thei
Slide 3: Regeneron Forward Looking Statements
Regeneron Forward Looking Statements This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially f
Slide 4: Agenda
Agenda PCSK9 Inhibitor Potential Market Opportunity ● Robert Terifay, Senior VP, Commercial, Regeneron Alirocumab Clinical Development ● Jay Edelberg, M.D., Ph.D. VP, Head of the PCSK9 Development & Launch Unit, Sanofi Q&A Session ● Robert Terifay, Jay Edelberg and Bill Sasiela, VP, Program Directio
Slide 5: PCSK9 Inhibitor Potential Market Opportunity
PCSK9 INHIBITOR POTENTIAL MARKET OPPORTUNITY Robert Terifay Senior Vice President, Commercial Regeneron 5
Slide 6: Despite Current Therapies, a Significant Population at High Cardiovascular Risk
Despite Current Therapies, There Exists a Significant Population of Patients at High Cardiovascular Risk Patient Flow 62.1 Projections for 2016 (Million Patients) US & EU5(1) 57% 30.2 (US) 35.7 Diabetics 0/1 Risk Factor 11.0 21.6 Diabetes + 2 Risk Factors with or w/o CV 11.1 Diabetes + 2 Risk Factor
Slide 7: Diabetics Represent a Significant Portion of High-Risk Population
Diabetics Represent a Significant Portion of The Population Who Are at High Risk ~22M Diabetes Patients With LDL-C >70 mg/dL on Statins Projections for 2016 (Million Patients) US & EU5(1) Illustrative Example Very ● 52 year-old male High CV Diabetes Risk ● Diagnosis: Primary Hypercholesterolemia + 2
Slide 8: Secondary Prevention Patients Are at Higher Risk of Cardiovascular Events
Secondary Prevention Patients Are at Higher Risk of Cardiovascular Events 7.6M Secondary Prevention Patients w/o Diabetes And Not at Goal on Statins Projections for 2016 (Million Patients) US & EU5(1) Illustrative Example History History ● 58 year-old male of ACS of CHD ● Diagnosis: Primary Hypercho
Slide 9: Significant Number of HeFH Patients Remain Undiagnosed or Far From Goals
Significant Number of HeFH Patients Remain Undiagnosed or Far From Desired LDL-C Goals Heterozygous Familial Hypercholesterolemia (HeFH) Number of patients - Projections for 2016 US & EU5(1) Illustrative Example ● 44 year-old female Diagnosed 250K ● Diagnosis: Primary Hypercholesterolemia ● Family h
Slide 10: A Large Number of Statin-Intolerant Patients Are at High Risk
A Large Number of Statin-Intolerant Patients Are at High Risk For Cardiovascular Diseases 5.8M Patients Intolerant to Statins Projections for 2016 (Million Patients) US & EU5(1) Very Illustrative Example High CV Risk ● 58 year-old male ● Diagnosis: Primary Hypercholesterolemia ● Patient history: Myo
Slide 11: Lipid-Lowering Market Sales Are ~$30 Billion
Lipid-Lowering Market Sales Are ~$30 Billion Lipid-Lowering Agents(1) Worldwide Sales 2013 $30 Billion ● Statins remain the primary treatment option for high LDL-C 8% 16% ● Many hypercholesterolemic patients not at LDL-C goal with statins ● Patients with LDL-C too high at 15% maximally tolerated sta
Slide 12: Economic Burden From CV Disease Remains Substantial
Economic Burden From CV Disease Remains Substantial Cost Estimation of Cardiovascular Disease Events in The US(1) Attributable Costs Per Patient Over 36 Months Following Event $73,300 $71,600 $36,000 Non-Fatal MI Hospitalizations Non-Fatal for Angina Hemorrhagic Stroke (1) O’Sullivan AK et al. Pharm
Slide 13: Alirocumab: Potential Novel Treatment For Patients at High CV Risk
Alirocumab: Potential Novel Treatment For Patients at High CV Risk With Unmet Needs ● Fully human monoclonal antibody against PCSK9 ● Binds PCSK9 with high affinity ● Up to 70% LDL-C reduction observed in Phase 2 trial ● Being investigated in a broad Phase 3 program to lower LDL-C and to reduce the
Slide 14: High Awareness of PCSK9 Class Among Physicians
High Awareness of PCSK9 Class Among Cardiologists, Endocrinologists, And Subset of PCPs Percent of Physicians Aware of PCSK9 Inhibitor Class And Perceiving New Class as Very or Extremely Innovative 11% 11% Awareness 66% 35% 57% 37% 84% 80% Innovation 89% 88% of Class 82% 86% Primary Care Physicians
Slide 15: High Likelihood to Prescribe a Self Injectable or Monoclonal Antibody Treatment
High Likelihood to Prescribe a Self Injectable Treatment or a Monoclonal Antibody Treatment Percent of Physicians Likely or Very Likely to Prescribe For Treating Hypercholesterolemia 29% 31% Self Injectable 53% 48% Treatment 52% 50% 27% 29% Monoclonal 51% 41% Antibody Treatment 52% 40% Primary Care
Slide 16: Market Development Activities Underway: Unbranded Education And Awareness Campaigns
Market Development Activities Underway: Unbranded Education And Awareness Campaigns “Looming Threat” of Unmet Need PCSK9 Role in LDL-C Metabolism 16
Slide 17: Alirocumab Clinical Development
ALIROCUMAB CLINICAL DEVELOPMENT Jay Edelberg, M.D., Ph.D. Vice President, Head of the PCSK9 Development & Launch Unit Sanofi 17
Slide 18: Blocking PCSK9 Lowers LDL-C Levels
Blocking PCSK9 Lowers LDL-C Levels Sources: (1) Tibolla G et al. Nutr Metab Cardiovasc Dis 2011;21:835-43. (2) Akram ON et al. Arterioscler Thromb Vasc Biol 2010;30:1279-81. (3) Duff CJ et al. Expert Opin Ther Targets 2011;15:157-68. (4) Horton JD et al. J Lipid Res 2009;50 Suppl:S172-7. (5) Cariou
Slide 19: Key Differentiating Features of The Phase 3 Alirocumab ODYSSEY Program
Key Differentiating Features of The Phase 3 Alirocumab ODYSSEY Program ● 14 studies with primary endpoint evaluated at 24 weeks ● Double-blind for 6, 12, 18, and 24 months ● Solid long-term double-blind exposure (≥5,000 patient years) at completion of studies ● This will allow for a robust character
Slide 20: ODYSSEY Phase 3 Clinical Trial Program: 14 Studies, 23,500 Patients
ODYSSEY Phase 3 Clinical Trial Program: 14 Studies Including More Than 23,500 Patients Patients receiving statins COMBO I (n=306) High CV Risk COMBO II (n=660) MI, Stroke, T2D, CKD OPTIONS I (n=350) OPTIONS II (n=300) LONG TERM(1) (n=2,100) CHOICE I (n=700, 300mg Q4W) High CV Risk FH I (n=471) HeFH
Slide 21: Lipid-Lowering Trials: Double-Blind for 6, 12, 18, and 24 Months
Lipid-Lowering Trials: Double-Blind for 6, 12, 18, and 24 Months(1) Double-Blinded Efficacy and Safety Evaluation Primary Endpoint Evaluation at Week 24 MONO (n=100) OPTIONS I (n=350) 24 Weeks OPTIONS II (n=300) CHOICE II (n=200) COMBO I (n=306) 52 Weeks CHOICE I (n=700) FH I (n=471) FH II (n= 250)
Slide 22: ODYSSEY Program Evaluates Multiple Options to Personalize Dosing Regimen
ODYSSEY Program Evaluates Multiple Options to Personalize Dosing Regimen Dosing Regimens Evaluated Looking to Flexible Dosing in Phase 3 Based on Patient Needs ● Q2W dosing Baseline ● 75mg Q2W as the starting dose LDL-C Values • Possibility to titrate up to 150mg Q2W if needed ● Alternatively, 150mg
Slide 23: ODYSSEY MONO: ~50% LDL-C Reduction With 75mg Q2W at 12 Weeks
ODYSSEY MONO(1): ~50% LDL-C Reduction Achieved With 75mg Q2W at 12 Weeks; Sustained Over 24 Weeks LDL-C % Change From Baseline ● Percent of patients reporting TEAEs Week 0 4 8 12 16 20 24 ● 78.4% with ezetimibe 0 ● 69.2% with alirocumab -10 Ezetimibe 10mg QD –17.2% ● Most common class of AEs –20.4%
Slide 24: Clinical Study Supports 150mg Q4W Dosing in Patients Not on Statins
Clinical Study Supports 150mg Q4W Dosing in Patients Not on Statins ~48% LDL-C Reduction Maintained Over 28-Day Dosing Interval(1) 10 Run-in(2) Alirocumab 150mg Q4W Follow-up(2) - Alirocumab + placebo (N=24) 0 - Alirocumab + ezetimibe (N=24) LDL-C % Change from D-29 Baseline - Alirocumab + fenofibra
Slide 25: Delivery Options Evaluated in ODYSSEY Program
Delivery Options Evaluated in ODYSSEY Program Option 1 ● Patient-friendly single-use, disposable pen being evaluated ● Small injection volume of 1ml (75 or 150mg) ● Allows quick injection ● Interchangeably injected in the abdomen, upper arm, or thigh(1) ● >90% compliance in Phase 2 open label extens
Slide 26: Alirocumab Generally Well Tolerated in Completed Studies
Alirocumab Generally Well Tolerated in Completed Studies(1) Most Frequent TEAEs From ODYSSEY Program Overseen by Two Pooled Phase 2 Studies Data Monitoring Committees (DMC) ● Injection site reactions ● DMC for the lipid program and DMC for the CV outcome trial ● Diarrhea ● DMCs meet every 3 months t
Slide 27: ODYSSEY OUTCOMES: Large CV Outcomes Trial Initiated in November 2012
ODYSSEY OUTCOMES: Large CV Outcomes Trial Initiated in November 2012 Patients with recent ACS Double-blind treatment period (minimum of 2 years) >40 years of age Run-in period Alirocumab 75mg SC Q2W Randomization must be Primary Primary N=9,000 Up-titration at Week 12 if needed 4-52 weeks Endpoint(3
Slide 28: Q&A
Q&A SANOFI REGENERON ., science to medicine®