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2013 - IR - Diabetes

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  • 1. IR THEMATIC CALL ON DIABETESChicago - June 24th, 2013
  • 2. 2Forward Looking StatementsThis presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of1995, as amended. Forward-looking statements are statements that are not historical facts. These statements includeprojections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions andexpectations with respect to future financial results, events, operations, services, product development and potential,and statements regarding future performance. Forward-looking statements are generally identified by the words"expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofismanagement believes that the expectations reflected in such forward-looking statements are reasonable, investors arecautioned that forward-looking information and statements are subject to various risks and uncertainties, many of whichare difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments todiffer materially from those expressed in, or implied or projected by, the forward-looking information and statements.These risks and uncertainties include among other things, the uncertainties inherent in research and development,future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or theEMA, regarding whether and when to approve any drug, device or biological application that may be filed for any suchproduct candidates as well as their decisions regarding labeling and other matters that could affect the availability orcommercial potential of such product candidates, the absence of guarantee that the product candidates if approved willbe commercially successful, the future approval and commercial success of therapeutic alternatives, the Groups abilityto benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of costcontainment policies and subsequent changes thereto, the average number of shares outstanding as well as thosediscussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under"Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofis annual report on Form20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake anyobligation to update or revise any forward-looking information or statements.
  • 3. 33AgendaInvestigational New Insulin U300(1)● Riccardo Perfetti, Senior Medical Officer, DiabetesLyxumia® (lixisenatide)(2)● Hugo Fry, Global Project Leader Lixisenatide FamilySanofi – A Long-Term Commitment to Fighting Diabetes● Pierre Chancel, Senior Vice President, DiabetesQ&A(1) Investigational New Insulin U300 is in Phase III clinical development.(2) Lyxumia® is the proprietary name approved by the EMA for lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration.In the U.S.; lixisenatide is currently under review by the FDA. Lixisenatide was in-licensed from Zealand Pharma A/S.
  • 4. Investigational New Insulin U300Riccardo PerfettiSenior Medical Officer, Diabetes - Sanofi4
  • 5. 5Investigational New Insulin U300: Building on theWealth of Evidence on Lantus®● : Prescribers’ first choice for insulin therapy● >10 years of broad clinical experience● >7m Lantus® patients worldwide● : A landmark seven-year cardiovascular (CV) outcomes trial(1)● Over 12,500 participants at high CV risk with impaired fasting glucose,impaired glucose tolerance or early type 2 diabetes● ORIGIN results on Lantus® CV safety recently integrated into EU product label● U.S. label expected to include CV safety findings from ORIGINLantus®The Gold Standard Basal Insulin(1) Gerstein H at al, Am Heart J 2008; 155(1): 26-32
  • 6. Investigational New Insulin U300: Striving to FurtherEnhance the Value of Current Gold Standard Basal Insulin6PK: Pharmacokinetics PD: PharmacodynamicsTargetedProductProfilePK/PDProfileClinicalBenefitsProductCharacteristics2 31
  • 7. U300 Provides Slower Insulin Glargine ReleaseAfter Subcutaneous Injection7 More concentrated formulation (X3) Reduced volume (1/3) and reduced surface area (1/2)of insulin glargine subcutaneous depot Slower release rate of insulin glargineSchematic illustrationU300
  • 8. Pharmacokinetic Profile Pharmacodynamic ProfileSerum Insulin Glargine Concentration Glucose Infusion RateDahmen R et al, ADA 2013, abstract no. 113-OR. Euglycemic clamp study in T1D in steady state.U300 Offers Even Flatter and More Prolonged PK/PDProfile than Lantus®U300 0.4U/KgLantus® 0.4U/Kg80 6 12 18 24 30 36051015202530LLOQ 5.02 µU.mL-1SC INJECTIONINSULIN-µU.mL-1TIME - hourU100 0.4 U.kg-1U300 0.4 U.kg-1LOESS 0.150 6 12 18 24 30 36012345DOSE 0.4 U.kg-1U300U100GIR-mg.kg-1.min-1TIME - hour
  • 9. EDITION: A Comprehensive Phase III ProgramFully Recruited9Study Population Intervention# of patientsrandomizedEDITION I Type 2 Basal + mealtime insulin 807EDITION II Type 2 Basal + oral therapy 811EDITION III Type 2 Insulin naïve 879EDITION IV Type 1 Basal + mealtime insulin 550EDITION JP I Type 1 Basal + bolus insulin 243EDITION JP II Type 2 Basal + oral therapy 240U300 vs.
  • 10. EDITION I: First Phase III Study Completed10Baseline characteristics All patientsAge 60 yearsDuration of diabetes 15.8 yearsA1c 8.15%BMI 36.6 kg/m2Previous basal inulin All patientsPrevious insulin Lantus 92%NPH 8%Duration of treatment 6.6 yearsPrevious dose 0.67 units/kgRiddle MC et al, ADA 2013, Late Breaking Poster 43-LBT2D: Type 2 Diabetes A1C: HbA1c or Glycated hemoglobinn=403Screening periodUp to 2 weeksTotal daily dose Lantus® ≥42 U(or equivalent dose of NPH)Plus mealtime insulin6-month efficacy and safety periodQualifying visit:7% ≤ A1c ≤10%Mealtime insulin analogue (±metformin)RT2DpatientsU300Lantus®n=404EndpointsFasting plasma glucose target: 80-100 mg/dL (4.4-5.6 mmol/L)Basal insulin dose adjusted once weeklyn=807
  • 11. Mean Change in A1c-0.83%EDITION I: U300 Showed Equivalent Glycemic Controland Fewer Nocturnal Hypoglycemic Events vs. Lantus®11Similar Reduction in A1c(1)in Both Groups21% Reduction in Nocturnal Hypoglycemia(Severe and/or Confirmed)with U300 from Month 3 to 6(2)Riddle MC et al, ADA 2013, Late Breaking Poster 43-LB(1) Primary endpoint: Change in A1c from baseline to Month 6(2) First main secondary endpoint: Number (%) percentage of patients reporting at least one severe or confirmed (plasma glucose ≤70 mg/dL)nocturnal [00:00 – 05:59 hrs] hypoglycemic event from month 3 to 6 (RR: Relative risk)U300Lantus®Patients with at least one eventRR (95% CI): 0.79 (0.67-0.93)p <0.004536.1%46.0%- 21%8.48.28.07.87.67.47.27.0Mean A1c (%) by visitLOCF – Last value during main 6-month on-treatment.MeanA1c(%)Baseline Week 12 Month 6 LOCFTimeNot significant differencebetween both groupsLantus® U300
  • 12. EDITION I: Lower Risk of Severe or ConfirmedHypoglycemia Consistent Across Study Periods12Severe or Confirmed Hypoglycemia(1)Nocturnal(2) Any Time of the Day (24-hour)Baselineto month 6Baselineto week 8Week 9to month 6(3)Baselineto month 6Baselineto week 8Week 9to month 6Lantus® U300Riddle MC et al, ADA 2013, Late Breaking Poster 43-LB(1) Number (%) percentage of patients reporting at least one severe or confirmed (plasma glucose ≤70 mg/dL) hypoglycemic event(2) Defined as severe or confirmed by plasma glucose ≤70 mg/dL which occurred between 24:00 and 5:59 hours(3) First main secondary endpointPatients with at least one event
  • 13. 13EDITION II: Topline Results Confirm Edition I FindingsScreening periodUp to 2 weeksTotal daily dose Lantus® ≥42 U(or equivalent dose of NPH)Plus OADs6-month efficacy and safety periodQualifying visit:7% ≤ HbA1c ≤10%Oral antihyperglycemic drug(s)(1)RT2DpatientsU300Lantus®EndpointsFasting plasma glucose target: 80-100 mg/dL (4.4-5.6 mmol/L)Basal insulin dose adjusted once weeklyn=811(1) Except sulfonylureas which were prohibited within 2 months before the screening visit and during participation to the studySimilar glycemic control while fewer patients experienced nocturnalhypoglycemic events compared with Lantus®Reduction in severe or confirmed nocturnal hypoglycemic events frommonth 3 to 6 were in the same range as that observed in EDITION I
  • 14. Investigational New Insulin U300: Potential to FurtherEnhance the Clinical Value of Basal Insulin● Improved PK/PD profile● Equivalent glycemic control with consistently fewer patientswith Type 2 diabetes experiencing hypoglycemic events ascompared to Lantus®● Consistent results in EDITION I and II● Next steps:● Topline results of EDITION III & IV expected in H2 2013● Expected regulatory submission in H1 2014 in U.S. and EU14U300
  • 15. Lyxumia® (lixisenatide)Hugo FryGlobal Project Leader Lixisenatide Family,Sanofi15
  • 16. 16● Key benefits of Lyxumia®complementing basal insulin● Pronounced post-prandial glucose(PPG) lowering effect● Beneficial effect on body weight● Minimal risk of hypoglycemia● Indicated in EU for combination usewith OADs and basal insulin● Attractive value propositionA Positive Addition for Patientson Basal Insulin(1) Lyxumia® is the proprietary name approved by the EMA for lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration.In the U.S.; lixisenatide is currently under review by the FDA. Lixisenatide was in-licensed from Zealand Pharma A/S.®Lyxumia®Easy-to-Use Once-Daily Prandial GLP-1First 2 weeks of therapyRemainder of therapyLyxumia®10 µg OD SCLyxumia®20 µg OD SCOD: Once-daily SC: Subcutaneous
  • 17. 0.0-0.2-0.4-0.6-0.8-1.0-25-20-15-10-50A1c Control and Postprandial Hyperglycemia Reduction (PPHG)with Lyxumia® as Add-on to Basal Insulin(1)17Reduction in A1c FromBaseline to Week 24LS mean difference -0.49p <0.0001LSmean±SEchangefrombaseline(%)A1c Reduction AchievedWith Lixisenatideas Add-on to Basal InsulinMC Riddle, ADA 2013 (abstract 941-P) Pooled data were from three 24-week, randomized Phase III studies of lixisenatideadded to basal insulin ± oral agents compared with placebo (GetGoal-L, GetGoal-DUO-1 & GetGoal-L-Asia) (n=753)AUC: Area under the curve LS: Least mean square SE: Standard error NS: Not significant 17-15-10-50Basal PostprandialNSLS mean difference –11.0p<0.0001Basal Hyperglycemic Exposure (AUCB) andPostprandial Hyperglycemic Exposure (AUCP)LSmean±SEchangefrombaseline(mmol/L·h)Decrease in PPHG ExposureAchieved With Lixisenatideas Add-on to Basal InsulinLixisenatide Placebo
  • 18. 0%20%40%60%80%Byetta Victoza Bydureon LyxumiaEU Rollout Will Continue Throughout 201318Market AccessActivities on Track● Already ~50% of key local formulary accesstarget● Reached ~70% unaided awareness intarget stakeholders(1)(1) Internal data (stakeholders: endocrinologists, diabetes specialist nurses, and payers)GLP-1 Weekly Market Shares (in Volume)Steady Market Penetration® ® ® ®®Pre-licence 1 2 3 Wave48.1%
  • 19. – Broad Phase IIIb Program Ongoing192012 20142013 2015Prior to the Main Meal vs. Priorto Breakfast AdministrationPPG Effects when Addedto Lantus® (vs. Liraglutide)Lixisenatide vs. Apidra® as an Add-on toLantus® (GetGoal Duo-2)On Top of Basal Insulin and/or OADs inelderly patients (GetGoal-O)Specific Studies for Asian MarketClinicalTrials.gov identifiers: NCT01147250, NCT01517412, NCT01596504, NCT 01768559, NCT01798706, and NCT01632163,,®CV outcomes studyEnrolment will be completed in 2013
  • 20. 20Combining Insulin Glargine with Lixisenatidein One Single Daily Injection (LixiLan)20Potential to Be the First Combinationof Basal Insulin + GLP-1 in One Daily Injection in the U.S+®● Phase II Proof-of Concept studycompleted● Results support Go decision to Phase III● Data guiding preparation for Phase IIIprogram● Full data to be submitted for publicationin a medical journal● Phase III start expected in H1 2014● Opportunities in patients not at targeton OADs and basal insulin
  • 21. Lyxumia®: New Step to Expand Sanofi’s Positionin the Injectable Antidiabetic Drugs Market● Encouraging launch progress in EU● Regulatory decision in Japan expected mid-2013● ELIXA CV outcome trial expected to complete enrolmentby end 2013● FDA review ongoing including interim ELIXA data● Start of Phase III program with LixiLan expected in H1 201421Lyxumia®
  • 22. Sanofi – A Long-Term Commitmentto Fighting Diabetes22Pierre ChancelSenior Vice President, Diabetes, Sanofi
  • 23. Sanofi Has a Well Established Global Presencein DiabetesNet sales growth is at constant exchange rate Market share: Source IMS Health MIDAS 2012 – Copyright 2012 – All rights reservedW. Europe: France, Germany, UK, Italy, Spain, Greece, Belgium, Luxembourg, Portugal, Austria, Switzerland, Sweden, Ireland, Finland, Norway, DenmarkEmerging Markets: World less North America (USA, Canada), Western Europe, Japan, Australia and New ZealandRoW: Japan, Canada, Australia and New ZealandDiabetes sales:€3,167m, +21.5%Diabetes market share:21.1%Diabetes sales:€1,012m, +6.3%Diabetes market share:18.1%17.5%Diabetes sales:€459m, +0.2%Diabetes market share:11.8%7.9%EmergingMarkets 19.8%2354.8%U.S.Diabetes sales:€1,144m, +22.5%Diabetes market share:14.9%Rest ofWorldWesternEuropeFY 2012 Sales€5,782m+16.7%
  • 24. A Portfolio of Key Globally Marketed BrandsSupporting Sales PerformanceNet Sales (€m)Net Sales (€m)Net Sales (€m)Net Sales (€m)24
  • 25. Strong Sales Evolution Across All GeographiesU.S. Net Sales (€m)Emerging Markets Net Sales (€m)Western Europe Net Sales (€m)Rest of the World Net Sales (€m)25Lantus®Apidra®Amaryl®Insuman®,,,
  • 26. On Track to Deliver on our 5-year Goal for 2013(1)x2® ® ® ®€bnGlobal Diabetes Sales26(1) Objective communicated at the IR Thematic Seminar on Diabetes held on September 30, 2010
  • 27. 27Sanofi is the Fastest Growing Insulin Player in the FastestGrowing Segment+17.6%+13.1%+ 4.4%41.1%+12.4%35.0%+18.9%21.4%+7.8%2.6%+8.9%Breakdown By Insulin PlayerMarket Share (%)Growth vs. Prior Year (%)Breakdown By Insulin TypeMarket Share (%)Growth vs. prior year (%)MAT Q1/2013 Worldwide Insulin Market Breakdown (Value)SanofiLillyOthersNovo BasalPremixShort Acting47.8%18.3%33.9%Source: Market share data from IMS Health MIDAS Q1/2013 – Copyright 2013– All rights reserved
  • 28. Sanofi Holds a Strong Position Among Insulin Players28MAT Q1/2013 Insulin Market Share by Insulin Player (Value)Market Share (%)Growth vs. Prior Year (%)Sanofi45%34%16%5%45%26%20%10%51%31%19%LillyOthersU.S. WesternEuropeEmerging Markets Japan/CanAus/NZ+ 23% + 24%+ 8%- 1%+ 21%+ 3%+ 1%+ 4%+ 4%+ 0%+ 7%+ 16%+ 14%+ 15%NovoSource: Market share data from Source IMS Health MIDAS Q1/2013 – Copyright 2013 – All rights reserved38%+24%38%+23%24%+8%
  • 29. Basal Insulins Constitute the Leading and FastestGrowing Insulin Segment Across All Geographies29BasalPremixShort ActingMAT Q1/2013 Insulin Market Breakdown by Insulin Type (Value)Market Share (%)Change vs. Prior Year (%)U.S. WesternEuropeEmerging Markets Japan/CanAus/NZ17%- 5%12%+ 7%25%- 5%50%+ 24%47%+ 5%43%+ 13%42%+ 12%38%+ 18%19%+ 10%36%+ 4%33%+ 6%38%+ 10%Source: Market share data from Source IMS Health MIDAS Q1/2013 – Copyright 2013 – All rights reserved
  • 30. State-of-the-Art, Easy-to-Use and Accurate Insulin Pensto Match the Needs of People with Diabetes30Disposable pen Reusable penReusable pento expand offeringin Emerging Markets
  • 31. Access andVolumeExpansionin EmergingMarketsMultiple Growth Drivers to Sustain Sales Growthof Lantus®Developmentof IntegratedSolutionsIncluding Pens& BGMsFurtherIncrease inPen UsageMore TimelyLantus®Initiation31Shift fromPremix toBasalCombinationwithLixisenatideLeveragingORIGINCV OutcomeStudyBasal UseCV DataMarket AccessDevicesNew Products
  • 32. Diabetes – A Key Growth Platform● Lantus® well-established Gold Standard insulin● First positive EDITION program results with InvestigationalNew Insulin U300● Lyxumia® expected to expand our leading positionin injectable antidiabetic drugs market● Start of Phase III program with LixiLan expected in H1 2014● Strong confidence in ability to deliver high-single digit salesCAGR over 2012-2015 for Diabetes32SanofiDiabetes
  • 33. Q&A SESSION33