2013/10 - IR - Multiple Sclerosis


Published on

2013/10 - IR - Multiple Sclerosis

Published in: Health & Medicine
  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

2013/10 - IR - Multiple Sclerosis

  1. 1. October 3rd, 2013 Teresa, Multiple Sclerosis, United States IR Thematic Call on Multiple Sclerosis
  2. 2. 2 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 their underlying assumptions, statements regarding plans, objectives, intentions and expectations 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 Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ 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 the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding, as well as those discussed 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 Sanofi's annual report on Form 20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
  3. 3. 3 Agenda Key Highlights on Multiple Sclerosis Market ● Bill Sibold - Senior Vice President, Head of Multiple Sclerosis - Genzyme Clinical Data Highlights ● Michael Panzara, MD, MPH - Therapeutic Area Head of MS & Neurology - Genzyme Genzyme MS Global Launch Update ● Bill Sibold - Senior Vice President, Head of Multiple Sclerosis - Genzyme Q&A Session
  4. 4. Multiple Sclerosis Market: Key Highlights Bill Sibold SVP, Head of Multiple Sclerosis - Genzyme 4
  5. 5. 5 Global MS Market - Significant and Growing Market Key Facts about MS ● Serious disease with significant unmet medical needs ● Symptoms include fatigue, weakness, walking and balance difficulties, vision problems ● A major impact on family, social and professional life ● ~2.1m patients worldwide(1) ● ~410,000 patients in the U.S.(1) ● ~630,000 patients in EU(2) Multiple Sclerosis (1) National Multiple Sclerosis Society (2) http://msj.sagepub.com/content/18/5/628.full.pdf (3) Adapted from Evaluate Pharma July 2013; Reported sales of Copaxone®, Avonex®, Rebif®, Betaseron/Betaferon®, Extavia®, Tysabri® and Gilenya® for 2012; 2007 sales converted using €/$ of 1.37, 2012 sales and 2017e sales converted using €/$ of 1.29 Multiple Sclerosis Market Global Sales(3) 2012 2017e U.S. ROW ~€11bn >€14bn 2007 ~€5bn ~40% ~60% 2012-17 growth driven by new therapies, satisfying the unmet needs of convenient administration and more efficacious therapy ~50% ~50%
  6. 6. MS Market in a State of Transition Presents Opportunities 6 Multiple Sclerosis Market Features Today ● 7 Mechanisms of Action ● 10 Marketed Products ● 3 Modes of Administration ● Greater Treatment Urgency In 2005 ● 2 Mechanisms of Action ● 4 Marketed Products ● 1 Mode of Administration ● More Acceptance of Disease Activity Increasing diversity of therapeutic options allowing a more individualized treatment approach
  7. 7. 7 MS Treatment Options Have Increased: Oral and Intravenous Products Share Has Grown Evolution of MS Market (1) Company reported sales of Avonex®, Betaseron®/Betaferon®, Copaxone®, Rebif® and Tysabri ® converted using €/$ rate of 1.33 (2) Company reported sales of MS products in H1 2013. Aubagio®, Betaseron®, Copaxone®, Rebif® converted using €/$ rate of 1.31 (3) Injectable therapies include Avonex®, Betaseron®/Betaferon®, Copaxone®, Rebif®, Extavia® (4) Intravenous therapies include Tysabri® (5) Oral therapies include Aubagio®, Gilenya® and Tecfidera® 74% 15% Total Half Year Sales €5.9bn H1 2007(1) H1 2013(2) Total Half Year Sales €2.4bn Orals(5) Intravenous Therapies(4) Injectable Therapies(3) 11% 96% 4%
  8. 8. 8 ● Oral therapy(2) share projected to increase four-fold to nearly 40% of the MS market by 2017 driven by new entrants ● Intravenous therapies(3) expected to approach 20% of the market ● Injectable therapies(4) (ABCRE’s) projected to decline by roughly half of current usage by 2017 (1) Evaluate Pharma July 2013 (2) Oral category includes Aubagio®, Gilenya®, Tecfidera®, laquinimod, 2nd Gen S1Ps (3) Intravenous category includes Tysabri®, Lemtrada®, ocrelizumab, daclizumab (4) Injectable category includes Avonex®, Betaseron/Betaferon®, Copaxone®, Rebif®, Extavia®, Plegridy™ Transition to Oral and Intravenous Therapies Expected to Continue 59% 0% 15% 30% 45% 60% 75% 90% 2012 2017e MS Market Evolution(1,2,3,4) (% market share) Injectables Intravenous Orals
  9. 9. 9 Michael Panzara, MD, MPH Therapeutic Area Head of MS & Neurology - Genzyme Clinical Data Highlights
  10. 10. Multiple Sclerosis Results in Significant Brain Injury with Irreversible Consequences 42 years-old 52 years-old Brain MRI Reveals Significant Progression of Atrophy Over 10 Years(1) (1) Courtesy of Beth Fisher and Rick Rudick Cleveland Clinic 10
  11. 11. New Treatment Goals - Focus on Patient Outcomes Unmet Needs New Goals Symptom Alleviation Decrease MS activity and improve quality of life Halt or reverse damage and disability Promote repair, remyelination, durable disability improvement Improve disease control Freedom from disease activity Convenient treatment regimens to improve compliance Dosing options, new routes of administration, less frequent dosing Maximize patient outcomes Superior effectiveness and favorable benefit/risk vs. existing treatment 11
  12. 12. 12 (1) O’Connor PW et al. N Engl J Med 2011;365:1293-1303 (2) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account (3) Kappos L et al. Mult Scler J 2012;18:(S4)9-53(153) Once-Daily Oral Therapy with Robust Efficacy TEMSO STUDY(1) TOWER STUDY(3) Annualized Relapse Rate(2) Placebo - 36.3% p=0.0001 - 31.5% p=0.0005 Aubagio® 14mg n=370 Placebo Aubagio® 14mg 0.539 0.3190.369 0.501 n=363 n=358 n=388 Annualized Relapse Rate(2)
  13. 13. 13 (1) O’Connor PW et al. N Engl J Med 2011;365:1293-1303 (2) At Week 108 (3) Derived using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates (4) Derived from log-rank test with stratification of EDSS strata at baseline and region (5) Kappos L et al. Mult Scler J 2012;18:(S4)9-53(153) Only Oral Therapy to Show Significant Effect on Disability in Two Phase III Trials TEMSO STUDY(1) TOWER STUDY(5) Reduction in Progression of Disability(2) Placebo -29.8%(3) p=0.0279(4) Aubagio® 14mg Placebo Aubagio® 14mg 0.273 0.158 0.202 0.197 -31.5%(3) p=0.0442(4) Reduction in Progression of Disability(2) n=363 n=388 n=370n=358
  14. 14. TEMSO(1) TEMSO Extension Study(2) 0.1710.177 0.369 0.539 14mg/ 14mg Placebo/ 14mg 14mgPlacebo Annualized Relapse Rate Annualized Relapse Rate Long-term Efficacy and Safety Supported by TEMSO Extension Trial 14 (1) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account (2) Freedman, M et al. Mult Scler J 2013; 19:(S1)74-558 ● TEMSO extension trial included patients receiving Aubagio® for up to 9 years (up to 7 years extension treatment) ● No new or unexpected safety signals emerged during the study ● Measured clinical and MRI disease activity remained low in patients continuing on study treatment
  15. 15. 15 Similar Incidence of SAEs Among Aubagio® and Placebo-treated Patients in Clinical Trials ● The Aubagio® label(1) includes: ● Risk of teratogenicity (based on animal data) and hepatotoxicity ● ALT elevations ● Alopecia ● Diarrhea ● Influenza ● Nausea ● Paresthesia SAE: Serious Adverse Event (1) Adapted from U.S. Prescribing Information and European SmPC
  16. 16. Relative Proportion of T Cells Increased with T-Reg Phenotype(2) Months on Therapy Potentially Rebalances the Immune System ● Selectively targets CD52 protein, depleting B and T cells responsible for MS inflammatory process ● A distinctive pattern of lymphocyte repopulation occurs over time(1) ● May reduce inflammatory processes in MS and have disease modifying effects ● Supported by durable efficacy after two short treatment courses 16 (1) Cox AL et al. Eur J Immunol 2005;35:3332-42., Hu Y et al. Immunology 2009;128:260-70, Havari E et al. ECTRIMS 2010, Jones JL et al. Brain 2010;133:2232-47 (2) Hartung HP et al. Mult Scler J 2012; 18:(S4)279-508 CD4TregCellCounts(%) Lemtrada® 12 mg/day Rebif® Lemtrada® has been granted marketing authorization by the European Commission and is under review by the regulatory authorities in the U.S. The mechanism by which it exerts therapeutic effect in multiple sclerosis is unknown. Lemtrada® is developed in collaboration with Bayer HealthCare
  17. 17. 17 CARE-MS I(1) CARE-MS II(2) Randomized Patients 581 840 Study Duration 2 years 2 years Patient Population Treatment naïve Relapsed on prior treatment Treatment Arms Lemtrada® vs. Rebif® Lemtrada® vs. Rebif® Active Comparator Set High Bar for Success (1) Coles AJ et al. Lancet. 2012;380(9856):1829-1839 (2) Cohen JA et al. Lancet. 2012;380(9856):1819-1828
  18. 18. 18 Rebif® - 55% p<0.0001 n=426 0.39 0.26 0.18 0.52 n=187 n=376 n=202 Lemtrada®Rebif® - 49% p<0.0001 CARE-MS I(1) CARE-MS II(2) Annualized Relapse Rate Annualized Relapse Rate Significant Comparative Efficacy Results with Unique Annual Dosing Regimen Lemtrada® (1) Coles AJ et al. Lancet. 2012;380(9856):1829-1839 (2) Cohen JA et al. Lancet. 2012;380(9856):1819-1828
  19. 19. HR: Hazard Ratio SAD: Sustained Accumulation of Disability (1) CARE-MS I study in treatment-naïve patients did not show a significant reduction in sustained accumulation of disability (2) Cohen J et al. AAN 2012:platform presentation of CARE-MS II. Time to SAD(1,2) CARE-MS II 19 21.1% 12.7% Rebif® Lemtrada®12 mg/dayHR 0.58 Treatment effect: 42% p=0.0084 Slowed Accumulation of Disability vs. Rebif®(1) PercentageofPatientswithSAD
  20. 20. Improvement in Pre-Existing Disability: 6-Month Sustained Reduction in Disability 6-Month SRD CARE-MS II(2) Follow-up Month 0 3 15 18 21 2412 PercentageofPatientswithSRD 10 40 6 90 30 20 HR: 2.57 p=0.0002 28.8% 12.9% 50 Rebif® Lemtrada®12 mg 20 ● Data suggests that improvement in pre-existing disability was more likely with Lemtrada® than Rebif® regardless of which functional system was impaired by prior MS disease activity(1) ● All functional systems contributed to EDSS improvement(1) RRMS: Relapse Remitting Multiple Sclerosis (1) Brinar, V ECTRIMS 2013 (P649) (2) Cohen J AAN 2012:platform presentation of CARE-MS-II
  21. 21. Durable Effect on Sustained Reduction in Disability Through Year 3 21(1) Hartung HP ECTRIMS 2013(P592) 6-Month SRD(1) CARE-MS II Extension Study ● More than 1/3 of Lemtrada® treated patients in CARE-MS II extension study attained sustained disability improvement by Year 3 ● Approximately 80% of patients did not receive re-treatment during Year 3 ● Fewer than 3% received another disease modifying treatment in Year 3 29% 35% 0 6 12 18 24 30 36 0 10 20 30 40 50 Follow-up Month PercentageofPatientswithSRD
  22. 22. Safety Experience from MS Development Program ● Infusion-associated reactions very common ● Premedication reduced/alleviated symptoms ● Infections common in both groups ● More common with Lemtrada®, low number of serious events ● Autoimmune events, some serious ● Detected via risk management plan allowing early diagnosis and treatment 22
  23. 23. 23 Significant Global Regulatory Milestones Achieved RRMS: Relapse Remitting Multiple Sclerosis (1) Not indicated for treating non-active patients and those stable on therapy ● EU approved for adult patients with RRMS ● New Active Substance designated by EMA providing 10 years of data exclusivity in the EU ● FDA approved for adult patients with relapsing forms of multiple sclerosis ● Also approved in Australia, Mexico, Argentina, Chile, South Korea ● EU approved for patients with RRMS with active disease as defined by clinical or imaging features(1) ● FDA decision expected in late Q4 2013 ● Regulatory reviews ongoing in several other regions
  24. 24. Global Launch Update Bill Sibold SVP, Head of Multiple Sclerosis - Genzyme 24
  25. 25. Genzyme’s Critical Success Factors in MS Products People Approach ● Lemtrada® and Aubagio® are highly differentiated novel products ● Fulfill unmet needs ● Well positioned for an evolving market ● Accomplished team ● Leveraging experienced Sanofi MS sales reps in European countries ● Strong commitment and relationships ● Science driven and patient focused ● Long term partners ● Be leaders 25
  26. 26. Cumulative U.S. Weekly TRx(1) Encouraging U.S. Launch Trends (1) IMS Weekly Total Prescriptions (2) Q3 2013 Aubagio® quarterly sales figure is an estimate to be validated when company earnings are released on October 30, 2013 Aubagio®: Quarterly Sales Week 48Week 1 60,000 Tecfidera® Gilenya® Aubagio® 26 Q4 2012 Q2 2013Q1 2013 €7m €20m €33m Tecfidera® Launch €44m(2) Q3 2013e 40,000 20,000
  27. 27. Broad Based Patient Demand DMT: Disease Modifying Therapy (1) Based on data collected at Genzyme's MS One to One™ Patient and Provider Support Center, Sep 2012-Sep 2013 (2) BioTrends Research Group, LaunchTrends®: Aubagio® (teriflunomide) - Multiple Sclerosis (Wave 3) 2013 Aubagio® Prior Therapy(1) (Enrolled Patients) 27 ● ~20% patients prescribed Aubagio® were treatment- naïve(2) ● >80% of patients switched to Aubagio® were most recently on ABCR’s ● Most frequently cited reasons for initiating Aubagio®(2) ● Oral administration ● Once-daily dosing ● Needle Fatigue/Phobia 30.6% 22.0% 14.1% 3.9% 17.4% 8.5% 1.3% Other 2.2%
  28. 28. 28 Launching a Global MS Franchise(1) (1) Timing of regulatory approvals and country reimbursement policies may impact projected launch timelines 2012 Selected Markets 2014 2012 Selected Markets 2014
  29. 29. 29 Ready to Launch Our MS Franchise in the EU Aubagio® and Lemtrada® approved Field forces hired and trained Patient support infrastructure and programs in-place First product shipments First EU sales in October 2013
  30. 30. 30 ● Multiple Sclerosis market is significant and growing ● New therapies, satisfying the unmet needs of convenient administration and increased efficacy, to drive growth ● Genzyme uniquely placed to seize opportunities in Multiple Sclerosis ● Multiple Sclerosis team with proven track record ● Aubagio® and Lemtrada® are positioned for success in an evolving market Committed to Being Leaders in MS
  31. 31. Q&A SESSION 31