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2012/04 - IR - Multiple Sclerosis
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2012/04 - IR - Multiple Sclerosis


2012/04 - IR - Multiple Sclerosis

2012/04 - IR - Multiple Sclerosis

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  • 1. Jannan, MSIR Thematic Call on Multiple Sclerosis April 25th, 2012
  • 2. Forward 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 statementsinclude projections and estimates and their underlying assumptions, statements regarding plans, objectives,intentions and expectations with respect to future financial results, events, operations, services, productdevelopment and potential, and statements regarding future performance. Forward-looking statements aregenerally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similarexpressions. Although Sanofi’s management believes that the expectations reflected in such forward-lookingstatements are reasonable, investors are cautioned that forward-looking information and statements are subjectto 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 orprojected by, the forward-looking information and statements. These risks and uncertainties include among otherthings, the uncertainties inherent in research and development, future clinical data and analysis, including postmarketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when toapprove any drug, device or biological application that may be filed for any such product candidates as well astheir decisions regarding labelling and other matters that could affect the availability or commercial potential ofsuch product candidates, the absence of guarantee that the product candidates if approved will be commerciallysuccessful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefitfrom 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 asthose discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listedunder “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annualreport on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofidoes not undertake any obligation to update or revise any forward-looking information or statements. 2
  • 3. Agenda Key Highlights on Multiple Sclerosis Market & Genzyme ● Bill Sibold - SVP, Head of Multiple Sclerosis - Genzyme ● Michael Panzara, MD, MPH - Therapeutic Area Head of Multiple Sclerosis - Genzyme Mechanism of Action of Lemtrada™ ● Alasdair Coles, PhD, FRCP - University of Cambridge, UK - CARE-MS Steering Committee CARE-MS Studies ● Jeffrey Cohen, MD - Cleveland Clinic, OH - CARE-MS Steering Committee Q&A Session Lemtrada™ is the trademark submitted to health authorities for the investigational agent alemtuzumab Aubagio™ is the trademark submitted to health authorities for the investigational agent teriflumomide 3
  • 4. KEY HIGHLIGHTSON MULTIPLE SCLEROSIS MARKET& GENZYMEBill SiboldSVP, Head of Multiple Sclerosis - Genzyme 4
  • 5. Global MS Market - Significant and Expected to Grow Multiple Sclerosis Market Key FactsSclerosis Multiple about MS Global Sales(2,3) ● ~2.1m patients worldwide(1) CAGR >6% ● Prevalent in young women $17.8bn (~2:1 female/male ratio) ● Life expectancy 5-10 years lower than unaffected people $12.5bn 54% ● A major impact on family, social and professional life U.S. 56% ● Symptoms include fatigue, weakness, walking and balance 46% difficulties, vision problems ROW 44% 2011 2016e (1) National Multiple Sclerosis Society (2) 2011: Reported sales of Copaxone®, Avonex®, Rebif®, Betaseron/Betaferon®, Extavia®, Tysabri®, and Gilenya® 5 (3) 2016e: Adapted from Evaluate Pharma report - December 2011
  • 6. Global MS Market - Still Dominated by ABCRE Products 2011 Sales and Key Facts about MS MS Therapies Market Share in Value(2) ● “ABCRE” products(1) represented 84% of the global MS market in $3,884m value in 2011 31% ● Moderate efficacy and patients $1,553m continue to relapse on therapy 12% $2,350m ● Require frequent injections 19% ● Latest entrants represent $2,686m 21% treatment alternatives $1,511m $154m 12% 1% ● Drives the benefit vs. risk discussion $494m 4% (1) ABCRE stands for Avonex®, Betaseron®/Betaferon®, Copaxone®, Rebif® and Extavia® (2) Reported sales of ABCRE products plus Tysabri®, and Gilenya® in 2011 6
  • 7. - A Strong Commitment to MS● Experience in developing innovative treatments for chronic disease Changing the● Promising Multiple Sclerosis treatment paradigm clinical development program across the MS spectrum of● Extensive global relationships disease with physicians, payers and patient advocacy groups 7
  • 8. Emergence of a Franchise Addressing Individual Needs for People Living with MS RRMS(2) and RMS(3) severe/ Early MS/CIS(1) early active MS highly active Unmet need 1 Unmet need 2 Unmet need 3 Convenience Convenience, Efficacy with & safety efficacy & safety manageable safety Aubagio™Aubagio® Rebif® Lemtrada™ Lemtrada™ (1) CIS – Clinically Isolated Syndrome, TOPIC Phase III study presently ongoing (2) RRMS – Relapse Remitting Multiple Sclerosis (3) RMS – Relapsing Multiple Sclerosis 8
  • 9. - Key Milestones for Genzyme MS Portfolio● CARE-MS I Data Presentation● CARE-MS II Data Presentation● FDA & EMA Regulatory Submissions Expected  Q2 2012● TEMSO/TENERE Data Presentations● FDA & EMA Regulatory Submissions● TOWER Headline Results Expected  Mid 2012 9
  • 10. KEY HIGHLIGHTSON MULTIPLE SCLEROSIS MARKET& GENZYME (cont’d)Michael Panzara, MD, MPHTherapeutic Area Head of MS - Genzyme 10
  • 11. New Treatment Goals - Focus on Patient Outcomes Unmet Needs New Goals Decrease MS activity and improve quality Symptom Alleviation of life Halt or reverse damage Promote repair, remyelination, durable and disability disability improvement Improve disease control Freedom from disease activity Convenient treatment regimens Dosing options, new routes of to improve compliance administration, less frequent dosing Superior effectiveness and favorable Maximize patient outcomes benefit/risk vs. existing treatment 11
  • 12. A Once-Daily Oral Therapy with “Interferon-like” Efficacy TEMSO STUDY TENERE STUDYAnnualized Relapse Rate(1) Annualized Relapse Rate(1) - 31.5%0.539 p=0.0005 p=ns 0.369 0.216 0.259n=363 n=359 n=109 n=104Placebo Aubagio™ Rebif® Aubagio™ 14mg 14mg (1) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account 12
  • 13. Significant Comparative Efficacy Results with Unique Annual Dosing Regimen CARE-MS I CARE-MS II Annualized Relapse Rate Annualized Relapse Rate - 49% 0.52 p<0.0001 - 55% p<0.00010.39 0.26 0.18n=187 n=376 n=202 n=426Rebif® Lemtrada™ Rebif® Lemtrada™ 13
  • 14. Only Therapy(1) Slowing Accumulation of Disability Sustained for 6 months vs. Active Comparator For Illustrative Purposes Higher Hurdle (2) Active  ComparatorsTypical Threshold for Approval   Placebo Higher Hurdle 3 month EDSS 6 month (1) Investigational compound (2) Based on CARE-MS II 14
  • 15. MECHANISM OF ACTIONOF LEMTRADA™Alasdair Coles, PhD, FRCPDepartment of Clinical Neurosciences,University of Cambridge, UKCARE-MS Steering Committee Member 15
  • 16. - Novel PK & PD Profile● Humanized monoclonal antibody Serum concentrations(1)● IV infusions administered in two courses: 4500 ● 12 mg daily on 5 consecutive days 3500 in the first year Concentration (ng/mL) ● 12 mg daily on 3 consecutive days 2500 12 months later● Serum concentrations of 1500 Lemtrada™ are low or undetectable 500 within ~30 days following treatment 0 –500● Leads to immunomodulation 0 1 3 6 9 12 13 15 18 21 24 through depletion and repopulation Months on Study (1) CARE-MS I data on file, Genzyme Corporation 16
  • 17. - Selectively Targets Lymphocytes● Selectively targets CD52 White Blood Counts in MS patients(5) protein, depleting B and T 5.0 cells responsible for MS inflammatory process 4.5 4.0 Neutrophils● B and T cell repopulation Cell Counts (109/L) begins within weeks and 2.0 continues over time(1) 1.5● Other white blood cells are 1.0 Lymphocytes minimally or transiently 0.5 Monocytes affected(2,3) Eosinophils 0.0 Basophils● Protective serum antibodies 0 1 2 3 4 5 6 7 8 9 10 11 12 are unaffected(4) Months after Alemtuzumab (1) Coles AJ et al. AAN 2010; poster P06.172 (2) Hu Y et al. Immunology 2009;128:260-270, Turner MJ, et al. ECTRIMS 2011; poster 791 (3) Coles AJ et al, AAN 2012; platform S01.006 (4) Coles AJ et al. Lancet 1999;354:1691-5, McCarthy CL, et al. ECTRIMS 2011; poster 781 17 (5) CARE-MS I data on file, Genzyme Corporation
  • 18. - Rebalancing the Immune System● A distinctive pattern of Increased % of T Cells lymphocyte repopulation with T-Regulatory Phenotype(1) occurs over time(1) 30 Percentage of CD4+ T Cells CD25high ● May reduce inflammatory * *p<0.01 processes in MS and have * disease modifying effects 20 ● Increased production of neurotrophic factors which may promote neural repair * 10● Supported by up to three 0 years durable efficacy after Healthy Pre- 1 3 6 9 12 Control treatment two short treatment Time in months courses(2) (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; poster 424, Jones JL et al. Brain 2010;133:2232-47 18 (2) Coles AJ et al. NEJM 2008;1786-1801
  • 19. CARE-MS STUDIESJeffrey Cohen, MDMellen Center, Cleveland Clinic,Cleveland, OHCARE-MS Steering Committee Member 19
  • 20. CARE - Comprehensive Study Program CARE-MS I CARE-MS II Randomized Patients 581 840 Study Duration 2 years 2 years Patient Treatment Relapsed on Population naïve prior treatment Treatment Alemtuzumab Alemtuzumab Arms vs. Rebif® vs. Rebif® CARE-MS Phase III program enrolled patients with relapsing-remitting multiple sclerosis 20
  • 21. CARE-MS I - Strong Effect on Relapse Relapse Rate by Year p<0.0001 p<0.0001 - 55% p<0.0001 p=0.0002 p=0.0002 Rebif® Lemtrada™ 12 mg/day 0.46 0.22 0.29 0.13 0.39 0.18 Coles AJ ECTRIMS 2011; platform presentation 21
  • 22. CARE-MS I - Strong Effect on Relapse Proportion of Relapse-Free Patients at Year 2 HR 0.45 Lemtrada™ 12 mg/day P<0.001 Rebif® 78% 59% Coles AJ ECTRIMS 2011; platform presentation 22
  • 23. CARE-MS II - Strong Effect on Relapse Relapse Rate by Year Rebif® Lemtrada™ 12 mg/day p<0.0001 - 49% p<0.0001 p=0.0017 0.59 0.28 0.42 0.25 0.52 0.26 0.59 0.28 0.42 0.25 0.52 0.26 Cohen J AAN 2012: platform presentation 23
  • 24. CARE-MS II - Slowing Accumulation of Disability Time to SAD Rebif® HR 0.58 Lemtrada™ 12 mg/day Treatment effect 42% p=0.0084 21.1% 12.7% HR: Hazard Ratio SAD: Sustained Accumulation of Disability Cohen J AAN 2012: platform presentation 24
  • 25. CARE-MS II - Reversing Disability in Some Patients Mean EDSS Change from Baseline Rebif® Lemtrada™ 12 mg/day 0.24 p=0.0064 p<0.0001 ‒0.17 p=0.0044 EDSS: Expanded Disability Status Score Cohen J AAN 2012; platform presentation 25
  • 26. CARE-MS - Substantial Treatment Effect vs. Rebif®● Substantial treatment effect on relapse rate ● Meeting co-primary endpoint vs. active comparator in CARE-MS I & II● Statistically significant difference in Time to 6-month SAD in CARE-MS II ● No statistical significant difference in CARE-MS I due to unexpected low rate of sustained disability in comparator arm● Patients treated with Lemtrada® in CARE-MS II were more than twice likely to experience disability improvement over Rebif®● Statistically significant treatment effect on other efficacy endpoints in both CARE-MS I & II SAD: Sustained Accumulation of Disability 26
  • 27. CARE-MS Overview of Adverse Events (AE) CARE-MS I CARE-MS II Rebif® Lemtrada™ Rebif® Lemtrada™ SC INFB-1a 12 mg/day SC INFB-1a 12 mg/day (%) (%) (%) (%) Adverse Events Patients with events 92.0 96.0 94.6 98.4 Infections 45.5 67.3 66.3 76.8 Thyroid Disorders 6.4 18.1 5.0 15.9 Immune Thrombocytopenia 0.5 0.8 0 0.9 AEs leading to treatment withdrawal 5.9 1.3 8.9 3.2 AEs leading to study discontinuation 2.7 0 3.0 0.2 Serious Adverse Events Patients with serious events 14.4 18.4 21.8 19.5 Serious Infections 1.1 1.9 1.5 3.7 Deaths 0 0.3(1) 0 0.5(2) CARE-MS data on file, Genzyme Corporation (1) This death was due to a motorcycle accident (2) One death was due to a pedestrian accident and the other was due to an incident of aspiration pneumonia following a severe MS relapse 27
  • 28. CARE-MS - Well Characterized Safety Profile ● Infusion-associated reactions very common ● Premedication reduced/alleviated symptoms ● Infections common in both groups ● Predominantly mild to moderate, some serious ● Autoimmune events included thyroid disorders and immune thrombocytopenia ● Detected via routine monitoring and generally managed using conventional therapies 28
  • 29. - A Transformative Approach to MS Treatment● Ground-breaking efficacy results● Treatment effects across multiple endpoints● Manageable and consistent safety profile● Monitoring program successful at early detection of AEs● Favorable benefit/risk● Convenient annual dosing CARE-MS data on file, Genzyme Corporation 29
  • 30. Q&A SESSION 30