J.P. Morgan Cazenove Therapeutic Seminar

Transcription

1 Jannan, MS J.P. Morgan Cazenove Therapeutic Seminar David Meeker - CEO, Genzyme June 25, 2012

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 labelling 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, Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 2

3 Agenda 1. Key Highlights on MS Market & Genzyme 2. The Aubagio Opportunity 3. The Lemtrada Opportunity 4. Summary Aubagio is the trademark submitted to health authorities for the investigational agent teriflumomide Lemtrada is the trademark submitted to health authorities for the investigational agent alemtuzumab 3

4 KEY HIGHLIGHTS ON MULTIPLE SCLEROSIS MARKET & GENZYME 4

5 Global MS Market - Significant and Expected to Grow Key Multiple Facts Sclerosis about MS Multiple Sclerosis Market Global Sales (2,3) ~2.1m patients worldwide (1) Prevalent in young women (~2.1 female/male ratio) CAGR >6% $17.8bn 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 difficulties, vision problems ROW 44% 46% e (1) National Multiple Sclerosis Society (2) 2011: Reported sales of Copaxone, Avonex, Rebif, Betaseron/Betaferon, Extavia, Tysabri, and Gilenya (3) 2016e: Adapted from Evaluate Pharma report - December

6 Global MS Market - Still Dominated by ABCRE Products Key Facts about MS MS Therapies ABCRE products (1) represented 84% of the global MS market in value in Sales and Market Share in Value (2) $3,884m 31% Moderate efficacy and patients continue to relapse on therapy Require frequent injections $1,553m 12% $2,350m 19% Latest entrants represent treatment alternatives Drives the benefit vs. risk discussion $2,686m 21% $1,511m 12% $494m 4% $154m 1% (1) ABCRE stands for Avonex, Betaseron /Betaferon, Copaxone, Rebif and Extavia. Avonex is a registered trademark of Biogen Idec; Betaseron is a registered trademarks of Bayer Healthcare; Copaxone is a registered trademark of Teva Pharmaceuticals Inc; Gilenya is a registered trademark of Novartis; Rebif is a registered trademark of EMD Serono, Inc.; Tysabri is a registered trademark of Biogen Idec. (2) Reported sales of ABCRE products plus Tysabri, and Gilenya in

7 Emergence of a Franchise Addressing Individual Needs for People Living with MS Early MS/CIS (1) RRMS (2) and early active MS RMS (3) severe/ highly active Unmet need 1 Convenience & safety Unmet need 2 Convenience, efficacy & safety Unmet need 3 Efficacy with manageable safety Aubagio Aubagio Rebif Lemtrada (1) CIS Clinically Isolated Syndrome, TOPIC Phase III study presently ongoing (2) RRMS Relapse Remitting Multiple Sclerosis (3) RMS Relapsing Multiple Sclerosis 7

8 - Key Milestones Complete CARE-MS I Data Presentation CARE-MS II Data Presentation FDA & EMA Regulatory Submissions TEMSO Data Presentations TENERE/TOWER Headline Results FDA & EMA Regulatory Submissions 8

9 The Aubagio Opportunity 9

10 Once-Daily Oral Therapy Solid Reduction of Relapse Rates TEMSO STUDY Annualized Relapse Rate (1) TOWER STUDY Annualized Relapse Rate (1) % p= % p= n=363 n=359 n=388 n=370 Placebo Aubagio 14mg Placebo Aubagio 14mg (1) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account 10

11 First Oral Therapy to Show Positive Results in Two Phase III Trials TEMSO STUDY Reduction in Progression of Disability (1) TOWER STUDY Reduction in Progression of Disability (1) % (2) p= (3) -31.5% (2) p= (3) Placebo Aubagio 14mg Placebo Aubagio 14mg (1) At Week 108 (2) Derived using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates (3) Derived from log-rank test with stratification of EDSS strata at baseline and region 11

12 Interferon-like Efficacy Observed in TENERE Study TENERE STUDY Annualized Relapse Rate (1) No statistically significant difference in adjusted ARR between teriflunomide 14 mg and IFNβ-1a 26% with T. 14 mg 22% with IFNβ-1a p=ns n=109 Rebif n=104 Aubagio 14mg (1) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account 12

13 Safety and Tolerability Summary Manageable safety profile across Phase III trials: Headache ALT elevations Hair thinning/decreased hair density Diarrhea Nausea Neutropenia 13

14 An Exciting Potential New Oral Treatment for Multiple Sclerosis Interferon-like efficacy on relapse rate reduction First oral to show significance on disability in two Phase III studies Solid safety profile Convenient once-daily oral dosing Aubagio data on file, Genzyme Corporation 14

15 The Lemtrada Opportunity 15

16 CARE - Comprehensive Study Program CARE-MS I CARE-MS II Randomized Patients Study Duration 2 years 2 years Patient Population Treatment Arms Treatment naïve Alemtuzumab vs. Rebif Relapsed on prior treatment Alemtuzumab vs. Rebif CARE-MS Phase III program enrolled patients with relapsing-remitting multiple sclerosis 16

17 Significant Comparative Efficacy Results with Unique Annual Dosing Regimen CARE-MS I Annualized Relapse Rate CARE-MS II Annualized Relapse Rate % p< % p< n=187 n=376 n=202 n=426 Rebif Lemtrada Rebif Lemtrada 17

18 CARE-MS I - Strong Effect on Relapse Proportion of Relapse-Free Patients at Year 2 HR 0.45 P<0.001 Lemtrada 12 mg/day Rebif 78% 59% Coles AJ ECTRIMS 2011; platform presentation 18

19 CARE-MS II - Slowing Accumulation of Disability Time to SAD HR 0.58 Treatment effect 42% p= Rebif Lemtrada 12 mg/day 21.1% 12.7% HR: Hazard Ratio SAD: Sustained Accumulation of Disability Cohen J AAN 2012: platform presentation 19

20 CARE-MS II - Reversing Disability in Some Patients Mean EDSS Change from Baseline Rebif Lemtrada 12 mg/day 0.24 p= p< p= EDSS: Expanded Disability Status Score Cohen J AAN 2012; platform presentation 20

21 Slowing Accumulation of Disability Sustained for 6 months vs. Active Comparator Higher Hurdle For Illustrative Purposes (1) Active Comparators Typical Threshold for Approval Placebo 3 month EDSS 6 month Higher Hurdle (1) Based on CARE-MS II 21

22 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 statistically 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 effect on other efficacy endpoints in both CARE-MS I & II SAD: Sustained Accumulation of Disability 22

23 CARE-MS Overview of Adverse Events (AE) CARE-MS I CARE-MS II Rebif SC INFB-1a Lemtrada 12 mg/day Rebif SC INFB-1a Lemtrada 12 mg/day (%) (%) (%) (%) Adverse Events Patients with events Infections Thyroid Disorders Immune Thrombocytopenia AEs leading to treatment withdrawal AEs leading to study discontinuation Serious Adverse Events Patients with serious events Serious Infections Deaths (1) (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 23

24 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 24

25 - 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 25

26 - A Strong Commitment to MS Experience in developing innovative treatments for chronic disease Promising Multiple Sclerosis clinical development program Extensive global relationships with physicians, payers and patient advocacy groups Changing the treatment paradigm across the MS spectrum of disease 26

27 Q&A SESSION 27

28 APPENDIX 28

29 - Novel PK & PD Profile Humanized monoclonal antibody IV infusions administered in two courses: 12 mg daily on 5 consecutive days in the first year 12 mg daily on 3 consecutive days 12 months later Serum concentrations of Lemtrada are low or undetectable within ~30 days following treatment Leads to immunomodulation through depletion and repopulation Concentration (ng/ml) Serum concentrations (1) Months on Study (1) CARE-MS I data on file, Genzyme Corporation 29

30 - Selectively Targets Lymphocytes Selectively targets CD52 protein, depleting B and T cells responsible for MS inflammatory process White Blood Counts in MS patients (5) B and T cell repopulation begins within weeks and continues over time (1) Other white blood cells are minimally or transiently affected (2,3) Protective serum antibodies are unaffected (4) Cell Counts (10 9 /L) Months after Alemtuzumab Neutrophils Lymphocytes Monocytes Eosinophils Basophils (1) Coles AJ et al. AAN 2010; poster P (2) Hu Y et al. Immunology 2009;128: , Turner MJ, et al. ECTRIMS 2011; poster 791 (3) Coles AJ et al, AAN 2012; platform S (4) Coles AJ et al. Lancet 1999;354:1691-5, McCarthy CL, et al. ECTRIMS 2011; poster 781 (5) CARE-MS I data on file, Genzyme Corporation 30

31 - Rebalancing the Immune System A distinctive pattern of lymphocyte repopulation occurs over time (1) May reduce inflammatory processes in MS and have disease modifying effects Supported by up to three years durable efficacy after two short treatment courses (2) Percentage of CD4 + T Cells CD25 high Increased % of T Cells with T-Regulatory Phenotype (1) Healthy Control Pretreatment * * * Time in months *p<0.01 (1) Cox AL et al. Eur J Immunol 2005;35: , Hu Y et al. Immunology 2009;128:260-70, Havari E et al. ECTRIMS 2010; poster 424, Jones JL et al. Brain 2010;133: (2) Coles AJ et al. NEJM 2008;