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2010 - IR - Diabetes and Oncology


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Diabetes and Oncology IR Thematic Seminar

Diabetes and Oncology IR Thematic Seminar

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  • 1. Diabetes and OncologyIR Thematic SeminarSeptember 30, 2010 1
  • 2. Forward Looking StatementsThis presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Actof 1995, 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-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements aresubject to various risks and uncertainties, many of which are difficult to predict and generally beyond the controlof sanofi-aventis, 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 includeamong 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 whetherand when to approve any drug, device or biological application that may be filed for any such product candidatesas well as their decisions regarding labelling and other matters that could affect the availability or commercialpotential of such products candidates, the absence of guarantee that the products candidates if approved will becommercially successful, the future approval and commercial success of therapeutic alternatives, the Group’sability to benefit from external growth opportunities as well as those discussed or identified in the public filingswith the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “CautionaryStatement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the yearended December 31, 2009.Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or reviseany forward-looking information or statements. 2
  • 3. IntroductionChristopher A. ViehbacherChief Executive Officer 3
  • 4. Agenda Oncology Diabetes Overview of Oncology Business Sanofi-aventis Poised for Growth in Division and Next Wave of Diabetes Oncology Drugs Pierre Chancel, Senior Vice President - Debasish Roychowdhury, Senior Vice Diabetes Division President - Oncology Division Building up on a Strong Commercial Update on BiPar and Iniparib Presence Atul Dhir, CEO - BiPar Sciences Christoph Heinemann, Vice President, Strategy & Operations - Diabetes Division Beyond Iniparib: Additional Phase III Candidates and Early Clinical Today’s Commitments for the Stage Pipeline Treatments of Tomorrow Tal Zaks, Vice President, Head of Jochen Maas, Vice President, Research Development - Oncology Division & Development - Diabetes Division Concluding Remarks Concluding Remarks Debasish Roychowdhury, Senior Vice Pierre Chancel, Senior Vice President - President - Oncology Division Diabetes Division Q&A Session Q&A Session 4
  • 5. OncologyIR Thematic SeminarSeptember 30, 2010 5
  • 6. Overview of Oncology BusinessDivision and Next Wave ofOncology DrugsDebasish RoychowdhurySenior Vice President – Oncology Division 6
  • 7. Oncology – A Strategic Priority Cancer is a leading cause Unmet Medical Need of death globally(1) requiring new treatment options Cancer is the #1 reason for Impact on Society economic loss among the top causes of death(2) Tumors now characterized Innovative Science at the molecular level, treatments more personalized Taxotere® and Eloxatin® Strong Heritage are the foundation of chemotherapy  Sanofi-aventis is poised to maximize the opportunity and potential in oncology(1) Source: World Health Organization; cancer accounted for 7.9 million deaths in 2007(2) Source: The American Cancer Society and Livestrong report “The Global Economic Cost of Cancer” 7
  • 8. Our Strategy in Oncology is Based on Five Core Beliefs Innovative treatments - Proven substantial benefits are necessary Personalization - Biomarkers, patient stratification tools, and targeted therapies Environment shaping - Facilitating patient access to medicine Creation of more synergies - Integrate business functions into the Division External partnering - Embrace external innovation to leverage internal capabilities Cambridge, MA headquarters Vitry, France headquarters 8
  • 9. A New Approach to Developing Cancer Therapies From To Known targets Innovative targets Small molecules, biopharmaceuticals, nanodelivery Small molecules technologies, etc. First in class, best in class, differentiated by Best in class, differentiation classical superior efficacy and unmet need Common cancers, all comers Genetically stratified, smaller populations Monotherapy, add-on Combination therapies, factorial designs Minimal biomarkers, diagnostics, Translational medicine embedded trials imaging Internal discovery Externalization U.S. and EU centric Increased focus on Asia  Our Oncology Division is flexible in adapting to a fast changing environment 9
  • 10. Redefining our Oncology Presence Recruiting Talent Streamlining Governance More than 100 new R&D centers reduced Creation of a new hires to the oncology from 11 to 3 Oncology Review division in 2010 Board to optimize and Jevtana® NDA filed in Many key hires have about 4 months of prioritize oncology academia and biotech pivotal results versus investments backgrounds the industry average of Global Protocol Oncology Division will 6 to 8 months Review Committee also be based in Improved target established to Cambridge to benefit selection and the use of facilitate accelerated from networking with translational medicine filing timelines a leading scientific to reduce development Empowerment of community costs teams  Creating an empowered and agile Oncology Division 10
  • 11. Maximizing Value Through the Integration of R&Dand Commercial Activities Fully integrated in 9 key countries Sales & Marketing, R&D, Market Access, Medical affairs Improves speed to market Russia Facilitates collaborative decision making U.S. Japan Rest of world managed China through regional offices Creation of a biotech center of excellence in China Research and development centers France Spain Direct countries in Oncology Division Cambridge, MA Italy UK Oncology Division facilities Vitry, France Germany San Francisco, CA (BiPar) 11
  • 12. New Leadership TeamBroad, Diverse and In-Depth Expertise Christoph Lengauer Debasish VP & Head of Oncology Drug Discovery & Preclinical Roychowdhury Research SVP & Head of Oncology • Exec Dir & Sr Unit Head Oncology Division Discovery, Novartis Institute for • Drug development and Biomedical Research clinical development in • Adjunct Associate Professor of oncology & hematology at Oncology, Johns Hopkins University GSK and Lilly • Oncologist, hematologist Tal Zaks Atul Dhir VP, Head of Tamas Suto Development, CEO, BiPar Sciences VP & Head of Medical Oncology • President, Cancer Affairs, Oncology • Genetic Research Group, Research Group, US • Therapeutic Head for Head Oncology Clinical Oncology Haematology/Oncology & Research Team, Cephalon • VP Healthcare, Monsanto Head of International • Adjunct Associate • Consultant, McKinsey Medical Affairs, Amgen Professor of Medicine, University of Pennsylvania Alain Curaudeau John Harrington VP, Head of Strategy & VP & Chief Commercial Portfolio Management, Officer, Oncology Oncology • VP & Head US Oncology Division, • SVP, Project Planning & sanofi-aventis Management at QTL • VP Metabolism Business Unit, • Head of Project sanofi-aventis US Management, Aventis • VP Primary Care Sales, Aventis US 12
  • 13. Internal and External Expertise as well as Networksto be Maximized External projects to have the choice of using sanofi-aventis platforms or working directly with external partners Overall objective is to have BiPar at least 50% of projects externalized Bring in learnings and transform internal process PI3K Competitive funding process for internal and internal project external projects externalized project 13
  • 14. A Partner of Choice in Oncology Demonstrating our ability to add value Cutting-edge technical expertise Investigating novel-novel combinations Global execution and distribution, especially in Emerging Markets Providing access to a broad industrial platform and control over supply chain Allowing partner to develop and prosper Enabling partner to lead key activities Collaborating while partner develops and expands expertise Flexible deal structure Regeneron - - Exclusive option of co-development - Opportunity for partner to lead clinical development - Acquisition but with significant autonomy 14
  • 15. Emerging Markets – Executing a Local Approach Addressing regional differences in cancer epidemiology and biology Differences in incidence require regional approach to each indication Eloxatin®: Development of liver cancer indication for the China Estimated Cancer Incidence(1) Asia-Pacific region CHINA ESTIMATED CANCER INCIDENCE: BOTH SEXES, ALL AGES Lung Jevtana®: Asia-Pacific region to 522 lead development in gastric cancer Stomach 464 Creating basic research alliances Liver 402 regionally, especially North East Asia Oesophagus 259 Specific development plans for Colorectum 221 these regions - executed in parallel Breast 185 Synchronized submission timelines 0 100 200 300 400 500 Providing access through Thousands multi-tiered pricing strategies or Number of new patients (2008) risk sharing models(1) Source: GLOBOCAN 2008, IARC - 12.6.2010 15
  • 16. Maximizing the Emerging Markets Opportunity New indications in China Taxotere® Relative Pricing(1) HRPC(2) in 2010 200 Advanced gastric cancer in 2012 150 Head and neck cancer in 2014 Expand the gastric cancer 100 indication in other Emerging Markets 50 Pursue breast and prostate cancer 0 indications in India, Russia, and EU5 China Russia Brazil Brazil Sustainable global sales post EU/U.S. patent expiries expected to be around €500m(1) Pricing comparisons are adjusted to a baseline of 100.(2) HRPC: Hormone Resistant Prostate Cancer 16
  • 17. Leveraging Brand Equity Settlement of U.S. patent litigation U.S. Eloxatin® Demand Inventory workdown is U.S. Eloxatin® Demand (MGs in 000s)(2) (MGs in 000s)(2) 1,500 progressing Reimbursement for Eloxatin® 1,200 expected to return to levels seen Generic oxaliplatin prior to generic entry in early 900 2011 Planned growth drivers in China: 600 Advanced HCC(1) in 2011 300 Branded Eloxatin Liquid solution launch in 2012 Advanced Gastric cancer in 2014 - Jan-10 Feb-10 Mar-10 Apr-10 May-10 Jun-10 Jul-10 Adjuvant Gastric cancer in 2015Sustainable global sales post EU/U.S. patent expiries expected to be around €300m(1) HCC: Hepatocellular cancer(2) Source: IMS 17
  • 18. Pipeline Rebuild Underway…February 2009Before Portfolio Review Phase I Phase II Phase III Marketed SAR3419 AVE 1642 Jevtana® Maytansin-loaded anti-CD19 mAb IGF1R mAb Taxane - Tubulin inhibitor Taxotere® non-Hodgkin’s lymphoma Breast Cancer docetaxel Prostate cancer aflibercept Eloxatin® SSR97225 1L mProstate; 2L NSCLC; oxaliplatin Antimitotic agent 2L mCRC; ombrabulin Elitek® Aflibercept Vascular disrupting agent rasburicase Sarcoma larotaxel Taxane – Tubulin inhibitor Oforta® fludarabine phosphate Pancreatic, Bladder cancer xaliproden Neurotrophic peripheral sensory neuropathies alvocidib Cyclin-dependent kinase inhibitor CLL TroVax (SAR109659) Renal Cancer Project terminated (Feb 2009 to Sept 2010) aflibercept 1st line mPancreatic cancer 18
  • 19. Pipeline Rebuild Underway…September 2010Rich and Strong Portfolio Phase I Phase II Phase III Marketed SAR3419* aflibercept* iniparib Taxotere® Maytansin-loaded anti-CD19 mAb VEGF-Trap PARP inhibition docetaxel non-Hodgkin’s lymphoma 1st line colorectal cancer mTNBC; NSCLC SAR153192* SAR245408 (XL147) aflibercept* Oral PI3K inhibitor 1st line mProstate; Eloxatin® Anti-DLL4 mAb 2nd line NSCLC; 2nd line mCRC oxaliplatin Solid tumors Endometrial & breast cancer SAR566658* SAR256212 (MM121) ombrabulin DS6 Antibody-Drug Conjugate anti-ErbB3 mAb Aflibercept Vascular disrupting agent Jevtana® DS6 Positive Solid Tumors Sarcoma cabazitaxel Breast cancer SAR650984* iniparib Elitek® Anti-CD38 naked mAb PARP inhibition rasburicase Hematological malignancies Ovarian cancer SAR103168 SAR245409 (XL765) Oforta® Multikinase inhibitor Oral dual inhibitor of PI3K/mTOR Fludarabine phosphate AML Cancer SAR302503 JAK2 inhibitor Myelofibrosis New clinical project since February 2009* Biologic product 19
  • 20. Our Next Wave of Oncology DrugsMaximizing Late Stage Opportunities Iniparib Aflibercept Ombrabulin 20
  • 21. A New Cytotoxic Agent The molecule New semi-synthetic taxane Selected to overcome the emergence of taxane resistance(1) Mechanism of action Microtubule stabilizer(2) Prostate cancer Estimated new cases of prostate cancer in U.S. in 2009 =192,000; Deaths 27,360 575,000 new cases of Prostate Cancer diagnosed in Europe and U.S. yearly(3) mHRPC accounts for 15% of patients Taxotere® chemotherapy is the current standard of care in mHRPC After Taxotere® failure, Jevtana® is the only approved drug - supportive care, unapproved agents, or hospice are other treatment options No improvement in overall survival demonstrated with current therapies(1) Attard G, Greystoke A, Kaye S, De Bono J. Pathol Biol (Paris). 2006;54(2):72-84.(2) Pivot X, Koralewski, P, Hidalho JL, et al. Ann Oncol. 2008;19(9):1547-1552.(3) Ferley J et al. Eur J Cancer 2010 – American Cancer Society, Facts & Figures, 2009 21
  • 22. Overall Survival (ITT Analysis) from TROPIC Proportion 100 of Overall MP CBZP Survival (%) Median OS (months) 12.7 15.1 80 Hazard Ratio 0.70 95% CI 0.59–0.83 P-value <.0001 60 40 cabazitaxel+prednisone (CBZP) 20 mitoxantrone+prednisone (MP) 0 0 month 6 months 12 months 18 months 24 months 30 months mitoxantrone 377 300 188 67 11 1 + prednisoneNumber at risk cabazitaxel 378 321 231 90 28 4 + prednisoneSource: TROPIC data per the Jevtana product insert 22
  • 23. Most Frequent Treatment-Emergent AEsin ≥2% of Patients (Grade ≥3)(1): Safety Population MP (n=371) CBZP (n=371) All grades (%) Grade ≥3 (%) All grades (%) Grade ≥3 (%) Any adverse event 88.4 39.4 95.7 57.4 Febrile neutropenia 1.3 1.3 7.5 7.5 Diarrhea 10.5 0.3 46.6 6.2 Fatigue 27.5 3 36.7 4.9 Asthenia 12.4 2.4 20.5 4.6 Back pain 12.1 3 16.2 3.8 Nausea 22.9 0.3 34.2 1.9 Vomiting 10.2 0 22.6 1.9 Hematuria 3.8 0.5 16.7 1.9 Abdominal pain 3.5 0 11.6 1.9(1) Sorted by decreasing frequency of events grade ≥3 in the CBZP arm.2010 Genitourinary Cancers SymposiumProgress in Multidisciplinary Management 23
  • 24. Launch Exceeding Expectations Sales tracking ahead of other analogs(1) at a similar time post-launch Launch Analogs (Sales: 2-months post launch)(4) FY 2010 sales expected to be around €60m Reimbursement: 80% of Medicare carriers have made coverage decisions Minimal formulary restrictions by the vast majority of payors Majority of plan decisions are expected by early 2011 Adopted into the NCCN(2) and EUA(3) guidelines Safety profile since launch has been Jevtana Abraxane® Afinitor® Ixempra® Sprycel® Tasigna® consistent with the TROPIC trial(1) Factors in analog selection include 2L or 3L indication in smaller metastatic patient populations with unmet medical need(2) National Comprehensive Cancer Network(3) EUA: European Urology Association(4) Source: IMS NSP 24
  • 25. Global Rollout Beginning in 2011Europe Planned launch schedule* CHMP opinion expected in H1 2011 2010 2011 2012 380,000 new cases of prostate cancer annually 12% mortality rate About 25,000 to 30,000 cases are treated with chemotherapyEmerging Markets 2011: Brazil, South Korea planned launches 2012: Turkey, South Africa planned launches Russia filing submitted in Q3 2010 * non exhaustive 25
  • 26. New Indications to Drive Future Growth Jevtana® Development Opportunities Phase III study in first line prostate cancer to begin enrolling Q1 2011 Faster 2L mHRPC Study to include about 1,100 mHRPC patients Primary endpoint: superiority of Launch Timing 2L SCLC cabazitaxel(1) vs. docetaxel in OS Gastric Phase II second line small cell lung Asymptomatic cancer study to begin H2 2011 prostate cancer Early clinical work in asymptomatic prostate cancer to 1L mHRPC begin in 2011 Slower Phase I bridging study in Japan to begin Q4 2010 Weaker Stronger Probability of SuccessJevtana® global peak sales in 2L mHRPC expected to be in the range of €300m to €500mSize of circle represents relative patient population size Based on total U.S. incidence of cancer type (not specific patient segment)(1) Cabazitaxel doses of 25 mg/m² or 20 mg/m² will be studied 26
  • 27. Update on BiPar & Iniparib*Atul Dhir, CEO – BiPar Sciences*Iniparib is the United States Adopted Name (USAN) for the investigational PARP1 inhibitor, BSI-201 BiPar is a wholly owned subsidiary of sanofi-aventis 27
  • 28. The BiPar Model: A New Model for Drug Development Biotech Large Pharma Entrepreneurial Global Scale Flexible / Nimble Technical expertise / Depth Outsourced partners Process Discipline BiPar Model Building an innovative platform within sanofi-aventis to improve speed and efficiency in drug development BiPar is a wholly owned subsidiary of sanofi-aventis 28
  • 29. Iniparib: A novel anticancer agent Hypothesized Anti-Tumor Activity • Novel agent for treating tumors with DNA repair DNA defects Chemotherapy Damage • Small molecule: penetrates Tumor blood brain barrier(4) Chemotherapy Alone Chemotherapy Plus Iniparib • Expected to be combined safely with multiple PARP1 Facilitates DNA Repair DNA PARP1 Activity Inhibited chemotherapy agents(1) Repair Iniparib DNA Not • Clinical evidence for efficacy Repaired in advanced breast cancer • No significant side effects at recommended dosing(1,2,3)PARP: Poly ADP-Ribose Polymerase(1) Phase 1b ASCO ’08 poster presentation (2) Phase 1 ASCO ’08 poster presentation (3) Phase 2 mTNBC SABCS ’09 oral presentation(4) ASCO 2010 online abstract: Pharmacokinetics of BSI-201, a poly (ADP-ribose) polymerase-1 (PARP1) inhibitor, in cerebrospinal fluid (CSF) of a breast cancer patient with carcinomatous meningitis. Michael Castro, Lingyun Li, and Todd Stallings BiPar is a wholly owned subsidiary of sanofi-aventis 29
  • 30. Iniparib in mTNBC: Phase II Trial Interim Data (Overall Survival) OS, %OShaughnessy J, et al. SABCS 2009. Abstract 3122. Months BiPar is a wholly owned subsidiary of sanofi-aventis 30
  • 31. Rapid Progress in Development of iniparib in mTNBC mTNBC Population • Phase II study in mTNBC • Overall Survival advantage without added toxicity • Final results in ESMO (October 2010) • Phase III in mTNBC Breast Cancer • Completed enrollment in February 2010 • Regulatory submission planned for Q1 2011 in U.S. and Q2 2011 in EU • Clinical development in mTNBC started in Japan TNBC: 15% • New trials to explore new combinations, schedules, etc. started in mTNBC • Neoadjuvant trials initiated in the U.S. and EU U.S. ~14,000 and to lay the groundwork for adjuvant therapy EU: ~ 17,000 First, second & third line(4) in early TNBCReferences:(1) Carey L et al. JAMA. 2006;295:2492-2502. (2) Swain S. ASCO Annual Meeting. June 3, 2008. (3) Public epidemiology sources and company models(4) Public epidemiology sources and company models BiPar is a wholly owned subsidiary of sanofi-aventis 31
  • 32. Lifecycle Plan for iniparib Lead Indication First Wave Second Wave Squamous NSCLC Bladder Cancer Pancreatic Cancer Metastatic Triple Recurrent Ovarian Cancer Colorectal Cancer Negative Breast Early-Stage TNBC Small Cell Lung Cancer Cancer (mTNBC) HER2-/HR+ Metastatic Breast Head and Neck Cancer Cancer Glioblastoma Multiforme  Broad development plan in multiple cancer indications BiPar is a wholly owned subsidiary of sanofi-aventis 32
  • 33. The Squamous Non-Small Cell Lung Cancer Opportunity Lung cancer deaths in the U.S.: • Squamous NSCLC biologically an 222,520 in 2010(4,5) attractive target • PARP1 upregulation(1) Lung cancer • Associated with basal-like phenotype, similar to TNBC(2,3) • Evidence of DNA repair impairment of BRCA pathway NSCLC: • High frequency of microsatellite 80% instability • High unmet patient need Squamous cell: • Gemcitabine + Carboplatin commonly 25-30% used in NSCLC(1) Ossovskaya et al. Genes and Cancer, in pressDakir et al. Carcinogenesis 2008;29:2377 (2) Dakir et al. Carcinogenesis 2008:29:2377(3) Chu et al. Histopathology 2001;39:9 (3) Reis-Filho et al. Virchows Arch 2003;443:122(4) GLOBOCAN 2008 ( (5) American Cancer Society: Cancer Facts and Figures 2010. Atlanta, Ga: American Cancer Society, 2010. BiPar is a wholly owned subsidiary of sanofi-aventis 33
  • 34. The Development of Iniparib in Lung Cancer Phase 3 Squamous Lung Cancer Study (International) Status STAGE IV STAGE IV Gemcitabine Gemcitabine • Initiated in US in March 2010 1:1 Carboplatin Carboplatin Squamous Squamous • EU and ROW sites opening Cell Lung Cell Lung Cancer in Q4 2010 Cancer Gemcitabine Gemcitabine Carboplatin Carboplatin • Primary analysis: H2 2012 n=825 n=825 iniparib iniparib Phase 2 Non-Small Cell Lung Cancer Trial (EU only) STAGE IV STAGE IV Gemcitabine Gemcitabine • Initiated in EU in May 2010 Cisplatin Cisplatin Non-Small Non-Small 2:1 Cell Lung Cell Lung • Close to half of patients Cancer Cancer accrued Gemcitabine Gemcitabine Cisplatin Cisplatin • Primary analysis: H2 2011 n=105 n=105 iniparib iniparib BiPar is a wholly owned subsidiary of sanofi-aventis 34
  • 35. Iniparib Development in Recurrent Ovarian Cancer ~22K new diagnoses and ~15K High unmet need deaths in the U.S. in 20091 • Leading cause of death from gynecologic malignancy • Poor prognosis in advanced-stage disease Ovarian cancer Rationale and opportunity for iniparib • Preclinical activity of iniparib in ovarian cancer models(2) • Sporadic cancers associated with Platinum- BRCA1/2 dysfunction Sensitive: ~65% • PARP1 is upregulated in ovarian cancers(3) • Gemcitabine/carboplatin is established regimen in recurrent ovarian cancer(1) Jemal et al. CA Cancer J Clin 2009;59:225.(2) Ossovskaya et al. AACR 2008(3) Ossovskaya et al. AACR 2007 BiPar is a wholly owned subsidiary of sanofi-aventis 35
  • 36. Ongoing Phase 2 Studies in Recurrent Ovarian Cancer Phase 2 Platinum-Sensitive Ovarian Cancer (U.S.) StatusPlatinum-Sensitive • Initiated in Dec 2009Platinum-SensitiveRecurrent OvarianRecurrent Ovarian • Minimum 8 responses to Cancer Cancer proceed to Stage 2 Stage 1 Stage 1 Stage 2 Stage 2 Gem/Carbo + Gem/Carbo + (n=17) (n=17) (n=24) (n=24) • Stage 1 response iniparib iniparib threshold reached n=41 n=41 • Interim analysis: H1 2011 Phase 2 Platinum-Resistant Ovarian Cancer (U.S.) • Initiated in Dec 2009 Platinum-Resistant Platinum-Resistant Recurrent Ovarian Recurrent Ovarian • Minimum 4 responses to Cancer Cancer proceed to Stage 2 Stage 1 Stage 1 Stage 2 Stage 2 Gem/Carbo + Gem/Carbo + (n=23) (n=23) (n=25) (n=25) • Stage 1 response iniparib iniparib threshold reached n=48 n=48 • Interim analysis: H1 2011 BiPar is a wholly owned subsidiary of sanofi-aventis 36
  • 37. Conclusions• Iniparib is a leading anti-cancer agent with PARP inhibitory activity with a survival advantage in mTNBC and an excellent safety profile• Major progress has been made in developing iniparib in breast, lung and ovarian cancer• Iniparib regulatory submissions in the U.S. and EU on track for 2011• Iniparib has tremendous potential across multiple cancers both clinically and commercially BiPar is a wholly owned subsidiary of sanofi-aventis 37
  • 38. Beyond iniparib: Additional Phase III Candidates Early Clinical Stage PipelineTal ZaksVice President, Head of Development 38
  • 39. Aflibercept and OmbrabulinA Commitment to Targeting Tumor Vasculature Avascular Angiogenic Vascularized phase switch tumor Tumor Late stage initiation Dissemination Antiangiogenic approach: Vascular-disrupting approach:  Prevention of new  Disruption of  vessel growth microvessels  Chronic inhibition  Acute blood flow shutdown, extensive of neovascularization tumor necrosis aflibercept ombrabulin 39
  • 40. Aflibercept – Novel Anti-VEGF CandidateDifferentiated from Bevacizumab Partnered with worldwide Structure of VEGF Trap VEGF Trap: a fusion protein blocking VEGF, a well-validated anti-angiogenic approach Bevacizumab Aflibercept Humanized MAb All human amino acid sequences ~160,000 MW ~110,000 MW Kd = 400-1000pM Kd = 0.5pM (tighter than Only blocks primate natural receptors) VEGF-A Blocks all mammalian Forms Immune VEGF-A, as well as VEGF- Complex with B & PIGF VEGF-A Binds VEGF-A as monomer without Immune Complex formation 40
  • 41. Aflibercept – Development Program Phase / Study Indication Design # of patients Data Expected 1st line metastatic Phase II colorectal cancer 230 Final Analysis H2 2011 AFFIRM 2nd line metastatic Phase III colorectal cancer 1200 Final analysis H2 2011 VELOUR + FOLFIRI (folinic acid / 5-FU / irinotecan) XL147 (PI3K) 2nd line metastatic non- Phase III small cell lung cancer + 900 Final analysis H1 2011 VITAL Taxotere® 1st line metastatic Interim analysis H1 2011/ Phase III hormone resistant 1240 VENICE prostate cancer + Final analysis H1 2012 Taxotere® prednisone Three Phase III studies fully enrolled VELOUR study continues based on recommendation by IDMC(1)(1) IDMC: Independent Data Monitoring Committee. Recommendation of IDMC was announced in September 2010 41
  • 42. Ombrabulin – Most Advanced Vascular Disrupting Agent Good safety profile and encouraging signs of activity in Phase I/II(3) No QT prolongation(1) observed and very limited hematotoxicity Antitumor activity observed in combination with chemotherapy Complete Response observed in triple-negative breast cancer patient Antivascular effect demonstrated using DCE-US(2) No potential for “VEGF-rebound” effect 2 classes of Vascular Disrupting Agents with different molecular targets Tubulin-binders: Unidentified target: Ombrabulin Vadimezan (ASA404): Phase III Promising early NSCLC 1st line trial failed Fosbretabulin Phase II data at Plinabulin ASCO & ITC 2010(1) Toxic effect on ECG observed with some agents in the class(2) Digital Contrast Enhanced Ultrasound(3) Presented at ASCO 2010 42
  • 43. Ombrabulin Development Program Shut Down of Tumor Blood Flow(1) Mechanism of action and preclinical data Baseline support development in most solid tumors High unmet medical need in soft-tissue sarcoma after failure of standard therapy Orphan Drug status expected Around 30,000 patients in the U.S. and EU with soft-tissue sarcoma Pivotal Phase III study is more than 85% enrolled After cisplatin/ombrabulin On track for U.S. and EU filing in 2011 Two Phase II proof of concept trials in preparation 1st line NSCLC to start 2011 2nd line ovarian cancer to start 2011(1) DCE-Ultrasound images of an ovarian cancer patient treated in a combination Phase I trial; the red contour outlines the tumor mass. 43
  • 44. Early Clinical Stage Pipeline:Our Oncology Discovery Approach Cancer Target Drug Discovering drugs against1 common cancer pathways Pathogenesis Focus on antibody drug2 conjugates Leverage external3 complementary innovation 44
  • 45. Biological Importance of PI3K Pathway in Cancer PI3K pathway: Mutations that activate this pathway occur Tumor Fraction Mutated frequently in human tumors and promote tumor Colon 32% cell growth and survival(1) Activation of the pathway is associated with Brain 27% resistance to cancer therapies Gastric 25% Two drugs targeting this pathway in clinical development: XL147, XL765 Breast 8% Preclinical cancer research projects against PI3K Lung 4% alpha and PI3K beta Locations of Activating Mutations in the PI3K Gene E545K H1047R Tumor Fraction mutated Colon 74/234 (32%) Brain 4/15 (27%) Gastric 3/12 (25%) Breast 1/12 (8%) Lung 1/24 (4%) C2 8% 47% 33%(1) Parsons et al., Nature 436 (2005)Diagram Source: Samuels et al., Science 304 (2004) , Samuels et al., Cancer Cell 561 (2005) 45
  • 46. XL147 - Potentially First in Class As a single-agent Strong inhibition of the PI3K/AKT Genetic pathway Alterations Moderate inhibition of the ERK/MAPK pathway(1) Preliminary anti-tumor activity in XL147 NSCLC, adenocarcinoma, vaginal PI3K carcinoma Phase II program started AKT Evaluating combinations with mTOR standard of care and novel agents Rapalogs No apparent additive toxicity or PK Growth interaction Survival Resistance Upregulation of ERBB3 is seen in a cell line model treated with XL147(2)Maximum tolerated dose is 600mg(1) Demonstrated in all tumor samples at the maximum tolerated dose(2) Hanker, Translational Cancer Medicine Meeting, 2010 46
  • 47. XL147 - Clinical Activity Observed 54 year-old patient with vaginal cancer Sequential CT scans of the abdomen 32% interval reduction of a left para-aortic soft tissue mass in Cycle 8 14% overall tumor reduction in Cycle 6; 21% reduction in Cycle 8 Multiple prior treatments(1) Vaginal Carcinoma Baseline Cycle 8 – 200 mg XL147(1) Surgical resection, pelvic and periaortic radiation, cisplatin weekly, paclitaxel/carboplatin, and investigational therapies 47
  • 48. XL147 – Development Program Phase Indication Combination Agent Number of Patients MTD with expansion in NSCLC Phase I Single agent 125 Lymphoma in MTD expansion Ph Ib/II NSCLC in MTD expansion Erlotinib 35 Endometrial, ovarian, Carboplatin and Ph Ib/II 74 paclitaxel NSCL cancer XL147 Phase(PI3K) II 2nd line endometrial cancer Single agent 80 Refractory HER2+ metastatic Trastuzumab or Phase II 74 Breast cancer Trastuzumab/paclitaxel Refractory ER/PR+ metastatic Phase II Breast cancer Letrozole 62 Three Phase II studies enrolling patients Extensive biomarker work being performedMTD: Maximum Tolerated Dose 48
  • 49. XL765 - PI3K and mTOR inhibition Compelling mechanism of action that blocks two different enzymatic Genetic activities along the same pathway Alterations As a single agent: Strong impact on PI3K and mTOR XL147 XL765 pathway PI3K Effect on ERK/MAPK pathway Dose limiting toxicity: AKT transaminase elevation In combination: mTOR Combination with temozolomide in Rapalogs glioblastoma and with erlotinib in Growth lung cancer Survival Resistance Dose escalation ongoingMaximum Tolerated Dose is 50 mg BID and 90mg QD 49
  • 50. XL765 - Demonstrates Robust PI3K Pathway Inhibition “Proof of mechanism" obtained by demonstrating inhibition of the PI3K pathway in tumor biopsies from treated patients Inhibition of ERK pathway demonstrated 100 XL765: Average of Percent Pathway Inhibition(1) % Inhibition (+s.d.) 80 60 40 20 0 pAKTT308 pAKTS473 pERKT202/Y204 Ki67(1) pEBP1T70, pPRAS40T246 and pS6S240/S244 also evaluated – post-dose decreases of 68%, 52% and 84%, respectively; TUNEL staining increased on average 1.6 fold. Note: This table summarizes results from all patients assessed for tumor pharmacodynamic response. Data on file. ASCO 2010 presentation. N = 9 patients. 50
  • 51. XL765 - Development Program Phase Indication Combination Agent Number of Patients Solid tumors Lymphoma in Phase I Single agent 120 MTD expansion Ph Ib/II Glioblastoma temozolomide 110 Ph Ib/II NSCLC in MTD expansion erlotinib 110 XL765 + letrozole in refractory Phase II letrozole 62 (1) ER/PR+ Breast cancer Phase II study in ER/PR+ breast cancer enrolling patients Extensive biomarker work being performed(1) Estrogen Receptor / Progesterone Receptor positive 51
  • 52. MM-121 - A Novel ERBB3 Antagonist Sensitivity Analysis of Ligand-Induced ERBB3 Importance of the ERBB3 receptor Pathway Activation(1) Central signaling node in maintaining growth of tumor cells Key regulator of AKT driven pro- survival signals Implicated in the development of resistance to targeted and chemotherapeutic agents Key modes of action Blocks HEREGULIN binding to and subsequent phosphorylation of ERBB3 Inhibition of the cross talk between ERBB3 and ERBB1 or ERBB2 and consequent downstream activation of AKT(1) Science Signaling, Therapeutically Targeting ErbB3: A Key Node in Ligand-Induced Activation of the ErbB Receptor–PI3K Axis by Birgit Schoeberl, et al, 30 June 2009 52
  • 53. MM-121 Development Program Phase Indication Combination Agent Number of Patients Phase I Solid Tumors Single agent 55 Gynecological tumors, Phase Ib paclitaxel Phase Ib: 24 Ovarian cancer Phase Ib: 24 XL147 Ph Ib/II NSCLC Erlotinib (PI3K) Phase II: 240 Phase II ER/PR+ Metastatic breast Exemestane 130 Translational medicine program to identify biomarkers integrated into clinical trials Phase II proof of concept program launched in July 2010 Several other phase II studies to be initiated in the near future 53
  • 54. Targeting Key Signaling Pathways PI3K and HER3 ERBB family receptor tyrosine kinases, such as EGFR and HER2/neu, can be activated by mutations ERBB3 activates the PI3K pathway in response to HEREGULIN growth factors(1) Plans to conduct combination trials: MM-121 and XL147; MM-121 and XL765Source: Drug discovery approaches targeting the PI3K/Akt pathway in cancer C Garcia-Echeverria and W R Sellers, Oncogene 27: 5511–5526.(1) Science Signaling, Therapeutically Targeting ErbB3: A Key Node in Ligand-Induced Activation of the ErbB Receptor–PI3K Axis by Birgit Schoeberl, et al, 30 June 2009 54
  • 55. TG 101348 / SAR302503Highly Potent and Selective JAK-2 Inhibitor Molecular characteristics Myelofibrosis disease burden Orally available U.S. prevalence is about 14,000 Highly potent against wild-type Median survival is about 5 years and mutant JAK2 kinase AML(1) transformation is 5% to 20% JAK2 selectivity reduces potential Clinical signs: enlarged spleen, bruising, for off-target side effects bleeding, fatigue, shortness of breath, anemia JAK Selectivity Profile (2,3) JAK1 JAK2 JAK3 TYK2 SAR302503 105 3 1002 405 INCB 18424 3.3 2.8 428 19 SB 1518 1276 22 528 Not reported CYT 387 11 18 155 17(1) AML: Acute Myelogenous Leukemia(2) Measured by IC50, nM(3) Sources: SAR302503 – Cancer Cell. 2008 April; 13:311-320; INCB 18424 - Blood. 2010 Apr 15;115(15):3109-17; SB 1518 - Blood 2009 November; 114: 3905; CYT387 - Blood. 2010 June; 115(25):5232-40 55
  • 56. SAR302503 - Potentially “Best in Class” for Myelofibrosis Potential for “best in class” and for myelofibrosis disease transformation Major spleen reduction and improvement in constitutional B symptoms(1) Lack of spleen and cytokine rebound after missed dose or discontinuation Signs of potential for reversal of fibrosis Reduction in JAK2 mutant allelic burden (V617F) Significant Spleen Size Reduction Pre-treatment After 36 weeks of SAR302503(1) Fever greater than 38° C, drenching sweats, unintentional weight loss of >10% of normal body weight over a period of 6 months or less 56
  • 57. SAR302503 - Development Program Phase I dose escalation study in MF Generally well tolerated with manageable gastrointestinal Decrease in Palpable Spleen Size(1) effects, primarily at high doses 80 Manageable anemia observed 70 Percentage of Subjects 60 Once-daily dosing 50 In the expansion cohort, 36/43 40 patients continued on active 30 treatment for at least 12 months 20 Phase II in MF to start Q1 2011 10 0 Refractory Polycythemia Vera (PV) Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6 >/=50% 100% PV is driven by JAK2 mutations Phase II dose ranging to start 2011(1) ASH 2009: A Phase I Evaluation of TG101348, A Selective JAK2 Inhibitor in Myelofibrosis – Clinical Response is Accompanied by a Significant Reduction In JAK2V617FAllele Burden 57
  • 58. SAR3419 – Antibody Drug (DM4) Conjugate CD19 Target Specifically expressed on B lymphocytes Monoclonal antibody that binds specifically Except plasma cells to an antigen target found on a cancer cell Including early B cell progenitors (unlike CD20) Linker that keeps the Drug ~ cytotoxic agent CD19 expressed in nearly all ~ Drug attached to the antibody until inside a B-cell malignancies(1) Drug ~ cancer cell, where it becomes activated Potentially increased ~ Drug Highly potent cytotoxic effect against cytotoxic molecule lymphoid tumors but with lower toxicity Phase I - Two dose-ranging studies in patients with refractory/relapsed B-cell lymphoma (NHL) TED6828 (U.S.) completed; once every 3-weeks x 6 cycles TED6829 (France) underway; weekly for 8 weeksSAR3419 was created under a research collaboration with ImmunoGen, Inc.(1) Except Multiple Myeloma 58
  • 59. Our Early Stage Development Portfolio:Exciting, Novel and Embracing External Innovation XL147 is potentially a Blocking of ErbB-family Activity with long-term first-in-class PI3K signaling through the tolerability in patients inhibitor node of highest pathway with myelofibrosis sensitivity XL765 is first in class Potential for best-in-class with a unique mechanism Anticipated favorable based on biochemical of action combining PI3K safety profile to facilitate profile and emerging and mTOR inhibition combinations clinical data Discovering activators Combining targeting BiTE® antibodies of p53 to restore tumor capability of a mAb with combine targeting cell sensitivity to cytotoxic “warhead” cancer with activating treatment immune cells Early signs of clinical Novel approach of activity in lymphoid Potential for treating inhibiting protein- malignancies with both solid and protein interactions SAR3419 hematological cancers 59
  • 60. Concluding RemarksDebasish Roychowdhury, MDSenior Vice President, Global Oncology Division 60
  • 61. Strong Commitment to Success Built Delivered Established a nimble organization Two fast track designations Solid portfolio after rigorous pipeline Approval and launch of Jevtana® review Improved life cycle management Leveraged internal expertise and embraced external innovation Realized synergies and new efficiencies across the entire oncology Created networks with scientific division community Transforming Attracting Implementing a new approach to the Drawing top talent with diverse development of late stage and early background from industry and biotech, stage cancer treatments academia Altering governance structures to Translating research findings from support innovative work environment academia to developing cancer drugs Changing attitude Creating new models for biotech alliances 61
  • 62. Q&A Session 62
  • 63. DiabetesIR Thematic SeminarSeptember 30, 2010 63
  • 64. Sanofi-aventis Poised for Growthin DiabetesPierre ChancelSenior Vice President - Diabetes Division 64
  • 65. A Strong and Experienced Team Presenting Today Pierre Chancel Senior Vice President Diabetes Division • Senior VP Global Marketing & Access, sanofi-aventis • Managing Director, Aventis UK & Ireland • VP Metabolism Worldwide, Aventis Jochen Maas Christoph Heinemann Vice President Vice President Research & Development, Strategy & Operations, Diabetes Division Diabetes Division • Vice President , R&D Europe • Director Marketing & Access, • General Manager, sanofi-aventis Germany R&D sanofi-aventis • Director Metabolism Business Units, Deutschland GmbH sanofi-aventis Germany • Professor at Gießen-Friedberg • Director Strategy & Business University of Applied Sciences Development, sanofi-aventis Germany 65
  • 66. Diabetes Burden Expected to Increase Dramatically Emerging global epidemic Diabetes Prevalence of diabetes (in million patients) More than 285m people 260 +48% worldwide are living with diabetes 240 Each year another 7m 220 % Growth over 2010-2020 people develop diabetes 200 2010 Diabetes causes about 5% 180 2015 2020 of all deaths globally each 160 +30% year +26% 40 +8% Diabetes deaths are likely 20 to increase by more than 50% in the next 10 years BRIC-M U.S. EU Japan Top 5Source: WHO, Multiple sources and internal estimates 66
  • 67. Diabetes is Associated with MultipleMicro and Macrovascular ComplicationsMicrovascular Complications Macrovascular Complications Risk of complications and HbA1c Relative risk in % Stroke Diabetic Retinopathy 25% of all ischemic 15 strokes are due to Leading cause of blindness Retinopathy diabetes alone or with in working-age adults 13 Nephropathy hypertension Neuropathy 11 Microalbuminuria 9 Diabetic Nephropathy Heart Disease Leading cause of mortality Leading cause of end-stage 7 in patients with Type 2 renal disease diabetes 5 3 Diabetic Neuropathy 1 Peripheral Leading cause of diabetic foot Vascular Disease 6 7 8 9 10 11 12 Leading cause of non- syndrome and non-traumatic HbA1c (%) traumatic lower-extremity lower-extremity amputations amputations Endocrinol Metab Clin 1996;25:243 - 254 (DCC Trial)Harris MI. Clin Invest Med 1995;18:231–239; Nelson RG et al. Adv Nephrol Necker Hosp 1995;24:145–156; World Health Organization 2002;Fact Sheet N° 138. 67
  • 68. Significant Unmet Needs in Diabetes U.S. and EU Countries BRIC-M Countries “Treat to Target”(1) Diagnosis(2) % of (in million patients) patients Recommended 50 HbA1c Target 45 165 40 42 58% 67% 35 37 above target undiagnosed 30 25 20 71 15 (43%) 10 13 5 4 4 0 <7% 7-8% 8-9% 9-10% >10% Diabetes Patients Diagnosed PatientsHbA1c – Glycated hemoglobin(1) Adelphi Disease Specific Program (DSP) III and VII (sample of over 10,000 diabetic patient records) (2) Multiple sources and internal estimates 68
  • 69. A Rapidly Changing Market 1990-2000 2000-2010 2010-2020 • Numerous novel drugs & regimens • Metformin / Sulfonylurea • Metformin / Sulfonylurea • New insulin forms, low-cost insulin Therapies • TZDs, GLP-1s, DPP-IVs analogs • Insulin • Insulin analogues / Lantus® • Disease modifying & regenerative medicine • Earlier insulinization • Holistic approach to diabetes care • 1 to 2 OADs Treatment • Late insulinization • More drugs in treatment • Identification of patientapproaches algorithms subpopulations • Premixed insulins • Disposable pens • Advances in insulin pump therapy • Disease management program • Broader role of PCPs offerings to payers Business • Insulin: Specialists • Higher regulatory hurdles • Cost-value relationship key to models • OADs: Primary Care Physicians • Greater market access decision challenges • Growing role of new players (e.g. telecom, digital media, nutrition) • Skyrocketing prevalence in Asia, • China the future largestGeographies • U.S. / Europe Latin America and the diabetes market in the world Middle-EastTZDs – Thiazolidinediones GLP-1s – Glucagon-like peptide 1 agonists DPP-IVs – Dipeptidyl peptidase-4 inhibitors OADS – Oral antidiabetic agents 69
  • 70. Diabetes Remains One of the Largest GrowthOpportunities in the Healthcare Space One of the fastest growing markets Global Diabetes Market(1,2) Outgrew pharma market by 5 pp between 2004 and 2010 €bn CAGR 50 +8% 48 A €33bn market projected to reach close to €50bn by 2015 Devices +7% 40 Multiple drivers for growth CAGR +9% 33 1% > 300m clinically obese people +1 globally(3) 30 Insulins & injectables 6% 5% Aging population + 20 20 Sedentary lifestyle +1 +4% Unhealthy diet +7 % 10 OADs Improved screening and earlier diagnosis 0 2004 2010e * 2015e *(1) IMS MIDAS Q2 2010, internal analysis (2) Multiple sources, internal estimates (3) WHO, “Global Infobase” 2010 and International Obesity Task Force (IOTF) 70
  • 71. Sanofi-aventis Has a Well Established Global Presencein Diabetes U.S. Western Europe Diabetes sales in 2009: €858m, +6.6% Diabetes sales in 2009: €1,972m, +23.8% Diabetes market share 19.4% Diabetes market share 17.1% Rank #2 Rank #2 52.4% 22.8% Emerging Markets Diabetes sales in 2009: €621m, +25.0% Diabetes market share 13.9% Rank #2 16.5% FY 2009 sanofi-aventis Rest of World diabetes sales Diabetes sales in 2009: €313m, +24.0% €3,764m Diabetes market share 13.6% 8.3% Rank #3 +19.4%Net sales growth is at constant exchange rate Market share in Diabetes market: IMS MIDAS MAT June 2010W. Europe: France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, DenmarkEmerging markets: World less North America (USA, Canada), Western Europe, Japan, Australia and New ZealandRoW: Japan, Canada, Australia and New Zealand 71
  • 72. : Strong Backbone for Sanofi-aventis A solid heritage Sanofi-aventis Sales in Diabetes : Still an opportunity for €bn 5 entry in volume markets : Remains a reference in 4 emerging markets and Japan CAGR 16.3% A success story based on innovation 3 : Our flagship brand # 1 insulin brand worldwide 2 # 1 anti-diabetic drug worldwide(1) : Add-on to Lantus® 1 in basal-bolus regimen Two award-winning pen devices 0 2005 2006 2007 2008 2009 H1 2010 Lantus® Apidra ® Insuman® Amaryl®(1) IMS MAT June 2010 72
  • 73. On Track to Deliver on our Ambition Global Diabetes Sales €bn 6 x2 4 2 0 2007 2008 2009 2010 2011 2012 2013 ® ® ® ® Lantus Apidra Insuman Amaryl 73
  • 74. Our Growth Drivers over 2010-2015 Potential further change to the treatment paradigm of type 2 diabetes BG StarTM Significant value added offering beyond glucose measurement i-BG Star® Competitive profile now emerging for lixisenatide within theLixisenatide growing GLP-1 segment Family Lixisenatide/Lantus® combination expected to offer good fasting and post-prandial glucose control Emerging Positioned to offer a full set of solutions to a fast growing Markets diabetes patient population Pipeline Covering the full treatment options to adress unmet needs inIn-Licensing diabetes 74
  • 75. Becoming the 360° Partner DeliveringBest-in-Class and Integrated Diabetes Solutions Disease management Blood Glucose Patient education Monitoring ® TM (BGStar , iBGStar ) Nutrition Reusable (ClikSTAR®) Oral therapies ® ® (Amaryl , Amaryl M ) Disposable (SoloSTAR®) Insulin & other injectables ® ® Pump (Lantus , Apidra , Regenerative lixisenatide) medicines 75
  • 76. One Global Diabetes Division:Delivering on Sanofi-aventis’ Ambition in Diabetes A global organization focused on diabetes leadership and innovation Headquartered in Frankfurt Objective to become the first global diabetes care company Integrated structure comprising all key functions working on diabetes R&D, Device Development, Medical Affairs, Commercial Operations and Business Development Direct responsibility for 12 markets (U.S., France, Germany, UK, Italy, Spain, Brazil, Mexico, China, Russia, India and Japan) 76
  • 77. Strong In-House Manufacturing Capabilities World-class integrated insulin- dedicated site in Frankfurt Active ingredient production, vials and cartridges filling, pen assembly & packaging Demonstrated ability to build innovative and competitive device solutions Fast track industrial projects in emerging markets Local insulin manufacturer acquired in Orel, Russia in 2009 Plant to manufacture Lantus® SoloSTAR® in Beijing, China, in 2012 77
  • 78. Diabetes R&D Pipeline Continues to Build Lixisenatide novel once-daily GLP-1 agonist in late phase III Competitive profile vs. other once-daily GLP-1 products Promising combination with Lantus® Devices to become strategic priority across the portfolio Blood glucose monitoring: Partnership with Pipeline expanding into novel classes via external innovation Potential first-in-class New powerful weapon New human peptide GPR119 receptor agonist to lowering LDL for islet neogenesis acting on both insulin cholesterol and secretion and GLP-1 CV risk release 78
  • 79. Building on aStrong Commercial PresenceChristoph HeinemannVice President, Strategy & Operations - Diabetes Division 79
  • 80. Sanofi-aventis Well Positioned to Sustain Growth in theFastest Growing Diabetes Market Segment Strong Historical Performance Global Injectables Sales in the Injectable Market(1) Expected to Grow Double-Digit(2) Share of Sales €bn 2550% 21 2040% CAGR 15 +11%30% 1220% 1010% 5 0% 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010e * 2015e * Sanofi-aventis Novo Nordisk Eli Lilly Insulins GLP-1s(1) Source: IMS Data (2) MS MIDAS Q2 2010, internal analysis 80
  • 81. A Portfolio of Four Marketed BrandsSupporting Growth 4 200 3 150 Net Sales (€bn) Net Sales (€m) 2 100 1 50 0 0 2005 2006 2007 2008 2009 2005 2006 2007 2008 2009 700 200 600 150 500 Net Sales (€m) Net Sales (€m) 400 100 300 200 50 100 0 0 2005 2006 2007 2008 2009 2005 2006 2007 2008 2009 81
  • 82. Strong Sales Evolution across all Geographies U.S. Western Europe 2 1000 800 1,5 Net Sales (€bn) Net Sales (€m) 600 1 400 0,5 200 0 Lantus® 0 2005 2006 2007 2008 2009 2005 2006 2007 2008 2009 Apidra® Insuman® Amaryl® Emerging Markets Rest of World 800 400 600 300 Net Sales (€m) Net Sales (€m) 400 200 200 100 0 0 2005 2006 2007 2008 2009 2005 2006 2007 2008 2009 82
  • 83. #1 Diabetes Brand Worldwide 4 Worldwide Rank of Leading Diabetes Brands #1 MAT June 2010 (€bn) 3 2 1 0 Lantus® Actos® Januvia®/ Accu-chek®* Novorapid® One Touch®* Humalog® Novomix® Levemir® Avandia® Janumet®* Includes meters and strip test products salesSource: IMS Data and Boston Biomedical consultantsWorldwide MAT June 2010 Diabetes Products Quarterly Review (data converted to € using 1.3$/€) 83
  • 84. Leading the Treatment Paradigm Shift towards Basal Insulin Global Insulin Market Share Lantus® Owns 2/3 of the by Class(1) Global Basal Market(1) Market share by type of basal insulin50% 70% 66% 44% 60% 54%40% 37% 50% 33% 33% 41%30% 40% 30% 23% 30%20% 20% 17%10% 17% 10% 3%0% 0% 2005 2006 2007 2008 2009 2005 2006 2007 2008 2009 Short Acting Premix Basal Lantus® Levemir® NPH(1) IMS Data 84
  • 85. China: Strong Growth due to and Top 8 Companies in Diabetes(1) Diabetes center of excellence Diabetes Market Share (%) MAT Growth Addressing need for medical vs. last year education 40% 60% 55% Train 10,000 healthcare 50% providers within 3 years 30% Significant clinical development 40% ORIGIN study: >450 patients 20% 30% from China Lantus® and Amaryl® Phase IV 20% trials 10% 10% Lixisenatide: participation in GetGoal program 0% 0% Partnerships with Chinese Diabetes Society S er SK tis er y sk ng M ill ay vi en di G B do iL r B or Se av El ua N fi - H o noov u ho saN gz an H(1) IMS CHPA MAT June 2010 85
  • 86. Brazil: Diabetes Leadership for Several Years Sales in the Brazilian Retail Market(1) Highly skilled sales force Sales (€m) 70 at specialist and GP levels Sanofi-aventis Long-term commitments 60 Novo Nordisk to medical education Eli Lilly 50 Full portfolio offer including Lantus® and 40 Amaryl® 30 High level of service to health-care system 20 (nurses, web, point-of-care) 10 0 2007 2008 2009 2010(1) IMS MAT June 2010 86
  • 87. Lantus Cornerstone in Treatment Guidelines Well-Established in ADA and Well-Established to Partner EASD Consensus Statement with Other Agents Tier 1: Well-Validated Core Therapies Approved Partner Studies Note indication Lifestyle Lifestyle + MET intervention + + Intensive Metformin   (1) – (5) At diagnosis Basal Insulin insulin Lifestyle Sulfonylurea   (1) – (5) + MET Lifestyle + MET Glitazones   Pioglitazone(5) + SU DPP-IVs   Sitagliptin(6,7) Exenatide(7,8) GLP-1s --  other studies Tier 2: Less Well-Validated Core Therapies running (1) Schreiber SA, et al. Diabetes Obes Metab 2007;9(1):31-38 (2) Schreiber SA, et al. Diabetes Technol Ther 2008;10(2):121-127 (3) Pfohl M, et al. ISPOR 2008 (4) Riddle M, et al. Diabetes Care 2003:26(11):3080-3086 (5) Reviewed in:Eskesen S, et al. Fam. Pract. 2006 Nov;55(11):1001-1003Adapted from D.M. Nathan et al. Diabetes Care (2009) 32 (1):193-203 (6) Arnolds S, et al. Diabetes Care July 2010 33:1509-1515ADA – American Diabetes Association EASD – European Association for the Study of Diabetes (7) Buse J, ADA 2010 (8) Bergenstal RM, EASD 2010 87
  • 88. Lantus Use Has Led to Earlier Insulinization EU U.S. Patients Patients on insulin on insulin60% 60%50% 50%40% 40%30% 30%20% 20%10% 10% 0% 0% 1-2 years 3-4 years 5-6 years 7-8 years 9-10 >10 1-2 years 3-4 years 5-6 years 7-8 years 9-10 >10 years years years years 2000 2010 2000 2010 Time from Diagnosis Time from Diagnosis Type 2 diabetes and specialists only Source: Adelphi DSP 88
  • 89. The ORIGIN Study Has the Potential to Change the Landscape of Type 2 Diabetes Treatment Endpoints: CV morbidity/mortality Patients at high CV risk and IFG, IGT +/- ω-3 PUFA All-cause mortality or newly detected diabetes Risk of diabetic or established diabetes Other agents for microvascular outcomes (on 0 or 1 oral agent) glycemic control Rate of progression of IFG +/- ω-3 PUFA or IGT to type 2 diabetes Intermediate Hyperglycemia an important predictor of diabetes and CV risk 2-fold increased risk of diabetes when both IFG and IGT are present(1) IGT a marker for both increased risk for diabetes and CV disease(1) More than 4 m people with early diabetes in the U.S. and top 5 EU countries(2)(1) Metabolic Disorders Study, Decision Resources, 2010 (2) GfK 2008 & Roper Global Diabetes Report. (Early diabetes: Type 2 diabetes patients with CV risk and on diet & exercise or 1 OADORIGIN: Rationale, design, and baseline characteristics in Gerstein HC, et al. Am Heart J 2008;155:26–32PUFA – Polyunsaturated fatty acids IFG– Impaired fasting glucose IGT– Impaired glucose tolerance 89
  • 90. Strong and Sustainable Platform for the FutureInsulin analogues are biological products Lantus® to Become Part Biotechnology-derived proteins of an Integrated offerLantus® covered by compound patentin key countries until November 2014 6-month pediatric exclusivity granted in the U.S. until February 2015 (pediatric study underway in EU)No specific regulatory pathway Patientcurrently established Support U.S.: Under consideration EU: Guidance only for biosimilar human soluble insulin since Medical June 2006 EducationProduction capacity to meet marketdemand an important factor Continuous COGS improvement Life-cycle management 90
  • 91. Blood Glucose Monitoring Market is a HighlyAttractive Market More Than 80% of Strips are Used Market Offers Sustainable Growth(2) by Insulin Patients(1) No Generics Strip €bn Strip Usage Pyramid usage 12 CAGR (2005-2015e): 10.8 % 8% 10 8 6.8 7.4 Pump 6.6 5.7 Users 6 5.0 4.7 65% Intensive 4 Insulin Users 2 Conventional 23% Insulin + Basal 0 05 06 07 08 09 E E E E E E 11% 10 11 12 13 14 15 OAD Users ± GLP-1 20 20 20 20 20 20 20 20 20 20 20 BGM Market Sales Forecasts Diet & Exercise (No drugs) 1%(1) Proprietary Market Research(2) Source: Sanofi-aventis analysis using data from Boston Biomedical consultantsWorldwide Q1:10 Diabetes Products Quarterly ReviewSales 2010-2015=$69,248bn  data converted to € using 1.3€/$ 91
  • 92. Strong Partnership with Co-Development of innovative Consenus Error Grid Devices & Strips iBGStarTM Meter (mg/dL) 600 Supply via Commercialization through 500 sanofi-aventis 400 Co-exclusive access to patented Dynamic 300 ElectrochemistryTM 200 New levels of accuracy 100% iBGStarTM in highest accuracy area(1) translating into higher patient 100 safety No-coding, fully compliant 0 0 100 200 300 400 500 600 with FDA requirements Reference: YSI 2300 (mg/dL) (no GDH-PQQ )GDH-PQQ – Gglucose dehydrogenase pyrroloquinoline quinoneSource: AgaMatrix(1) Parkes, J.L., et al Diabetes Care; 23:1143-1148, 2000. 92
  • 93. Leading Innovation TowardsMobile Diabetes Management • First meter to connect to iPhone and iPod touch • Easy-to-use, no-coding • Discreet design • Applications to support Disease ManagementCE mark and 510 k submission planned in Q4 2010 for iBGStarTM 93
  • 94. Smartphone Platform ProvidingSuperior Applications for Patient Self-management Distribution of Smartphone Users Among Diabetes Population (U.S. estimates) million 14 12 3.1 10 2.6 65+ 8 2.0 45-64 6.5 6 1.5 5.3 20-44 4.1 4 1.1 3.1 2 2.1 4.1 2.6 3.3 1.3 1.9 0 2010 2011 2012 2013 2014 • Electronic logbook for blood glucose, insulin dose and carbohydrates • Color-coding for hypo-hyperglycaemia Smart phone usage of diabetic patients increasing from 17% today to 46% in 2014 • Seamless data exchange & communication Sources: AdMob Mobile Metrics Highlights May 2010, Gartner Mobile Trends 2010,CE mark and 510 k submission planned in Q4 2010 for iBGStarTM International Diabetes Federation website 94
  • 95. Designed by Listening to Patients Mini-USB for data Mini-USB for data transfer to PC transfer to PC Meal-time tagging Meal-time tagging for glucose patterns Easy-to-use meter Easy-to-use meter for glucose patterns No coding Positive feedback Positive feedback No coding Large, backlit display Large, backlit display Patented Dynamic Electrochemistry® for assured accuracy Integrated Support Services24h / 7d for Insulins, SoloSTAR® / ClikSTAR® and iBGStarTM 95
  • 96. All Elements in Place for Successful BGM Market Entry Advanced technology: Launches in U.S., Germany and Expertise with pen devices France early Q1 2011 Further roll-out across Europe Strong commercial presence in 2011 Physicians, nurses, pharmacies Asia and Latin America launches planned for 2012 Business model leveraging synergies Diabetes sales forces for HCPs DTC for patients Distribution: Wholesalers, pharmacy CE mark and 510K obtained for and mail-order BGStar® Customer service integrating Lantus® CE mark and 510 k submission planned in Q4 2010 for iBGStarTM Revenues on sales of strips Positive halo effect expected on Lantus® and other products 96
  • 97. BGStar® and iBGStarTM: Introductory video 97
  • 98. Today’s Commitmentsfor the Treatments of TomorrowJochen MaasVice President, Research & Development - Diabetes Division 98
  • 99. Holistic Approach to Innovation in DiabetesInnovative Improvement of + Risk Factorsthe Classical Paradigm • Lipid disorders• New drug combinations • Obesity• New modes of action • Metabolic syndrome• New insulins + Diagnosis and Devices • Monitoring Diabetes • Delivery (pen devices, pumps) + Late Manifestations • Microvascular complications • Macrovascular complications  Pre-Diabetes and Diabetes are the “entry” into multiple diseases 99
  • 100. Diversity of Targets to Address Unmet Needs inDiabetes – Five Main Pillars for R&D Less Morbidity, Better Quality of Life, “More Value for Money” Short-Mid Term Win Long-Term Win Improve on Towards artificial Correct metabolic Address -cell Protect classical paradigm pancreas dysfunction defect end-organs • Extended drug action Development of • Mimic caloric • Protect/improve - • Microvascular • Combinations closed-loop system restriction cell function complications: • Improved devices •Continuous glucose • Target mitochondria • Preserve/increase - Nephropathy • Safer compounds sensors dysfunction cell mass Neuropathy •Insulin pumps, IT • Address lipid • Replace -cell pool Limb ischemia • Disruptive device and control algorithm dysfunction (lipid via regeneration, technology Retinopathy •Short-acting toxicity, dyslipidemia, cell or gene therapy • New superior insulins Wound healing insulins and NAFLD/NASH) • Cost-effective • Address vascular and • Macrovascular glucagon analogues solutions cardiomuscular complications: metabolism CAD / MI dysfunction Stroke Clinicians Health Care Providers Patients Payers NAFLD – Non-Alcoholic Fatty Liver Disease NASH – Non-Alcoholic Steato Hepatitis 100
  • 101. Worldwide Connected Network ofSelected Partners U.S. EUROPE ASIA Corporate Partners Corporate Partners • AgaMatrix • Genfit, France Corporate Partners • CureDM • Huya, China • Regeneron • Zealand Pharma, Denmark • Wellstat • Metabolex Academia/Consortia • AVIESAN (Alliance Nationale pour les Sciences de la Vie et de la Santé), France • IMI (Innovative Medicines Initiative) / IMIDIA (Innovative Medicines Initiative Diabetes project), EU • Institut de la Vision, France • Charité - Universitätsmedizin Berlin, Germany • Juvenile Diabetes Research Foundation (JDRF), WW Academia Academia • California Institute of Technology • SIBS (Shanghai Institutes for • Salk Institute for Biological Studies Biological Sciences), China • Burnham Institute 101
  • 102. Already a Significant Expansion of the DiabetesR&D Portfolio Pipeline Products in Development Status Update lixisenatide (AVE0010) Planned submissions for EU and Japan in GLP-1 agonist Type 2 diabetes H2 2011 and for the U.S. in H2 2012 Phase III Lantus® Insulin glargine ORIGIN study results expected in 2012 Reduction in CV morbidity & mortality SAR260093 (MBX-2982) GPR-119 agonist Phase IIa study results expected in Q4 2010 Type 2 Diabetes Phase II SAR176975 (PN2034) Evaluating preclinical observations and Insulin sensitizer Type 2 diabetes performing additional preclinical work lixisenatide + Lantus® GLP-1 agonist + insulin glargine Type 2 diabetes Investigated as “free combination” in Phase III Phase I SAR236553 (REGN727) Anti-PCSK9 mAb Initiation of Phase II expected in H1 2011 HypercholesterolemiaPartners: Lixisenatide (AVE0010)/Zealand Pharma – SAR176975 (PN2034)/Wellstat Therapeutics – SAR260093 (MBX-2982 )/Metabolex – SAR236553 (REGN727)/Regeneron 102
  • 103. Lixisenatide: A New GLP-1 to Overcome Limitations of Standard Type 2 Diabetes Treatments Current Therapy Limitations GLP-1 Actions • Risk of hypoglycemia • Low risk of hypoglycemia • Inadequate PPG control • Pronounced effect on PPG • Weight gain • Weight loss • Specific adverse events • Good safety profile • Progressive ß-cell failure • ß-cell preservation effect (animal models) Lixisenatide • Modified exendin-4 molecule • SIP® technology • Half life ideal for once daily dosingPPG – Post-Prandial Plasma Glucose 103
  • 104. Lixisenatide: Promising Profile in Phase IIb Good effect on HbA1c, HbA1c (%) (Baseline mean HbA1c: 7.55%) postprandial glucose levels and 5 10 20 30 μg μg μg μg placebo weight loss 0 Change in HbA1c at -0.2 Favorable gastrointestinal Week 13 -0.4 tolerability profile (nausea, -0.6 vomiting or diarrhea) -0.8 AVE0010 QD Dose Convenient once-daily subcutaneous injection Mean Body Weight (kg) Clear dose-effect relationship (Baseline mean weight: 89kg) 20 μg once-daily selected for 5 10 20 30 placebo μg μg μg μg phase III 0 Change in Weight at -1 Week 13 -2 -3 -4 AVE0010 QD DoseRatner R, Poster 433P, ADA 200813-week, multicenter, randomized, placebo-controlled, parallel-group study in metformin-treatedpatients (52-56 patients/group) – Results of 5, 10, 20, 30μg BID not given in above charts 104
  • 105. Phase III Program Covers Multiple Treatment Paradigms Study Objective # of Patients Program fully enrolled(1) Monotherapy GETGOAL-MONO 360 All studies expected to be completed and analyzed in GETGOAL-M Dose flexibility 680 2010 or 2011 Titration regimen (1 or 2-step titration) GETGOAL-F1 450 Lixisenatide given 20 µg once-daily for 24 weeks(2) GETGOAL-S Efficacy on top of SU (+ MET) 855 Long-term study extensions Efficacy on top of pioglitazone GETGOAL-P 450 included (+ MET) Head-to head vs. exenatide First results available for GETGOAL-X (+ MET) 600 Efficacy on top of basal insulin GETGOAL-MONO GETGOAL-L (+ MET) 450 GETGOAL-L Asia GETGOAL-L Efficacy on top of basal insulin 300 Asia (+ SU) Phase II/IIIb studies initiated GETGOAL-MONO Monotherapy 66 Japan Vs. liraglutide GETGOAL-M-As Efficacy on top of MET (+ SU) 380 Vs. sitagliptin China(1) Except GETGOAL-M-As which started mid-2010 (2) Except in GETGOAL-MONO (12 weeks) SU – Sulfonylurea MET – Metformin 105
  • 106. GETGOAL-MONO:Encouraging Initial Phase III Data Statistically significant improvement Efficacy Parameters in all blood glucose parameters Two-Step One-Step Pronounced effect on PPG Titration Titration Change in HbA1c (%) -0.54 -0.66 More patients reached HbA1c targets vs. placebo in lixisenatide groups Change in FPG -0.87 -1.08 (mmol/L) vs. placebo Mean decrease in body weight (-2 kg) Change in 2-hour PPG -3.86 -4.82 observed in all study groups (mmol/L) vs. placebo % of patients with 31.9 25.4 Good safety and tolerability HbA1c 6.5% Gastro-intestinal adverse events (12.5% in placebo group) Nausea: 22.2% (lixi.) vs. 4.1% (placebo) % of patients with 52.5 46.5 HbA1c <7% Vomiting: 7.1% vs. 0% (26.8% in placebo group) Diarrhoea: 2.9% vs. 2.5%FPG - Fasting Plasma Glucose PPG – Post-Prandial Plasma GlucoseGETGOAL-MONO: 12-week study in patients with type 2 diabetes not treated with antidiabetic agents (361 patients randomized)Baseline overall mean HbA1c 8.04 % Baseline overall mean body weight 87.2 kg 106
  • 107. GETGOAL-L Asia Shows First Results of LixisenatideUsed on Top of Basal Insulins Lixisenatide given as add-on Mean Change in HbA1c treatment to basal insulin ± SU Baseline to Endpoint 0,2 0.11 60% of patients on Lantus® Study met HbA1c primary 0 Placebo endpoint Lixisenatide N=154 N=146 No specific safety concern -0,2 Full data presentation expected in 2011 at ADA -0,4 Similar GETGOAL-L trial in U.S., EU & other countries -0,6 -0,8 -0,77 p<0.0001 -1 LS Mean Change vs. Placebo -0.88GETGOAL-L Asia: 24-week study in patients with Type 2 diabetes previously treated with basal insulin ± sulfonylurea (311 patients randomized)Baseline mean HbA1c: lixisenatide 8.54% Placebo 8.52% 107
  • 108. Lixisenatide, Emerging Competitive Profile in theGLP-1 Arena Current trial results bode well for the success in demonstrating an Full Range of Delivery excellent profile Systems Considered The right candidate after OAD failure or as an add-on to basal insulins Pen device planned for market entry Cardiovascular investigational plan aiming at making lixisenatide the first GLP-1 with a cardio-safety “claim” at launch (U.S.) Cardiovascular outcome study initiated mid-2010 6,000 patients with Type 2 Diabetes who experienced an Acute Coronary Syndrome event 108
  • 109. Lixisenatide: the 1st Step to aUnique Combination with Lantus® Elements in favor of a GLP-1 acting Expected Benefits on Fasting on PPG vs. short-acting or premix and Post-Prandial Glucose insulins Better weight management Blood glucose Lower risk of hypoglycemia Limited number of daily injections Strong rationale for combination with Lantus® Lantus® the only true 24h basal insulin Blood glucose Mixability of compounds Lixisenatide successfully tested on top of Lantus® in GETGOAL-L Asia Complete Phase III development plan being finalized following interactions with FDA / EMA Breakfast Lunch DinnerPPG – Post-Prandial Plasma Glucose 109
  • 110. Different Patient Populations Likely to Benefit from lixisenatide and Lantus® Combined Use Estimated Target Population(1) (U.S. and top 5 EU countries) Patients who have failed on OADs Early stage patients failing 1 or 2 OADs ~5m patients (HbA1c>8.0%) and overweight or obese (BMI>30) GLP-1 optimization Patients already treated with a GLP-1 and still uncontrolled (HbA1c>7.5%) ~1.8m patients Lantus® optimization Patients already on Lantus® who could benefit from a GLP-1 induced additional ~2.2m patients post-prandial effect Currently investigated in clinical trial(2)(1) Adelphi estimates (2) Study EFC10781 110
  • 111. : Continuous Commitment to Safety Any new observational study on the associations between insulin and cancer risk needs to be of the highest standards Consensus on Best Practices published in December 2009(1) Ambitious epidemiological investigational plan ongoing: Two retrospective cohort studies Prescription databases in Nordic countries U.S. diabetes registries Data presentation expected in 2012 One case-control study The International Study on Insulin and Cancer (ISAC) A case-control study of recent breast cancer occurring in patients with diabetes selected from general practice France, UK and Canada Data presentation expected in 2013(1) P Boyle, ecancer, 174, 11/12/2009 111
  • 112. Targeting Slowdown of Diabetes Progression with aNovel GPR Agonist  SAR260093: A potent selective orally active GPR119 agonist  Unique dual mechanism of action (insulin secretion and GLP-1 release)  Phase IIa results expected in Q4 2010GPR – G-protein-coupled receptorsFigure sourced from Overton, HA et al.; Br. J. Pharmacol. 2008, 153, S76-S81. 112
  • 113. Corrections of Metabolic DysfunctionsLower PCKS9 Leads to Lower LDL and CV Risk(1) LDL LDLR PCSK9 LDLR degradation Inhibition of the # of Low Density PCSK9 enzyme LDL levels Lipoprotein Receptors (LDLR)(1) Cohen J, et al. N Engl J Med 2006; 354:1264-1272c 113
  • 114. Encouraging Early Phase I Data:Read Out with our Anti-PCSK9 mAb > 60% LDL reduction following SAR236553 Single Dose single iv dose sc Effect on LDL Similar LDL reduction with single 0 1 3 7 10 14 0% Days dose delivered sc % Change in LDL from Baseline -10% Duration of effect with sc dosing suggests at least q2week dosing, -20% if not more -30% No serious adverse events to date -40% Preliminary data suggest similar -50% magnitude of LDL reduction when -60% added to statins in Familial -70% Hypercholesterolemia (FH) and non-FH subjects Dose G Dose H Dose I Initiation of Phase II program expected in H1 2011SC– Sub-cutaneous 114
  • 115. One of the First Regenerative Approaches Entering intoClinical Trials Pancreatic islet neogenesis, one of the potential curative approaches to restore patients own pancreatic function SAR288233, the Human proIslet Peptide (HIP)(1) 14-amino acid bioactive peptide Improved glycemic control and significant increased islet number observed in mice(2) Could apply to both type 1 and type 2 patients Ready to enter Phase I in 2011 Light green: Adult pancreatic islet containing ß-cells which still proliferate(1) Partnership with CureDM(2) Levetan C et al. Endocr Pract. 2008;14(No. 9);1075-1083 115
  • 116. Early Projects Directly Addressing Complicationsof Diabetes Cardiovascular complications Increased Risk of Serious Complications in Strong effectiveness evidenced with Cathepsin A inhibitor SAR164653 Diabetes(1,2) in pharmacological models of heart failure 2-fold increase in the risk of Innovative first-in-class approach death within one year post-MI Very favorable ADME and safety profile demonstrated in preclinical studies Phase I expected to start in 2011 Diabetic nephropathy Diabetes, the leading cause SAR101099, a long lasting of kidney failure Urotensin II antagonist Phase I initiated in Q3 2010 Intensive cooperation with internal Diabetic retinopathy, a partners (e.g. Fovea, Fibrosis Unit) leading cause of blindness(1) AHA heart disease statistics 2010 (2) 116
  • 117. Concluding RemarksPierre ChancelSenior Vice President - Diabetes Division 117
  • 118. Sanofi-aventis – Poised for Growth in Diabetes Diabetes presents healthcare and economic challenges in terms of prevention and control Diabetes is one of the largest business opportunities in the healthcare space and a growth platform for sanofi-aventis Sanofi-aventis is well positioned with concrete steps forward fulfilling our vision to deliver tailored and integrated solutions to people living with diabetes and healthcare providers Lantus® poised for future growth despite a more complex environment Lixisenatide and [lixisenatide + Lantus®] opportunity to open new avenues in the management of diabetes R&D and business development fully committed to adress unmet needs Towards an integrated offer with new devices 118
  • 119. Q&A Session 119
  • 120. ConclusionHanspeter SpekPresident, Global Operations 120