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Investor Event at ACR ´07 in Boston 9 November 2007

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Investor Event at ACR ´07 in Boston 9 November 2007 Investor event at ACR ´07 in Boston 9 November 2007 Forward-looking statements This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Please see www.roche.com for full information on Roche products mentioned. 2 Introduction Dr. Karl Mahler, Head of Investor Relations Agenda • Actemra´s TOWARD trial –Dr. Mark Genovese, Associate Professor of Medicine, Co-Chief Division of Immunology and Rheumatology, Stanford University School of Medicine • Actemra program overview – Don MacLean, Actemra Lifecycle Leader • Building a new franchise in Inflammation/Autoimmune Diseases – Dr. Urs Schleuniger, VP, Head of Strategic Marketing Inflammation • Questions & Answers 4 Roche’s key therapeutic areas Current and future pillars of growth Neurology / Psychiatry Virology 6 phase I compounds Tamiflu Pegasys R1626 Polym. Inh. R7227 Protease Inh. R7128 Polym. Inh. Metabolic R3484 HPV16 R1583 GLP-1 R1658 CETP Inh. R1439 dual PPAR R1579 DPP-IV RA/Autoimmune 3 phase I compounds MabThera Actemra R1594 ocrelizumab PNP inhibitor Oncology 5 phase I compounds Xeloda MabThera Herceptin Avastin Tarceva Pertuzumab Apomab Apo2L/TRAIL ARQ 15 phase I compounds Promising Late Emerging Early On Hand Stage Mid-Term Stage 5 Roche in Inflammation/Autoimmune Diseases Building a new therapeutic franchise MabThera/Rituxan Ocrelizumab Rheumatoid Arthritis Rheumatoid Arthritis, Multiple Sclerosis, Lupus • Launched in RA anti-TNFa inadequate • Phase II trial in RA met primary and secondary responders (IR) in U.S. and EU endpoints, presented at ACR ’06 • Filing for RA in DMARD IR in 2008 • Phase III program in RA running • Phase III in SLE to start Q4-2007 and LN in early 2008 Multiple Sclerosis (MS), Lupus, Vasculitis • Phase III in PPMS, SLE, LN and ANCA ass. • Phase II in RRMS to start H1 2008 vasculitis ongoing Phase 1 Actemra • 5 compounds for Inflammation/ Autoimmune Diseases Rheumatoid Arthritis • Filed in Japan • Broad international phase III program closing – four trials reported in 2007 10 phase III projects • Global filing Q4-2007 3 phase II projects 6 Actemra´s TOWARD trial Dr. Mark Genovese, Associate Professor of Medicine, Co-Chief Division of Immunology and Rheumatology, Stanford University School of Medicine IL-6: Fundamental role in the inflammation that drives RA Endothelial cells Monocytes/ macrophages Mesenchymal cells, fibroblasts/synoviocytes IL-6 T cell activation Hepatocytes Acute-phase proteins hepcidin, CRP Maturation of B cells megakaryocytes Osteoclast activation Bone resorption Thrombocytosis Auto-antibodies (RF) Hyper γ-globulinaemia Nature Nat Rev Drug Disc Firestein GS. 2003;423:356–361; Smolen JS and Steiner G. 2003;2:473–488 8 Genovese et al., Abstract L15 Tocilizumab: Humanized anti-IL-6R monoclonal antibody Tocilizumab binds to both the mIL-6R and the sIL-6R, preventing binding of IL-6 and association with the gp130β chain and thus IL-6-mediated signalling IL-6 sIL-6R X X mIL-6R Cell membrane X gp130 gp130 X Signal transduction inhibited 9 Genovese et al., Abstract L15 The TOWARD Study: Tocilizumab in cOmbination With traditional DMARD therapy Objectives • To asses the efficacy and safety of tocilizumab 8 mg/kg in combination with conventional DMARD therapy Patients • Moderate to severe RA ≥ 6 months duration, with an inadequate response to conventional DMARDs • Excluding patients unsuccessfully treated with an anti-TNF agent 10 Genovese et al., Abstract L15 TOWARD Study Study design • Phase III, double-blind, placebo-controlled, international, multicenter study – 50% of the study sites located in USA, which enrolled 41% of patients Randomization (1:2) Primary endpoint Proportion of patients Placebo + DMARDs (n = 415)* achieving ACR20 N = 1220 TCZ 8 mg/kg + DMARDs (n = 805)* Week 084122016 24 iv Infusion *2 patients did not receive study medication and were subsequently excluded • Patients who did not achieve a 20% improvement from baseline in both SJC and TJC at week 16 were offered rescue therapy (adjustment of the background DMARD dose and/or treatment with a different conventional DMARD) 11 Genovese et al., Abstract L15 TOWARD Study Demographics and baseline characteristics Placebo Tocilizumab 8 mg/kg + DMARDs + DMARDs Characteristics n = 413 n = 803 Age, years (mean) 53.5 53.0 Female gender, % 84 81 Duration of disease, years (mean ± SD) 9.8±9.1 9.8±8.8 DAS28 (mean ± SD) 6.6±1.0 6.7±1.0 TJC (mean ± SD) 29.1±14.8 30.1±16.0 SJC (mean ± SD) 18.7±10.8 19.7±11.6 RF positive, % 75 78 Prior DMARDs/Anti-TNFs, n (mean ± SD) 1.6±1.6 1.6±1.6 Previous anti-TNF use, % 15 17 Methotrexate dose, mg/week (mean ± SD) 15.0±5.0 14.7±5.0 12 Genovese et al., Abstract L15 TOWARD Study Concomitant medication at baseline Placebo Tocilizumab 8 mg/kg + DMARDs + DMARDs Co-medication use, % n = 413 n = 803 Methotrexate 73.9 75.8 Chloroquine/hydroxychloroquine 19.8 20.6 Sulfasalazine 14.3 13.1 Leflunomide 15.5 12.1 Parenteral gold 0.7 0.2 Azathioprine 2.2 2.2 Oral steroids 54.6 51.2 NSAIDs 77.1 71.4 13 Genovese et al., Abstract L15 TOWARD Study Patient disposition 1220 Patients enrolled 415 Randomly assigned to 805 Randomly assigned to Tocilizumab Placebo + DMARDsa 8 mg/kg + DMARDsb 43 (10%) 53 (7%) Withdrew Withdrew 45 (11%) 19 (2%) on rescue therapy on rescue therapy 0 Withdrew 0 Withdrew 370 (89%) Completed the study 751 (93%) Completed the study Initial therapy (325) Initial therapy (732) Rescue therapy (45) Rescue therapy (19) aIncludes 2 patients randomized to placebo who were not dosed and 2 patients who were randomized to placebo but received tocilizumab 8 mg/kg throughout the study bIncludes 2 patients randomized to tocilizumab 8 mg/kg who were not dosed and 3 patients who were randomized to tocilizumab 8 mg/kg but received placebo throughout the study 14 Genovese et al., Abstract L15 TOWARD Study 70 60 ACR responses at Week 24 Δ 50 = 36.3* 40 60.8 30 20 Patients10 with an ACR response,24.5 % 0 Δ Genovese et al., Abstract L15 = 28.6* ACR20 ACR50 ACR7037.6 Placebo + DMARDs *p < 0.0001 9.0 TOWARD Study Δ = 17.6* Tocilizumab 8 mg/kg + DMARDs 70 20.5 ACR20 response at Week 24 60 2.9 50 by background therapy 59.0 40 30 65.4 Placebo + DMARDs 20 25.0 Patients with an ACR20 response (%) 10 65.7 0 Tocilizumab 8 mg/kg + DMARDs N = 224 456 50 78 16 35 17 33 4 12 82 152 15 26 15 18.0 63.6 GenoveseMe et tal.,h oAbstracttrexa L15te 29.4 Leflunomide 0.0 65.8 Sulfasalazine 33.3 29.3 57.7 Chloroquine 46.7 Hydrochloroquine 0.0 Azathioprine 2 DMARDs ≥ 3 DMARDs 16 TOWARD Study ACR20 response over time 70 60 50 40 p < 0.0001 30 20 * 10 Patients with an ACR20 response (%) response ACR20 with an Patients 0 0 4 8 12162024 Time (weeks) Placebo + DMARDs Tocilizumab 8 mg/kg + DMARDs *Statistically significant vs placebo from Week 2 onwards 17 Genovese et al., Abstract L15 TOWARD Study DAS28 scores and EULAR response at Week 24 Mean change from baseline Good/moderate EULAR response* in DAS28 score* Tocilizumab Δ = 42.1 Placebo + DMARDs 8mg/kg + DMARDs 90 p<0.0001 0 79.7 80 -0.5 70 -1 60 -1.16 50 -1.5 40 37.6 score -2 Patients (%) Patients 30 -2.5 20 -3 10 0 -3.5 -3.17 Mean change from baseline in DAS28 from change Mean Δ = -2.01 Placebo + DMARDs Tocilizumab p < 0.0001 8mg/kg + DMARDs *DAS28 was calculated based on ESR 18 Genovese et al., Abstract L15 TOWARD Study Disease activity at Week 24 Disease remission (DAS28 <2.6) Low disease activity (DAS28 ≤3.2) at Week 24* at Week 24* Δ = 39.7 50 50 45.3 40 Δ = 26.8 40 p < 0.0001 30.2 30 30 20 20 Patients (%) Patients Patients (%) Patients 10 10 5.6 3.4 0 0 Placebo + DMARDs Tocilizumab 8mg/kg Placebo + DMARDs Tocilizumab + DMARDs 8mg/kg + DMARDs *DAS28 was calculated based on ESR 19 Genovese et al., Abstract L15 TOWARD Study Change in CRP levels over time 3 2.5 2 1.5 1 p < 0.0001 Mean CRP (mg/dL) Mean 0.5 ULN = 0.3 mg/dL 0 04812162024 Time (weeks) Placebo + DMARDs Tocilizumab 8 mg/kg + DMARDs 20 Genovese et al., Abstract L15 TOWARD Study Increase in haemoglobin levels in patients with haemoglobin < LLN 13.5 LLN=13 mg/dL 13.0 12.5 12.0 11.5 Mean hemoglobin (mg/dL) hemoglobin Mean 11.0 0 4 8 12 16 20 24 Time
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