Microsoft PowerPoint - Roche IR Event EULAR Final.ppt

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Actemra Potential to become a significant new RA treatment First-in-class agent • Humanized monoclonal antibody blocking the activity of IL-6 • Conclusions from phase III Jap trials – Impressive efficacy in DMARD inadequate responders – Effective as monotherapy – Well tolerated Large international phase III program • 5 registration trials (>4‘000 patients) - recruitment completed • Mono and combo therapy • Patient populations studied: – MTX inadequate responders – DMARD inadequate responders – TNFα inadequate responders – MTX naïve patients • First 2 trials (OPTION and TOWARD) met primary endpoint • Further clinical data during 2007 Filed in Japan in April 2006 Global filing 2007 62
Actemra: <strong>Roche</strong>’s ongoing phase III program Additional international trials TRIAL / Treatment Arms Topline Data Timing Sample Size Patient population Endpoints TOWARD Actemra 8 mg + DMARDs DMARDs Top line announced June 6, 2007 1’200 DMARD inadequate responders ACR 20 response at Wk 24 RADIATE Actemra 4 mg + MTX Actemra 8 mg + MTX 2007 570 Anti-TNFα inadequate responders ACR 20 response at Wk24 MTX AMBITION Actemra 8 mg monotherapy 2007 550 MTX naive ACR 20 response at Wk 24 MTX LITHE Actemra 4 mg + MTX Actemra 8 mg + MTX 2008 1’170 MTX inadequate responders ACR 20 at Wk 24 Sharp Score at Wk 52 Sharp Score at Wk 104 MTX Physical function at Wk 104 Filing on track for 2007 63
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Roche Analyst Meeting EULAR 2007 Ba
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Introduction Dr. Karl Mahler Head o
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Roche’s key therapeutic areas Cur
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RA: A very concentrated market 6.00
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Increased penetration of biologics
Page 12 and 13: Actemra: The OPTION trial results P
Page 14 and 15: Elevated IL-6 plays central role in
Page 16 and 17: The OPTION study TOcilizumab Pivota
Page 18 and 19: Demographics Intent-to-treat popula
Page 20 and 21: Results: Efficacy and safety 20
Page 22 and 23: Rapid onset of action with tocilizu
Page 24 and 25: Tocilizumab induces rapid CRP norma
Page 26 and 27: Most frequently reported AEs Incide
Page 28 and 29: Adverse events Consistent with thos
Page 30 and 31: MabThera: Longer-term repeat treatm
Page 32 and 33: Rituximab selectively targets CD20-
Page 34 and 35: Rituximab: Advancing in RA Initial
Page 36 and 37: Inhibition of radiographic progress
Page 38 and 39: Efficacy: Repeat treatment courses
Page 40 and 41: Patient exposure to repeat courses
Page 42 and 43: ACR scores are sustained Repeated c
Page 44 and 45: Consistent time intervals between t
Page 46 and 47: More than 2400 patient-years As of
Page 48 and 49: No increase in infection rates with
Page 50 and 51: IgM RF levels by treatment course o
Page 52 and 53: Rates of serious infection Similar
Page 54 and 55: Roche’s franchise in autoimmune d
Page 56 and 57: Overview of autoimmune disorders IN
Page 58 and 59: Not all patients respond to current
Page 60 and 61: Major players are active in this ar
Page 64 and 65: Ocrelizumab in autoimmune diseases
Page 66 and 67: Multiple sclerosis An emerging ther
Page 68 and 69: Prevalence of MS in Europe ~260,000
Page 70 and 71: Development hurdles & treatment cha
Page 72 and 73: Roche in autoimmune disorders Roche
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Microsoft PowerPoint - Roche IR Event EULAR Final.ppt

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