Microsoft PowerPoint - Roche IR Event EULAR Final.ppt

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Major players are active in this area… …Yet opportunities remain for novel therapies Phase I/II Denosumab Amgen Ocrelizumab Roche Orals e.g. p38 HuMax 20 GenMab Belimumab HGS/CAT/GSK Tru015 Trubion/Wyeth Phase III Actemra Roche Cimzia Celltech/UCB Golimumab J&J Launched Enbrel Amgen Remicade J&J Humira Abbott MabThera Roche Orencia BMS 1998 1999 2000 2001 2002 2003 2004 2005 2006 2008 and later Anti-TNF Other MoA Costimulation modulator B-Cell Targeted Therapy Roche 60
MabThera: Roche’s ongoing phase III program Trial Data timing Treatment Sample Size Endpoints MTX-IR SERENE 2008 MTX + placebo vs. MTX + MabThera 1g vs. MTX + MabThera 2g 495 Reduction in signs and symptoms MTX-IR Dose escalation MIRROR 2008 Rituximab 1g retx 1g vs. Rituximab 1g retx 2g vs. Rituximab 2g retx 2g 375 Effect of further courses and dose escalation DMARD-IR SCORE 2009 MTX + placebo vs. MTX + MabThera 1g vs. MTX + MabThera 2g 180 MRI changes at 6 months MTX naïve (X-ray study) IMAGE 2010 MTX vs. MTX + MabThera 1g vs. MTX + MabThera 2g 852 Reduction in signs and symptoms Inhibition of structural joint damage Improvement in physical function EU filing on track for 1H 2008 61
Page 2 and 3:
Roche Analyst Meeting EULAR 2007 Ba
Page 4 and 5:
Introduction Dr. Karl Mahler Head o
Page 6 and 7:
Roche’s key therapeutic areas Cur
Page 8 and 9:
RA: A very concentrated market 6.00
Page 10 and 11: 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 62 and 63: Actemra Potential to become a signi
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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