Therapeutic Clinical Intelligence - Rheumatoid Arthritis

Table of Contents

Section 1: Executive Summary

• Rheumatoid Arthritis Disease Overview
• Epidemiology of RA: Current and predicted prevalence
• RA Treatment Algorithm
• Unmet Needs in RA Market
• RA Market Concentration
• Clinical endpoints used in RA trials
• Overview of Clinical Trials Landscape
• Ongoing Clinical Trials in RA: Marketed Products
• Key Players in RA Research & Development
• RA Competitive Landscape SnapShot
• Overview of Competitive Landscape
• Comparison of Product Profiles for marketed RA products
• Comparison of Efficacy of TNF-Inhibitor products in RA (ACR50 at 1-year)
• Comparison of Efficacy of TNF-Inhibitor products in RA (ACR50 & ACR70 at 1-year)

Section 2: The Current Market Leaders in Rheumatoid Arthritis

• Enbrel (etanercept)
• Enbrel Product Overview-Competitor Snapshot
• Enbrel Phase 3 Pivotal Trial Overview
• Phase 1 Pharmacokinetic Study: Design & Results Overview
• Enbrel Phase II Study Design & Results
• Enbrel Phase III Pivotal Trial Design & Results (Study-1)
• Enbrel Phase III Pivotal Trial Design & Results (Study-2)
• Enbrel Phase III Trial Design & Results (ERA)
• Enbrel Phase 3 Study Design (ERA)
• Enbrel Phase III Trial Efficacy Results (ERA)
• Enbrel Phase III Pivotal Trial Design & Results (TEMPO)
• Remicade (infliximab)
• Remicade Product Overview-Competitor Snapshot
• Remicade Phase I/II Study Design & Results
• Remicade Phase II Study Design & Results
• Remicade Phase III Study Design & Results (ATTRACT)
• Remicade ATTRACT Study Efficacy Results
• Remicade ATTRACT Study Safety Data
• Remicade Phase III Trial Design (ASPIRE)
• Remicade Phase III Trial Efficacy Results (ASPIRE)
• Remicade Phase III Trial Design & Results (START)
• Remicade Phase III Trial Design & Results (iRAMT)
• Remicade Phase III Trial Design & Results (PROMPT)
• Humira (adalimumab)
• Humira Product Overview-Competitor Snapshot
• Humira Phase II Trial Design & Results (DE009)
• Humira Phase II & Phase III Trial Design (DE009 & DE011)
• Humira Phase III Trial Design & Results (DE011)
• Humira Phase III Trial Efficacy Results (DE011)
• Humira Phase III Trial Design & Results (DE011 Open-Label Extension)
• Humira Phase III Trial Design & Results (DE019)
• Humira Phase III Trial Design (DE019)
• Humira Phase III Pivotal Trial Design & Results (DE031)
• Humira Phase III Pivotal Trial Design (DE031)
• Humira Phase III Pivotal Trial Safety Results (DE031)
• Humira Phase IV Trial Design & Results (ReAct)
• Orencia (abatacept)
• Orencia Product Overview-Competitor Snapshot
• Orencia RA Clinical Development Program Overview
• Orencia Phase II Study Design & Results
• Orencia Phase IIb Pivotal Study Design & Results (Study 1)
• Orencia Phase III Pivotal Study Design & Results (AIM)
• Orencia Phase III Pivotal Study Design (AIM)
• Orencia Phase III Pivotal Study Efficacy Results (AIM)
• Orencia Phase III Pivotal Study Design (AIM Long-Term Extension Study)
• Orencia Phase III Pivotal Study Efficacy Results (AIM Long-Term Extension)
• Orencia Phase III Pivotal Study Design & Results (ATTAIN)
• Orencia Phase III Pivotal Study Design (ATTAIN)
• Orencia Phase III Pivotal Study Efficacy Results (ATTAIN)
• Orencia Phase IIIb Study Design & Results (ARRIVE)
• Orencia Phase IIIb Safety Results (ARRIVE)
• Rituxan (rituximab)
• Rituxan Product Overview-Competitor Snapshot
• Rituxan RA Clinical Development Program Overview
• Rituxan RA Development Plan
• Rituxan Phase II Study Design & Results
• Rituxan Phase IIb Study Design & Results (DANCER)
• Rituxan Phase IIb Study Design & Patient Disposition (DANCER)
• Rituxan Phase IIb Study Efficacy Results (DANCER)
• Rituxan Phase III Pivotal Study Design & Results (REFLEX)
• Rituxan Phase III Pivotal Study Design (REFLEX)
• Rituxan Phase III Pivotal Study Efficacy Results (REFLEX)
• Rituxan Phase III Pivotal Study Efficacy Results (REFLEX)

Section 3: Future Competitive Threats-Novel Biologics on the Horizon

• Actemra (tocilizumab)
• Actemra Product Overview: Competitor Snapshot
• Actemra Phase I Study Design & Results (Pilot Study)
• Actemra Phase I Study Design & Results
• Actemra Phase II Study Design & Results
• Actemra Phase II Study Safety Results (con' t)
• Actemra Phase II Study Design & Results
• Actemra' s international phase III program in RA
• Actemra Pivotal Phase III Study in RA (TOWARD-1)
• Actemra Pivotal Phase III Study Design & Results (OPTION)
• Actemra Phase III Study Design (OPTION)
• Actemra Phase III Study Efficacy Results (OPTION)
• Actemra Phase III Study Safety Data (OPTION)
• Actemra Pivotal Phase III Study in RA (RADIATE)
• Actemra Pivotal Phase III Study in RA (LITHE)
• Actemra Pivotal Phase III Study in RA (AMBITION)
• Cimzia (certolizumab pegol)
• Cimzia Product Overview: Competitor Snapshot
• Cimzia Phase II Study Design & Results
• Cimzia Phase II Study Design & Results
• Cimzia Phase III Pivotal Study Design & Results (RAPID-1)
• Cimzia Phase III Pivotal Study Design & Results (RAPID-2)
• Ocrelizumab (2nd Generation anti-CD20)
• Ocrelizumab Product Overview: Competitor Snapshot
• Ocerlizumab Phase I/II Study (ACTION) Design & Results
• Ocrelizumab Ongoing Pivotal Phase III Study in RA (FILM)
• Ocrelizumab Ongoing Pivotal Phase III Study in RA (SCRIPT)
• Ocrelizumab Ongoing Pivotal Phase III Study in RA (STAGE)
• Golimumab (CNTO-148)
• Golimumab Product Overview: Competitor Snapshot
• Golimumab Product Overview: Centocor Positioning
• Golimumab Phase II Study Design & Results
• Golimumab Phase II Efficacy Results (ACR response)
• Golimumab Phase 3 Development Program (All Indications)
• Golimumab Ongoing Pivotal Phase III Study in RA (IV Formulation)
• Golimumab Ongoing Pivotal Phase III Study in RA (SC Formulation/MTX Refractory Patients)
• Golimumab Ongoing Pivotal Phase III Study in RA (SC Formulation/MTX Naive Patient)
• Golimumab Ongoing Pivotal Phase III Study in RA (SC Formulation/TNF Refractory Patients)
• ofatumumab (HuMax-CD20)
• Ofatumumab Product Overview: Competitor Snapshot
• Ofatumumab Phase 2 Study Design & Results
• Ofatumumab Phase III Ongoing Pivotal Trial Design (GEN410/OFA110635)
• Ofatumumab Phase III Ongoing Pivotal Trial Design (GEN411/OFA110634)
• Belimumab (LymphoStat-B)
• Belimumab Product Overview: Competitor Snapshot
• Belimumab Phase II Study Design & Results
• AMG-108
• AMG-108 Product Overview: Competitor Snapshot
• AMG-108 Phase II Study Design
• AMG-108 Phase II Study Design
• AMG-714
• AMG-714 Product Overview: Competitor Snapshot
• AMG-714 Phase I/II Study Design & Results
• AMG-714 Phase II Study Design & Results
• Denosumab (AMG-162)
• Denosumab Product Overview: Competitor Snapshot
• Denosumab Phase II Study Design & Results
• TRU-015
• TRU-015 Product Overview: Competitor Snapshot
• TRU-015 Phase I Study Design & Results
• TRU-015 Phase I Study Results
• TRU-015 Phase IIa Study Design & Results
• TRU-015 Phase IIa Study Results
• TRU-015 Phase IIb Preliminary Results
• TRU-015 Phase IIb Study Design & Final 24-wk Results
• TRU-015 Phase IIb Efficacy Results (DAS28)
• TRU-015 Phase IIb Safety Data
• TRU-015 Phase IIb Safety Data
• Phase IIa Patient Retreatment Study Design & Results
• TRU-015 Retreatment Study Efficacy Results
• TRU-015 Retreatment Study Safety Results
• Atacicept (TACI-Ig)
• Atacicept Product Overview: Competitor Snapshot
• Atacicept Phase II Ongoing Study Design
• baminercept (BG-9924)
• baminercept Product Overview: Competitor Snapshot
• baminercept Phase IIa Study Design
• baminercept Phase IIa Preliminary Efficacy* Results
• baminercept Phase IIa Preliminary Safety Results
• baminercept Phase IIb Study Design (Ongoing)
• baminercept Phase IIb Study Design (Ongoing)
• canakinumab (ACZ885)
• canakinumab Product Overview: Competitor Snapshot
• canakinumab Phase II/III Ongoing Trial Design
• MM-093
• MM-093 Product Overview: Competitor Snapshot
• MM-093 Phase II Study Design (Completed)
• PD-360324
• PD-360324 Product Overview: Competitor Snapshot
• AIN-457
• AIN-457 Product Overview: Competitor Snapshot
• ARG-098
• ARG-098 Product Overview: Competitor Snapshot
• 315234
• 315234 Product Overview: Competitor Snapshot

Section 4: Future Competitive Threats-Novel Small Molecules in Development

• R788 (tamatinib fosdium)
• R788 Product Overview: Competitor Snapshot
• R788 Phase II Trial Design
• R488 Phase II Trial Efficacy Results
• R488 Phase II Trial Efficacy Results
• AZD9056
• AZD9056 Product Overview: Competitor Snapshot
• AZD9056 Phase IIb Ongoing Study Design
• AZD9056 Phase IIb Ongoing Study Design
• AZD5672
• AZD5672 Product Overview: Competitor Snapshot
• VX-702
• VX-702 Product Overview: Competitor Snapshot
• VX-702 Phase II Study Design & Results (VeRA)
• CP-690,550
• CP-690,550 Product Overview: Competitor Snapshot
• CP-690,550 Phase IIa Study Design & Results
• CP-690,550 Phase IIa Efficacy Results
• CP-690,550 Phase II Study Design (Ongoing)
• CP-690,550 Phase II Study Design (Ongoing)
• CP-690,550 Phase IIb Study Design (Ongoing)
• PH-797804
• PH-797804 Product Overview: Competitor Snapshot
• PH-797804 Phase IIa Study Design (Ongoing)
• prinaberel (ERB-041)
• prinaberel Product Overview: Competitor Snapshot
• prinaberel Phase II Study Design (Ongoing)
• AVE-9897/MLN-3897
• AVE-9897/MLN-3897 Product Overview: Competitor Snapshot
• AVE-9897/MLN-3897 Phase II Study Design (Ongoing)
• 681323
• 681323 Product Overview: Competitor Snapshot
• 681323 Phase 1 Study Design (Completed*)
• 681323 Phase II Study Design (Completed*)
• 681323 Phase II Study Design (Completed*)
• 856553
• 856553 Product Overview: Competitor Snapshot
• 856553 Phase II Study Design (Ongoing)
• maraviroc (Selzentry/Celsentri)
• Maraviroc Product Overview: Competitor Snapshot
• Maraviroc Phase II Study Design (Ongoing)
• CP-195543
• CP-195543 Product Overview: Competitor Snapshot
• CP-195543 Phase II Study Design (Ongoing)
• K-832
• K-832 Product Overview: Competitor Snapshot
• CE-224535
• CE-224535 Product Overview: Competitor Snapshot
• CE-224535 Phase I Study Design (Completed)

Section 5: Ongoing Clinical Trial in Rheumatoid Arthritis

Section 6: APPENDIX

• Disclaimer
• Report Licensing