関節リウマチ治療薬の開発動向

Abstract

The world-wide market for Rheumatoid Arthritis (RA) therapeutics has undergone significant change over the past 5-10 years with the introduction of biologics. These biologic products, specifically, the anti-TNF-alpha monoclonal antibodies-Enbrel, Humira, and Remicade-are dominating the moderate-to-severe RA therapeutic market, with newcomers Rituxan and Orencia garner single digit market share.

The biologics due have the potential to shift the treatment paradigm by increasing utilization anti-TNFs in earlier lines of therapy. However, the competitive intensity within the RA segment is on the rise as companies are aggressively developing both novel and second-generation compounds that have the potential to challenge the competitive position of these market leaders in the future.

Potential threats on the horizon include novel biologic therapies such as Actemra, Cimzia, Golimumab, Ocrelizumab, and TRU-015. Additionally, the development landscape for targeted small molecules could produce therapeutic alternatives that would directly compete with the anti-TNFs and other biologics in earlier lines of therapy. Novel compounds including CP-690,550 and Prinaberel have a convenience and cost advantage over the biologics due to their oral formulation and potential attractiveness to managed care organizations and pharmacy benefit managers (payers). However it is yet to be seen if any of these agents will be able to consistently demonstrate superior efficacy over the current market leaders for .

The Rheumatoid Arthritis Therapeutic Clinical Intelligence report provides an in-depth assessment of the R&D competitive landscape for Rheumatoid Arthritis (RA) therapeutics from a product-level and clinical perspective. We profile the supporting clinical data for 37 compounds in phase 2 of development and beyond-including key in-line products. Specifically, our analysis concentrates on the clinical study protocol design and efficacy and safety data for these products, which we believe, have the potential to alter the market dynamics in RA over the next 3-7 years. This methodological approach is intended to provide insight into the market opportunities and challenges, as well as the clinical hurdles facing RA drug developers.

Reports contain synthesized information and analysis of clinical development activities for key marketed and pipeline products within multiple therapeutic categories and generally include the following data points:

Product Overview: Mechanism of Action, Developing Companies, Indications and Phase of Development.

Clinical Trial Assessments: Detailed evaluations of completed and ongoing competitor studies that capture key elements of the study protocol including:

• Trial design
• Start and end dates
• Study size and patient type
• Number of participating sites
• Dosing regimen
• Endpoints
• Safety and efficacy results

Clients utilize the report as a critical resource used to support key strategic decisions including:

• Analyzing the overall depth and breadth of the competitive landscape within a therapeutic area
• Assessing target product profiles of key current and future competitors
• Benchmarking competitor clinical trial designs and results
• Developing clinical analogues to support go-no-go decisions
• Identifying clinical hurdles posed by competitors
• Designing clinical trials more effectively to maximize a product' s penetration

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