Market Report Source

Overview

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 Patients)
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
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