Market Report Source

Overview

Rheumatoid arthritis (RA) is a chronic and debilitating autoimmune disease that affects an estimated 2 million people in the United States and an estimated 20 million individuals worldwide. The RA treatment market has undergone significant changes over the past 5-10 years with the introduction of biologic, Disease Modifying Antirheumatic Drugs (DMARDs)—specifically, the Tumor Necrosis Factor-alpha (TNF-α) class of protein therapeutics. Products such as Enbrel (etanercept), Remicade (infliximab), and Humira (adalimumab) have established themselves as the standard of care in RA patients failing to respond to conventional DMARDs and in turn have generated significant financial windfalls for their developers and marketers.

The success of the TNF-α class of therapeutics, in conjunction with the large patient population they address, has created an explosion in R&D activity for new biologic and small-molecule treatments. As of January 2009, Austin Research Group has identified and is tracking 96 active programs in clinical trials.

Austin Research Group’s Therapeutic Clinical Intelligence (TCI) report provides clients with an exhaustive compilation and in-depth assessment of the entire clinical R&D competitive landscape for RA therapeutics.

This TCI report is the most comprehensive assessment of the RA competitive landscape published to date. The report contains more than 300 pages of detailed intelligence, analysis, and commentary on the clinical profiles 96 active RA programs from market to phase 1 that have the potential to alter the market dynamics in RA over the next 5-10 years.

This actionable deliverable captures detailed intelligence on competitive clinical programs in a ready-to-use format, enabling fast analysis without wading through voluminous text and white space common in other therapeutic area publications.

Competitor profiles consist of:

Competitor SnapShot: Mechanism of Action, Developing Companies, Indications, Phase of Development, Route of Administration, and Dosing Frequency, analyst commentary

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

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

Actionable & Comprehensive Deliverable
Austin Research Group’s Therapeutic Clinical Intelligence report is the most comprehensive resource available for assessing the RA R&D competitive landscape.

The actionable report format enables clients to quickly analyze and reference:

Depth and breadth of competitive landscape

• Competitor Target Product Profiles
• Trends in clinical trial designs and endpoints utilized by competition
• Efficacy and safety hurdles posed by competition

Table of Contents

Section 1 – Executive Summary

Section 2 – Market Leaders & Near-Term Competitors
Enbrel (etanercept)
Remicade (infliximab)
Humira (adalimumab)
Rituxan (rituximab)
Orencia (abatacept)
Actemra (tocilizumab)
Cimzia (certolizumab pegol)
Simponi (Golimumab)
Ocrelizumab
Arzerra (ofatumumab)
CP-690,550

Section 3: Mid-Stage Competition to Watch
TRU-015
INCB018424
R788 (fostamatinib)
Belimumab (LymphoStat-B)
AZD9056
canakinumab (ACZ885)

Section 4a: Phase 2 Pipeline: Biologics
LY-2127399
CNTO-136
ALD-518
ART-621
MDX-1100
BT-061
T-1h-mAb (h-T1)
315234
KB-002/KB-003
LY-2189102
AIN-457
Atacicept
MM-093

Section 4b: Phase 2 Pipeline: Small-Molecule (Orals)
681323
856553
BMS-582949
PH-797804
KC-706
RWJ-445380
AZD5672
CH-1504
4SC-101
Panaclar
DE-096
ARRY-162
Apilimod
TAK-783
CF-101
SSR-150106
CE-224535
Rabeximod
PG-760564
Rimacalib
PMI-001
K-832
VX-702
LX-2931
HE-3286

Section 5: On the Radar: Overview of Phase 1 RA Programs
Small Molecules
Biologics
Undisclosed Programs

Section 6: Discontinued RA Programs

Section 7 – Appendix
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