Advanced in the Rheumatoid Arthritis Market - New Research Report adds report Advanced in the Rheumatoid Arthritis Market to its store. Rheumatoid arthritis (RA) is a chronic disorder for which there is currently no cure. It affects around 23.5 million adults in the world (WHO, 2013) and approximately 294,000 children under the age of 18 are affected by pediatric arthritis and other rheumatologic conditions (PhRMA, 2013).

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In 2012, immunology drugs generated global sales of around US$36.6bn of which two thirds were associated with the management rheumatology related conditions (US$24.5bn), the remainder of sales were split evenly between the treatment of dermatological and gastroenterology related conditions. Revenues growth has been driven by improvements in diagnosis and early, more aggressive treatment of RA, the approval of new disease modifying anti rheumatic drugs (DMARDs), new formulations/devices and line extensions. By 2018, we forecast the immunology market will be worth over US$38.5bn as leading players focus on growing their RA franchises in the emerging markets, launch innovative targeted synthetic DMARDs and biologic DMARDs to address unmet clinical needs and biosimilars emerge in the European market to carve out US$3bn share of revenues.

The market is on the cusp of change as the first orally active biologic Xeljanz (tofacitimib) from Pfizer/Takeda entered the US market at the end of 2012; several new synthetic and biological DMARDs are in late stage clinical development and Europe approved the first biosimilar generic infliximab (Remicade) from Celltrion/Egis and Hospira in September 2013. Generic entanercept (Enbrel) is not far behind from Baxter/Cogerus and several manufacturers have begun to make copycat versions of Humira which goes off patent in the US in 2016.

This report examines in more detail the recent developments that have occurred in the RA market, including the expansion of approved products for new indications, formulations and new market launches and analyses the progression of pipeline products. It assesses how the new American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) guidelines will impact product uptake and discusses the potential impact of biosimilars on the global RA market.

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Table of Contents

Scope Of The Report 2

Catalyst 3
About the Author 4

Section 1: Why Is Rheumatoid Athritis Important, Why Now? 5
Introduction –where are we now?5
Around a half of patients stop responding to DMARDs within 5 years  7
2012 ACR guidelines recommend more aggressive, early treatment of RA 7
2013 EULAR guidelines include the use of Pfizer new oral agent Xeljanz  9
What synthetic DMARDs lead the field in the treatment of rheumatoid arthritis? 11
MTX is the preferred sDMARD for first line therapy in early and active disease 12
Pfizer’s Xeljanz is the first targeted sDMARD to reach the market13
Will Pfizer’s Xeljanz be able to compete in psoriasis? 14
Will Pfizer’s Xeljanz be able to compete on price? 14
Eisai/Toyama’s Careram a new DMARD for the Japanese market15
How do bDMARDs compare with one another?15
Humira, Enbrel and Remicade are the most prescribed bDMARDs across the globe  18
Comparative effectiveness studies with bDMARDs are limited20
Head to head study Orencia comparable to Humira20
Head to head study show Actemra superior to Humira20
New formulations and devices help drive patient compliance and product acceptance 21
Oral agents may cause a new shift in RA treatment paradigms21
Subcutaneous formulations remain the mainstay for biological DMARDs  21
New Infusion formulations add value22
New indications stimulate sales growth in bDMARDs23
Humira’s new indications “will add roughly US$15bn in incremental global sales 25
Janssen to seek several new line extension for Simponi and Stelara before 2017  25
Cimzia sales growth stimulated by new indications and new markets 26
Companies turn to Japan and the emerging markets to grow DMARD sales 26
AbbVie set sights on BRIC economies to drive Humira franchise forward 27
Amgen expanding capabilities in Japan to commercialize its product pipeline  27
BMS partnered with Simcere to maximize Orencia penetration in the emerging markers 27
Pricing and reimbursement28
US reimbursement of DMARDS mainly through private insurance programs 28
In Europe DMARDs reimbursed based on clinical and economic data and price referencing 28
Reimbursement of Japanese drugs set Chuikyo29
Patient’s face high out-of-pockets expenses in the emerging economies 30
Chinese government has accelerated and expanded patient access to DMARDs  31
Russian Federation has expand access to innovative biologics 31
High out of pocket expenses curb bDMARD use India 31
What impact will biosimilars have on the treatment of RA?32
Biosimilar etanercept33
Biosimilar etanercept available in China and India33
Etanercept biosimilars are under clinical development in Europe and the US 33
Biosimilar adalimumab34
Biosimilar infliximab36
The first infliximab biosimilar now approved in Europe36
Several infliximab biosimilars are under development for the developed markets 37
Biosimilar rituximab38
Rituximab biosimilars available in India since 200738
Several Rituximab biosimilars under development in the emerging economies 38
Advances in the Rheumatoid Arthritis Market
Antirheumatoid arthritis disease modifying drugs - Market forecasts 40

New Strategies In The Management Of Rheumatoid Arthritis  43
New regulatory guidance to fuel RA development44
New dr ugs on the bloc k 45
Approach 1: Tar geted sDMARDs  46
Drug type 1: Oral kinase inhi bitors  46
Ones to watch 47
Baricitinib (Eli Lilly/Incyte) 47
VX-509 (Vertex)48
Waitin g in the win gs 49
ASP015K (Janssen/Astellas Pharma) 49
INCB039110 (Incyte) 49
GLPG0634 (AbbVie/Galapagos) 50
Long shots 51
IPI-145 (Infinity Pharmaceuticals) 51
Approach 1: Tar geted sDMARDs Drug type 2: Non -kinase agents  52
Waitin g in the win gs 53
Apremilast (Celgene) 53
CCX354 (ChemoCentry/GSK) 53
Long shots  55
LX2931 (Lexicon Pharmaceuticals) 55
PLX5622 (Plexxikon/ Daiichi Sankyo Company) 55
Concl usions on sDMARD developments – forecasts  56
Approach 2: Biolo gical agents  57
Drug type 2: Anti -interle ukin inhi bitors  58
Ones to watch  59
Sirukumab (Janssen/GlaxoSmithKline) 59
Sarilumab (Sanofi/Regeneron)60
Secukinumab (Novartis) 62
Waitin g in the win gs 64
Clazakizumab (BMS/Alder Pharmaceuticals)64
Long shots  65
ALX-0061(AbbVie/Ablynx) 65
Guselkumab (Janssen Biotech/MorphoSys)  65
Ixekizumab (Eli Lilly) 65
Olokizumab (Eli Lilly)66
Approach 2: Biolo gical agents 67
Drug type 2: Non anti -interle ukin strate gies 67
Waitin g in the win gs 68
Mavrilimumab (MedImmune)68
MOR103 (GlaxoSmithKline/MorphoSys)68
Tregalizumab (AbbVie/Biotest GA) 69
Advances in the Rheumatoid Arthritis Market Table of Contents
Long shots  70
AMP-110 (Amplimmune) 70
BIIB 023 (Biogen Idec) 70
Dekavil (Pfizer/Philogen SpA) 70
Otelixizumab (GlaxoSmithKline/Tolerx) 70
PRTX-100 (Protalex) 70
TNF-Kinoid (Neovacs) 71
Concl usions on bDMARD developments – forecasts  72

Appendix 173
Clinical endpoints to assess disease activity and response to treatment  73

Primary research 74
Secondary research 74


Endnotes 79

List of Tables

Table 1: Leading oral synthetic DMARDs11
Table 3: Leading bDMARDs SC formulations22
Table 4: Leading bDMARDs IV formulations23
Table 5: Line extensions of leading DMARDs24
Table 6: Enbrel regional sales 201233
Table 7: Etanercept biosimilars under development34
Table 9: Adalimumab biosimilars under development35
Table 10: Remicade regional sales 201236
Table 11: Infliximab biosimilars under development 37
Table 12: Rituxan sales 201238
Table 13: Rituximab biosimilars under development 38
Table 14: Synthetic and biological DMARDs, biosimilar sales forecasts, 2011-2018 (US$mn)41
Table 15: Recent small molecule agents discontinued in clinical trials in RA  44
Table 16: Recent biological agents discontinued in clinical trials in RA  44
Table 17: Oral kinase inhibitors in clinical development 46
Table 18: Phase II baricitinib data in RA patients at week 1247
Table 19: Phase II baricitinib data in RA patients at week 2447
Table 20: Phase II INCB039110 data in RA patients at week 12 48
Table 21: Phase II INCB039110 data in RA patients at week 1249
Table 22: Non-kinase inhibitors in clinical development52
Table 23: Phase II PoC data in RA patients at week 1253
Table 24Developmental sDMARD kinase inhibitor forecasts56
Table 25: Anti-interleukin agents in clinical development 58
Figure 24: Clinical efficacy of sirukumab SC in patients with RA 59
Table 26: Phase II sarilumab clinical data in RA patients 60
Table 27: Phase II Secukinumab clinical data in RA patients62
Table 28: Phase II Secukinumab clinical data in RA patients62
Table 29: Phase III secukinumab clinical data in psoriasis patients62
Table 31: Phase II Ixekizumab clinical data in plaque psoriasis patients at week 12 66
Table 33: Phase II Mavrilimumab data in RA patients at week 12 68
Developmental bDMARD anti-interleukin forecasts72

List of Figures

Figure 1: Main pharmacological strategies for rheumatoid arthritis6
Figure 2: Classification of DMARDs for the management of RA7
Figure 3: ACR Guidelines for the Management of Early RA8
Figure 4: Guidelines for the Management of Established RA9
Figure 5: EULAR Guidelines for the Management of RA - Phase I10
Figure 6: EULAR Guidelines for the Management of RA - Phase II10
Figure 8: Overall clinical benefits events associated with the treatment of RA with conventional sDMARDs  12
Figure 9: Overall adverse events associated with the treatment of RA with conventional sDMARDs  13
Figure 10: Overall clinical benefit events associated with the treatment of RA with bDMARDs  17
Figure 11: Overall adverse events associated with the treatment of RA with bDMARDs 18
Figure 12: Humira, Enbrel and Remicade are the most prescribed bDMARD in the US19
Figure 13: Humira, Enbrel and Remicade are the most prescribed bDMARD in the ex US markets  19
Figure 14: Roche’s Actemra gains market share in biologic monotherapy based on ADACTA data 20
Figure 15: Two thirds of immunology drug sales treat rheumatology related conditions, 2012 25
Figure 16: Cimzia sales momentum driven by new indications26
Figure 17: Emerging markets to deliver strong pharma growth27
Figure 18: Drug access and pricing across the globe28
Figure 19: Drug financing for emerging economies30
Figure 20: Patent expiration of leading bDMARDs32
Figure 21: Clinical development of rheumatoid arthritis drugs, 201343
Figure 22: INCB039110 response rates over 12 weeks50
Figure 23: Novel targets for the development of new rheumatoid arthritis drugs57
Figure 25: Sarilumab’s on-going clinical trial program 61
Figure 26: Percentage of patients achieving ACR and EULAR responses at week 4 68
Figure 27: Percentage of patients achieving DAS28, mean changes from baseline 69

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