Inflammatory Bowel Disease

Syndicated Thought Leader Insight

Thought Leader Insight & Analysis Report
Inflammatory Bowel Disease Q1 2011
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Autoimmune Disorders, Gastroenterology

Crohns disease, ulcerative colitis
Gastroenterologists/N. America, Europe
6
162
March 2011
Tricia L. Hanlon
Kim Grant
Jeffrey D. Berk, Ph.D., MBA
MGIUCQ111-11
$7,500
www.medpredict.com or call (513) 271-1924

Abstract: Gastroenterology Thought Leader Panel #11 summarizes our recent discussions with six internationally
recognized experts in the treatment of Crohns disease and ulcerative colitis. There were a few new and emerging
themes in this panel.
The first is that there will be much more price inelasticity in inflammatory bowel disease than in rheumatoid arthritis
and psoriasis. In particular, payers will not be able for force gastroenterologists to give up their infusion cash cows
like they did to the rheumatologists.
The second theme is that class effects are not holding up in IBD as they generally do in RA and psoriasis. Success
and failure of individual drugs are less likely to portend the future of follow ons.
Finally, as in other immunology categories, there are numerous new therapeutic approaches that will be segmented
in the market based on efficacy, safety, convenience and cost.
Key mechanisms discussed in this report include TNF, integrin/MAdCAM, p40 (IL-23, IL-12, p19), IL-6 / JAK1 / JAK3,
IFN, IL-17, CCR9, IL-22, NK, antibiotics and stem cell transplant.
In addition, the Panel offers some thoughts on payers/reimbursement, biomarkers, and (one panelist weighs in on)
differences in Asian vs. US/EU approaches to treatment of IBD.

Full transcripts of six qualitative interviews with gastroenterologists are included with this report.

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MedPredict Thought Leader Panel IBD Q1 2011

Companies/compounds discussed in this report:

Company
Abbott (Eisai)
Ablynx / Pfizer
Ablynx
Allostera
Amgen
Avaxia
Celgene
Cephalon
ChemoCentryx /
GlaxoSmithKline
Elan / Biogen
Emergent / Pfizer
Ferring
Genentech / Roche
Roche / Chugai
J&J / Centocor / Merck / Essex
Lilly
Merck (Schering-Plough)
Millennium / Takeda
Novartis
Novo Nordisk
Osiris Therapeutics
PDL
Pfizer
Salix
Teva
UCB

Generic
adalimumab
briakinumab; ABT-874
ATN-103
ALX-0061
APG-2305
AMG-827
AMG-139
AVX-470; polyclonal bovine
anti-TNF
PDA001
apremilast
CEP-37248
CCX-282 B

Brand
Humira (with Eisai)

natalizumab
X1 TNFR x Anti-IL6
FE-301
rhuMAb-b7; RG7413
RG4934
tocilizumab
infliximab
ustekinumab; CNTO-1275
golimumab
LY2439821
INCB-28050 / LY3009104
SCH-900222
vedolizumab (MLN-02)
secukinumab; AIN-457
NN 8555
mesenchymal stem cell
fontolizumab
tasocitinib; CP-690550
PF-00547659
fezakinumab; PF-5212367
rifaximin
laquinimod
certolizumab
CDP-6038

Tysabri

Traficet-EN

Actemra / RoActemra
Remicade
Stelara
Simponi

Prochymal

Xifaxan
Cimzia

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MedPredict Thought Leader Panel IBD Q1 2011

Table of Contents
EXECUTIVE SUMMARY ................................................................................................. 4
Report Highlights ........................................................................................................................... 6

KEY FINDINGS ............................................................................................................. 17

General Comments ...................................................................................................................... 17
Payers ..................................................................................................................................................... 17
Biomarkers .............................................................................................................................................. 20
Asian Crohns / UC Market Dynamics ................................................................................................... 23
TNF................................................................................................................................................. 24
Remicade (infliximab; Centocor) ........................................................................................................ 26
Humira (adalimumab; Abbott) ............................................................................................................. 30
Cimzia (certolizumab; UCB) ............................................................................................................... 38
Simponi; golimumab (Centocor / Schering-Plough / Merck) .............................................................. 41
apremilast; CC-10004; (Celgene) ...................................................................................................... 45
AVX-470 Avaxia.................................................................................................................................. 46
ATN-103 (Anti-71)$EO\Q[3IL]HU ................................................................................................ 47
TM
X1 TNFR x Anti-IL-6/IL-6R SCORPION Therapeutic (Pfizer / Emergent) ...................................... 47
Integrin / MAdCAM ....................................................................................................................... 48
Tysabri (natalizumab; Biogen / Elan).................................................................................................. 49
vedolizumab (MLN-02 / MLN-0002; Takeda) ..................................................................................... 51
RG7413; rhuMAb-b7 (Genentech) ..................................................................................................... 59
PF-00547659 (Pfizer) ......................................................................................................................... 61
p40: Anti-IL-12 / Anti-IL-23 ......................................................................................................... 63
Stelara (ustekinumab / CNTO-1275; Centocor/Janssen-Cilag) ......................................................... 65
briakinumab (ABT-874; Abbott) .......................................................................................................... 69
SCH900222 (p19 IL-23 selective MAb; Merck / Schering-Plough) .................................................... 72
CEP-37248 (Cephalon) ...................................................................................................................... 74
APG2305 (Allostera) ........................................................................................................................... 74
IL-6 / JAK1/JAK3 ........................................................................................................................... 75
Actemra/RoActemra (tocilizumab; Roche / Chugai) ........................................................................... 75
ALX-0061 (anti-IL6R; Ablynx) ............................................................................................................. 76
CDP6038 (UCB) ................................................................................................................................. 76
FE301 (Ferring / Conaris) ................................................................................................................... 77
tasocitinib; CP-690550 (Pfizer) ........................................................................................................... 77
INCB 28050 (LY 3009104; Lilly / Incyte) ............................................................................................ 80
C326 / AMG-139 (Avidia / Amgen) ..................................................................................................... 80
IFN g............................................................................................................................................... 81
fontolizumab (IFN g; PDL Biopharma)................................................................................................ 81
IL-17 ............................................................................................................................................... 81
secukinumab; AIN-457 (Novartis)....................................................................................................... 83
AMG-827 (Amgen).............................................................................................................................. 83
RG4934 (Roche / Genentech) ........................................................................................................... 84

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MedPredict Thought Leader Panel IBD Q1 2011

Immunosuppressants / Immunomodulators ............................................................................. 85
Imuran (azathioprine).......................................................................................................................... 85
laquinimod (Teva) ............................................................................................................................... 88
CCR9 .............................................................................................................................................. 89
Traficet-EN (CCX-282-B; ChemoCentryx/GSK) ................................................................................. 89
IL-22 ............................................................................................................................................... 92
fezakinumab (PF-5212367 / ILV-094; Pfizer) ..................................................................................... 92
Natural Killer ................................................................................................................................. 93
NN8555 (Novo Nordisk) ..................................................................................................................... 93
antibiotics...................................................................................................................................... 93
rifaximin (Salix) ................................................................................................................................... 93
Stem Cell Transplant .................................................................................................................... 94
Prochymal (Osiris Therapeutics) ........................................................................................................ 95
PDA-001; Celgene Cellular Therapeutics .......................................................................................... 98

APPENDIX 1: FANTASY FORMULARY SURVEY...................................................... 99

Ground Rules and Scoring ................................................................................................................. 99
Results......................................................................................................................................... 101
Table 1: Preferred Product Class......................................................................................................... 101
New Therapeutic Approaches ................................................................................................... 102

APPENDIX 2: UNMET NEEDS .................................................................................. 104

Mucosal Healing / Antifibrotic ........................................................................................................... 104
Steroid-Sparing ................................................................................................................................. 108
Pain / Neuropathy ............................................................................................................................. 108
Reduce Serious Adverse Events ...................................................................................................... 111
Diagnostics ....................................................................................................................................... 112

THOUGHT-LEADER INTERVIEWS............................................................................ 113

Interview OHIID02540 .................................................................................................................. 113
Interview OHIID02541 .................................................................................................................. 121
Interview OHIID02542 .................................................................................................................. 130
Interview OHIID02543 .................................................................................................................. 137
Interview OHIID02544 .................................................................................................................. 145
Interview OHIID02545 .................................................................................................................. 154

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Telephone: 513.271.1924 Email: info@medpredict.com Website: www.medpredict.com
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