Inflammatory Bowel Disease-Competition Increases for the Biologics
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Inflammation and Immune Disorders pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the IBD market - page 3
- CHAPTER 2 EPIDEMIOLOGY AND PATIENT NUMBERS - page 14
- Definition and diagnosis - page 14
- Patient segmentation in the Inflammatory Bowel Disease spectrum - page 17
- Prevalence and incidence of Inflammatory Bowel Disease - page 18
- Crohn's disease - page 18
- Ulcerative colitis - page 19
- Overview of Inflammatory Bowel Disease epidemiology studies - page 21
- US - page 22
- Europe - page 23
- Japan - page 24
- Ulcerative colitis incidence stabilizes as Crohn's disease continues to rise - page 26
- Reduction in North-South prevalence divide - page 27
- NOD2 genetic connection - page 28
- Definition and diagnosis - page 14
- CHAPTER 3 MARKET DEFINITION AND OVERVIEW - page 29
- Current market players - page 29
- Centocor and Procter and Gamble's blockbuster products lead, but Salix's diversity and UCB's pipeline are significant - page 29
- Current treatment classes - page 32
- Anti-inflammation drugs - page 32
- Corticosteriods - page 33
- Traditional immunosuppressants - page 34
- Biologic targeted immunosuppression - page 35
- Antibiotics - page 35
- Anti-diarrheal and fluid replacements - page 35
- ICD-10 codes used to define the IBD indications - page 36
- Ulcerative colitis ICD-10 definition - page 36
- Crohn's disease ICD-10 definition - page 36
- Treatment algorithm - page 37
- Ulcerative colitis does differ in treatment from Crohn's disease - page 38
- 5-ASAs tend to be more effective in ulcerative colitis - page 38
- Crohn's disease is treated with a wider range of drugs as surgery is not always effective - page 39
- Step-up versus top-down - page 40
- Ulcerative colitis does differ in treatment from Crohn's disease - page 38
- Unmet needs and challenges in Inflammatory Bowel Disease - page 41
- How many rescue therapies can patients use? - page 41
- Patient compliance an issue for 5-ASAs - page 42
- Maintenance of remission and mucosal healing need to be proven - page 42
- Standardized ulcerative colitis endpoints - page 43
- Immunogenicity of biologic products - page 43
- Current market players - page 29
- CHAPTER 4 COMMERCIAL FORECAST ANALYSIS - page 45
- Remicade approval in ulcerative colitis - page 45
- Remicade is first to market in ulcerative colitis for induction AND maintenance of remission - page 45
- EMEA approves Remicade in EU to treat ulcerative colitis - page 45
- Remicade boosted by prompt approval for maintenance of remission in ulcerative colitis in the US and EU - page 49
- Remicade is first to market in ulcerative colitis for induction AND maintenance of remission - page 45
- Additional anti-TNF brand launches - page 50
- The biologic battle begins - page 50
- Cimzia predicted to launch first in the US, but Humira likely to beat Cimzia to the European market - page 50
- Centocor, Schering-Plough and Tanabe continue to roll out the approvals - page 54
- Approval of Remicade for children with active Crohn's disease in US and EU - page 54
- Remicade approved for maintenance of remission in Crohn's disease in Japan - page 56
- Remicade approved as second-line therapy in Crohn's disease in the EU - page 57
- NICE review of Remicade, Cimzia and Tysabri - page 58
- The biologic battle begins - page 50
- Launch of 5-ASAs reformulations and new delivery technologies - page 59
- Reformulations dominate the 5-ASAs - page 59
- Pentasa increases US price in January 2006 - page 59
- Salix invests in Colazal development - page 60
- Reformulations dominate the 5-ASAs - page 59
- Retail corticosteroids - page 61
- Entocort EC is the leading retail corticosteroid - page 61
- Entocort EC (budesonide) capsules recommended by the American Gastroenterology Association as first-line therapy for the treatment of mild to moderate Crohn's Disease - page 61
- Entocort EC is the leading retail corticosteroid - page 61
- Warnings and safety issues - page 63
- Immunosuppression can be a dangerous treatment path - page 63
- Health Canada warn about cancer links in children and adolescents treated with Remicade - page 63
- Hepatitis B reactivation warning for all anti-TNF agents in Canada - page 63
- Immunosuppression can be a dangerous treatment path - page 63
- Patent expiries - page 64
- Impact of patent expiries increases as cost containment becomes a global issue - page 64
- US is trying to catch up with the EU in the biosimilars' race - page 64
- Colazal patent expiry - page 65
- Impact of patent expiries increases as cost containment becomes a global issue - page 64
- Data definitions, limitations and assumptions - page 65
- Standard units - page 65
- Japanese market data - page 66
- Derivation of sales forecasts and pricing trends - page 66
- Inflammatory Bowel Disease indication breakdown - page 66
- Diagnosis value based on retail data only - page 68
- Remicade approval in ulcerative colitis - page 45
- CHAPTER 5 LATE-STAGE PIPELINE ANALYSIS - page 69
- Key classes in the pipeline - page 69
- Anti-TNF - page 77
- Cytokine - page 77
- Mesalazine - page 78
- Regional launch dates and prices for new products - page 78
- Humira (adalimumab) - page 82
- Forecast and assumptions - page 83
- Historical delay between submission and approval used to predict launch date - page 84
- Patient and marketing potential - page 85
- Humira rapidly achieves multiple indications - page 85
- Humira is well positioned for use in Remicade failures, estimated at 60% after a year - page 86
- Approval in ulcerative colitis expected to follow - page 86
- Overview of latest Humira clinical trials - page 86
- Forecast and assumptions - page 83
- Cimzia (certolizumab pegol) - page 88
- Forecast and assumptions - page 89
- Strong uptake expected but competition reduces potential - page 89
- Cost advantage hangs in the balance - page 90
- Market and patient potential - page 91
- Patient friendly injector may come too late as the competition beats UCB to it - page 91
- Priority backing and Inflammatory Bowel Disease support by UCB essential for Cimzia to finally reach the market - page 92
- Poor response in low CRP patients casts a shadow over trial results - page 92
- Overview of latest Cimzia clinical trials - page 92
- Forecast and assumptions - page 89
- Nuvion (visilizumab) - page 94
- Forecast and assumptions - page 95
- Uptake limited to steroid-refractory ulcerative colitis patients - page 95
- Patient and marketing potential - page 97
- Fast Track status will help but cytokine release syndrome and Epstein-Barr virus side effects reduce patient potential - page 97
- Clinical trial overview - page 97
- Ulcerative colitis - page 97
- Crohn's disease - page 98
- Forecast and assumptions - page 95
- Tysabri (natalizumab) - page 99
- Forecast and assumptions - page 100
- Approval in Crohn's disease forecast following MS approval but uptake will be limited by TOUCH program - page 100
- High cost may recoup some revenue but sales in MS are more likely to provide the return on investment - page 101
- Patient and marketing potential - page 102
- PML risk and poor response in low CRP patients limits use to after anti-TNF therapy - page 102
- Clinical trial overview - page 102
- Forecast and assumptions - page 100
- Prograf/Protopic (tacrolimus) - page 104
- Forecast and assumptions - page 105
- Prograf listed in pipeline for UC in Japan, and expansion into other markets is not expected - page 105
- Patient and marketing potential - page 106
- Clinical trial overview - page 106
- Forecast and assumptions - page 105
- Leukine/Prokine (sargramostim) - page 108
- Forecast and assumptions - page 109
- Patient and marketing potential - page 110
- Multiple studies are planned but recruitment may be an issue here - page 110
- Studies show some efficacy but the use of the higher CDAI 100 as an endpoint should be taken into account - page 110
- Clinical trial overview - page 111
- Mesavance (mesalazine MMX) - page 112
- Forecast and assumptions - page 113
- Off-label use is also predicted on the launch of Mesavance as is seen in all other 5-ASA products - page 114
- Patient and marketing potential - page 115
- A once-daily formulation meets a high unmet need but the physical size of the tablet may cause an issue with patients - page 115
- Shire also markets Pentasa in the US and the launch of Mesavance will create conflict, although Pentasa's high proportion of sales from off-label CD indications may save it - page 117
- Clinical trial overview - page 117
- Forecast and assumptions - page 113
- Tetomilast (OPC-6535) - page 122
- Forecast and assumptions - page 122
- Tetomilast is expected to be used as an alternative to 5-ASAs but uptake will depend on results of more efficacy data - page 123
- Patient and marketing potential - page 123
- Pre-clinical and early phase results are promising but more side-effect data are essential - page 123
- Clinical trial overview - page 124
- Forecast and assumptions - page 122
- Colal-Pred (prednisolone sodium metasulfobenzoate) - page 125
- Forecast and assumptions - page 126
- Patient and marketing potential - page 127
- Clinical trial overview - page 128
- ABT-874 - page 128
- Forecast and assumptions - page 128
- Patient and marketing potential - page 129
- Clinical trial overview - page 130
- Other Inflammatory Bowel Disease pipeline agents - page 130
- Salofalk Granu-Stix - page 130
- Alicaforsen (ISIS-2302) - page 131
- Golimumab (CNTO-148) - page 132
- CNT0-1275 - page 132
- Colirest (CBP-1011) - page 133
- Gastrom enema formulation (ecabet/TA-2711E) - page 133
- MLN02 - page 134
- TC-2401 - page 135
- Nicotine - page 136
- HuZaf (fontolizumab) - page 136
- Apilimod (STA-5326) - page 137
- Traficet-EN (CCX-282) - page 138
- RDP-58 - page 138
- Teduglutide - page 139
- Recently discontinued projects - page 140
- Apaza (NAA-004) - page 140
- Key classes in the pipeline - page 69
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 141
- Summary Inflammatory Bowel Disease market data - page 141
- Pricing calculations and assumptions - page 143
- Biologic key brands - page 144
- Immunosuppressant key brands - page 146
- Intestinal anti-inflammatory key brands - page 147
- Corticosteroids key brands (retail only) - page 152
- APPENDIX B - MARKET FORECAST DATA - page 153
- US forecast data - page 153
- EU forecast data - page 155
- Japan forecast data - page 157
- APPENDIX C- BIBLOGRAPHY AND METHODOLOGY - page 158
- Report methodology - page 164
- Forecast methodology - page 164
- About Datamonitor - page 165
- About Datamonitor Healthcare - page 165
- About the IDI analysis team - page 166
- Disclaimer - page 167
- List of Tables
- Table 1: Prevalence and incidence of Crohn's disease in the seven major markets by country, 2006 - page 18
- Table 2: Prevalence and incidence of ulcerative colitis in the seven major markets by country, 2006 - page 19
- Table 3: Epidemiology studies into incidence and prevalence of IBD, 1984-2002 - page 21
- Table 4: Incidence of IBD in the European over-15 population, October 1991-September 1993 - page 23
- Table 5: Prevalence studies for IBD in Europe - page 24
- Table 6: Estimated prevalence and incidence of Crohn's disease in Japan, 1986-1998 - page 25
- Table 7: Key players in IBD in the seven major markets, 2006 - page 30
- Table 8: Remicade ACT 1&2 trial results (Patient % achieving response, remission and mucosal healing) - page 47
- Table 9: Cimzia and Humira forecast launch dates - page 52
- Table 10: Remicade's pediatric Crohn's disease results - page 55
- Table 11: Late-Phase IBD pipeline products, 2006 - page 70
- Table 12: Phase I and II IBD pipeline, 2006 - page 72
- Table 13: Estimated launch dates across the US, EU and Japan for late-phase pipeline IBD products, 2006 - page 79
- Table 14: Benchmark brand $ per SU values, 2005 - page 80
- Table 15: Formulary price comparison between regions for biologic products, 2006 - page 81
- Table 16: Humira past and forecast time delay between submission and approval for the FDA and EMEA, 2002-06 - page 84
- Table 17: Tacrolimus studies in refractory IBD, 1998-2006 - page 107
- Table 18: Brands currently approved in IBD for sulfasalazine and its derivatives, 2006 - page 116
- Table 19: Abstracts and posters presented at key GI conferences in 2006 for mesavance - page 118
- Table 20: Estimated Crohn's disease sales in seven major markets, by class - page 141
- Table 21: Estimated ulcerative colitis sales in seven major markets, by class - page 142
- Table 22: Intestinal anti-inflammatory dollar per standard unit assumptions, 2005 - page 143
- Table 23: Remicade: key facts - page 144
- Table 24: Humira: key facts - page 145
- Table 25: Neoral: key facts - page 146
- Table 26: Salazopyrin: key facts - page 147
- Table 27: Asacol: key facts - page 148
- Table 28: Pentasa: key facts - page 149
- Table 29: Colazal: key facts - page 150
- Table 30: Dipentum: key facts - page 151
- Table 31: Entocort: key facts - page 152
- Table 32: US forecast sales data, $m, 2005-2015 - page 153
- Table 33: Five major EU markets sales forecast, $m, 2005-2015 - page 155
- Table 34: Japanese sales forecast, $m, 2005-2015 - page 157
- List of Figures
- Figure 1: Ulcerative colitis and Crohn's disease in the digestive tract - page 15
- Figure 2: Trends in Crohn's disease incidence over time and by age group, 1940-1993 - page 22
- Figure 3: Sales of top five marketed IBD products in the seven major markets ($m), 2002-05 - page 29
- Figure 4: Gastroenterology brands marketed by Salix, 2006 - page 32
- Figure 5: IBD overview treatment algorithm - page 38
- Figure 6: Step-up versus top-down approach - page 40
- Figure 7: Sustained response and remission in ulcerative colitis for both weeks 8 and 30, ACT 1 & 2 trial data - page 46
- Figure 8: Remicade uptake in IBD in the US and 5EU, 2002-2015 - page 49
- Figure 9: Comparative advantages and disadvantages of Humira and Cimzia - page 51
- Figure 10: Remicade global* sales, split by IBD and other indications, 2005-2015 - page 54
- Figure 11: Tanabe's expectations for Remicade approvals in Japan - page 56
- Figure 12: Estimated percentage use of Remicade in Japan by indication, 2006 - page 57
- Figure 13: Pentasa sales value and volume ($m and SU), 2002-2015 - page 60
- Figure 14: Entocort US forecast ($m), 2006-2015 - page 62
- Figure 15: Estimated sales breakdown by indication for key US brands, 2005 - page 67
- Figure 16: EU key brands with estimated sales breakdown by indication, 2005 - page 68
- Figure 17: Breakdown of clinical trial pipeline for IBD agents, 2006 - page 69
- Figure 18: Working hypothesis regarding the role of cytokines in the pathogenesis of Crohn's disease - page 78
- Figure 19: Humira commercial and clinical scores - page 83
- Figure 20: Humira's forecast for Crohn's disease and total brand sales in the seven major markets ($), 2002-2015 - page 84
- Figure 21: Cimzia commercial and clinical scores - page 89
- Figure 22: Cimzia global (7MM) Crohn's disease forecast, 2006-2015 - page 90
- Figure 23: Nuvion commercial and clinical scores - page 95
- Figure 24: Nuvion global (7MM) forecast in ulcerative colitis - page 96
- Figure 25: Tysabri commercial and clinical scores - page 100
- Figure 26: Tysabri global Crohn's disease sales forecast, 2005-2015 - page 101
- Figure 27: Tysabri ENACT-1 and 2 results - page 103
- Figure 28: Prograf commercial and clinical scores - page 105
- Figure 29: Leukine commercial and clinical scores - page 109
- Figure 30: Mesavance commercial and clinical scores - page 113
- Figure 31: Mesavance global sales forecast, 2005-2015 - page 115
- Figure 32: Mesavance results from two combined Phase III clinical trials in moderate to severe ulcerative colitis - page 120
- Figure 33: Tetomilast commercial and clinical scores - page 122
- Figure 34: Colal-Pred commercial and clinical scores - page 125
- Figure 35: Colal-Pred ulcerative colitis sales, 2005-2015 - page 126
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