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