ABOUT DATAMONITOR HEALTHCARE
- About the Immune Disorders and Inflammation analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor insight into the IBD market
CHAPTER 2 PATIENT POTENTIAL
- Definition of IBD
- CD
- UC
- Segmentation of the IBD population
- CD
- Mild to moderate
- Moderate to severe
- Severe fulminant disease
- Remission
- UC
- Mild
- Moderate
- Severe
- Epidemiology of the IBD population
- Unmet needs in IBD
- Efficacy
- Side effects
- Convenience
- Products covered in this analysis
CHAPTER 3 R&D APPROACH
- Classification of pipeline products
- Clinical trial design and endpoints in IBD
- Practical challenges in IBD trial design
- CD trial design: a work in progress
- Measuring efficacy in CD: indexes and beyond
- CDAI for beginners
- CDAI issues and debates
- INTER-RATER AND INTRA-RATER VARIABILITY
- ROLE OF SUBJECTIVE ELEMENTS
- DEAR DIARY? PATIENT DIARY ISSUES
- Additional endpoints
- IBDQ
- PHYSICIAN'S GLOBAL ASSESSMENT (PGA)
- Improvements possible to CDAI gold standard
- Using the CDAI: continuous index, or proportions of patients?
- Placebo response in CD: trial design challenges and solutions for
biologics
- Efficacy endpoints in CD: how high is the bar?
- Measuring efficacy in UC: indexes and beyond
- DAI for beginners
- DAI issues and debates
- Placebo as active intervention in UC?
- Diary keeping in UC: another active intervention?
CHAPTER 4 COMMERCIAL ANALYSIS
- Remicade: localized strategies deliver outstanding growth in a tale of
three companies
- Profile
- Drug overview
- MULTIPLE INDICATIONS AND LICENSING PARTNERS DRIVE GLOBAL GROWTH
- PATENT LICENSES: ADDITIONAL ROYALTIES TO PAY?
- MANUFACTURING AGREEMENT AIMS AT LOWERING COST OF GOODS
- Marketing partners deliver global growth
- Johnson & Johnson: relentless investment sustains growth
- REMICADE AND CENTOCOR: RIGHT PRODUCT, RIGHT COMPANY, RIGHT TIME: WINNING
STRATEGIC ACQUISITION FOR JOHNSON & JOHNSON
- R&D INVESTMENT PAYS DIVIDENDS
- FORTUNE FAVORS REMICADE AS COMPETITORS FALL BY THE WAYSIDE
- Schering-Plough: Remicade provides relief in troubled times
- LICENSING DEAL PRE-DATES JOHNSON & JOHNSON BUT HELPS BUILD GLOBAL
BRAND
- REMICADE, MONEY WELL SPENT FOR SCHERING-PLOUGH
- LAG IN CD APPROVALS COSTLY AS COMPETITORS LEARN FROM FIRST-TO-MARKET
EXPERIENCES
- REMICADE: BRIDGE OVER TROUBLED SCHERING-PLOUGH WATERS
- Tanabe: physician education to drive sales as epidemiology and market gaps
define Remicade's niche
- ADDITIONAL INDICATIONS PROVIDE GROWTH OPPORTUNITIES...
- ... BUT PIECEMEAL LABELING EXPANSION COSTS PATIENT POTENTIAL
- CHANGE IN TREATMENT PRACTICES REQUIRED FOR SUCCESS
- UC: NOT ATTRACTIVE ENOUGH (FOR NOW)
- INTRAVENOUS ADMINISTRATION UNLIKELY TO BLOCK GROWTH
- PATIENT EDUCATION NECESSARY...
- ... BUT PHYSICIAN EDUCATION IS KEY FOR REMICADE
- CAREFUL CHOICE OF INDICATIONS MAXIMIZES GROWTH POTENTIAL
- BEST IS YET TO COME
- Forecast assumptions
- US
- EUROPE
- JAPAN
CHAPTER 5 LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview
- Pipeline summary
- Product assessment methodology
- Prograf
- Profile
- Drug overview
- WAITING FOR APPROVAL
- TACROLIMUS FAMILY EXPANDING
- LICENSING DEALS: BITTER-SWEET
- HELP AT HAND FROM DOMESTIC SUITOR
- Clinical trial data
- TRIAL TITLE
- TRIAL REFERENCE
- LEAD INVESTIGATOR
- DATE
- BACKGROUND
- STUDY DESIGN
- RESULTS
- AUTHOR CONCLUSIONS
- DATAMONITOR COMMENTS
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- EFFICACY
- SIDE EFFECTS
- CONVENIENCE
- Forecast assumptions
- US
- EUROPE
- JAPAN
- Humira
- Profile
- Drug overview
- FLYING START IN RA
- ACCESS PROGRAM POSITIONS HUMIRA FOR SLICE OF MEDICARE PIE
- DEVELOPMENT DEALS: MAXIMIZING VALUE, BUT AT WHAT COST?
- PATENT LICENSING: SWEET AND SOUR
- MANUFACTURING FACILITIES IN PLACE AS ABBOTT LEARNS FROM ENBREL EXPERIENCE
- FULL STEAM AHEAD WITH PHASE III CD TRIALS
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- EFFICACY
- SIDE EFFECTS
- CONVENIENCE
- Forecast assumptions
- US
- EUROPE
- JAPAN
- Alicaforsen sodium
- Profile
- Drug overview
- ISIS: MAKING SENSE OF ANTISENSE
- COLLABORATIONS: PAST, PRESENT, FUTURE
- Clinical trial data
- ALICAFORSEN: LEARNING THE HARD WAY IN CD
- UC: SOME WAY BEHIND
- EARLY DATA
- PHASE II
- POUCHITIS: ANOTHER POTENTIAL INDICATION
- Patient potential
- MULTIPLE INDICATIONS A DRIVER FOR GROWTH, BUT DOSING POSSIBLY DIFFICULT
- Marketing factors
- Satisfaction of unmet needs
- EFFICACY
- SIDE EFFECTS
- CONVENIENCE
- Forecast assumptions
- US
- EUROPE
- JAPAN
- CDP870
- Profile
- Drug overview
- LESS IS MORE: ANTIBODY FRAGMENT OFFERS UNIQUE ADVANTAGES
- CDP870 SUFFERS THE CRUELEST CUT
- UCB DEAL RAISES QUESTIONS FOR CDP870
- DEALS IN PLACE TO ENSURE PRODUCTION RAMP UP
- MIXED TRIAL RESULTS BUT DEVELOPMENT CONTINUES
- Clinical trial data
- TRIAL REFERENCE
- LEAD INVESTIGATOR
- DATE
- BACKGROUND
- STUDY DESIGN
- RESULTS
- AUTHOR CONCLUSIONS
- DATAMONITOR COMMENTS
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- EFFICACY
- SIDE EFFECTS
- CONVENIENCE
- Forecast assumptions
- US
- EUROPE
- JAPAN
- OPC-6535
- Profile
- Drug overview
- OPC-6535: SMOOTH PROGRESS SO FAR
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- EFFICACY
- SIDE EFFECTS
- CONVENIENCE
- Forecast assumptions
- US
- EUROPE
- JAPAN
- Antegren
- Profile
- Drug overview
- LICENSING AGREEMENTS POSITION ANTEGREN FOR GROWTH
- ANTEGREN THREATENS MANUFACTURING "BLOW-OUT" BUT BIOGEN IDEC
PRODUCTION CAPACITY SHOULD PROVE SUFFICIENT
- MERGER: BIGGER BUT NOT NECESSARILY BETTER (FOR ANTEGREN)
- ANTEGREN FOLLOWING NOVEL PATHWAYS
- TROUBLED HISTORY PUTS SPOTLIGHT ON DEVELOPMENT DECISIONS
- MLN02 FAILURE CASTS SHADOWS OVER ANTEGREN
- Clinical trial data
- TRIAL TITLE
- DATE
- BACKGROUND
- STUDY DESIGN
- RESULTS
- AUTHOR CONCLUSIONS
- DATAMONITOR COMMENTS
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- EFFICACY
- SIDE EFFECTS
- CONVENIENCE
- Forecast assumptions
- US
- EUROPE
- JAPAN
- COLAL-PRED
- Profile
- Drug overview
- ORAL ADMINISTRATION BUT LOCAL DELIVERY: A WINNING COMBINATION?
- A "VIRTUAL" COMPANY
- PHASE III - JUST
- Clinical trial data
- BACKGROUND
- STUDY DESIGN
- RESULTS
- DATAMONITOR COMMENTS
- Patient potential
- REGULATORY POSITION TO BOOST PATIENT POTENTIAL
- Marketing factors
- Satisfaction of unmet needs
- EFFICACY
- SIDE EFFECTS
- CONVENIENCE
- Forecast assumptions
- US
- EUROPE
- JAPAN
- Other drugs in IBD
CHAPTER 6 OPINION LEADER TRANSCRIPTS
- Opinion leader interviews: methodology
- Opinion leader interviews: biographies
- Professor Anthony Axon (ATR Axon, Anthony Thomas Roger Axon, Tony Axon)
- Professor Danial Baker
- Professor Subrata Ghosh
- Professor Tetsuya Mine
- Opinion leader interviews: questions
- Opinion leader interviews: answers
CHAPTER 7 APPENDIX
- Report methodology
- Japanese market data
- Standard units
- Pricing forecasts
- Exchange rates and calendrical notes
- Bibliography
- Disclaimer
List of Tables
- Table 1: Prevalence and incidence of CD by country
- Table 2: Prevalence and incidence of UC by country
- Figure 1: Unmet needs in IBD
- Table 3: ATC and Anatomical Classification of Pharmaceutical Products
codes, identifying codes covered in this analysis
- Table 4: CDAI variables, scores, and multipliers
- Table 5: DAI scores assigned to varying severities of disease in DAI
subsections
- Table 6: Remicade assessment
- Table 7: Remicade US indications by approval date
- Table 8: Remicade EU and Japan indications by company and approval date
- Table 9: Remicade R&D indications by company, territory, and phase
- Table 10: Global Remicade sales ($m) and growth (%) by company, 1998-2003
- Table 11: Selected products in late-stage R&D for IBD, 2004
- Table 12: Score assignments for external factors for product evaluation
- Table 13: Score assignments for internal factors for product evaluation
- Table 14: Opportunities and threats weightings
- Table 15: Strengths and weaknesses weightings
- Table 16: Prograf assessment
- Table 17: Prograf Japanese R&D indications by phase
- Table 18: Humira assessment
- Table 19: Humira indications by company, territory, and approval date
- Table 20: Humira R&D indications by company, territory, and phase
- Table 21: Alicaforsen assessment
- Table 22: Alicaforsen R&D indications by phase
- Table 23: CDP870 assessment
- Table 24: CDP870 R&D indications by phase
- Table 25: OPC-6535 assessment
- Table 26: OPC-6535 R&D indications by phase
- Table 27: Antegren assessment
- Table 28: Antegren R&D indications by territory and phase
- Table 29: COLAL-PRED assessment
- Table 30: COLAL-PRED R&D indications by phase
- Table 31: Selected products in Phase II for IBD, 2004
- Table 32: Exchange rates to the US dollar used in this analysis
- Table 33: Years as stated in this analysis and Japanese financial years
List of Figures
- Figure 2: Remicade assessment
- Figure 3: Global Remicade sales ($m) and growth (%) by company, 1998-2003
- Figure 4: Assessment of selected products in late-stage R&D for IBD
- Figure 5: Assessment of selected products in late-stage R&D for IBD
- Figure 6: Prograf assessment
- Figure 7: Humira assessment
- Figure 8: Alicaforsen assessment
- Figure 9: CDP870 assessment
- Figure 10: OPC-6535 assessment
- Figure 11: Antegren assessment
- Figure 12: COLAL-PRED assessment
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