Introduction
IBD pipeline products are set to challenge Remicade and other existing
therapies in the management of the disease. Competition will intensify as
CDP870, Antegren, and Humira provide new alternatives in the severe Crohn's
disease market, and mode of administration will be a key element of product
differentiation. In ulcerative colitis, drugs with novel mechanisms will compete
for patient share.
Scope of this report
- Assessment of epidemiological data and patient potential
- Analysis of IBD product pipeline with emphasis on Phase III, including
trial results and opinion leader insight
- Seven country sales forecasts to 2014
- Transcripts of interviews with key IBD opinion leaders in the US, UK, and
Japan
Research and analysis highlights
Antegren has been filed early for multiple sclerosis on the basis of one year
data from Phase III studies. Strong uptake of Antegren in multiple sclerosis,
followed by approval for Crohn's disease in 2006, will put pressure on Biogen
Idec's manufacturing capabilities, making swift completion of a new production
plant in San Diego crucial.
Patients who received a limited course of induction therapy with Remicade in
effect were "immunized" against the product, and sometimes have not
been able to benefit from maintenance therapy when this indication has been
approved. This has shrunk the potential patient population for Remicade in
Crohn's disease, reducing revenues.
A desire to stay with "tried and trusted" Remicade means that in
Crohn's disease, switching from Remicade caused by Medicare drug coverage in
2006 will be limited. Uptake of CDP870, Antegren, and Humira in Crohn's disease
will be boosted by Medicare reform, but probably not at Remicade's expense.
Key reasons to read this report
- Understand the impact of Medicare reform in the biologics for IBD market
and how companies are positioning products for maximum benefit
- In a sector heavily dependent on licensing deals, appreciate why big
pharma needs to worry about alienating potential partners
- Explore IBD clinical trial design and recruitment strategies to understand
how to maximize chances for success
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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