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Published by: Datamonitor
Published: Apr. 17, 2003 - 102 Pages
Table of Contents
CHAPTER 1 EXECUTIVE SUMMARY
Background and Scope of the analysis
Datamonitor insight into the hepatitis C market
Key metrics
CHAPTER 2 DISEASE OVERVIEW
Key findings
Disease definition
Disease progression
Epidemiology
Disease segmentation (HCV genotypes)
Response rate for different segments
Diagnosis and treatment
CHAPTER 3 PRODUCT ANALYSIS
Key findings
History of HCV therapy
PEG-Intron and Rebetol
PEG-Intron
Rebetol
Combination therapy
Clinical trials
Phase III clinical trial
Phase II clinical trial
Other trials and studies
Pegasys and Copegus
Pegasys
Copegus
Combination therapy
Clinical trials
Peginterferon Alpha-2a Plus Ribavirin for Chronic HCV Infection Trial
Results
Phase III randomized controlled trial to determine the safety, efficacy and dosage
of Pegasys in combination with Copegus.
Other trials and studies
Pegasys versus PEG-Intron
Commercial potential
Comparing cost of therapy
Comparing clinical results
CHAPTER 4 CORPORATE STRATEGIES
Key findings
The significance of corporate strategies in the HCV market
Geographical advantages
Geographic strengths of key players
Market specific benefits
The US and Europe
Japan: the key to success?
Strength of current portfolio
Key franchises
Roche’s infectious disease portfolio
Schering-Plough’s infectious diseases portfolio
Pipelines
Schering-Plough
Roche
Promotional strategy
DTC advertising
Online promotion
Managed care programs
Schering-Plough’s Be in Charge Program
Roche’s Pegassist
Shortcomings of peginterferon promotion
CHAPTER 5 FUTURE TRENDS IN THE HCV MARKET
Key findings
Growth drivers of the HCV market
Pegylated interferon in Japan
New indications for pegylated interferons
Pegasys in HBV
PEG-Intron in malignant melanoma
The HALT-C trial
Trial design
Commercial potential
Patient pool
Incidence of HCV and diagnosis rates
Barriers to growth of the HCV market
Genericization of ribavirin
History of generic ribavirin
Commercial impact of generic ribavirin
HCV research and development pipeline
Late-stage developmental compounds
Zadaxin
Multiferon
Innogenetics’ therapeutic vaccine
BILN
ISIS
Ceplene
Merimepodib
Viramidine
Omega interferon
Early-stage developmental compounds
Levovirin
Conclusions
Sales forecasts in HCV
APPENDIX A
Contributing experts
List of tables
List of figures
Bibliography
Epidemiology
Clinical trial data
APPENDIX B
About Datamonitor
About Datamonitor Healthcare
Datamonitor Healthcare’s research and analysis methodologies
Datamonitor Healthcare’s therapy area capabilities
About Disease analysis team
Datamonitor Healthcare’s Consulting expertise
Datamonitor’s Therapeutic Consulting expertise
Key therapy team members
Simon Hemsworth, Director of Therapy Area Analysis
John Savopoulos , Director of Infectious Diseases
David Abramson, Therapeutic Lead Consultant
Disclaimer
Table 1: Estimated number of HCV infected patients, diagnosed and treated across the seven major markets, 2002
Table 2: Global sales of Roche and Schering-Plough’s interferon and peginterferon based franchises, 2001-02
Table 3: Forecast sales of PEG-Intron and Pegasys ($m), 2003-10
Table 4: Summary of factors influencing HCV progression towards cirrhosis and end-stage liver disease
Table 5: Prevalence of HCV in the seven major markets, 2002
Table 6: Distribution of HCV genotypes in the seven major markets (%), 2002
Table 7: Sustained viral response of different genotypes
Table 8: Physician perception of HCV diagnosis and treatment rates in the seven major markets, 2002
Table 9: SVR rates for PEG-Intron and Rebetol per treatment arm
Table 10: SVR rates with optimized weight-based dosing with PEG-Intron and >10.6 mg/kg/daily Rebetol
Table 11: End-of-treatment virologic response for Pegasys and Copegus and SVR rates per treatment arms
Table 12: Proportion of patients with an SVR as a function of HCV genotype and HCV genotype plus base-line HCV RNA, for Pegasys and Copegus
Table 13: Sustained virologic response to combination therapy as a function of genotype
Table 14: Sales of PEG-Intron and Pegasys, 2001-02
Table 15: US pricing of PEG-Intron, Pegasys and Rebetol, 2003
Table 16: Comparison of the SVR obtained in trials comparing Rebetron therapy with peginterferon and ribavirin combinations
Table 17: Summary of principal differences between Pegasys & Copegus and PEG-Intron & Rebetol combination therapies
Table 18: Geographic distribution of Roche’s ethical sales in 2001-02
Table 19: Geographic distribution of Schering-Plough’s ethical sales, 2001-02
Table 20: EU and US approval dates of Roche and Schering-Plough’s peginterferon monotherapies and combination products
Table 21: Sales of key Japanese interferon products during the 2001-02 fiscal year
Table 22: Roche’s prescription drug sales broken down by therapeutic area, 2001-02
Table 23: Schering-Plough’s prescription drug sales broken down by therapeutic area, 2001-02
Table 24: Key developmental compounds in Roche and Schering-Plough’s R&D pipeline, Q4 2002
Table 25: Key content of Roche and Schering-Plough’s peginterferon drug websites, 2003
Table 26: Prevalence of HBV in the US, Japan and five largest European markets in 2002
Table 27: Prevalent cases of melanoma in the seven major markets, 2002-10
Table 28: Inclusion criteria and amendments to the HALT-C trial design
Table 29: HCV products in Phase II and III clinical trials
Table 30: HCV products in Phase I trials, 2003
Table 31: Global sales of Roche and Schering-Plough’s interferon and ribavirin franchises 2001-02
Table 32: Forecast sales of PEG-Intron and Pegasys ($m), 2003-10
LIST OF FIGURES
Figure 1: PEG-Intron and Rebetol Phase III study design
Figure 2: PEG-Intron and Rebetol Phase II study design
Figure 3: Pegasys and Copegus Phase III clinical trial design
Figure 4: Pegasys and Copegus Phase III clinical trial design
Figure 5: Geographical breakdown of Roche and Schering-Plough’s sales in 2002
Figure 6: Flow of HCV patients in Japan, 2002
Figure 7: Roche and Schering-Plough’s ethical drug sales broken down by therapeutic area in 2002
Figure 8: Main impacting factors affecting sales of the Intron franchise, 1996-2003
Figure 9: Forecast sales of PEG-Intron and Pegasys ($m) 2002-10
Figure 10: Datamonitor’s Healthcare Consultancy
Figure 11: Datamonitor Healthcare’s Therapeutic Consulting capabilities
AbstractIntroduction
Alpha interferons have been the drug of choice for the treatment of hepatitis C since their discovery. However, the launch of pegylated interferons, namely Roche's Pegasys and Schering-Plough's PEG-Intron, has begun to revolutionize hepatitis C therapy and the dynamics of this market.
Scope
Overview if the epidemiology of HCV and the existing patient potential for peginterferon-based therapies
Analysis of the impact of Roche’s new product launch, Pegasys, on the HCV market and particularly the preformance of Schering-Plough's PEG-Intron
Comparison of the individual strengths of both companies along with their promotional efforts
Examination of potential drivers and barriers of growth for the pegylated interferons, with sales forecasts for the two leading products
Report Highlights
HCV incidence is decreasing, with the new cases in the US falling by approximately 88% since 1989, to 22,000 new infections by 2002.
Roche’s Pegasys and Schering-Plough’s PEG-Intron dominate the HCV interferon market, generating 2002 sales of $24m (launched mid-year) and $810m (IMS MIDAS), respectively.
There are approximately 2 million HCV infected patients in Japan, creating a significant demand for peginterferon-based therapies. This market will be key to the overall success of Roche’s Pegasys.
Reasons to Purchase
Understand the competitive dynamics of the hepatitis C market
Evaluate the relative clinical advantages of pegylated interferon products
Analyze key promotional strategies and predict the future success of pegylated interferons
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