Stakeholder Opinions: Respiratory Syncytial Virus (RSV) - A market yet to reach its full potential

Table of Contents

• ABOUT HEALTHCARE
  • About the Infectious Diseases and Respiratory (ID&R) analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the report
  • Contributing experts
• CHAPTER 2 DISEASE BACKGROUND
  • Etiology of the RSV virus
    • RSV is easily transmitted
    • Immune response does not sufficiently protect from further infection
  • Symptoms and classification
  • Groups at risk of severe disease caused by RSV infection
    • Young children and premature infants
    • Elderly
    • People with underlying cardiac or pulmonary disease
    • Immunocompromised patients
    • Nosocomial RSV infections
    • RSV reinfection
  • The seasonality of RSV
  • Mortality is low in most risk groups
  • Hospitalization expenses make RSV infections costly
• CHAPTER 3 DIAGNOSIS
  • Viral culture is the current gold standard
  • Polymerase chain reaction may become new gold standard
  • Antigen detection assays are fast but lack sensitivity
  • Bronchiolitis guidelines
• CHAPTER 4 CURRENT TREATMENT AND PREVENTION OPTIONS
  • Synagis has monopoly in RSV infection prophylaxis
    • The Phase III IMpact trial showed efficacy and safety
    • Separate trial in children with congenital heart disease leads to indication expansion
    • Synagis' s cost-effectiveness is doubtful
  • Virazole' s reputation is damaged by negative trials
  • Lack of evidence for use of pharmacological symptom treatment
    • Beta2-agonists
    • Ipratropium bromide
    • Epinephrine
    • Corticosteroids
  • Non-pharmacological symptom treatments show some improvement in subpopulations
  • Bronchiolitis guidelines
  • Prescribing trends
• CHAPTER 5 FUTURE TRENDS
  • Most important unmet need is the lack of RSV treatment and vaccines
  • Future trends in treatment
    • The antivirals class is the most advanced (Phase II)
    • RNA interference (RNAi) as antiviral is a promising approach
    • Antisense drugs not in clinical trials yet
    • An RSV treatment used in the hospital could have peak sales of $700-750 million
    • An RSV treatment used in the community could have peak sales of more than $1 billion
  • Future trends in prophylaxis
  • Future trends in vaccines
    • Types of vaccines in development for RSV
    • Strategies of a vaccination program
    • MedImmune also dominates limited RSV vaccine development
• APPENDIX A BIBLIOGRAPHY
  • Press releases
• APPENDIX B COMMERICALLY AVAILABLE ANTIGEN DETECTION ASSAYS
  • Disclaimer
  • List of Tables
    • Table 1: RSV prevalence in the seven major markets, 2006
    • Table 2: RSV prevalence in the US, 2006
    • Table 3: RSV prevalence in Japan, 2006
    • Table 4: RSV prevalence in France, 2006
    • Table 5: RSV prevalence in Germany, 2006
    • Table 6: RSV prevalence in Italy, 2006
    • Table 7: RSV prevalence in Spain, 2006
    • Table 8: RSV prevalence in the UK, 2006
    • Table 9: Children under four years of age with RSV infection, 2006
    • Table 10: RSV infection in premature babies in the seven major markets, 2006
    • Table 11: Elderly infected with RSV virus, 2006 and 2015
    • Table 12: Group of CHF patients in class II or higher, at risk of RSV infection, 2006
    • Table 13: High-risk population with RSV infection including CHF, asthma and COPD patients, 2006
    • Table 14: Bone marrow transplant recipients with RSV infection, 2006
    • Table 15: Summary of Synagis trials
    • Table 16: Cost-benefit of Synagis
    • Table 17: Institutional variation of medical management of bronchiolitis caused by RSV
    • Table 18: Percentage of respondents applying different treatment options in infants hospitalized with acute bronchiolitis
    • Table 19: Non serious adverse events of RSV-604 in Phase I trial
    • Table 20: RSV hospitalizations in different high risk groups in the seven major markets
  • List of Figures
    • Figure 1: Respiratory syncytial viral structure
    • Figure 2: A schematic representation of RSV infection of the respiratory epithelium
    • Figure 3: RSV disease severity over four consecutive seasons
    • Figure 4: RSV is a major pediatric pathogen
    • Figure 5: Example of definition of high-risk chronic heart failure patients in the US, 2005
    • Figure 6: Group of adults over 21 years of age with or without underlying disease that are annually hospitalized due to an RSV infection
    • Figure 7: Several factors increase the likelihood of nosocomial infection
    • Figure 8: Positive RSV tests in the US (%), July 2004-October 2006
    • Figure 9: Laboratory reports to CDSC* of infections due to RSV, England and Wales, by date of report 1990-2006 (4 weekly)
    • Figure 10: The process of polymerase chain reaction (PCR)
    • Figure 11: Overview of several antigen detection assays commercially available
    • Figure 12: RSV product sales in the seven major markets by year, Q3 2001-Q2 2006 (RespiGam only US)
    • Figure 13: Synagis is currently the only marketed RSV prophylaxis
    • Figure 14: Synagis sales in the seven major markets by quarter, Q3 2001-Q2 2006
    • Figure 15: Small Particle Aerosol Generator Model-2 (SPAG-2)
    • Figure 16: Virazole sales in the seven major markets by quarter, Q3 2001-Q2 2006
    • Figure 17: The American Academy of Pediatrics (AAP) bronchiolitis guidelines
    • Figure 18: Proportion of clinical episodes in which inhaled and systemic treatment approaches were used
    • Figure 19: Future trends in RSV treatment, prophylaxis and vaccines
    • Figure 20: Overview of companies involved in development of RSV treatment, 2006
    • Figure 21: Percentage of RSV hospitalizations in pivotal Numax trial
    • Figure 22: Size of very high risk vaccine target populations across the seven major markets, 2006
    • Figure 23: Size of pediatric vaccine target populations across the seven major markets, birth cohort and catch-up pool, 2006