Stakeholder Opinions: Biologics in Infectious Diseases - Well defined target populations are key to commercial success

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Infectious Diseases and Respiratory pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the analysis
  • Datamonitor insight into biologics infectious diseases
  • Contributing experts
  • Related reports
  • Upcoming related reports
• CHAPTER 2 COMMERCIAL OUTLOOK
  • Unmet needs
  • Development issues
    • Difficulties in identification of antigenic targets
  • Competitive pressure from vaccines and conventional anti-infectives
    • Strategy for antibody use
      • Prophylaxis
      • Treatment
    • Vaccine use will be in patients with sufficient time to mount an immune response
• CHAPTER 3 BIOLOGICS TECHNOLOGY OVERVIEW
  • Biologics comprise of a range of products
    • Therapeutic proteins
    • Vaccines
    • Monoclonal antibodies
      • Antibody structure and role in immune response
      • Production of monoclonal antibodies
      • Newer production methods
    • Mammalian cell culture is the most widely used system
    • Emerging technologies
      • Antibody fragments
      • Polyclonal antibodies
    • Antibody mechanism of action and target identification for infectious disease
    • Monoclonal antibodies as anti-infective agents
      • Potential advantages of MAb therapy
      • Potential disadvantages of MAb therapy
• CHAPTER 4 ANTIVIRALS
  • Respiratory syncytial virus (RSV)
    • Disease background
      • Etiology and targets for drug development
    • Lack of effective antivirals or a vaccine has created an opportunity for prophylactic agents
    • Antibody-based prophylaxis dominates the market
    • Despite Synagis' success there are relatively few MAbs in late-stage development for RSV
      • Motavizumab
  • HIV
    • Disease background
    • Current treatment options
    • HIV etiology and drug targets
      • Neutralizing antibodies targeting the virus and infected cells
      • MAbs targeting the uninfected cell
    • Pipeline overview of HIV anti-cell MAbs in development
      • TNX-355
      • PRO-140
      • HGS004
    • Where do MAbs fit into HAART?
  • Hepatitis C
    • Disease background
    • Targets for antibody development and pipeline overview
      • XTL-6865
      • Bavituximab
      • HuMax-HepC
      • IB-657
    • Other viral infections
      • Rabies
      • West Nile virus
      • SARS
• CHAPTER 5 ANTIBACTERIALS
  • Resistance to current antibiotics driving the investigation of novel approaches
  • MRSA most popular target for antibody development but the real need is for new gram-negative therapies
  • Bacterial targets for antibody development
  • Staphylococci
    • Several antibiotics are addressing the issue of resistance reducing the need for novel approaches
    • Patient groups that would potentially benefit from anti-staph antibody-based therapy
    • Potential targets and products in development
      • Protein A may limit effectiveness of immunotherapeutic approaches
    • Majority of pipeline products aimed at MRSA infections
      • Aurograb
      • BSYX-A110
      • Aurexis
      • ETI-211
  • Enterococci
    • The elderly are most at risk from enterococcal infections
    • Most pipeline products are in very early stages of development
  • Clostridium difficile
    • Increase in Clostridium difficile-associated disease attributed to hypervirulent strain
    • Immunological approaches to treatment could cut reliance on antibiotics, restoring the patient' s commensal flora
    • Pipeline overview
      • MDX-066 + MDX1388
      • NTCD
  • Pseudomonas aeruginosa
    • Lack of novel antibiotics targeting multi-drug resistant strains indicates a high unmet need
    • Pipeline overview
      • KB001
      • KPB101
  • Bacillus anthracis
    • Abthrax (raxibacumab)
    • Valortim (MDX-1303)
    • AVP-21D9
    • ETI-204
• CHAPTER 6 ANTIFUNGALS
  • Resistance and toxicity have heightened the need for novel approaches to antifungal treatment
    • NeuTec/Novartis' s Mycograb targets the highly conserved Hsp90
• BIBLIOGRAPHY
  • Journal papers
  • Websites
  • Other
  • Contributing experts
• APPENDIX B
  • About Datamonitor
    • About Datamonitor Healthcare
    • About the Disease analysis team
    • Disclaimer
  • List of Tables
    • Table 1: Overview of anti-cell antibodies in development, 2008
    • Table 2: HCV pipeline overview
    • Table 3: Rabies pipeline overview
    • Table 4: West Nile virus pipeline overview, 2008
    • Table 5: SARS pipeline overview, 2008
    • Table 6: Staphylococcal pipeline overview, 2008
    • Table 7: Enterococcal pipeline overview
    • Table 8: Pipeline overview
    • Table 9: Pseudomonas pipeline overview
    • Table 10: Pipeline overview for B. anthracis infections
  • List of Figures
    • Figure 1: Summary of the main development issues
    • Figure 2: Summary of possible solutions to development issues
    • Figure 3: Antibody structure
    • Figure 4: Hybridoma technique for production of monoclonal antibodies
    • Figure 5: Murine, chimeric, humanized and human antibody structures
    • Figure 6: Percentage of products in Phase I-III development by type of infection
    • Figure 7: Respiratory syncytial viral structure
    • Figure 8: HIV fusion and entry
    • Figure 9: HIV antibody mechanism of action
    • Figure 10: HCV etiology
    • Figure 11: Total number of patients developing nosocomial infections in an average year in the US
    • Figure 12: S. aureus virulence factors