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SUMMARY
Overview
Introduction
Antibody-based agents represent a novel approach to the treatment and
prophylaxis of infectious diseases. In recent years, considerable interest has
been expressed in their further development, driven by advances in technology
that improve manufacturing cost and tolerability: fully human antibody
reagents avoid the toxicities associated with traditional human- or
animal-derived serum therapy.
Scope
- An overview of the past, current and emerging technologies for biologics
as well as obstacles faced in development
- Discussion of antibody products in development for several viral
infections and their probable use
- An assessment of pipeline antibody agents targeting important bacterial
and fungal nosocomial pathogens
- A review of the key unmet needs within bacterial, viral and fungal
infections along with an outline of the commercial outlook for antibody agents
Report Highlights
Antibodies offer several advantages over conventional anti-infectives and
vaccines but their cost and mode of administration limits their use in certain
areas.A high unmet need and defined target groups are required to gain
commercial success.Pipeline products fulfilling these criteria have a greater
chance of commercial and scientific success.
Accounting for the majority of nosocomial infections, MRSA is the most popular
target for antibody development. Despite concerns over resistance there are
still several antibiotics that can treat multi-drug resistant S.aureus,
reducing the need for antibody-based therapeutics. The greater need lies in
treatment of Pseudomonas and fungal infections.
For most viral infections, conventional therapies are able to control disease
progression effectively. In HIV and HCV the real need is for a cure or
preventative measure but the majority of pipeline products are being developed
for treatment of these infections.
Reasons to Purchase
- Identify the key antibody products in development for bacterial, viral and
fungal infections
- Examine the remaining and emerging unmet needs in the infectious diseases
market and identify opportunities for antibody product development
- Gain an overview of the commercial outlook for antibody based products and
their likely positioning in the prophylaxis and treatment of infections
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
- 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
- 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
- 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
- Pseudomonas aeruginosa
- Lack of novel antibiotics targeting multi-drug resistant strains
indicates a high unmet need
- Pipeline overview
- 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
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