Market Report Source

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 of this report

• 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.

Research and analysis 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.

Key reasons to read this report

• 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

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
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