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Overcoming Challenges in Antibacterial Drug Discovery and Development

Published by: Decision Resources

Published: Mar. 30, 2007 - 39 Pages

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Table of Contents


Executive Summary

Strategic Considerations

Stakeholder Implications

Highly Mature Markets

Drivers in Antibacterial Drug Discovery

Antibiotic Resistance and Different Resistance Mechanisms

Emerging Pathogens and Diseases

Community Setting

Hospital Settings

Biodefense Initiatives

New Approaches to Discovering Antibacterial Agents

The Impact of Genomics

Successful Genomics Endeavors

Genomics-Driven, High-Throughput Screening

Novel Targets and Approaches

Novel Antibodies

Topical Antibacterial Agents

Quorum Sensing Antagonists

Peptide Deformylase (PDF) Inhibitors

Novel Beta-Lactams

Peptides and Peptide Mimetics

Spectrum Executive Commentary: Quorum Sensing: Preventing Bacteria From Behaving Badly

Fatty Acid Biosynthesis Inhibitors

Combination Therapies

Oxazolidinone-Quinolone Hybrid

Effl ux Pump Inhibitors (EPIs)

Beta-Lactamase Inhibitors

Significant Clinical Challenges

The Conundrum of Spectrum vs. Indication

Regulatory Hurdles

Business Strategies

Drug Discovery

Marketing and Sales Alliances

Big Pharma’s Outlicensing Programs

Mergers & Acquisitions (M&As)

Strategies for Niche Markets

Company Profiles

Oscient Pharmaceuticals

Cubist Pharmaceuticals

Replidyne

Novexel

Outlook

Commercial Opportunity

Development Incentives

Diagnostic Testing Incentives

Regulatory Incentives

Financial and Legislative Incentives

Tables:

1. Mechanisms of Bacterial Resistance to Select Antibiotic Drug Classes

2. Companies Involved in Antibacterial Drug Discovery Programs: Key Products

3. Antibacterial Research and License Agreements, 2005-2007

4. Key Patent and Exclusivity Expiries of Drugs Used to Treat Bacterial Infections

Figures:

1. Market Tenure of Antibiotic Classes

2. Mechanisms of Transferring or Spreading Drug Resistance

3. Mechanisms of Antibiotic Drug Resistance

4. Development Timeline for Antibacterial Drugs

5. Top Worldwide Antibacterial Franchises, 2005

6. Blockbusters and Best-Selling Antibacterials Worldwide, 2005

7. Relative Size of Smaller Pharmaceutical and Biotech Companies Involved in Antibacterial Drug Development

A. Selected Quorum-Sensing Antagonists

Abstract

The antibacterial market is highly mature, yet there is a compelling need to discover new antibacterials to combat the escalating threats of drug resistance, the threats posed by new and reemerging pathogens, and bioterrorism threats. In recent years, unmet medical needs and the advent of genomics technologies renewed companies’ interest concerning antibacterial drug discovery. Smaller pharmaceutical companies and biotech companies have filled the void created when big pharma abandoned the arena and are now developing more than 80% of today’s emerging antibacterial agents.

Get the Answers You Need to Shape Your Strategy
  • Some approaches to antibacterial drug development are more notable advances than others. What approaches are these and which approaches should produce drugs that command higher prices than conventional antibiotics?
  • Several factors are driving today’s antibacterial drug discovery efforts. What factors are most relevant to fi ghting pathogens in community settings? What factors are most relevant to fighting pathogens in hospital settings?
  • Although big pharma has largely abandoned the development of antibacterial agents, it has maintained a stake in the antibacterial market through a variety of marketing and sales alliances. Which current partnerships between big pharma and smaller pharmaceutical companies show the greatest promise?
  • Several antibacterial blockbusters were on the market in 2005, yet most pharmaceutical companies had a sparse antibacterial drug portfolio. Which company is an exception to the rule that the antibacterial drug portfolio of big pharma companies typically is dominated by a blockbuster agent? What lessons can be learned from this company’s strategy of developing several moderately successful drugs?
  • Despite fi nancial and regulatory hurdles impeding the development of antibacterial agents, commercial opportunities to develop antibacterials that are effective against drug-resistant pathogens, especially in hospital settings, still remain. What are these opportunities? What incentives would bring more players into antibacterial drug discovery and development?


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