抗菌薬の創薬と開発における課題克服

Abstract

Introduction

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 fi lled 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 fi ghting 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?

Scope

• New approaches to discovering antibacterial agents: the relative importance of genomics, novel antibodies, topical antibacterial agents, PDF inhibitors, novel beta-lactams, peptides and peptide mimetics, fatty acid biosynthesis inhibitors, and combination therapies.
• Business strategies: drug discovery, marketing and sales alliances, big pharma' s out-licensing programs, mergers and acquisitions, and strategies for niche markets.
• Company profi les: Oscient Pharmaceuticals, Cubist Pharmaceuticals, Replidyne, Novexel.
• Outlook: commercial opportunity and diagnostic, regulatory, fi nancial, and legislative incentives.
• Spectrum expert commentary: an award-winning researcher explains how quorum sensing may shine light on a new path to novel antibacterial drug development.

Companies and Organizations

• Abbott
• Abraxis BioScience
• Advanced Life Science
• Adventrx
• Affi nium
• Apotex
• Ariagen
• Astellas
• Aventis
• AstraZeneca
• Basilea
• Bayer AG
• Baxter
• Biolinerx
• Biosynexus
• Biovertis
• BioXell
• Bristol-Myers Squibb
• California Institute of
• Technology
• Cerexa
• Chiron
• Chiron Healthcare Ireland
• Cilag
• Crystal Genomics
• Cubist
• Daiichi-Sankyo
• Department of Defense
• Eisai
• Eli Lilly
• Elusys
• Forest Laboratories
• Genentech
• Genesoft
• Genome Therapeutics
• Genzyme
• GlaxoSmithKline
• Inhibitex
• Intercell
• InterMune
• Janus
• Johnson & Johnson
• Kalobios
• King
• Kirin
• LG Life Sciences
• Medarex
• MedImmune
• Meiji Seika Kaisha
• Menarini
• Merck
• Mpex
• Mylan Laboratories
• Nabriva
• National Institutes of
• Health
• Nektar Therapeutics
• NeuTec
• Nordic
• Novartis
• Novexel
• Novozyme
• Oragenics
• Ortho-McNeil
• Oscient
• Paratek
• Par Pharmaceutical
• Peninsula
• Pfi zer
• Prolysis
• Replidyne
• Roche
• Sanofi -Aventis
• Schering-Plough
• Shionigi
• Taisho
• Takeda
• Targanta
• Teijin
• Teva
• Theravance
• Toyama Chemical
• Tyco Healthcare
• United States Army
• Medical Research Institute
• of Infectious Diseases
• VaxGen
• Vicuron
• Wyeth
• XOMA

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
• Signifi cant 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 Profi les
  • 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