172 pages

Date published 
July 2008

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Antibiotic R&D Report Table of Contents


Antibiotic R&D:
Resolving the Paradox between Unmet Medical Need and Commercial Incentive

Author: Leslie A. Pray, PhD

Table of Contents

Chapter 1
Antibiotic Research and Development: An Industry in Transition

1.1. Drivers of Antibiotic R&D
1.2. Resistance
MRSA in the Media
MRSA: Just the Tip of the Iceberg
Resistance among Gram-Negative Bacteria
Resistance is Not New
1.3. Economics of Antibiotics: Contrary to Popular Opinion, Antibiotics Can Be Lucrative
1.4. Other Unmet Medical Needs: The Emergence and Spread of Non-Resistant Bacterial Strains

C. difficile and CDAD
1.5. Changing Demographics of the Global Population
1.6. Biodefense and Other Antibacterial-Related US Federal Funding Initiatives
Other, Non-Biodefense US Federal Funding Initiatives of Relevance
1.7. The Risky Nature of Antibiotic R&D
Large Pharma Exodus from Antibiotic R&D
Challenges Facing Small Pharma
Smaller Firms Seeking Single-Indication Products
1.8. Big Pharma Shows Renewed Interest

Chapter 2
The Difficult Science of Antibacterial Discovery
2.1. What Makes Antibiotics Unique?
2.2. Looking for New Leads: Back to Nature?
A Brief History of the Antibiotic Era: From Its Natural Roots to the High-Throughput Search for Synthetics
Target-Based High-Throughput Screening: Still Fine-Tuning the Approach
Antibiotics au Naturel: Exploring Untapped Natural Resources
Screening Uncultivable Bacteria
Beyond Microbes
Other Select Companies Involved in Natural Product Screening
            InterMed Discovery
            Albany Molecular Research (AMRI)
Conventional Analogue Improvement: Still the Discovery Method of Choice for Many Companies
2.3. Discovery Is Not Enough: Getting to the Target
Knowing the Target Is Not Enough: Issues of Permeability and Penetration
2.4. Prolonging the Inevitability of Resistance
Combination Antibiotic Therapy
Procarta Biosystems: A Different Type of Combination Therapy

Chapter 3
The Antibacterial Pipeline Today
3.1. Diversity among Products in Development: Gram-Positive Thinking
Advanced Life Sciences’ Cethromycin
Arpida’s Iclaprim
Inimex Pharmaceuticals: Taking a Different Antibacterial Approach by Stimulating the Innate Immune Response
Novozymes’ Novel Peptide Approach
Profos: Re-Visiting Phages
Targanta Therapeutics’ Oritavancin
Theravance’s Telavancin
3.2. Drug-Resistant Gram-Negative Bacteria: An Emerging Storm on the Horizon
New Antibacterial Agents for the Treatment of Gram-Negative Infections: The Development Pipeline
Beta-Lactams and Beta-Lactamase Inhibitors
           Novexel’s NXL104, a Novel Beta-Lactamase Inhibitor
           Basilea’s BAL30376: Another Novel, Combination Beta-Lactamase Inhibitor

Chapter 4
Blockbuster or Bust? Economic Opportunities, Regulatory Challenges
4.1. Alternatives to the Blockbuster Model
The Value of Single-Indication Antibiotics
4.2. Antibiotics for Biotech
Trius Therapeutics
4.3. Challenges from a Biotech Perspective
Regulatory Hurdles and Moving Goalposts: The Need for Clearer Regulatory Guidelines
           FDA Stance on Non-Inferiority
           Clinical Endpoints: Patient- or Parent-Reported Outcome Measures
4.4. Redefining Innovation

Chapter 5
Company Portraits & Expert Interviews
5.1. Interview with Ron Najafi, PhD, Chairman and CEO, NovaBay Pharmaceuticals (Emeryville, CA)
5.2. Interview with Graham Johnson, PhD, Chief Research Officer, Rib-X Pharmaceuticals (New Haven, CT)
5.3. Interview with Kenneth J. Collins, MBA, Co-Founder, President, and Chief Executive Officer; Roger M. Echols, MD, Chief Medical Officer; and Peter W. Letendre, PharmD, former Chief Commercial Officer; Replidyne (Louisville, CO)
5.4. Interview with Steven Gilman, PhD, Senior Vice President, Discovery & Nonclinical Development and Chief Scientific Officer, Cubist Pharmaceuticals (Lexington, MA) 
5.5. Interview with Thomas J. Dougherty, PhD, Senior Principal Scientist, Infection Discovery, AstraZeneca R&D Boston (Waltham, MA)

Chapter 6
Results From CHI’s Antibacterial R&D and Commercialization Survey: March–April 2008
6.1. Types of Organizations
6.2. Titles of Respondents
6.3. Focus on Antibiotics
6.4. Antibiotic Discovery Technology
6.5. Antibiotic Products
6.6. Challenges and Regulatory Issues


Company Index with Web Addresses