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

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

Published by: CHI Insight Pharma Reports

Published: Jul. 1, 2008 - 172 Pages

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
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
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
Replidyne
Trius Therapeutics: 4.3. Challenges from a Biotech Perspective
Regulatory Hurdles and Moving Goalposts: The Need for Clearer Regulatory Guidelines: 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
References
Tables: Sampling of Federal Funding Opportunities for Antibacterial R&D; Market Dominance of Natural Products; Snapshot of the Late-Stage Antibacterial Pipeline
Figures: The Rapid Rate of Resistance; Back to the Pre-Biotic Age?

Abstract

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

Author: Leslie A. Pray, PhD

The current crisis in antibiotic R&D is attributed to an industry pipeline with few late-stage candidates capable of combating the emergence and spread of novel, drug-resistant bacterial strains. This new report offers in-depth analysis of:

Factors driving the field forward and opportunities for large and small pharma
The key scientific challenges to antibiotic drug discovery
The economic and regulatory realities of antibiotic R&D
The broad range of antibacterial approaches being taken across the industry
Select compounds in clinical development

Many experts consider the emergence and spread of antibiotic resistance to be a paramount public health threat of the 21st century. While most resistant microbes continue to emerge in the hospital setting, more resistance is being found outside of the hospital environment. Nonetheless, only 2 new classes of antibiotics have reached the market over the past 30 years. This report explores the interrelated factors leading to the current crisis.

The rapid emergence and spread of resistance is a challenge shared by no other type of drug—one that companies must consider from both a scientific and economic standpoint. The need for more regulatory clarity regarding drug approval standards is another great challenge that many antibiotic companies currently face, as is examined in this report.

Antibiotic R&D: Resolving the Paradox between Unmet Medical Need and Commercial Incentive explores the lucrative potential of antibiotic commercialization, despite the popular conception that antibiotic R&D is too great an economic risk to become involved in. As is described, dealing with the economic realities of antibiotic development and commercialization will require a shift away from the blockbuster model toward niche-market products.

From a scientific standpoint, combating resistance will require the discovery and development of new antibiotics with novel potential to inhibit bacterial growth, reproduction, and resistance. This report features some of the more promising late-stage products with novel mechanisms of action. Scientists and industry leaders are taking as many different approaches as there are companies. Among those described in this report:

Entirely different antibacterial approaches, such as phage enzyme therapy and innate defense regulation
Looking to the natural world for more complex bioactive molecules that would be less likely to induce resistance than small-molecule inhibitors
Combinations of antibacterial/antibiotic agents

Antibiotic R&D: Resolving the Paradox between Unmet Medical Need and Commercial Incentive includes interviews with experts from companies engaged in both early and late-stage antibiotic R&D, including companies that have a marketed product. Additionally, it provides an analysis of results from a recent survey relating to the research, development, and commercialization of antibacterial agents.

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

Table of Contents

Abstract