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Frontier Pharma: Antibiotics - Identifying and Commercializing First-in-Class Innovation

Summary

An Extensive Developmental Pipeline, but Limited First in Class Innovation

The antibiotics pipeline is very active, with 741 products in development. Of these, the majority (85%) are at the Discovery or Preclinical stages and have not yet entered human trials. Such a high proportion of drugs at the earliest stages of development would, in other indications, provide hope of a steady stream of drugs due to advance through the stages of development and be approved within the next decade. However, the development of antibiotics, particularly the progression of drug candidates from Discovery to human trials, is notoriously difficult, with only 12 new antibiotics approved since 2000. Of these pipeline drugs, the distribution of molecular targets is very limited, with the majority having targets observed among marketed products.

Reflecting this trend is the fact that despite the large pipeline, first-in-class drug development is minimal, with only 10% of pipeline drugs acting on a first-in-class target. This distribution reflects the pipeline, in which 85% is at either Discovery or Preclinical. Three first-in-class drugs are at Phase I, eight are at Phase II, but none are at Phase III. These 75 drugs act on 38 first-in-class targets.

Diversity is low among these 38 targets, of which 21, acted upon by 39 products, have mechanisms of action that can be classified under the broad modes of action common to established classes of antibiotics. One of the most common is protein synthesis inhibitors, under which eight first-in-class targets can be grouped. Other categories include RNA and DNA synthesis inhibitors, as well as bacterial cell wall and membrane disruptors. Of the drugs targeting first-in-targets, clinical trial data regarding their safety and efficacy are limited, with the majority of drugs being at either the Discovery or Preclinical stages of development. As such, firm conclusions can only be drawn on a select number of targets. Those with the most promising results include inhibitors of UDP2 epimerase, Methionine tRNA synthase, the FtsZ proteins, and NDM-1 beta lactamase.

Many of the targets under these categories were highlighted by research into conserved genomes of bacteria, driven by a desire to generate antibiotics with as broad a spectrum of use as possible. These studies have uncovered a plethora of targets that act upon mechanisms not yet utilized in the treatment of bacterial infection. It was hoped that high-throughput screens against these targets would lead to the development of novel classes of antibiotics; however, since the 1990s, only four new classes of antibiotics have been approved. With the failure of the genomic approach and the fact that the natural sources of many bacteria are thought to be exhausted, many companies have left the field altogether. However, incentives to draw pharma back to the field, and methods of improving success with compound searches, as outlined in this report, provide hope for the future.

A Moderate Number of Deals and Strategic Consolidations, but Little Interest in First-in-Class Products

Deals involving antibiotics are common, with 266 conducted from 2006–2014. Of these, the majority were licensing deals (64%), with 46% conducted once the product was marketed. This reflects the fact that drug development in antibiotics is relatively simple and has easy-to-assess endpoints, reducing the requirement of co-development deals to develop an antibiotic successfully once a strong lead candidate has been identified.

Deal values varied widely from $4.3m to $480m, but most were below $100m. Only 19% of deals were completed before the drug entered human trials, again supporting the theory that drug development in antibiotics does not require significant investment.

Reflective of the lack of first-in-class targets in the developmental pipeline, only six deals involve drugs against first-in-class targets. Two deals were conducted at Phase I, two at Phase II and one at an undisclosed Phase. No robust trends can be drawn from such limited data. However, with all disclosed deals conducted after the drug has entered human trials, it can be speculated that the historic trend in the failure of identified chemicals to translate into lead compounds strongly deters potential investors from investing in first-in-class compounds. With few first-in-class compounds in the current developmental pipeline, 80% of which are at Discovery or Preclinical, few deals involving first-in-class drugs are expected to be announced within the next few years.

Scope

The report covers and provides -
- A brief introduction to antibiotics, including profiles of clinically relevant infectious strains, bacteria virulence, and an overview of pharmacotherapy
- Highlights of the changing molecular target landscape between market and pipeline, focusing on points of innovation
- An overview of how innovation products are contributing to the pipeline and market for antibiotics
- A comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of Phase distribution, molecule type, molecular target, and route of administration
- Identification and assessment of first-in-class molecular targets with a particular focus on early-stage programs of which clinical utility has yet to be evaluated, as well as literature reviews of novel molecular targets
- Assessment of the licensing and co-development deals for antibiotic therapies

Reasons to buy

The report provides the following -
- Understanding of the overall focal shifts in the molecular targets in the antibiotics pipeline
- Understand of the distribution of pipeline programs by Phase of development, molecule type and molecular target
- Scientific and clinical analysis of first-in-class developmental programs
- Assessment of the valuations of licensed and co-developed antibiotic treatments
- A list of first-in-class therapies potentially open to deal-making opportunities
- Analysis of financial valuations on licensed or co-developed first-in-class therapies and generics

Table Of Contents

Frontier Pharma: Antibiotics - Identifying and Commercializing First-in-Class Innovation
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3
2 Executive Summary 4
2.1 A Low Degree of First-in-Class Innovation in a Very Active Pipeline 4
2.2 A low Diversity in the Mechanisms of Action of First-in Class Targets 4
2.3 A High Number of Deals Involving Antibiotics, but Few involving First-in-Class Targets 5
3 The Case for Innovation in Antibiotic Development 6
3.1 Diversification of Molecular Targets 6
3.2 Growing Opportunities for Biological Products 6
3.3 Innovative First-in-Class Product Developments Remain Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7
3.5 Financial Incentives 8
3.6 Report Guidance 8
4 Clinical and Commercial Landscape 9
4.1 Etiology 9
4.1.1 Adherence to Host Cells and Biofilm Formation 9
4.1.2 Toxins and Toxin Secretion Systems 11
4.1.3 Ability to Evade the Host Immune System 12
4.2 Pathophysiology 12
4.3 Traditional Antibiotic Development and Associated Mechanisms of Action 13
4.3.1 Overview 13
4.3.2 DNA Synthesis and Transcription Machinery 15
4.3.3 RNA Synthesis Arrest 15
4.3.4 Disruption of Cell Wall Stability of Formation 16
4.3.5 Disruption of Cell Membrane Formation and Stability 17
4.3.6 Disruption of Cell Metabolism 17
4.3.7 Inhibition of Protein Synthesis 17
4.4 Mechanisms of Antibiotic Resistance 19
4.4.1 Target Modification 19
4.4.2 Efflux Pumps 19
4.4.3 Enzymatic Inactivation of Antibiotics 20
4.4.4 Changes to Outer Membrane Permeability 20
4.5 Treatment Algorithm 21
4.6 The Future of Antibiotic Development 22
5 Assessment of Pipeline Product Innovation 26
5.1 Antibiotic Pipeline by Phase, Molecule Type and Molecular Target 26
5.2 Antibiotic Pipeline by Mechanism of Action 27
5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 31
6 First-in-Class Target Evaluation 35
6.1 Pipeline Programs which Target Lipoteichoic Acid or Lipoteichoic Acid Synthase 35
6.2 Pipeline Programs which Target Pseudomonas Aeruginosa Lectins LecA and LecB 37
6.3 Pipeline Programs which Target Sortase A 38
6.4 Pipeline Programs which Target Pyruvate Kinase 41
6.5 Pipeline Programs which Target UDP-N-acetylglucosamine 2-epimerase 43
6.6 Pipeline Programs which Target Peptide Deformylase 44
6.7 Pipeline Programs which Target LpxC enzyme 46
6.8 Pipeline Programs which Target Sialic Acid Transporter TRAP 48
6.9 Pipeline Programs which Target Methionine tRNA Ligase 49
6.10 Pipeline Programs which Target FtsZ Protein 51
6.11 Pipeline Programs which Target Clostridium Difficile Toxins A and B 53
6.12 Pipeline Programs which Target Staphylococcus Enterotoxins A and B 55
6.13 Pipeline Programs which Target NDM-1 Beta Lactamase 56
6.14 Pipeline Programs which Target DegS Serine Endoprotease 57
6.15 Pipeline Programs which Target A Disintegrin and Metalloproteinase 10 59
6.16 Pipeline Programs which Target Translocase-1 60
7 Patent Filings 63
8 Deals and Strategic Consolidations 65
8.1 Industry Wide First-in Class Deals 65
8.2 Antibiotics Deals Landscape 66
8.3 Licensing Deals 67
8.3.1 Molecule Type and Mechanism of Action 69
8.4 Co-Development Deals 72
8.4.1 Molecule Type and Mechanism of Action 73
8.5 First-in-Class Programs Not Involved in Licensing or Co-Development Deals 77
9 Appendix 79
9.1 Abbreviations 79
9.2 References 79
9.3 Contact Us 91
9.4 Disclaimer 91

1.1 List of Tables

Table 1: Market for Antibiotics, Global, Bacterial Species Specifically Mentioned in Chemical Entity Patent Families, (2003-2012) 63
Table 2: Organizations Frequently Applying for Antibiotic Chemical Entity Patent Families, 2003-2012 64
Table 3: Abbreviations 79

1.2 List of Figures

Figure 1: Sales Performance of First-in-Class and Non-First-in-Class Product post-Marketing Approval 7
Figure 2: Marketed Products by Mechanism of Action 14
Figure 3: Treatment, Development and Resistance and Mechanisms of Resistance Across Different Bacterial Species 21
Figure 4: Conserved Bacterial Molecular Targets 25
Figure 5: Pipeline Overview 27
Figure 6: Developmental Pipeline by Mechanism of Action 28
Figure 7: Molecular Target Category Comparison, Pipeline and Marketed Products 30
Figure 8: Molecular Target Category Comparison for Traditional Antibiotics, Pipeline and Marketed Products 31
Figure 9: First-in-Class and Non-First-in-Class Pipeline Product Comparison 33
Figure 10: Market for Antibiotics, Global, Developmental Pipeline, 2014 34
Figure 11: LTA and LTA Synthase as Therapeutic Targets 36
Figure 12: Pipeline Programs Targeting LTA and LTA Synthase 37
Figure 13: LecA and LecB as Therapeutic Targets 38
Figure 14: Pipeline Programs Targeting Pseudomonas Aeruginosa Lectins LecA and LecB 38
Figure 15: Sortase A as a Therapeutic Target 40
Figure 16: Pipeline Programs Targeting Sortase A 41
Figure 17: Pyruvate Kinase as a Therapeutic Target 42
Figure 18: Pipeline Programs Targeting Pyruvate Kinase 42
Figure 19: UDP-N-acetylglucosamine 2-epimerase as a Therapeutic Target 43
Figure 20: Pipeline Programs Targeting UDP-N-acetylglucosamine 2-epimerase 44
Figure 21: Peptide Deformylase as a Therapeutic Target 45
Figure 22: Pipeline Programs Targeting Peptide Deformylase 46
Figure 23: LpxC enzyme as a Therapeutic Target 47
Figure 24: Pipeline Programs Targeting LpxC Enzyme 47
Figure 25: Sialic Acid Transporter TRAP as a Therapeutic Target 48
Figure 26: Pipeline Programs Targeting Sialic Acid Transporter TRAP 49
Figure 27: Methionine tRNA Ligase as a Therapeutic Target 50
Figure 28: Pipeline Programs Targeting Methionine tRNA Ligase 51
Figure 29: FtsZ Protein as a Therapeutic Target 52
Figure 30: Pipeline Programs Targeting FtsZ Protein 52
Figure 31: TcdA and TcdB as Therapeutic Targets 54
Figure 32: Pipeline Programs Targeting TcdA and TcdB 54
Figure 33: SEA and SEB as Therapeutic Targets 55
Figure 34: Pipeline Programs Targeting SEA and SEB 56
Figure 35: NDM-1 Beta Lactamase as a Therapeutic Target 57
Figure 36: Pipeline Programs Targeting NDM-1 Beta Lactamase 57
Figure 37: DegS Serine Endoprotease as a Therapeutic Target 58
Figure 38: Pipeline Programs Targeting DegS Serine Endoprotease 58
Figure 39: A Disintegrin and Metalloproteinase 10 as a Therapeutic Target 59
Figure 40: Pipeline Programs Targeting A Disintegrin and Metalloproteinase 10 60
Figure 41: Translocase-1 as a Therapeutic Target 61
Figure 42: Pipeline Programs Targeting Translocase-1 62
Figure 43: Chemical Entity Patent Families Filed and Granted for Antibiotics, Global, 2003-2012 63
Figure 44: Industry-Wide Deals by Stage of Development, 2006-2014 65
Figure 45: Industry Licensing Deal Values by Stage of Development, 2006-2014 66
Figure 46: Licensing Deals, Geographic Distribution, 2006-2014 67
Figure 47: Licensing Deals, 2006-2014 68
Figure 48: Licensing Deals Analysis, 2006-2014 69
Figure 49: Licensing Deals, 2006-2014 - Part 1 70
Figure 50: Licensing Deals, 2006-2014 - Part 2 71
Figure 51: Co-Development Deals, Geographic Distribution, 2006-2014 72
Figure 52: Co-Development Deal Value Analysis, 2006-2014 73
Figure 53: Co-Development Deals Analysis, 2006-2014 74
Figure 54: Developmental Pipeline, 2014 - Part 1 75
Figure 55: Developmental Pipeline, 2014 - Part 2 76
Figure 56: Market for Antibiotics, First-in-class Programs with no Recorded Prior Deal Involvement, 2006-2014 78

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