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Antibacterial Drug Licensing Opportunities: Analysis, Rating, and Ranking - A Worldwide Study


Description: This report is designed to provide a useful tool to professionals in research and development (R&D), marketing, business development, licensing, and strategic planning who are involved, or are anticipating involvement, in the discovery, development, licensing, and/or marketing of therapeutics and prophylactics for the treatment of bacterial infections.


Contents: Antibacterial Drug Licensing Opportunities SUMMARY TABLE OF CONTENTS EXECUTIVE SUMMARY......................................................................................................................................... i Section 1 INTRODUCTION TO ANTIBACTERIALS........................................................................................... 1 1.1 SCOPE AND OBJECTIVES OF RESEARCH INVESTIGATION........................................................... 1 1.2 METHODOLOGY OF INVESTIGATION................................................................................................ 1 1.3 LIMITATIONS OF INVESTIGATION ..................................................................................................... 2 1.4 INTRODUCTION TO BACTERIAL INFECTIONS AND THEIR THERAPY ....................................... 3 1.4.1 Introduction to Bacteria and Bacterial Infections............................................................................ 3 1.4.2 Bacterial Groups .............................................................................................................................. 4 1.5 GLOSSARY OF TERMS ......................................................................................................................... 12 Section 2 DELPHI PANEL AND THOUGHT LEADER INTERVIEW: DISCUSSION AND SUMMARY OF ANTIBACTERIAL THERAPEUTICS INNOVATION........................................................... 17 2.1 INTRODUCTION .................................................................................................................................... 17 2.2 RESULTS OF DELPHI PANEL INTERVIEWS..................................................................................... 17 2.3 DELPHI SUMMARY............................................................................................................................... 33 Section 3 BACTERIAL INFECTIONS BY THERAPEUTIC AREA.................................................................. 35 3.1 RESPIRATORY TRACT INFECTIONS ................................................................................................. 35 3.1.1 Diseases Involved ........................................................................................................................... 35 3.1.2 Current and Likely Future Treatments........................................................................................... 36 3.1.3 Market Analysis............................................................................................................................. 37 3.2 GENITOURINARY TRACT INFECTIONS ........................................................................................... 40 3.2.1 Diseases Involved ........................................................................................................................... 40 3.2.2 Current and Likely Future Treatments........................................................................................... 40 3.2.3 Market Analysis............................................................................................................................. 41 3.3 GASTROINTESTINAL TRACT INFECTIONS ..................................................................................... 43 3.3.1 Diseases Involved ........................................................................................................................... 43 3.3.2 Current and Likely Future Treatments........................................................................................... 44 3.3.3 Market Analysis............................................................................................................................. 45 3.4 SKIN AND SOFT TISSUE INFECTIONS .............................................................................................. 47 3.4.1 Diseases Involved ........................................................................................................................... 47 3.4.2 Current and Likely Future Treatments........................................................................................... 47 3.4.3 Market Analysis............................................................................................................................. 47 3.5 OTHER INFECTIONS............................................................................................................................. 50 3.5.1 Central Nervous System Infections................................................................................................. 50 3.5.2 Intra-abdominal infections ............................................................................................................. 51 3.5.3 Ear infections ................................................................................................................................ 51 3.5.4 Bacteremia and Septicemia ............................................................................................................ 51 3.5.5 Bone and Joint Infections ............................................................................................................... 51 3.5.6 Stomatological Infections ............................................................................................................... 51 Section 4 ANTIBIOTICS......................................................................................................................................... 53 4.1 INTRODUCTION TO ANTIBIOTICS .................................................................................................... 53 4.2 MECHANISMS OF ANTIBIOTIC ACTION .......................................................................................... 53 4.2.1 Inhibition of Cell Wall Synthesis .................................................................................................... 53 4.2.2 Disruption of Cell Membrane Structure......................................................................................... 53 ii 4.2.3 Inhibition of Protein Synthesis ....................................................................................................... 54 4.2.4 Inhibition of DNA Transcription .................................................................................................... 54 4.3 CLASSES OF ANTIBIOTICS.................................................................................................................. 54 4.3.1 Penicillins, Cephalosporins, and Other Beta-Lactams .................................................................. 54 4.3.2 Aminoglycosides............................................................................................................................ 57 4.3.3 Tetracyclines ................................................................................................................................. 59 4.3.4 Macrolides..................................................................................................................................... 61 4.3.5 Streptogramins ............................................................................................................................... 63 4.3.6 Rifamycins ..................................................................................................................................... 65 4.3.7 Glycopeptides and Other Peptide Antibiotics................................................................................. 65 4.3.8 Quinolones .................................................................................................................................... 69 4.3.9 Oxazolidinones ............................................................................................................................... 74 4.3.10 Other Antibiotics ............................................................................................................................ 75 4.4 MECHANISMS OF ANTIBIOTIC RESISTANCE ................................................................................. 76 4.4.1 Antibiotic Inactivation................................................................................................................... 76 4.4.2 Antibiotic Entry and Efflux............................................................................................................. 76 4.4.3 Mutation of the Antibiotic Target Site ............................................................................................ 76 4.4.4 Alternative Metabolic Pathways..................................................................................................... 77 Section 5 TECHNOLOGY PLATFORMS OTHER THAN ANTIBIOTICS...................................................... 79 5.1 OTHER LOW-MOLECULAR-WEIGHT THERAPEUTICS.................................................................. 79 5.1.1 Trimethoprim and Sulfonamides .................................................................................................... 79 5.1.2 Metronidazole................................................................................................................................ 80 5.1.3 Nitrofurantoin and Other Nitrofurans............................................................................................ 80 5.2 VACCINES AND IMMUNOTHERAPIES.............................................................................................. 80 5.2.1 Vaccines ........................................................................................................................................ 80 5.2.2 Antibodies...................................................................................................................................... 86 5.2.3 Other Immunotherapies................................................................................................................. 87 5.3 OTHER TECHNOLOGIES...................................................................................................................... 88 Section 6 OVERALL ANALYSIS AND FORECAST FOR ANTIBACTERIALS ............................................. 89 6.1 PRODUCT TECHNOLOGY ANALYSIS AND FORECAST ................................................................ 89 6.2 MARKET ANALYSIS AND FORECAST ............................................................................................ 104 6.3 EVALUATION OF LICENSING OPPORTUNITIES – RATINGS AND RANKINGS....................... 107 Section 7 COMPANY PROFILES OF INNOVATIVE FIRMS REPRESENTING ACQUISITIONS, LICENSING, AND COMARKETING OPPORTUNITIES IN antiBACTERIAL THERAPY ..................................................................................................................................................... 121 7.1 ACAMBIS .............................................................................................................................................. 121 7.2 ANTEX BIOLOGICS............................................................................................................................. 122 7.3 ANTIGENICS......................................................................................................................................... 122 7.4 AVANT IMMUNOTHERAPEUTICS ................................................................................................... 123 7.5 AXCAN PHARMA ................................................................................................................................ 123 7.6 CSL ...................................................................................................................................................... 124 7.7 CUBIST PHARMACEUTICALS........................................................................................................... 124 7.8 DAIICHI SEIYAKU............................................................................................................................... 125 7.9 DEMEGEN............................................................................................................................................. 126 7.10 ESSENTIAL THERAPEUTICS............................................................................................................. 126 7.11 GENOME THERAPEUTICS ................................................................................................................. 127 7.12 ID BIOMEDICAL CORPORATION ..................................................................................................... 127 7.13 INCYTE GENOMICS ............................................................................................................................ 128 7.14 INTERMUNE......................................................................................................................................... 129 7.15 INTRABIOTICS..................................................................................................................................... 130 7.16 LIGOCYTE PHARMACEUTICALS..................................................................................................... 130 7.17 MEDIMMUNE....................................................................................................................................... 131 7.18 MEIJI SEIKA.......................................................................................................................................... 131 iii 7.19 MICROLOGIX BIOTECH..................................................................................................................... 132 7.20 NABI ...................................................................................................................................................... 132 7.21 NEOSE TECHNOLOGIES .................................................................................................................... 133 7.22 NEWBIOTICS........................................................................................................................................ 133 7.23 NIPPON MEDICAL RESEARCH ......................................................................................................... 134 7.24 POWDERJECT PHARMACEUTICALS............................................................................................... 134 7.25 SEQUELLA............................................................................................................................................ 134 7.26 SHIONOGI ............................................................................................................................................. 135 7.27 SHIRE PHARMACEUTICALS GROUP............................................................................................... 136 7.28 SIGA TECHNOLOGIES........................................................................................................................ 136 7.29 TAIHO PHARMACEUTICAL COMPANY.......................................................................................... 137 7.30 TAKEDA CHEMICAL INDUSTRIES .................................................................................................. 137 7.31 TOYAMA CHEMICAL CO................................................................................................................... 137 7.32 VERSICOR............................................................................................................................................. 138 7.33 VICAL .................................................................................................................................................... 138 7.34 WAKUNAGA PHARMACEUTICAL CO............................................................................................. 139 7.35 XOMA .................................................................................................................................................... 139 iv Antibacterial Drug Licensing Opportunities DETAILED TABLE OF CONTENTS EXECUTIVE SUMMARY................................................................................................................................................i Section 1 INTRODUCTION TO ANTIBACTERIALS........................................................................................... 1 1.1 SCOPE AND OBJECTIVES OF RESEARCH INVESTIGATION........................................................... 1 1.2 METHODOLOGY OF INVESTIGATION................................................................................................ 1 1.3 LIMITATIONS OF INVESTIGATION ..................................................................................................... 2 1.4 INTRODUCTION TO BACTERIAL INFECTIONS AND THEIR THERAPY ....................................... 3 1.4.1 Introduction to Bacteria and Bacterial Infections............................................................................ 3 1.4.2 Bacterial Groups .............................................................................................................................. 4 1.5 GLOSSARY OF TERMS ......................................................................................................................... 12 Section 2 DELPHI PANEL AND THOUGHT LEADER INTERVIEW: DISCUSSION AND SUMMARY OF ANTIBACTERIAL THERAPEUTICS INNOVATION........................................................... 17 2.1 INTRODUCTION .................................................................................................................................... 17 2.2 RESULTS OF DELPHI PANEL INTERVIEWS..................................................................................... 17 Common and Important Pathogenic Bacteria ..................................................................................................................17 Emerging Bacterial Infections .........................................................................................................................................20 Bacteriological Warfare...................................................................................................................................................22 Antibiotics and Antibiotic Resistance .............................................................................................................................23 Vaccines ..........................................................................................................................................................................28 Other Future Developments.............................................................................................................................................30 2.3 DELPHI SUMMARY............................................................................................................................... 33 Section 3 BACTERIAL INFECTIONS BY THERAPEUTIC AREA.................................................................. 35 3.1 RESPIRATORY TRACT INFECTIONS ................................................................................................. 35 3.1.1 Diseases Involved ........................................................................................................................... 35 3.1.2 Current and Likely Future Treatments........................................................................................... 36 3.1.3 Market Analysis............................................................................................................................. 37 3.2 GENITOURINARY TRACT INFECTIONS ........................................................................................... 40 3.2.1 Diseases Involved ........................................................................................................................... 40 3.2.2 Current and Likely Future Treatments........................................................................................... 40 3.2.3 Market Analysis............................................................................................................................. 41 3.3 GASTROINTESTINAL TRACT INFECTIONS ..................................................................................... 43 3.3.1 Diseases Involved ........................................................................................................................... 43 3.3.2 Current and Likely Future Treatments........................................................................................... 44 3.3.3 Market Analysis............................................................................................................................. 45 3.4 SKIN AND SOFT TISSUE INFECTIONS .............................................................................................. 47 3.4.1 Diseases Involved ........................................................................................................................... 47 3.4.2 Current and Likely Future Treatments........................................................................................... 47 3.4.3 Market Analysis............................................................................................................................. 47 3.5 OTHER INFECTIONS............................................................................................................................. 50 3.5.1 Central Nervous System Infections................................................................................................. 50 3.5.2 Intra-abdominal infections ............................................................................................................. 51 3.5.3 Ear infections ................................................................................................................................ 51 3.5.4 Bacteremia and Septicemia ............................................................................................................ 51 3.5.5 Bone and Joint Infections ............................................................................................................... 51 3.5.6 Stomatological Infections ............................................................................................................... 51 Section 4 ANTIBIOTICS......................................................................................................................................... 53 4.1 INTRODUCTION TO ANTIBIOTICS .................................................................................................... 53 v 4.2 MECHANISMS OF ANTIBIOTIC ACTION .......................................................................................... 53 4.2.1 Inhibition of Cell Wall Synthesis .................................................................................................... 53 4.2.2 Disruption of Cell Membrane Structure......................................................................................... 53 4.2.3 Inhibition of Protein Synthesis ....................................................................................................... 54 4.2.4 Inhibition of DNA Transcription .................................................................................................... 54 4.3 CLASSES OF ANTIBIOTICS.................................................................................................................. 54 4.3.1 Penicillins, Cephalosporins, and Other Beta-Lactams .................................................................. 54 Overview.........................................................................................................................................................................54 Utility ..............................................................................................................................................................................55 Strengths and Weaknesses...............................................................................................................................................55 Noteworthy Developments..............................................................................................................................................56 Forecast ...........................................................................................................................................................................57 4.3.2 Aminoglycosides............................................................................................................................ 57 Overview.........................................................................................................................................................................57 Utility ..............................................................................................................................................................................58 Strengths and Weaknesses...............................................................................................................................................58 Noteworthy Developments..............................................................................................................................................58 Forecast ...........................................................................................................................................................................59 4.3.3 Tetracyclines ................................................................................................................................. 59 Overview.........................................................................................................................................................................59 Utility ..............................................................................................................................................................................60 Strengths and Weaknesses...............................................................................................................................................60 Noteworthy Developments..............................................................................................................................................60 Forecast ...........................................................................................................................................................................61 4.3.4 Macrolides..................................................................................................................................... 61 Overview.........................................................................................................................................................................61 Utility ..............................................................................................................................................................................61 Strengths and Weaknesses...............................................................................................................................................62 Noteworthy Developments..............................................................................................................................................62 Forecast ...........................................................................................................................................................................63 4.3.5 Streptogramins ............................................................................................................................... 63 Overview.........................................................................................................................................................................63 Utility ..............................................................................................................................................................................63 Strengths and Weaknesses...............................................................................................................................................64 Noteworthy Developments..............................................................................................................................................64 Forecast ...........................................................................................................................................................................64 4.3.6 Rifamycins ..................................................................................................................................... 65 Overview.........................................................................................................................................................................65 Utility ..............................................................................................................................................................................65 Strengths and Weaknesses...............................................................................................................................................65 Noteworthy Developments..............................................................................................................................................65 Forecast ...........................................................................................................................................................................65 4.3.7 Glycopeptides and Other Peptide Antibiotics................................................................................. 65 Overview.........................................................................................................................................................................65 Utility ..............................................................................................................................................................................66 Strengths and Weaknesses...............................................................................................................................................66 Noteworthy Developments..............................................................................................................................................66 Forecast ...........................................................................................................................................................................69 4.3.8 Quinolones .................................................................................................................................... 69 Overview.........................................................................................................................................................................69 Utility ..............................................................................................................................................................................70 Strengths and Weaknesses...............................................................................................................................................70 Noteworthy Developments..............................................................................................................................................71 Forecast ...........................................................................................................................................................................73 4.3.9 Oxazolidinones ............................................................................................................................... 74 4.3.10 Other Antibiotics ............................................................................................................................ 75 Overview.........................................................................................................................................................................75 Utility ..............................................................................................................................................................................75 Strengths and Weaknesses...............................................................................................................................................75 Noteworthy Developments..............................................................................................................................................75 vi Forecast ...........................................................................................................................................................................76 4.4 MECHANISMS OF ANTIBIOTIC RESISTANCE ................................................................................. 76 4.4.1 Antibiotic Inactivation................................................................................................................... 76 4.4.2 Antibiotic Entry and Efflux............................................................................................................. 76 4.4.3 Mutation of the Antibiotic Target Site ............................................................................................ 76 4.4.4 Alternative Metabolic Pathways..................................................................................................... 77 Section 5 TECHNOLOGY PLATFORMS OTHER THAN ANTIBIOTICS...................................................... 79 5.1 OTHER LOW-MOLECULAR-WEIGHT THERAPEUTICS.................................................................. 79 5.1.1 Trimethoprim and Sulfonamides .................................................................................................... 79 Overview.........................................................................................................................................................................79 Utility ..............................................................................................................................................................................79 Strengths and Weaknesses...............................................................................................................................................79 Noteworthy Developments..............................................................................................................................................80 Forecast ...........................................................................................................................................................................80 5.1.2 Metronidazole................................................................................................................................ 80 5.1.3 Nitrofurantoin and Other Nitrofurans............................................................................................ 80 5.2 VACCINES AND IMMUNOTHERAPIES.............................................................................................. 80 5.2.1 Vaccines ........................................................................................................................................ 80 Overview.........................................................................................................................................................................80 Utility ..............................................................................................................................................................................82 Strengths and Weaknesses...............................................................................................................................................82 Noteworthy Developments..............................................................................................................................................82 Forecast ...........................................................................................................................................................................86 5.2.2 Antibodies...................................................................................................................................... 86 5.2.3 Other Immunotherapies................................................................................................................. 87 5.3 OTHER TECHNOLOGIES...................................................................................................................... 88 Overview.........................................................................................................................................................................88 Noteworthy Development ...............................................................................................................................................88 Section 6 OVERALL ANALYSIS AND FORECAST FOR ANTIBACTERIALS ............................................. 89 6.1 PRODUCT TECHNOLOGY ANALYSIS AND FORECAST ................................................................ 89 6.2 MARKET ANALYSIS AND FORECAST ............................................................................................ 104 6.3 EVALUATION OF LICENSING OPPORTUNITIES – RATINGS AND RANKINGS....................... 107 Section 7 COMPANY PROFILES OF INNOVATIVE FIRMS REPRESENTING ACQUISITIONS, LICENSING, AND COMARKETING OPPORTUNITIES IN ANTIBACTERIAL THERAPY ................................................................................................................................. 121 7.1 ACAMBIS .............................................................................................................................................. 121 7.2 ANTEX BIOLOGICS............................................................................................................................. 122 7.3 ANTIGENICS......................................................................................................................................... 122 7.4 AVANT IMMUNOTHERAPEUTICS ................................................................................................... 123 7.5 AXCAN PHARMA ................................................................................................................................ 123 7.6 CSL ...................................................................................................................................................... 124 7.7 CUBIST PHARMACEUTICALS........................................................................................................... 124 7.8 DAIICHI SEIYAKU............................................................................................................................... 125 7.9 DEMEGEN............................................................................................................................................. 126 7.10 ESSENTIAL THERAPEUTICS............................................................................................................. 126 7.11 GENOME THERAPEUTICS ................................................................................................................. 127 7.12 ID BIOMEDICAL CORPORATION ..................................................................................................... 127 7.13 INCYTE GENOMICS ............................................................................................................................ 128 7.14 INTERMUNE......................................................................................................................................... 129 7.15 INTRABIOTICS..................................................................................................................................... 130 7.16 LIGOCYTE PHARMACEUTICALS..................................................................................................... 130 7.17 MEDIMMUNE....................................................................................................................................... 131 7.18 MEIJI SEIKA.......................................................................................................................................... 131 7.19 MICROLOGIX BIOTECH..................................................................................................................... 132 vii 7.20 NABI ...................................................................................................................................................... 132 7.21 NEOSE TECHNOLOGIES .................................................................................................................... 133 7.22 NEWBIOTICS........................................................................................................................................ 133 7.23 NIPPON MEDICAL RESEARCH ......................................................................................................... 134 7.24 POWDERJECT PHARMACEUTICALS............................................................................................... 134 7.25 SEQUELLA............................................................................................................................................ 134 7.26 SHIONOGI ............................................................................................................................................. 135 7.27 SHIRE PHARMACEUTICALS GROUP............................................................................................... 136 7.28 SIGA TECHNOLOGIES........................................................................................................................ 136 7.29 TAIHO PHARMACEUTICAL COMPANY.......................................................................................... 137 7.30 TAKEDA CHEMICAL INDUSTRIES .................................................................................................. 137 7.31 TOYAMA CHEMICAL CO................................................................................................................... 137 7.32 VERSICOR............................................................................................................................................. 138 7.33 VICAL .................................................................................................................................................... 138 7.34 WAKUNAGA PHARMACEUTICAL CO............................................................................................. 139 7.35 XOMA .................................................................................................................................................... 139




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