“The search for bioactive metabolites from marine microbes has only just begun”—David Newman, D. Phil, and Russell Hill, PhD, New Drugs from Marine Microbes: The Tide is Turning (2006)

STUDY GOALS AND OBJECTIVES

BCC’s goal in conducting this study was to determine the current status of the global marine-derived pharmaceutical market, including its growth potential during the period of 2011 to 2016. Our key objective is to present a comprehensive analysis of marine life and technology as they relate to pharmaceutical applications and to forecast this market’s future direction.

REASONS FOR DOING THIS STUDY

Our understanding of marine life only began during the last half of the 20th century. The first marine discovery that led to a pharmaceutical drug began in the 1950s when chemists Bergmann and Feeney isolated nucleosidic compounds from the Caribbean sponge Cryptotethya crypta. Marine drugs on the market today can be traced to this discovery (e.g., anticancer drug cytarabine).

While marine life is used for many applications, including food and industrial processing, its use in the pharmaceutical industry has just begun. Marine life offers a complex and diverse genetic resource unavailable on land, which has led to the exploration of the oceans to find new tests and cures for illnesses. Entire classes of antibiotics desperately needed for a world surviving on relatively few antibiotics, which people are becoming resistant to, could be found in just a few marine samples.

This report describes the potential of marine research and its growth prospects. It is estimated that marine-derived drugs will essentially double in number from 2011 to 2016. Because marine-derived drugs already account for a few powerful drugs, this area of the drug industry has already generated billions of dollars to date.

SCOPE OF REPORT

The scope of this study encompasses research organizations, the U.S. government chiefly in the form of the National Cancer Institute (NCI), and companies that develop or help in the development process of pharmaceuticals derived from marine life. Included are extensive descriptions, perspectives, and predictive information, including forecasts of growth over the next 5 years. Technological issues, including the latest trends, are discussed.

INTENDED AUDIENCE

In this report, marine-derived pharmaceuticals are described in terms of their history in medicine, technology types and categories, research organizations, major companies, impact on the pharmaceutical market, applications, current market values, growth potential, and significant trends. This study will be of interest to non-profits and the government sector as well as the biotechnology and pharmaceutical industries and related life science, analytics, drug discovery, and diagnostic test manufacturing companies as well as all those interested in or actively working in drug and imaging agent research and investors in all of the above.

METHODOLOGY

BCC presents an analysis of the types of technologies, applications, and therapeutic areas representing the financial value of marine-derived pharmaceuticals. Estimated values are based on actual aggregate sales for the years discussed. Information, in general, is compiled through a combination of primary and secondary research, including annual reports and interviews with company and government officials as well as experts in academia.

INFORMATION SOURCES

BCC’s analysis includes the review of more than 50 companies and information from financial and trade publications as well as the U.S. Food and Drug Administration (FDA). Included were pharmaceutical and biotechnology companies as well as support companies to them.

Table Of Contents

CHAPTER ONE: INTRODUCTION 1
STUDY GOALS AND OBJECTIVES . 1
REASONS FOR DOING THIS STUDY . 1
SCOPE OF REPORT .. 2
INTENDED AUDIENCE 2
METHODOLOGY ... 2
INFORMATION SOURCES ... 2
ABOUT THE AUTHOR .. 3
RELATED BCC REPORTS 3
BCC ONLINE SERVICES .. 4
DISCLAIMER . 4
CHAPTER TWO: EXECUTIVE SUMMARY ... 5
SUMMARY TABLE GLOBAL FORECAST FOR MARINE-DERIVED
DRUGS BY TYPE, THROUGH 2016 ($ MILLIONS) ... 5
SUMMARY FIGURE GLOBAL FORECAST FOR MARINE-DERIVED
DRUGS, 2010-2016 ($ MILLIONS) 6
EXECUTIVE SUMMARY (CONTINUED) 7
INVESTMENT AND PATH FORWARD ... 8
INVESTMENT AND PATH FORWARD (CONTINUED) .. 9
KEY DRIVERS .. 10
KEY CHALLENGES. 11
KEY TRENDS ... 11
DEVELOPMENT OF MICROBES SYMBIOTIC WITH MARINE
INVERTEBRATES ... 12
USE OF ALGAE IN NOVEL WAYS . 12
GREATER USE OF ESTABLISHED MARINE LIFE
LIBRARIES ... 13
CONTINUED FOCUS ON CANCER 13
EXPANSION OF KNOWLEDGE AND USE OF
CONOPEPTIDES . 14
IMMUNE CELL INDUCEMENT THERAPY ... 14
INVESTMENT LANDSCAPE .. 14
KEY INVESTMENTS/COLLABORATIONS IN MARINEDERIVED
DRUG DEVELOPMENT 15
Abbott Laboratories and Seattle Genetics .. 15
Algenics, IFREMER, Roquette Group 15
Aphios Corp., Novartis, Bayer, Bristol-Myers Squibb, Eli
Lilly, Baxter Healthcare, Sigma-Aldrich .. 15
Aquapharm Biodiscovery, Ltd. and Albany Molecular
Research Group .. 16
ArcticZymes, Universities in Tromsø, Trondheim
(NTNU/Norway), and Umeå (Sweden) .. 16
ASKA and Yakult Honsha .. 16
AstraZeneca (MedImmune) and Xenome ... 16
Azur Pharma and Eisai ... 17
Boehringer Ingelheim, Sigma-Tau, Pacira . 17
Cognetix, Inc. and the University of Utah . 17
Genzyme and Abbott Laboratories . 17
Gilead Sciences, Inc. and UC Santa Cruz .. 17
GlaxoSmithKline and Pfizer ... 18
GlaxoSmithKline/Pronova, Affiris, and Stellar
Biotechnologies ... 18
GlycoMar and Verona Pharma ... 18
Johnson and Johnson, PharmaMar, and Taiho
Pharmaceuticals . 18
National Cancer Institute and Bristol-Myers Squibb 19
Nautilus Biosciences Canada, Inc. and the NRC-INH on
the campus of UPEI ... 19
Scripps Institution of Oceanography, Trius Therapeutics,
and Nereus Pharmaceuticals . 19
Seattle Genetics, Astellas, CellDex, Millennium ... 20
Stellar Biotechnologies, Bayer Innovation, Amgen, Merck,
Biovest, Neovacs, Affiris, GlaxoSmithKline .. 21
Triton Biopharma, University of Mississippi, PharmaMar ... 21
CHAPTER THREE: OVERVIEW .. 22
HISTORY OF MARINE DRUGS.. 22
HISTORY OF MARINE DRUGS (CONTINUED) 23
HISTORY OF MARINE DRUGS (CONTINUED) 24
TABLE 1 KEY DATES IN MARINE-DERIVED DRUG HISTORY 25
TABLE 2 GROWTH IN THE INTEREST IN MARINE NATURAL
PRODUCTS BASED ON THE NUMBER OF PRODUCTS
DESCRIBED IN SCIENTIFIC JOURNALS, 1999-2004 ... 26
MAJOR CATEGORIES OF MARINE DRUGS 26
MAIN CHEMICAL CLASSES ... 27
Phenols . 27
Steroids 27
Ether 27
Strigolactones .. 27
Peptides 28
MAIN MARINE LIFE GROUPINGS 28
Marine Microorganisms .. 29
Marine Algae 30
Marine Invertebrates .. 31
Porifera .. 31
Discodermolide .. 31
Cnidarians . 32
Ctenophora 32
Bryozoa .. 32
Mollusca 32
Echinoderms .. 33
Protozoa . 34
Chordates .. 34
FIGURE 1 THE TUNICATE ECTEINASCIDIA TURBINATE FROM
WHICH YONDELIS (TRABECTEDIN) FOR CANCER TREATMENT
IS MADE 34
FIGURE 2 MARINE SPECIES PER PHYLUM BASED ON WORMS ... 35
FIGURE 3 APPROXIMATION OF KNOWN VERSUS POSSIBLE
SPECIES WITHIN THREE PHYLA, 2011 ... 36
CHAPTER FOUR: MARKET LANDSCAPE . 37
COMMERCIALIZED MARINE LIFE DRUGS BY TYPE ... 37
ANTIVIRALS . 37
ANTI-LEUKEMIC DRUG . 37
IMMUNOTHERAPEUTIC 37
PAIN MEDICATION FOR CANCER PATIENTS 38
TRIGLYCERIDE-LOWERING DRUG .. 38
ANTICANCER DRUG ... 38
BREAST CANCER DRUG . 39
ANTIBODY DRUG CONJUGATE 39
FIGURE 4 COMMERCIALIZED MARINE DRUGS BY MARINE LIFE
TYPE, 2011 AND 2016 (NO. OF UNITS) 40
FIGURE 5 COMMERCIALIZED MARINE DRUGS*, 2010-2016
(NUMBER OF UNITS**) .. 41
FIGURE 6 GLOBAL FORECAST FOR MARINE-DERIVED DRUGS* BY
THERAPEUTIC CATEGORY, 2009-2016 ($ MILLIONS) ... 42
FIGURE 7 COMMERCIALIZED MARINE DRUGS BY THERAPEUTIC
AREA, 2011 (NUMBER OF UNITS EXPRESSED AS A %) ... 43
FIGURE 8 COMMERCIALIZED MARINE DRUGS BY MARINE LIFE
TYPE, 2016 (NUMBER OF UNITS EXPRESSED AS A %) 44
PHARMACEUTICAL MARKET IN GENERAL . 44
PHARMACEUTICAL MARKET IN GENERAL (CONTINUED) 45
FIGURE 9 GLOBAL PHARMACEUTICAL DRUG SALES, 2010 ($
BILLIONS) . 46
FIGURE 10 GEOGRAPHIC DISTRIBUTION OF PHARMACEUTICAL
SALES, 2010 AND 2016 (% OF MARKET SHARE) .. 47
TABLE 3 TOP 10 PHARMA IN SALES IN 2010 ($ BILLIONS) . 48
MARINE-DERIVED DRUG LANDSCAPE . 49
APPROVED DRUGS .. 50
AZT, Retrovir, Combivir, AZT/3TC (Zidovudine) ... 50
Zovirax (Acyclovir, Aciclovir) .. 51
Ara-C, Cytosar-U, or DepoCyt (Cytarabine)... 51
Vira-A (Vidarabine) . 52
Prialt (Ziconotide) 52
Lovaza/Omacor (Fish-Derived Omega-3s) .. 53
Immucothel/(Keyhole Limpet Hemocyanin) ... 53
Halaven (Eribulin Mesylate) ... 54
Yondelis (Trabectedin) 55
Adcetris (Brentuximab Vedotin) . 56
Adcetris (Brentuximab Vedotin) (Continued) . 57
TABLE 4 PHARMAMAR RandD PIPELINE IN THE U.S. OR EUROPE,
2011 58
DRUGS IN DEVELOPMENT 58
Phase III ... 58
Yondelis (Trabectedin) .. 58
BiovaxID 58
Phase II 59
Soblidotin (YHI-501) . 59
Aplidin (Plitidepsin) .. 59
TABLE 5 MARINE-DERIVED DRUGS APPROVED AND IN LATESTAGE
DEVELOPMENT*, 2011 .. 60
TABLE 5 (CONTINUED) 61
TABLE 5 (CONTINUED) 62
Affitope AD02 63
DMXBA . 63
Bryostatin .. 63
Plinabulin (NPI-2358) ... 64
Elisidepsin (Irvalec, PM02734) 64
PM1004 (Zalypsis) 65
Squalamine (Evison) . 65
CDX-011 65
Xen2174 . 66
Phase I.. 66
Affitope AD 03 ... 66
ASG-5ME .. 67
ASG-22ME. 67
Tasidotin (ILX-651) ... 67
Hemiasterlin (E7974) ... 68
Salinosporamide A (NPI-0052) . 68
SGN-75 .. 69
COMMERCIALIZATION LANDSCAPE BY 2016 .. 69
FORERUNNERS IN THE MARINE-DERIVED DRUG
COMMERCIALIZATION RACE .. 69
Aplidin (Plitidepsin): PharmaMar .. 69
PM01183 and Yondelis (Trabectedin): PharmaMar and
Johnson and Johnson 69
Plinabulin (NPI-2358): Nereus Pharmaceuticals ... 70
CDX-011: CellDex Therapeutics . 70
Envizon (Squalamine): Ohr Pharmaceuticals 70
BiovaxID: Biovest Using Stellar Biotechnologies’ KLH. 71
BiovaxID: Biovest Using Stellar … (Continued) . 72
MECHANISMS OF ACTION ... 72
TABLE 6 MARINE-DERIVED DRUGS/DRUG CANDIDATE’S
MECHANISM OF ACTION . 73
MARINE DRUG CULTIVATION 73
MARINE DRUG CULTIVATION (CONTINUED) ... 74
MARINE DRUG CULTIVATION (CONTINUED) ... 75
TABLE 7 KEY MARINE-DERIVED PRODUCT LIBRARIES. 76
TABLE 7 (CONTINUED) ... 77
FIGURE 11 MARINE SAMPLE/MOLECULE CULTIVATION AND
PROCESSING 78
PRIVATE RESOURCES 79
Aphios Corp. . 79
Magellan Bioscience Group . 79
Phycosource.. 79
Aquapharm Biodiscovery, Ltd. 80
CASE STUDIES . 80
Movement of Drug from Lab to Trials 80
Academic-Industrial Collaboration . 81
PharmaMar Serves as an Example of an Integrated
Developer 82
CHALLENGES TO CULTIVATION/PRODUCTION ... 83
REGULATORY ENVIRONMENT ... 83
PATENTS .. 84
CASE STUDIES . 85
Development is Lagging behind Novel Patents . 85
Patenting Areas of Growth .. 86
MARINE DRUG DEVELOPMENT: AREAS OF FOCUS TO WATCH .. 86
ENZYMES .. 86
Enzymes (Continued) .. 87
Enzymes (Continued) .. 88
EXTREMOPHILES 89
Extremophiles (Continued) . 90
FLUORESCENT PROTEINS 91
Developments in Fluorescent Proteins ... 92
Photo-Activatable Green Fluorescent Protein (PAGFP)
. 92
Dronpa Fluorescent Protein Chromophore
Photoswitching 92
Photoconvertable Fluorescent Proteins ... 92
Fluorescent Proteins as Vectors ... 93
ANTICANCER/ONCOLOGY . 93
MMP Inhibitors ... 94
Protein Kinase C .. 94
Topoisomerase Inhibitors 94
Nuclear Factor-?B (NF-?B) Inhibitors ... 94
Hypoxia-Inducible Factors Inhibitors . 95
MARINE DRUG DEVELOPMENT RESEARCH 95
TABLE 8 KEY MARINE-DERIVED DRUG RESEARCH CANDIDATES:
COMPOUNDS BY DRUG TYPE ... 95
TABLE 8 (CONTINUED) 96
TABLE 8 (CONTINUED) ... 97
TABLE 8 (CONTINUED) 98
DISEASES/CONDITIONS MOST OFTEN TREATED WITH MARINE
DRUGS . 99
CANCER DRUG PIPELINE: 2011 AND BEYOND . 99
Breast Cancer .. 99
TABLE 9 GLOBAL PHASE III PIPELINE FOR BREAST CANCER
THROUGH 2016 .. 100
Brain Cancer .. 100
TABLE 10 GLOBAL PHASE III PIPELINE FOR BRAIN OR CNS
CANCER, THROUGH 2016 ... 101
Bladder Cancer .. 101
TABLE 11 GLOBAL PHASE III PIPELINE FOR BLADDER CANCER,
THROUGH 2016 .. 101
Colorectal Cancer... 102
TABLE 12 GLOBAL PHASE III PIPELINE FOR COLORECTAL
CANCER, THROUGH 2016 ... 102
Head and Neck Cancer .. 102
TABLE 13 GLOBAL PHASE III PIPELINE FOR HEAD AND NECK
CANCER, THROUGH 2016 ... 103
Kidney Cancer ... 103
TABLE 14 GLOBAL PHASE III PIPELINE FOR KIDNEY CANCER,
THROUGH 2016 .. 104
Leukemia ... 104
TABLE 15 GLOBAL PHASE III PIPELINE FOR LEUKEMIA,
THROUGH 2016 .. 105
TABLE 15 (CONTINUED) 106
Liver Cancer .. 106
TABLE 16 GLOBAL PHASE III PIPELINE FOR LIVER CANCER
THROUGH 2016 .. 106
TABLE 16 (CONTINUED) 107
Lung Cancer ... 107
TABLE 17 GLOBAL PHASE III PIPELINE FOR LUNG CANCER
THROUGH 2016 .. 107
TABLE 17 (CONTINUED) 108
Lymphoma . 108
TABLE 18 GLOBAL PHASE III PIPELINE FOR LYMPHOMA,
THROUGH 2016 .. 109
TABLE 18 (CONTINUED) 110
Multiple Myeloma .. 110
TABLE 19 GLOBAL PHASE III PIPELINE FOR MULTIPLE
MYELOMA, THROUGH 2016 110
Ovarian Cancer .. 111
TABLE 20 GLOBAL PHASE III PIPELINE FOR OVARIAN CANCER,
THROUGH 2016 .. 111
Pancreatic Cancer .. 111
TABLE 21 GLOBAL PHASE III PIPELINE FOR PANCREATIC
CANCER, THROUGH 2016 ... 112
Prostate Cancer . 112
TABLE 22 GLOBAL PHASE III PIPELINE FOR PROSTATE CANCER,
THROUGH 2016 .. 113
TABLE 22 (CONTINUED) 114
Sarcoma .. 114
TABLE 23 GLOBAL PHASE III PIPELINE FOR SARCOMA, THROUGH
2016 .. 114
Skin Cancer 115
TABLE 24 GLOBAL PHASE III PIPELINE FOR SKIN CANCER,
THROUGH 2016 .. 115
Solid Tumors .. 116
TABLE 25 GLOBAL PHASE III PIPELINE FOR SOLID TUMORS,
THROUGH 2016 .. 116
Stomach Cancer . 116
TABLE 26 GLOBAL PHASE III PIPELINE FOR STOMACH CANCER,
THROUGH 2016 .. 116
CHAPTER FIVE: COMPANY PROFILES .. 117
ABBOTT LABORATORIES 117
AFFIRIS AG 117
AKER BIOMARINE ASA ... 118
ALGENICS .. 119
APHIOS CORP. ... 120
APP PHARMACEUTICALS ... 121
ARCTICZYMES .. 122
ASKA PHARMACEUTICAL CO., LTD. 123
ASTELLAS (AGENSYS, INC.) ... 124
ASTELLAS (AGENSYS, INC.) (CONTINUED) . 125
AQUAPHARM BIODISCOVERY, LTD. 126
AZUR PHARMA .. 126
BASF SE .. 127
BAYER INNOVATION ... 128
BEDFORD LABORATORIES 129
BIOSYN CORP. ... 130
BIOVEST INTERNATIONAL, INC. .. 130
BTG INTERNATIONAL, LTD. .. 131
CATABASIS PHARMACEUTICALS, INC. ... 132
CELLDEX THERAPEUTICS . 132
CENTOCOR ORTHO BIOTECH ... 133
COGNETIX, INC. ... 133
COMENTIS . 134
CYANOTECH CORP. . 134
EISAI CO., LTD. . 135
ELAN CORP. (ELAN PHARMACEUTICALS, INC.) 136
EUROPHARMA, INC. 136
GENZYME .. 137
GILEAD SCIENCES, INC. . 138
GLAXOSMITHKLINE 138
GLYCOMAR, LTD. . 139
TABLE 27 GLYCOMAR POLYSACCHARIDE CHARACTERIZATION
SERVICES ... 140
TABLE 27 (CONTINUED) 141
GILEAD SCIENCES ... 141
HOSPIRA, INC. .. 142
IMMUNOPHOTONICS .. 142
INTEGRIN ADVANCED BIOSYSTEMS ... 143
INTERMED DISCOVERY GMBH . 143
INTRACEL .. 144
KLINIPHARM GMBH 144
KLINIPHARM GMBH (CONTINUED) .. 145
MAGELLAN BIOSCIENCE GROUP, INC 146
MARINE POLYMER TECHNOLOGIES, INC. . 147
MARINOVA PTY, LTD. .. 147
MARINOVA PTY, LTD. (CONTINUED) 148
MARTEK BIOSCIENCES CORP. .. 149
MEDIMETRIKS PHARMACEUTICALS ... 149
MERA PHARMACEUTICALS ... 150
MILLENNIUM, A TAKEDA ONCOLOGY CO. 151
NAUTILUS BIOSCIENCES CANADA, INC. 151
NÉOVACS ... 152
NEUROBIOPHARM, INC. (PART OF NEPTUNE TECHNOLOGIES) .. 153
NEREUS PHARMACEUTICALS .. 154
NEREUS PHARMACEUTICALS (CONTINUED) . 155
OHR PHARMACEUTICALS .. 156
PACIRA PHARMACEUTICALS, INC. .. 156
PHARMAMAR 157
PHARMAMAR (CONTINUED) ... 158
PHARMA MARINE USA, LLC .. 159
PHYCOSOURCE 160
PML APPLICATIONS, LTD. .. 160
PRIMEX EHF .. 161
PROLUME, LTD. 161
PRONOVA BIOPHARMA ASA .. 162
SEA RUN HOLDINGS ... 163
SEATTLE GENETICS, INC. .. 164
SEATTLE GENETICS, INC. (CONTINUED) 165
SIGMA-TAU PHARMACEUTICALS, INC. ... 166
STELLAR BIOTECHNOLOGIES .. 166
STELLAR BIOTECHNOLOGIES (CONTINUED) . 167
STELLAR BIOTECHNOLOGIES (CONTINUED) . 168
STRATEGRO INTERNATIONAL, LLC 169
TAIHO PHARMACEUTICALS .. 169
TEQUESTA BIOVENTURES 170
TRITON BIOPHARMA ... 170
TRIUS THERAPEUTICS ... 171
VERONA PHARMA, PLC ... 172
XENOME, LTD. .. 172
YAKULT HONSHA CO, LTD. ... 173
ZELTIA GROUP (GRUPO ZELTIA) .. 173
ZELTIA GROUP (GRUPO ZELTIA) (CONTINUED) . 174
ZELTIA GROUP (GRUPO ZELTIA) (CONTINUED) . 175
APPENDIX: RESOURCES ... 176
TABLE 28 MARINE RESEARCH RESOURCES BY CATEGORY ... 176
TABLE 28 (CONTINUED) 177
TABLE 28 (CONTINUED) 178
TABLE 29 KEY RESEARCHERS/LEADERS AFFECTING MARINEDERIVED
DRUG INDUSTRY ... 178
TABLE 29 (CONTINUED) 179

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