BOTANICAL AND PLANT-DERIVED DRUGS: GLOBAL MARKETS

Transcription

1 BOTANICAL AND PLANT-DERIVED DRUGS: GLOBAL MARKETS BIO022G August 2015 Kim Lawson Project Analyst ISBN: X BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1) information@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY BACKGROUND 2 STUDY GOAL AND OBJECTIVES 2 INTENDED AUDIENCE 3 SCOPE OF REPORT 3 METHODOLOGY AND INFORMATION SOURCES 4 COMMERCIAL DRUGS 4 AL DRUGS 4 TABLE A FDA APPROVAL PROCESS FOR NEW DRUGS 5 ANALYST'S CREDENTIALS 5 RELATED BCC RESEARCH REPORTS 6 BCC RESEARCH WEBSITE 6 DISCLAIMER 6 CHAPTER 2 SUMMARY 8 SUMMARY TABLE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS, THROUGH 2020 ($ MILLIONS) SUMMARY FIGURE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS, ($ MILLIONS) CHAPTER 3 OVERVIEW 16 BRIEF HISTORY OF PLANT-DERIVED MEDICINES 17 TABLE 1 KEY DATES IN BOTANICAL MEDICINE 18 TABLE 2 WELL KNOWN PLANT-DERIVED DRUGS 18 OPPORTUNITY LIES BEYOND WHAT IS KNOWN 19 FIGURE 1 TYPE OF NATURAL PRODUCT DRUGS SUBMITTED AS IND APPLICATIONS TO THE FDA, 2008 (% SHARES) GETTING STARTED 22 KEY DRIVERS 23 KEY CHALLENGES 24 U.S. GOVERNMENT INVESTMENT 25 INDUSTRY INVESTMENT 27 TABLE 3 SWOT ANALYSIS OF BOTANICAL DRUG 32 TABLE 4 KEY INVESTMENTS IN BOTANICAL AND OTHER PLANT-DERIVED DRUGS 34 NUTRITION SCIENCE PARTNERS LTD. (NESTLE HEALTH): A CASE STUDY 38 BOTANICAL DRUGS DEFINED 40 UNDERSTANDING THE REGULATORY PROCESS 42 TABLE 5 DISTINCTIONS AMONG PRODUCTS THAT USE PLANTS MEDICINALLY 43 INVESTIGATIONAL NEW DRUG APPLICATIONS 43 CLINICAL TRIALS 44 NEW DRUG APPLICATION 44 THE FIRST AND SECOND APPROVED BOTANICAL 45 VEREGEN (CHINESE GREEN TEA CATECHINS) 45 Advice from FDA Based on Veregen Approval 46 FULYZAQ (CROFELEMER) 47 BOTANICAL CANDIDATES IN THE PIPELINE 48 19

3 SAMITAL AND PANAX GINSENG 48 TCM-700C 49 FEMARELLE AND BRIZO 50 SHINBARO CAPSULE 51 DANSHEN DRIPPING PILL (CARDIOTONIC PILL) 51 EISO (EAST INDIAN SANDALWOOD OIL) 53 MICROBIO AND WH-1, MB-6, AND OB TABLE 6 BOTANICAL COMPOSITION OF MENERBA (MF 101)* 56 A GROWING PIPELINE 57 FIGURE 2 TOP THERAPEUTIC AREAS OF FDA DRUG APPROVALS*, 2014 (NO. OF DRUG APPROVALS) FIGURE 3 SNAPSHOT OF U.S. FDA BOTANICAL PIPELINE IN OVERALL PHARMA LANDSCAPE 59 TABLE 7 TOP PHARMA COMPANIES BY SALES, 2014 ($ BILLIONS) 61 TABLE 8 MAJOR UPCOMING U.S. PATENT EXPIRIES, FIGURE 4 PHARMA DRUG SALES BY REGION, 2014 AND 2019 (% OF MARKET SHARE) MAJOR CLASSES OF PLANT DRUGS 63 Terpenes and Steroids 63 Terpenes 63 Steroids 64 Alkaloids and Glycosides 64 Alkaloids 64 Ergot Alkaloids 65 Morphine Alkaloids 65 Vinca Alkaloids 65 Glycosides 66 Cardiac Glycosides 66 Anthraglycosides 66 Phenols 66 E. Cava Algae 66 Flavonoids 66 Resveratrol 67 Coumarin 67 Catechins 67 Proanthocyanidins 67 INTELLECTUAL PROPERTY 68 PRODUCTION 69 A NEW TYPE OF PRODUCTION: PLANT-MADE DRUGS 71 MOVING PRODUCTION FORWARD 72 ARTEMISININ: A CASE STUDY 75 SUPPLY AND LEGAL ISSUES 76 TABLE 9 MAJOR PRODUCERS OF RAW MATERIALS FOR PLANT-BASED MEDICINALS 77 DRUG AND MANUFACTURE 78 TABLE 10 KEY COMPANIES WITH NATURAL PRODUCT LIBRARIES CHAPTER 4 MARKET SEGMENTATION 82 GEOGRAPHIC SEGMENTATION 82

4 SALES OF PLANT-DERIVED DRUGS BY REGION 82 THERAPEUTIC AREA SEGMENTATION 82 NUMBER OF PLANT-DERIVED DRUGS BY THERAPEUTIC AREA 82 TABLE 11 NUMBER OF FDA APPROVED BOTANICAL DRUGS, THROUGH 2020 (NUMBER) FIGURE 5 COMPOSITION OF FDA APPROVED BOTANICAL INDICATIONS FORECAST BY THERAPEUTIC AREA, 2015 AND 2020 (%) VALUE OF PLANT-DERIVED DRUGS BY THERAPEUTIC AREA 84 TABLE 12 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS) FIGURE 6 RELATIVE VALUE SHARE OF FDA APPROVED BOTANICAL DRUGS FORECAST BY THERAPEUTIC AREA, 2015 AND 2020 (%) CHAPTER 5 THERAPEUTIC AREAS FOR BOTANICAL AND PLANT-DERIVED DRUGS 87 HORMONE THERAPY AND METABOLISM APPLICATIONS 87 TABLE 13 PLANT-DERIVED HORMONE THERAPY AND METABOLISM DRUGS IN LATE STAGE INFECTIOUS DISEASE APPLICATIONS 88 TABLE 14 PLANT-DERIVED INFECTIOUS DISEASE DRUGS IN LATE STAGE PAIN AND CENTRAL NERVOUS SYSTEM DISEASE APPLICATIONS 91 TABLE 15 BRAIN DISORDERS THAT ARE REFRACTORY TO SMALL MOLECULE DRUGS 91 TABLE 16 PLANT-DERIVED PAIN AND CNS DRUGS IN LATE STAGE 92 CARDIOVASCULAR AND METABOLIC DISEASE APPLICATIONS 94 TABLE 17 PLANT-DERIVED CARDIOVASCULAR AND METABOLIC DRUGS IN LATE STAGE RESPIRATORY, INFLAMMATION (BOTH NONRELATED AND RELATED TO ORTHOPEDIC) AND AUTOIMMUNE APPLICATIONS TABLE 18 PLANT-DERIVED RESPIRATORY, INFLAMMATION (BOTH NON-RELATED AND RELATED TO ORTHOPEDIC) AND AUTOIMMUNE DRUGS IN LATE STAGE DERMATOLOGY APPLICATIONS 96 TABLE 19 PLANT-DERIVED DERMATOLOGY/WOUND CARE DRUGS IN LATE STAGE GASTROINTESTINAL APPLICATIONS 97 TABLE 20 PLANT-DERIVED GASTROINTESTINAL DRUGS IN LATE STAGE ONCOLOGY APPLICATIONS 99 TABLE 21 ESTIMATED U.S. CANCER CASES BY GENDER, TABLE 22 PLANT-DERIVED ONCOLOGY DRUGS IN LATE STAGE 102 BOTANICAL DRUGS IN LATE STAGE 108 TABLE 23 BOTANICAL DRUGS IN LATE STAGE WITH POSSIBLE FDA-APPROVED COMMERCIALIZATION, THROUGH CHAPTER 6 COMPANY PROFILES 113 ABBOTT LABORATORIES 113 ACORDA THERAPEUTICS, INC. 113 AMAREX CLINICAL RESEARCH 114 ANALYTICON DISCOVERY GMBH 114 ARTECEF BV 115

5 AVESTHAGEN LTD. 115 BAYER HEALTHCARE PHARMACEUTICALS 116 BEIJING PEKING UNIVERSITY WBL BIOTECH CO. LTD. 117 BIONORICA SE 118 BIONUMERIK PHARMACEUTICALS INC. 118 BOEHRINGER INGELHEIM 119 PHARMATON SA 119 BOTANICAL DRUG CORP. 120 BRISTOL MYERS SQUIBB 121 CARDAX PHARMACEUTICALS 124 CHI-MED 125 CHONG KUN DANG PHARMACEUTICAL CORP. 125 CURAPHARM INC. 126 DONG-A-ST 126 DONGWHA PHARM CO. LTD. 127 EISAI INC. 127 EISAI, INC. U.S. 127 EKOMED LLC 128 ELI LILLY 129 FYTOKEM PRODUCTS INC. 129 GALAPAGOS NV 130 GENSPERA INC. 131 GLAXOSMITHKLINE 131 GLENMARK PHARMACEUTICALS LIMITED 133 GREEN CROSS CORP. 133 GREEN LABORATORIES, LLC 134 GW PHARMACEUTICALS PLC 135 HAMIDA PHARMA INC. 136 HANMI PHARMA CO. LTD. 136 HETEROGENEITY LLC 136 INDENA 137 INDUS BIOTECH 139 IZUN PHARMACEUTICALS CORP. 139 JOHNSON & JOHNSON 140 LANZHOU FOCI PHARMACEUTICALS CO. LTD. 141 LEO PHARMA 141 LUPIN LTD. 142 LUPIN PHARMACEUTICALS INC. 142 MEDIGENE 143 MEDIGENE INC. (U.S. DIVISION) 143 MERCK & CO. INC. 144 MERLION PHARMACEUTICALS 145 MICROBIO CO. LTD. 146 MYCOSYNTHETIX, INC. 147 NAPO PHARMACEUTICALS INC. 147 NOVARTIS INTERNATIONAL AG 148 PFIZER 149

6 THE PHARMACEUTICAL PLANT CO. 151 PHARMANUTRIENTS BOTANICAL CORP. 152 PHYNOVA 152 PHYTOCEUTICA INC. 153 PHYTOMYCO RESEARCH PVT. LTD. 154 PHYTOPHARMACON INC. 155 PIRAMAL PHYTOCARE LTD. 156 PRAIRIE PLANT SYSTEMS INC. 156 PUNISYN PHARMACEUTICALS LTD. (RIMONEST LTD.) 157 PURAPHARM INTERNATIONAL LTD. 157 PURGENESIS TECHNOLOGIES INC. 158 QUERCEGEN PHARMACEUTICALS LLC 158 ROTTAPHARM (MADAUS) 159 SANOFI 160 SCHWABE PHARMACEUTICALS 161 SE-CURE PHARMACEUTICALS LTD. 161 SEQUOIA SCIENCES INC. 162 SUN PHARMACEUTICAL INDUSTRIES LTD. 163 SUN TEN PHARMACEUTICAL CO. LTD. 164 TASLY PHARMACEUTICALS INC. 165 TCM BIOTECH INTERNATIONAL CORP. 166 TFS CORPORATION LTD. 167 VALEANT PHARMACEUTICALS INTERNATIONAL INC. 168 SALIX PHARMACEUTICALS INC. 168 VEDIC LIFESCIENCES PVT. LTD. 169 VIROXIS 170 XIANGXUE PHARMACEUTICALS, CO. LTD. 170 ZHEJIANG KANGLAITE GROUP 171 KANGLAITE USA 171 CHAPTER 7 APPENDIX 173 TABLE 24 PLANT-DERIVED DRUGS: THEIR ORIGIN AND ACTIONS 173 TABLE 25 USEFUL RESOURCES FOR THE BOTANICAL DRUG INDUSTRY 178

7 LIST OF TABLES TABLE HEADING TABLE A FDA APPROVAL PROCESS FOR NEW DRUGS 5 SUMMARY TABLE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS, THROUGH 2020 ($ MILLIONS) TABLE 1 KEY DATES IN BOTANICAL MEDICINE 18 TABLE 2 WELL KNOWN PLANT-DERIVED DRUGS 18 TABLE 3 SWOT ANALYSIS OF BOTANICAL DRUG 32 TABLE 4 KEY INVESTMENTS IN BOTANICAL AND OTHER PLANT-DERIVED DRUGS 34 TABLE 5 DISTINCTIONS AMONG PRODUCTS THAT USE PLANTS MEDICINALLY 43 TABLE 6 BOTANICAL COMPOSITION OF MENERBA (MF 101)* 56 TABLE 7 TOP PHARMA COMPANIES BY SALES, 2014 ($ BILLIONS) 61 TABLE 8 MAJOR UPCOMING U.S. PATENT EXPIRIES, TABLE 9 MAJOR PRODUCERS OF RAW MATERIALS FOR PLANT-BASED MEDICINALS 77 TABLE 10 KEY COMPANIES WITH NATURAL PRODUCT LIBRARIES 79 TABLE 11 NUMBER OF FDA APPROVED BOTANICAL DRUGS, THROUGH 2020 (NUMBER) TABLE 12 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS) TABLE 13 PLANT-DERIVED HORMONE THERAPY AND METABOLISM DRUGS IN LATE STAGE TABLE 14 PLANT-DERIVED INFECTIOUS DISEASE DRUGS IN LATE STAGE TABLE 15 BRAIN DISORDERS THAT ARE REFRACTORY TO SMALL MOLECULE DRUGS 91 TABLE 16 PLANT-DERIVED PAIN AND CNS DRUGS IN LATE STAGE 92 TABLE 17 PLANT-DERIVED CARDIOVASCULAR AND METABOLIC DRUGS IN LATE STAGE TABLE 18 PLANT-DERIVED RESPIRATORY, INFLAMMATION (BOTH NON-RELATED AND RELATED TO ORTHOPEDIC) AND AUTOIMMUNE DRUGS IN LATE STAGE TABLE 19 PLANT-DERIVED DERMATOLOGY/WOUND CARE DRUGS IN LATE STAGE TABLE 20 PLANT-DERIVED GASTROINTESTINAL DRUGS IN LATE STAGE TABLE 21 ESTIMATED U.S. CANCER CASES BY GENDER, TABLE 22 PLANT-DERIVED ONCOLOGY DRUGS IN LATE STAGE 102 TABLE 23 BOTANICAL DRUGS IN LATE STAGE WITH POSSIBLE FDA-APPROVED COMMERCIALIZATION, THROUGH 2020 TABLE 24 PLANT-DERIVED DRUGS: THEIR ORIGIN AND ACTIONS 173 TABLE 25 USEFUL RESOURCES FOR THE BOTANICAL DRUG INDUSTRY

8 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS, ($ MILLIONS) FIGURE 1 TYPE OF NATURAL PRODUCT DRUGS SUBMITTED AS IND APPLICATIONS TO THE FDA, 2008 (% SHARES) FIGURE 2 TOP THERAPEUTIC AREAS OF FDA DRUG APPROVALS*, 2014 (NO. OF DRUG APPROVALS) FIGURE 3 SNAPSHOT OF U.S. FDA BOTANICAL PIPELINE IN FIGURE 4 PHARMA DRUG SALES BY REGION, 2014 AND 2019 (% OF MARKET SHARE) 62 FIGURE 5 COMPOSITION OF FDA APPROVED BOTANICAL INDICATIONS FORECAST BY THERAPEUTIC AREA, 2015 AND 2020 (%) FIGURE 6 RELATIVE VALUE SHARE OF FDA APPROVED BOTANICAL DRUGS FORECAST BY THERAPEUTIC AREA, 2015 AND 2020 (%)