BIOMARKERS: TECHNOLOGIES AND GLOBAL MARKETS

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1 : TECHNOLOGIES AND GLOBAL MARKETS BIO061C April 2014 Jackson Highsmith Project Analyst ISBN: 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 GOALS AND OBJECTIVES 2 REASONS FOR DOING THE STUDY 2 SCOPE OF REPORT 2 INTENDED AUDIENCE 3 METHODOLOGY AND INFORMATION SOURCES 4 ANALYST'S CREDENTIALS 4 RELATED BCC RESEARCH REPORTS 4 BCC RESEARCH WEBSITE 5 DISCLAIMER 5 CHAPTER 2 SUMMARY 7 SUMMARY TABLE GLOBAL FORECAST BY SEGMENT, THROUGH 2018 ($ MILLIONS) SUMMARY FIGURE GLOBAL FORECAST BY SEGMENT, ($ MILLIONS) 7 7 CHAPTER 3 OVERVIEW 11 INTRODUCTION 11 TABLE 1 GLOBAL MARKET FOR, THROUGH 2013 ($ MILLIONS) 12 ENABLING ADVANCEMENTS DRIVING MARKET GROWTH 12 DRIVE SPEED, COST AND QUALITY IMPROVEMENTS ACROSS THE DRUG DEVELOPMENT SPECTRUM COST REDUCTION OPPORTUNITIES ARISING FROM BIOMARKER APPLICATIONS Elements of Cost in Healthcare 14 STRATEGIC BIOMARKER APPLICATIONS 15 Targeted Therapies 15 Product Extensions 16 Ultra-Blockbuster 17 BIOMARKER APPLICATIONS: DRUG DEVELOPMENT 17 Safety/Toxicology Biomarkers 18 TABLE 2 NOVEL SAFETY/TOXICOLOGY USED IN CANCER, CARDIO AND RENAL Dose Selection and Dose Optimization 19 TABLE 3 NOVEL DOSE SELECTION USED IN CANCER, DIABETES, METABOLIC AND LIVER DISEASE Improved Measurement of Therapeutic Efficacy 20 Outcome Biomarkers and Surrogate Endpoints 21 TABLE 4 PATIENT OUTCOME MEASUREMENTS 21 EARLY-STAGE CLINICAL TRIAL APPLICATIONS 21 LATE-STAGE CLINICAL TRIAL APPLICATIONS 22 Phase III 22 Phase IV 22 : CHALLENGES AND OPPORTUNITIES 22 SUMMARY 22 CHALLENGES

3 OPPORTUNITIES 25 CLINICAL VALIDITY: REQUIREMENTS 26 BIOMARKER OPPORTUNITIES 26 PRODUCT SUMMARY AND MARKET 26 GENOMICS 26 TABLE 5 GLOBAL MARKET FOR, 2013 ($ MILLIONS) 27 IMAGING 27 PROTEOMICS 27 BIOINFORMATICS 28 OTHER 29 Metabolomics 29 BIOMARKER ADOPTION BY THE PHARMACEUTICAL INDUSTRY 29 GROWTH DRIVERS AND RESISTORS 29 FACTORS INFLUENCING BIOMARKER ADOPTION IN CLINICAL TRIALS 29 CLINICAL TRIAL BENEFITS: COST AND RISK AVOIDANCE 30 IMPACT OF DRUG FAILURE IN LATE-STAGE CLINICAL TRIALS 30 Merck: Vicriviroc 30 Myriad: Flurizan 31 ADDITIONAL CAPABILITIES BY LARGE SERVICE PLAYERS 31 TECHNOLOGICAL ADVANCEMENTS IN GENOMICS AND PROTEOMICS 31 BIOMARKER MARKET FORECAST 31 TABLE 6 GLOBAL BIOMARKER MARKET FORECAST, THROUGH 2018 ($ MILLIONS) 32 CHAPTER 4 REGULATORY DYNAMICS, INTELLECTUAL PROPERTY AND ETHICAL CONSIDERATIONS INTRODUCTION 34 BIOMARKER LABORATORY REGULATORY SUMMARY 34 DEFINITION OF AN IVD COMPANION DIAGNOSTIC 35 Labeling 37 Investigational Use 38 MINI REVIEW OF FDA GUIDANCE ON APPROVAL OF THE COMPANION DIAGNOSTIC Summary 38 Timing Considerations 39 Regulatory Pathways Outside of the United States (k) vs PMA 40 ASSAY DEVELOPMENT AND VALIDATION IN DRUG DIAGNOSTIC CO-DEVELOPMENT Overview 41 General Considerations in Drug Diagnostic Co-Development 42 Implementation of Companion Diagnostic in Clinical Design 42 Two-Arm Clinical Design 43 Randomization with the Diagnostic 43 Restricted Approach 44 Establishing a Training and Test Set of Samples 45 Patient Population Consistency 45 Iterative Evaluation Cycles 46 Clinical Material Considerations

4 Technical Considerations 47 Testing Volume 47 Ease of Use 48 Number of Analytes 48 Multiple Analyte versus Few Analyte Classifiers 49 Instrument 50 Reagent Status 51 Assay Validation 51 Assay Characterization or Qualification 51 Analytical Validation of a Companion Diagnostic 52 Studies to Demonstrate Accuracy, Precision, Specificity and Sensitivity Sample Requirements 54 Analyte Concentration Specifications 54 Cutoff Establishment 54 Controls and Calibrators 55 Precision 56 Analytical Specificity 56 Assay Conditions 57 Sample Carryover 57 Limiting Factors 57 CLINICAL VALIDATION 57 ROLE OF THE FOOD AND DRUG ADMINISTRATION 58 TABLE 7 FDA GUIDELINES FOR BIOMARKER APPLICATIONS 59 EUROPEAN MEDICINES AGENCY 60 REGULATORY IMPACT ON DRUG SAFETY 60 INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING 61 APPROVED PATENT ANALYSIS 61 TABLE 8 ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN THE U.S., EUROPE AND JAPAN, THROUGH 2013 COMPETITIVE LANDSCAPE 61 LATE-STAGE CLINICAL TRIALS: COMPETITIVE POSITIONING 62 TABLE 9 CURRENT GLOBAL MARKET FOR TOTAL CLINICAL STAGE BY SERVICES AND PRODUCTS, THROUGH 2018 ($ MILLIONS) TABLE 10 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY, TABLE 11 REPRESENTATIVE LIST OF INDUSTRY ADVANCEMENTS AND APPROVED BIOMARKER PATENTS IN THE U.S., EUROPE AND JAPAN ETHICAL CONSIDERATIONS 69 SUMMARY 69 Respect for Persons 71 Beneficence 71 Justice 72 BIOMARKER APPLICATIONS OF ETHICAL CONSIDERATIONS 72 Race and Genotype 72 Negligence 72 Informed Consent 73 Privacy

5 Market Segmentation 74 Professional, Media and Opinion Leader Edification 74 REGULATORY IMPLICATIONS 75 CHAPTER 5 APPLICATION BY THERAPY AREA 77 TABLE 12 GLOBAL MARKET FOR CLINICAL STAGE BY THERAPEUTIC AREA, THROUGH 2018 ($ MILLIONS) ONCOLOGY 80 TABLE 13 REPRESENTATIVE IN CLINICAL USE: ONCOLOGY 81 BREAST CANCER 81 MAMMAPRINT 82 TABLE 14 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: BREAST CANCER ONCOTYPE DX 83 TEST ADOPTION 84 COLORECTAL CANCER 86 CETUXIMAB 86 PANITUMUMAB 88 ELESCLOMOL 90 HERCEPTIN 90 OTHER PREDICTIVE TESTS 90 TABLE 15 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: ONCOLOGY, OTHER PROGNOSTIC TESTS 92 PREDICTIVE TESTS IN BREAST CANCER 94 HORMONAL THERAPIES 94 TAXANES/ANTHRACYCLINES 96 BIOLOGICALS 98 TRIPLE NEGATIVE BREAST CANCER 99 OTHER NOVEL 100 LUNG CANCER 101 INTRODUCTION 101 PREDICTIVE TESTS 102 TABLE 16 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: LUNG CANCER 102 GEFITINIB 103 ERLOTINIB 104 OTHER PREDICTIVE TESTS 106 NOVEL THERAPIES 106 OTHER ONCOLOGY 107 PROSTATE CANCER 107 OVARIAN CANCER 109 MALIGNANT MELANOMA 109 TABLE 17 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: MALIGNANT MELANOMA OTHER DISEASES 111 CARDIOVASCULAR 111 TABLE 18 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: CARDIOVASCULAR

6 TABLE 19 REPRESENTATIVE IN CLINICAL USE: CARDIOVASCULAR 113 CENTRAL NERVOUS SYSTEM 113 TABLE 20 REPRESENTATIVE IN CLINICAL USE: CNS DISEASE 115 IMMUNOLOGY 115 TABLE 21 REPRESENTATIVE IN CLINICAL USE: IMMUNOLOGY 116 Immunology: Benlysta: Human Genome Sciences 116 EXPEDITION and IDENTITY Alzheimer's Trial: Eli Lilly 117 CLINICAL : THERAPEUTIC DISEASE MARKET FORECAST 117 TABLE 22 GLOBAL MARKET FORECAST FOR CLINICAL STAGE, THROUGH 2018 ($ MILLIONS) TABLE 23 GLOBAL MARKET FORECAST OF IN LATE-STAGE CLINICAL USE BY THERAPEUTIC AREA, THROUGH 2018 ($ MILLIONS) CHAPTER 6 ACTIVELY GUIDING DRUG DEVELOPMENT 119 INTRODUCTION 119 TABLE 24 RECENT CORPORATE ALLIANCES BETWEEN BIOMARKER AND DRUG DEVELOPMENT COMPANIES ASURAGEN 120 BACKGROUND 120 COLLABORATION: MERCK & CO. 121 BG MEDICINE 121 BACKGROUND 121 COLLABORATION: CORDEX PHARMA 121 COLLABORATION: SIEMENS 121 BIOMERIEUX 122 BACKGROUND 122 COLLABORATIONS: ISPEN 122 ADNA PROJECT 122 CELERA 124 BACKGROUND 124 COLLABORATIONS 124 Abbott 124 Merck & Co. 124 Ipsen 124 AVACTA 125 BACKGROUND 125 COLLABORATION: TAKEDA 125 DAKO 125 BACKGROUND 125 COLLABORATIONS 125 Genentech 125 Bristol-Myers Squibb 126 DXS 126 BACKGROUND 126 COLLABORATIONS 127 Amgen 127 Roche Molecular Diagnostics 127 GE HEALTHCARE

7 BACKGROUND 128 COLLABORATION: ELI LILLY 128 GENOMIC HEALTH 128 BACKGROUND 128 COLLABORATIONS 128 Pfizer 128 Bristol-Myers Squibb and ImClone Systems 129 HISTORX 129 BACKGROUND 129 COLLABORATION 129 Lilly 129 LABCORP 130 BACKGROUND 130 COLLABORATIONS 130 ARCA biopharma 130 Vanda Pharmaceuticals 131 Medco Health Solutions 132 MONOGRAM BIOSCIENCES (A LABCORP COMPANY) 132 BACKGROUND 132 COLLABORATIONS 132 Pfizer HIV partnership 132 VeraTag Oncology Platform 132 ONCOMETHYLOME SCIENCES (NOW MDX HEALTH) 133 BACKGROUND 133 COLLABORATIONS 133 Merck KGaA 133 Schering-Plough 133 GlaxoSmithKline Biologicals 133 Abbott 134 XDX 134 BACKGROUND 134 COLLABORATION 134 Bristol-Myers Squibb 134 CHAPTER 7 COMPANY ANALYSIS 136 TABLE 25 PRINCIPAL FOCUS OF : PHARMACEUTICAL COMPANIES BY THERAPEUTIC AREA ABBOTT LABORATORIES INC. 136 COMPANY OVERVIEW 136 PRODUCTS AND SERVICES 136 TABLE 26 ABBOTT: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 137 AFFYMETRIX INC. 138 COMPANY OVERVIEW 138 PRODUCTS AND SERVICES 138 TABLE 27 AFFYMETRIX: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING

8 COMPANY STRATEGY 138 ASTELLAS PHARMA INC. 139 COMPANY OVERVIEW 139 PRODUCTS AND SERVICES 139 TABLE 28 ASTELLAS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 140 ASTRAZENECA LTD. 140 COMPANY OVERVIEW 141 PRODUCTS AND SERVICES 141 TABLE 29 ASTRAZENECA: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 142 BANYAN INC. 142 COMPANY OVERVIEW 142 PRODUCTS AND SERVICES 142 TABLE 30 BANYAN: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 143 BAYER SCHERING PHARMA AG 143 COMPANY OVERVIEW 143 PRODUCTS AND SERVICES 143 TABLE 31 BAYER SCHERING: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 144 BG MEDICINE INC. 146 COMPANY OVERVIEW 146 PRODUCTS AND SERVICES 146 TABLE 32 BIOPHYSICAL: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 146 BIOPHYSICAL CORP. 147 COMPANY OVERVIEW 147 PRODUCTS AND SERVICES 147 TABLE 33 BIOSYSTEMS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 148 BIOSYSTEMS INTERNATIONAL INC. 148 COMPANY OVERVIEW 148 PRODUCTS AND SERVICES 149 COMPANY STRATEGY 149 BOEHRINGER INGELHEIM GMBH 149 COMPANY OVERVIEW 149 PRODUCTS AND SERVICES 149 TABLE 34 BMS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 150 BRISTOL-MYERS SQUIBB CO. 150 COMPANY OVERVIEW

9 PRODUCTS AND SERVICES 151 TABLE 35 BMS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 151 CAPRION PROTEOMICS INC. 152 COMPANY OVERVIEW 152 PRODUCTS AND SERVICES 152 COMPANY STRATEGY 153 Infectious Diseases 153 Diabetes and Metabolic Disease 153 Oncology 153 DAIICHI SANKYO CO. LTD. 154 COMPANY OVERVIEW 154 PRODUCTS AND SERVICES 154 TABLE 36 DAIICHI SANKYO: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 155 EISAI CO. LTD. 155 COMPANY OVERVIEW 156 PRODUCTS AND SERVICES 156 TABLE 37 EISAI: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 156 ELI LILLY AND CO. 157 COMPANY OVERVIEW 157 PRODUCTS AND SERVICES 157 TABLE 38 ELI LILLY: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 158 EPIGENOMICS AG 158 COMPANY OVERVIEW 158 PRODUCTS AND SERVICES 159 TABLE 39 EPIGENOMICS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 159 GENEDATA AG 160 COMPANY OVERVIEW 160 PRODUCTS AND SERVICES 160 TABLE 40 GENEDATA AG: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 160 GENENEWS LTD. 161 COMPANY OVERVIEW 161 PRODUCTS AND SERVICES 161 COMPANY STRATEGY 161 GLAXOSMITHKLINE 162 COMPANY OVERVIEW 162 PRODUCTS AND SERVICES

10 TABLE 41 GSK: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 163 JOHNSON & JOHNSON LTD. 163 COMPANY OVERVIEW 163 PRODUCTS AND SERVICES 164 TABLE 42 JOHNSON & JOHNSON: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 164 MERCK & CO. 165 COMPANY OVERVIEW 165 PRODUCTS AND SERVICES 165 TABLE 43 MERCK: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 166 NOVARTIS AG 166 COMPANY OVERVIEW 166 PRODUCTS AND SERVICES 167 TABLE 44 NOVARTIS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 167 PFIZER INC. 168 COMPANY OVERVIEW 168 PRODUCTS AND SERVICES 168 TABLE 45 PFIZER: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 169 ROCHE LTD. 169 COMPANY OVERVIEW 169 PRODUCTS AND SERVICES 169 TABLE 46 ROCHE: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 170 SANOFI-AVENTIS 171 COMPANY OVERVIEW 171 PRODUCTS AND SERVICES 171 TABLE 47 SANOFI-AVENTIS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 172 TAKEDA PHARMACEUTICALS LTD. 173 COMPANY OVERVIEW 173 PRODUCTS AND SERVICES 173 TABLE 48 TAKEDA PHARMACEUTICALS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY 174 TEVA PHARMACEUTICAL INDUSTRIES LTD. 174 COMPANY OVERVIEW 174 PRODUCTS AND SERVICES

11 TABLE 49 TEVA PHARMACEUTICAL: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING COMPANY STRATEGY

12 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL FORECAST BY SEGMENT, THROUGH 2018 ($ MILLIONS) TABLE 1 GLOBAL MARKET FOR, THROUGH 2013 ($ MILLIONS) 12 TABLE 2 NOVEL SAFETY/TOXICOLOGY USED IN CANCER, CARDIO AND RENAL TABLE 3 NOVEL DOSE SELECTION USED IN CANCER, DIABETES, METABOLIC AND LIVER DISEASE TABLE 4 PATIENT OUTCOME MEASUREMENTS 21 TABLE 5 GLOBAL MARKET FOR, 2013 ($ MILLIONS) 27 TABLE 6 GLOBAL BIOMARKER MARKET FORECAST, THROUGH 2018 ($ MILLIONS) 32 TABLE 7 FDA GUIDELINES FOR BIOMARKER APPLICATIONS 59 TABLE 8 ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN THE U.S., EUROPE AND JAPAN, THROUGH 2013 TABLE 9 CURRENT GLOBAL MARKET FOR TOTAL CLINICAL STAGE BY SERVICES AND PRODUCTS, THROUGH 2018 ($ MILLIONS) TABLE 10 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY, TABLE 11 REPRESENTATIVE LIST OF INDUSTRY ADVANCEMENTS AND APPROVED BIOMARKER PATENTS IN THE U.S., EUROPE AND JAPAN TABLE 12 GLOBAL MARKET FOR CLINICAL STAGE BY THERAPEUTIC AREA, THROUGH 2018 ($ MILLIONS) TABLE 13 REPRESENTATIVE IN CLINICAL USE: ONCOLOGY 81 TABLE 14 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: BREAST CANCER 83 TABLE 15 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: ONCOLOGY, TABLE 16 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: LUNG CANCER 102 TABLE 17 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: MALIGNANT MELANOMA TABLE 18 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: CARDIOVASCULAR TABLE 19 REPRESENTATIVE IN CLINICAL USE: CARDIOVASCULAR 113 TABLE 20 REPRESENTATIVE IN CLINICAL USE: CNS DISEASE 115 TABLE 21 REPRESENTATIVE IN CLINICAL USE: IMMUNOLOGY 116 TABLE 22 GLOBAL MARKET FORECAST FOR CLINICAL STAGE, THROUGH 2018 ($ MILLIONS) TABLE 23 GLOBAL MARKET FORECAST OF IN LATE-STAGE CLINICAL USE BY THERAPEUTIC AREA, THROUGH 2018 ($ MILLIONS) TABLE 24 RECENT CORPORATE ALLIANCES BETWEEN BIOMARKER AND DRUG DEVELOPMENT COMPANIES TABLE 25 PRINCIPAL FOCUS OF : PHARMACEUTICAL COMPANIES BY THERAPEUTIC AREA TABLE 26 ABBOTT: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 27 AFFYMETRIX: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 28 ASTELLAS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 29 ASTRAZENECA: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 30 BANYAN: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING

13 TABLE HEADING TABLE 31 BAYER SCHERING: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 32 BIOPHYSICAL: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 33 BIOSYSTEMS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 34 BMS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 35 BMS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 36 DAIICHI SANKYO: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 37 EISAI: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 38 ELI LILLY: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 39 EPIGENOMICS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 40 GENEDATA AG: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 41 GSK: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 42 JOHNSON & JOHNSON: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 43 MERCK: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 44 NOVARTIS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 45 PFIZER: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 46 ROCHE: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 47 SANOFI-AVENTIS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 48 TAKEDA PHARMACEUTICALS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING TABLE 49 TEVA PHARMACEUTICAL: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING

14 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL FORECAST BY SEGMENT, ($ MILLIONS) 7

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