DRUGS FOR TREATING SYSTEMIC LUPUS ERYTHEMATOSUS: GLOBAL MARKETS

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1 DRUGS FOR TREATING SYSTEMIC LUPUS ERYTHEMATOSUS: GLOBAL MARKETS PHM159A March 2014 Sanjukta Bhattacharyya Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1)

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY GOALS AND OBJECTIVES 2 REASONS FOR DOING THIS STUDY 2 SCOPE OF REPORT 2 INTENDED AUDIENCE 2 METHODOLOGY 2 INFORMATION SOURCES 2 ANALYST'S CREDENTIALS 3 RELATED BCC RESEARCH REPORTS 3 BCC RESEARCH ONLINE SERVICES 3 DISCLAIMER 3 CHAPTER 2 EXECUTIVE SUMMARY 5 SUMMARY TABLE A GLOBAL SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS, BY REGION, THROUGH 2018 (MILLIONS) SUMMARY FIGURE A GLOBAL SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS, BY REGION, (%) SUMMARY TABLE B GLOBAL SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS SUMMARY FIGURE B GLOBAL SLE MARKET-SHARE OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS, (%) KEY FACTORS DRIVING THE MARKET 8 KEY FACTORS RESTRICTING THE MARKET 9 NOTABLE PIPELINE ACTIVITIES 9 KEY CHALLENGES IN THE MARKET FOR SLE THERAPIES 10 KEY OPPORTUNITIES IN THE MARKET FOR SLE THERAPIES 10 SUMMARY TABLE C SUMMARY OF KEY PARAMETERS OF SYSTEMIC LUPUS ERYTHEMATOSUS MARKET, THROUGH CHAPTER 3 OVERVIEW 14 SIGNS AND SYMPTOMS 14 TYPES OF LUPUS 16 SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) 16 CUTANEOUS LUPUS ERYTHEMATOSUS (CLE) 16 DRUG-INDUCED LUPUS 16 NEONATAL LUPUS ERYTHEMATOSUS 16 PATHOPHYSIOLOGY 17 DISEASE DEFINITION 17 CLINICAL MANIFESTATIONS 17 TABLE 1 PERCENTAGE OF PATIENTS WITH DIFFERENT CLINICAL MANIFESTATIONS OF SLE DISEASE TABLE 2 DESCRIPTION OF DIFFERENT TYPES OF SLE DISEASE MANIFESTATIONS 18 TABLE 3 CLASSIFICATION OF LUPUS NEPHRITIS 20 TABLE 4 WORLD HEALTH ORGANIZATION CLASSIFICATION OF LUPUS NEPHRITIS 20 PROGRESSION AND SEVERITY 22 ETIOLOGY 23 GENETIC FACTORS 23 17

3 ENVIRONMENTAL FACTORS 25 Ultraviolet Light: 25 HORMONAL FACTORS 25 EPIDEMIOLOGY AND PATIENT POPULATIONS 25 U.S. 26 FRANCE 26 GERMANY 27 U.K. 27 SPAIN 27 ITALY 27 JAPAN 27 DIAGNOSED AND DRUG TREATED POPULATION 28 TABLE 5 DIAGNOSED PREVALENCE AND DRUG TREATED SLE PATIENT POPULATION 29 CHAPTER 4 CURRENT MEDICAL PRACTICE AND MARKET PROFILES 31 DIAGNOSIS SCREENING AND PUBLIC AWARENESS 31 KEY DIAGNOSTIC TESTS 31 Serologic Tests 31 Anti-nuclear Antibody (ANA) 31 Antibodies to Extractable Nuclear Antigens (ENAs) 32 Prognostic Markers and the Role of Autoantibodies 32 CLINICAL RECOMMENDATIONS AND DIAGNOSIS ALGORITHM 32 FIGURE 1 DIAGNOSIS OF SYSTEMIC LUPUS ERYTHEMATOSUS 32 DIFFERENTIAL DIAGNOSIS 33 TABLE 6 DIAGNOSIS OF SYSTEMIC LUPUS ERYTHEMATOSUS BASED ON MANIFESTATIONS FIGURE 2 PATIENT CARE PATH IN SYSTEMIC LUPUS ERYTHEMATOSUS 35 FIGURE 3 TREATMENT DECISION TREE FOR SYSTEMIC LUPUS ERYTHEMATOSUS 36 TABLE 7 TREATMENT ALGORITHM OF SYSTEMIC LUPUS ERYTHEMATOSUS 37 REFERRAL PATTERNS 39 U.S. 39 FRANCE 40 GERMANY 42 U.K. 43 SPAIN 44 ITALY 44 JAPAN CHAPTER 5 CURRENT THERAPIES 48 TABLE 8 CURRENT DRUGS USED IN THE TREATMENT FOR SYSTEMIC LUPUS ERYTHEMATOSUS AND THEIR MECHANISM ANTIMALARIAL DRUGS 50 NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) 50 CORTICOSTEROIDS 50 CYTOTOXIC AND IMMUNOSUPPRESSIVE DRUGS 51 CYCLOPHOSPHAMIDE 51 Azathioprine 51 MYCOPHENOLATE MOFETIL 51 48

4 METHOTREXATE 52 CYCLOSPORINE 52 TACROLIMUS 52 BIOLOGICS 52 B-CELL TARGETED THERAPY 53 BLYS-BLOCKERS (BELIMUMAB) 53 BIOLOGICS APPROVED FOR TREATING SLE 53 BELIMUMAB 53 TABLE 9 BELIMUMAB EFFICACY DATA (BLISS-52: PRIMARY ENDPOINT AND COMPONENTS OF SLE RESPONDER INDEX) TABLE 10 ENDPOINTS USED IN CLINICAL TRIALS FOR SLE 56 BIOLOGICS USED OFF-LABEL 56 ANTI-CD20 ANTIBODY: RITUXIMAB (RITUXAN/MABTHERA; BIOGEN IDEC/ROCHE/ZENYAKU KOGYO) SMALL MOLECULES 58 TABLE 11 CURRENT THERAPIES FOR SYSTEMIC LUPUS ERYTHEMATOSUS, TREATMENT BY DAILY DOSE AND THE MANIFESTATION TARGETED TABLE 12 TREATMENT FOR SYSTEMIC LUPUS ERYTHEMATOSUS BASED ON ORGAN INVOLVEMENT AND DISEASE SEVERITY TABLE 13 STEROIDS USED FOR TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS ACROSS DIFFERENT DISEASE SEVERITY CHAPTER 6 UNMET NEEDS 62 EFFICACY AND SAFETY 63 NEED FOR PREVENTION OF ATHEROSCLEROSIS 63 STEROID SPARING THERAPY TO REDUCE THE DOSE AND DURATION OF STEROID USE THERAPIES TAILORED TO INDIVIDUAL PATIENTS 64 PREVENTION OF NEUROCOGNITIVE DYSFUNCTION 65 PREVENTION OF OSTEOPOROSIS AND OSTEONECROSIS 66 EARLY DIAGNOSIS CHAPTER 7 EMERGING THERAPIES 68 DRUG DEVELOPMENT AND REGULATORY CHALLENGES 68 EMERGING THERAPIES 69 B-CELL MODULATORS 69 BELIMUMAB 69 ATACICEPT 70 EPRATUZUMAB 70 TABALUMAB: 71 RIGERIMOD 71 BLISIBIMOD 72 T-CELL MODULATORS 72 IMMUNOSUPPRESSIVE AND CYTOTOXIC DRUGS 73 PROINFLAMMATORY AND CYTOKINE INHIBITORS 73 ANTI-IFN-Α/γ 73 TABLE 14 EMERGING THERAPIES BY PHASES OF DEVELOPMENT 73 TABLE 15 NUMBER OF PROGRAMS AT EACH CLINICAL PHASES OF CLINICAL DEVELOPMENT 76

5 FIGURE 4 NUMBER OF PROGRAMS AT EACH CLINICAL PHASE 76 TABLE 16 POSITIONING OF LEADING EMERGING THERAPIES FOR THE TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS IN THE FUTURE 77 CHAPTER 8 MARKET OUTLOOK 79 TABLE 17 GLOBAL SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS, ($ MILLIONS) TABLE 18 GLOBAL SYSTEMIC LUPUS ERYTHEMATOSUS MARKET -SALES IN MAJOR MARKETS, THROUGH 2018 ($ MILLIONS) TABLE 19 GLOBAL SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS FIGURE 5 GLOBAL SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG CLASSES, 2013 AND 2018 UNITED STATES 82 TABLE 20 U.S. SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS, ($ MILLIONS) FIGURE 6 U.S. SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG FRANCE 83 TABLE 21 FRANCE: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS FIGURE 7 FRANCE: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG GERMANY 84 TABLE 22 GERMANY: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS FIGURE 8 GERMANY: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG U.K. 85 TABLE 23 U.K.: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS FIGURE 9 U.K: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG SPAIN 86 TABLE 24 SPAIN: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS FIGURE 10 SPAIN: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG ITALY 87 TABLE 25 ITALY: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS FIGURE 11 ITALY: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG JAPAN 88 TABLE 26 JAPAN: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS FIGURE 12 JAPAN: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET VALUE OF DRUG TABLE 27 SALES OF BIOLOGICS AND SMALL MOLECULE DRUGS TO TREAT SYSTEMIC LUPUS

6 TABLE 28 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF THE U.S., THROUGH 2018 ($ MILLIONS) TABLE 29 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF FRANCE, THROUGH 2018 ($ MILLIONS) TABLE 30 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF GERMANY,THROUGH 2018 ($ MILLIONS) TABLE 31 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF THE U.K., THROUGH 2018 ($ MILLIONS) TABLE 32 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF SPAIN, THROUGH 2018 ($ MILLIONS) TABLE 33 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF ITALY, THROUGH 2018 ($ MILLIONS) TABLE 34 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF JAPAN, THROUGH 2018 ($ MILLIONS) CHAPTER 9 PATENTS 98 TABLE 35 NO. OF PATENTS 98 TABLE 36 ISSUED PATENTS 100 TABLE 37 PATENT APPLICATIONS 107 CHAPTER 10 COMPANY PROFILES 116 ANTHERA PHARMACEUTICALS INC 116 BIOTEST AG 116 BIOTICA TECHNOLOGY LTD. 117 CEPHALON 117 CORNERSTONE THERAPEUTICS INC. 118 CREABILIS THERAPEUTICS S.R.L. 118 DYNAVAX TECHNOLOGIES 119 ELI LILLY 119 F. HOFFMANN-LA ROCHE LTD 120 EVENTS OF 2013 AND GLAXOSMITHKLINE PLC (GSK) 121 HADASIT MEDICAL RESEARCH SERVICES AND DEVELOPMENT 122 HANSA MEDICAL AB 123 HARBOR BIOSCIENCES 123 IMMUNOMEDICS, INC. 124 IDERA PHARMACEUTICALS INC. 124 IMMUPHARMA PLC 125 JOHNSON & JOHNSON LTD. 126 ISOTECHNIKA PHARMA INC 127 KINETA INC. 128 KYORIN PHARMACEUTICALS CO. LTD 129 LYCERA CORPORATION 129 MERCK KGAA 129 MACROGENICS, INC. 131 NOVO NORDISK 132 NEOVACS S.A. 133 NASVAX LTD. 133 ONYX PHARMACEUTICALS INC. 133

7 PHARMACYCLIS 134 PORTOLA PHARMACEUTICALS INC. 135 PFIZER LIMITED 135 REVO BIOLOGICS 136 RIGEL PHARMACEUTICALS INC 137 SANOFI 137 TEVA PHARMACEUTICAL INDUSTRIES LTD. 138 UCB GROUP/ IMMUNOMEDICS 138 VACCINEX INC. 139

8 LIST OF TABLES TABLE HEADING SUMMARY TABLE A GLOBAL SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS, BY REGION, THROUGH 2018 (MILLIONS) SUMMARY TABLE B GLOBAL SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS SUMMARY TABLE C SUMMARY OF KEY PARAMETERS OF SYSTEMIC LUPUS ERYTHEMATOSUS MARKET, THROUGH 2018 TABLE 1 PERCENTAGE OF PATIENTS WITH DIFFERENT CLINICAL MANIFESTATIONS OF SLE DISEASE TABLE 2 DESCRIPTION OF DIFFERENT TYPES OF SLE DISEASE MANIFESTATIONS 18 TABLE 3 CLASSIFICATION OF LUPUS NEPHRITIS 20 TABLE 4 WORLD HEALTH ORGANIZATION CLASSIFICATION OF LUPUS NEPHRITIS 20 TABLE 5 DIAGNOSED PREVALENCE AND DRUG TREATED SLE PATIENT POPULATION 29 TABLE 6 DIAGNOSIS OF SYSTEMIC LUPUS ERYTHEMATOSUS BASED ON MANIFESTATIONS TABLE 7 TREATMENT ALGORITHM OF SYSTEMIC LUPUS ERYTHEMATOSUS 37 TABLE 8 CURRENT DRUGS USED IN THE TREATMENT FOR SYSTEMIC LUPUS ERYTHEMATOSUS AND THEIR MECHANISM TABLE 9 BELIMUMAB EFFICACY DATA (BLISS-52: PRIMARY ENDPOINT AND COMPONENTS OF SLE RESPONDER INDEX) TABLE 10 ENDPOINTS USED IN CLINICAL TRIALS FOR SLE 56 TABLE 11 CURRENT THERAPIES FOR SYSTEMIC LUPUS ERYTHEMATOSUS, TREATMENT BY DAILY DOSE AND THE MANIFESTATION TARGETED TABLE 12 TREATMENT FOR SYSTEMIC LUPUS ERYTHEMATOSUS BASED ON ORGAN INVOLVEMENT AND DISEASE SEVERITY TABLE 13 STEROIDS USED FOR TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS ACROSS DIFFERENT DISEASE SEVERITY TABLE 14 EMERGING THERAPIES BY PHASES OF DEVELOPMENT 73 TABLE 15 NUMBER OF PROGRAMS AT EACH CLINICAL PHASES OF CLINICAL DEVELOPMENT TABLE 16 POSITIONING OF LEADING EMERGING THERAPIES FOR THE TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS IN THE FUTURE TABLE 17 GLOBAL SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS, ($ MILLIONS) TABLE 18 GLOBAL SYSTEMIC LUPUS ERYTHEMATOSUS MARKET -SALES IN MAJOR MARKETS, THROUGH 2018 ($ MILLIONS) TABLE 19 GLOBAL SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS TABLE 20 U.S. SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS, ($ MILLIONS) TABLE 21 FRANCE: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS TABLE 22 GERMANY: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS TABLE 23 U.K.: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS TABLE 24 SPAIN: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS TABLE 25 ITALY: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS TABLE 26 JAPAN: SALES OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS

9 TABLE HEADING TABLE 27 SALES OF BIOLOGICS AND SMALL MOLECULE DRUGS TO TREAT SYSTEMIC LUPUS TABLE 28 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF THE U.S., THROUGH 2018 ($ MILLIONS) TABLE 29 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF FRANCE, THROUGH 2018 ($ MILLIONS) TABLE 30 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF GERMANY,THROUGH 2018 ($ MILLIONS) TABLE 31 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF THE U.K., THROUGH 2018 ($ MILLIONS) TABLE 32 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF SPAIN, THROUGH 2018 ($ MILLIONS) TABLE 33 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF ITALY, THROUGH 2018 ($ MILLIONS) TABLE 34 SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS IN THE MAJOR PHARMACEUTICAL MARKET OF JAPAN, THROUGH 2018 ($ MILLIONS) TABLE 35 NO. OF PATENTS 98 TABLE 36 ISSUED PATENTS 100 TABLE 37 PATENT APPLICATIONS

10 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE A GLOBAL SALES OF DRUGS TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS, BY REGION, (%) SUMMARY FIGURE B GLOBAL SLE MARKET-SHARE OF DRUG CLASSES USED TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS, (%) FIGURE 1 DIAGNOSIS OF SYSTEMIC LUPUS ERYTHEMATOSUS 32 FIGURE 2 PATIENT CARE PATH IN SYSTEMIC LUPUS ERYTHEMATOSUS 35 FIGURE 3 TREATMENT DECISION TREE FOR SYSTEMIC LUPUS ERYTHEMATOSUS 36 FIGURE 4 NUMBER OF PROGRAMS AT EACH CLINICAL PHASE 76 FIGURE 5 GLOBAL SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG CLASSES, 2013 AND 2018 FIGURE 6 U.S. SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG FIGURE 7 FRANCE: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG FIGURE 8 GERMANY: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG FIGURE 9 U.K: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG FIGURE 10 SPAIN: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG FIGURE 11 ITALY: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET-VALUE OF DRUG FIGURE 12 JAPAN: SYSTEMIC LUPUS ERYTHEMATOSUS MARKET VALUE OF DRUG

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