Next Decade Generic String Of Pearls Opportunities: Sustainability Assessment With Respect To Therapeutic Positioning
SKU ID : MP-11465569 | Publishing Date : 24-Nov-2017 | No. of pages : 127
Detailed TOC of Next Decade Generic String Of Pearls Opportunities: Sustainability Assessment With Respect To Therapeutic Positioning
EXECUTIVE SUMMARY 8 FACTORS TO BE CONSIDERED DURING THE PRODUCT EVALUATION PROCESS 16 STAGES IN THE DEVELOPMENT OF A GENERIC DRUG PRODUCT 16 POTENTIAL CHALLENGES IN THE VARIOUS DEVELOPMENT STAGES 17 OPPORTUNITY AREAS FOR GENERIC PRODUCT DEVELOPMENT 17 JAKAFI 21 MECHANISM OF ACTION 21 JAKAFI IN MYELOFIBROSIS (MF) 21 JAKAFI IN POLYCYTHEMIA VERA (PCV) 22 JAKAFI IN GRAFT-VERSUS-HOST DISEASE (GVHD) 23 CLINICAL STUDY DATA 24 The COMFORT-I and –II study 24 COMFORT-I: 24 The primary end point: 24 Secondary end points: 25 COMFORT –II: 27 RESPONSE trial: 28 The primary end point: 28 The secondary end points: 29 ONGOING RESEARCH PROGRAM: 32 ORKAMBI 34 CLINICAL STUDY DATA: 36 TRAFFIC and TRANSPORT 36 PROGRESS STUDY 38 LABEL EXPANSION TO TREAT 6- TO 11-YEAR-OLD: 38 MARKET PERFORMANCE AND COMPETITION: 38 IMBRUVICA 42 AN OVERVIEW OF THE FDA APPROVAL HISTORY OF IMBRUVICA 43 IMBRUVICA IN CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) 44 IMBRUVICA IN WALDENSTRÖM'S MACROGLOBULINEMIA(WM) 45 IMBRUVICA IN MANTLE CELL LYMPHOMA (MCL) 45 IMBRUVICA IN MARGINAL ZONE LYMPHOMA (MZL): 46 IMBRUVICA IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVHD) 46 CLINICAL STUDY DATA 47 MANTLE-CELL LYMPHOMA 47 The PCYC-1104 47 CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): 49 RESONATE TRIAL: Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia 49 Long-term follow-up results from the pivotal Phase 3 RESONATE trial: 51 RESONATE-2: Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia 51 Updated results from the pivotal Phase 3 RESONATE-2 trial: 54 Imbruvica in Waldenstrom's macroglobulinemia: 54 Imbruvica for Relapsed/Refractory Marginal Zone Lymphoma (MZL): 54 Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease: 55 IMBRUVICA- ON THE VERGE OF BECOMING A MEGA-BLOCKBUSTER DRUG 55 MARKET PERFORMANCE AND COMPETITION: 55 ENTRESTO 59 CLINICAL STUDY DATA 60 PARADIGM-HF 60 MARKET PERFORMANCE AND COMPETITION 62 IBRANCE 66 CLINICAL STUDY DATA 66 PALOMA-1: 67 PALOMA-2: 67 PALOMA-3: 68 ONGOING RESEARCH 72 1. The PATINA trial- 72 2. The PALLAS Trial 72 3. NCT02499120: 72 EPCLUSA 75 CLINICAL STUDY DATA 77 ASTRAL-1: 77 ASTRAL-2 and ASTRAL-3: 77 ASTRAL-4 78 ASTRAL-5 80 MARKET PERFORMANCE AND COMPETITORS 80 LYNPARZA 85 HARNESSING THE POTENTIAL OF PARP INHIBITORS IN OVARIAN CANCER 86 CLINICAL STUDY DATA 87 SOLO-2: 87 Study 19 88 MARKET PERFORMANCE AND COMPETITION: 91 ONGOING RESEARCH 93 Lynparza: Paving its way towards BRCA-Mutated Breast Cancer- the OlympiAD trial 93 PAOLA trial 94 POLO trial 94 PROfound trial 94 CONCERTO trial 94 UPTRAVI 97 CLINICAL STUDY DATA 98 GRIPHON trial: 98 MARKET PERFORMANCE AND COMPETITORS 102 ONGOING RESEARCH 102 TRITON trial: 103 TRANSIT TRIAL: 103 INGREZZA 105 CLINICAL STUDY DATA: 106 KINECT 3- 106 Extension study of INGREZZA 40 mg and INGREZZA 80 mg (Intent-to-treat-ITT population): 109 MARKET PERFORMANCE AND COMPETITION 111 T-Forward Study 112 T-Force GREEN Study 112 T-Force GOLD study 113 OCALIVA 116 CLINICAL STUDY DATA 117 The POISE trial- 117 Open-Label Extension 118 MARKET PERFORMANCE AND COMPETITION 121 FDA concern regarding incorrect dosing of Ocaliva 121 ONGOING RESEARCH: 122 COBALT trial- 122 REGENERATE trial- effect of Obeticholic Acid treatment on nonalcoholic steatohepatitis (NASH) 122 FLINT Trial 122 LIST OF FIGURES FIGURE: 1.THE THERAPY CLASSES COVERED IN THIS REPORT 8 Figure 2 16 STAGES IN THE DEVELOPMENT OF A GENERIC DRUG PRODUCT 16 Figure 3 17 POTENTIAL CHALLENGES IN THE VARIOUS DEVELOPMENT STAGES 17 Figure 4 19 JAKAFI KEY POINTS 19 Figure 5 25 COMFORT I PRIMARY END POINT 25 FIGURE 6 26 COMFORT I SECONDARY END POINT 26 Figure 7 27 COMFORT II PRIMARY END POINT 27 Figure 8 29 RESPONSE PRIMARY END POINT 29 Figure 9 33 ORKAMBI KEY POINTS 33 Figure 10 37 EFFICACY RESULTS FROM TRAFFIC AND TRANSPORT 37 Figure 11 40 IMBRUVICA KEY POINTS 40 Figure 12 43 AN OVERVIEW OF THE FDA APPROVAL HISTORY OF IMBRUVICA 43 Figure 13 48 THE PCYC-1104 RESULTS 48 Figure 14 50 RESONATE TRIAL-PROGRESSION-FREE AND OVERALL SURVIVAL 50 FIGURE 15: 52 PROGRESSION-FREE SURVIVAL WITH IBRUTINIB VERSUS CHLORAMBUCIL. 52 Figure 16 53 OVERALL SURVIVAL AND RESPONSE RATES WITH IBRUTINIB VERSUS CHLORAMBUCIL. 53 FIGURE 17 57 ENTRESTO KEY POINTS 57 Figure 18 61 PARADIGM-HF: CLINICAL ENDPOINTS 61 FIGURE 19 65 IBRANCE KEY POINTS 65 Figure 20 73 EPCLUSA KEY POINTS 73 Figure 21 83 LYNPARZA KEY POINTS 83 Figure 22 88 SOLO-2 TRIALS RESULTS 88 Figure 23 90 STUDY 19 RESULTS 90 Figure 24 95 UPTRAVI KEY POINTS 95 Figure 25 100 PRIMARY ENDPOINT:TIME TO FIRST DISEASE PROGRESSION EVENT IN THE GRIPHON TRIAL 100 Figure 26 101 GRIPHON TRIAL PRIMARY ENDPOINT EVENTS UP TO THE END OF TREATMENT 101 Figure 27 104 INGREZZA KEY POINTS 104 FIGURE 28 108 KINECT-3 RESULTS 108 Figure 29 110 Results of extension study of INGREZZA 110 Figure 30 115 OCALIVA KEY POINTS 115 FIGURE 31 119 PRIMARY COMPOSITE END POINT IN THE DOUBLE-BLIND AND OPEN-LABEL EXTENSION PHASES 119 FIGURE 32 120 ALKALINE PHOSPHATASE AND TOTAL BILIRUBIN LEVELS IN THE DOUBLE-BLIND AND OPEN-LABEL EXTENSION PHASES 120 LIST OF TABLES Table 1 18 LIST OF SELECTED MOLECULES 18 TABLE 2 20 JAKAFI PATENT DETAILS 20 TABLE 3 34 ORKAMBI PATENT DETAILS 34 TABLE 4 41 IMBRUVICA PATENT DETAILS 41 TABLE 5 58 ENTRESTO PATENT DETAILS 58 Table 6 63 MAJOR TRIALS IN THE FORTIHFY PROGRAM 63 TABLE 7 66 IBRANCE PATENT DETAILS 66 TABLE 8 68 RESULTS OF PALOMA-2 TRIAL 68 Table 9 71 RESULTS OF PALOMA-3 TRIAL 71 TABLE 10 74 EPCLUSA PATENT DETAILS 74 Table 11 79 ASTRAL TRIALS- STUDY OUTCOME 79 TABLE 12 84 LYNPARZA PATENT DETAILS 84 TABLE 13 97 UPTRAVI PATENT DETAILS 97 TABLE 14 105 INGREZZA PATENT DETAILS 105 TABLE 15 116 OCALIVA PATENT DETAILS 116 TABLE 16-COMPETITIVE LANDSCAPE FOR THE SELECTED MOLECULES 124 |
List of Figures, Tables and Charts Available in Next Decade Generic String Of Pearls Opportunities: Sustainability Assessment With Respect To Therapeutic Positioning
Table 1 LIST OF SELECTED MOLECULES TABLE 2 JAKAFI PATENT DETAILS TABLE 3 ORKAMBI PATENT DETAILS TABLE IMBRUVICA PATENT DETAILS TABLE 5 ENTRESTO PATENT DETAILS Table 6 MAJOR TRIALS IN THE FORTIHFY PROGRAM TABLE 7 IBRANCE PATENT DETAILS
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