Next Decade Generic String Of Pearls Opportunities: Sustainability Assessment With Respect To Therapeutic Positioning

The rapid growth of the generic industry has come with a number of challenges, such as heavy competition, including from authorized generics and government-mandated price cuts. All contribute to diminishing prices and ever decreasing margins. In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Diversification of product portfolios, vertical integration across the manufacturing process, and expanding their geographic presence, especially into emerging markets are some of the key strategies which can be implemented by the generic companies to overcome the existing challenges.
 
 One of the most initial and important step for the development of a prospective generic drug product comprises of product (Active Pharmaceutical Ingredient-API) selection and identification. API is the primary constituent of a pharmaceutical drug product that governs the final cost of the drug product as well as the commercial profit earned by the company. Early access to high-quality active pharmaceutical ingredients (API) that are not infringing patents is critical to success in regulated finished-dose markets as a significant part of generics’ profits is made during the early days of their availability.
 
 Factors which have to be taken into consideration during the generic product evaluation process include:
 
 • The total geographical and target disease market size.
 • Therapeutic areas of the product-whether the drug in question is approved for a niche condition or is trying to make a space for itself in the already crowded therapy class.
 • Competitor intelligence.
 • Current market sales of the innovator product.
 • Patent/exclusivity time frame.
 • Complexity in the development and time frames.
 • Availability of API, equipment and expertise.
 • Budget required and return on investment.
 
 Keeping in mind the above mentioned elements we have scrutinized and selected 10 drug molecules. This information in the report can aid a prospective generic developer to review and evaluate products which can be incorporated in the company’s developmental pipeline.
 
 The therapy classes covered in this report are:
 

 • Oncology
 • Cardiovascular
 • Respiratory
 • Gastroenterology
 • Psychiatry
 • Infectious disease
 
 The following points were considered while selecting the products:
 

 • Blockbuster drugs with a likelihood of lucrative future sales.
 • Drugs with novel therapeutic approach for rare disease.
 • Specialized products in niche therapeutic markets with no existing competitors.
 • Products with robust ongoing clinical trials which will lead to future label expansions and ultimately act as sales booster.
 • First in class drug products with novel targeting mechanism. 

 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 WALDENSTRÖMS 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 Waldenstroms 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 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
 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
  


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
 
 Companies Mentioned
 
 Novartis,
 Vertex Pharmaceuticals,
 Abbvie,
 Johnson & Johnson,
 Pfizer,
 Gilead Sciences,
 Astra Zeneca,
 Actelion,
 Neurocrine,
 Intercept,
 Eli Lilly,
 Teva


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