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

Report Code: HC-R-18-309 | Page Numbers: 127

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...

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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 WALDENSTR?M'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
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.
"

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