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 therapy classes covered in this report are:
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.
The therapy classes covered in this report are:
- Oncology
- Cardiovascular
- Respiratory
- Gastroenterology
- Psychiatry
- Infectious disease
- 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
FACTORS TO BE CONSIDERED DURING THE PRODUCT EVALUATION PROCESS
STAGES IN THE DEVELOPMENT OF A GENERIC DRUG PRODUCT
POTENTIAL CHALLENGES IN THE VARIOUS DEVELOPMENT STAGES
OPPORTUNITY AREAS FOR GENERIC PRODUCT DEVELOPMENT
JAKAFI
MECHANISM OF ACTION
JAKAFI IN MYELOFIBROSIS (MF)
JAKAFI IN POLYCYTHEMIA VERA (PCV)
JAKAFI IN GRAFT-VERSUS-HOST DISEASE (GVHD)
CLINICAL STUDY DATA
The COMFORT-I and –II study
COMFORT-I
The primary end point
Secondary end points
COMFORT –II
RESPONSE trial
The primary end point
The secondary end points
ONGOING RESEARCH PROGRAM
ORKAMBI
CLINICAL STUDY DATA
TRAFFIC and TRANSPORT
PROGRESS STUDY
LABEL EXPANSION TO TREAT 6- TO 11-YEAR-OLD
MARKET PERFORMANCE AND COMPETITION: IMBRUVICA
AN OVERVIEW OF THE FDA APPROVAL HISTORY OF IMBRUVICA
IMBRUVICA IN CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
IMBRUVICA IN WALDENSTRÖM'S MACROGLOBULINEMIA(WM)
IMBRUVICA IN MANTLE CELL LYMPHOMA (MCL)
IMBRUVICA IN MARGINAL ZONE LYMPHOMA (MZL)
IMBRUVICA IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVHD)
CLINICAL STUDY DATA
MANTLE-CELL LYMPHOMA
The PCYC-1104
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
RESONATE TRIAL: Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia
Long-term follow-up results from the pivotal Phase 3 RESONATE trial
RESONATE-2: Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia
Updated results from the pivotal Phase 3 RESONATE-2 trial
Imbruvica in Waldenstrom's macroglobulinemia
Imbruvica for Relapsed/Refractory Marginal Zone Lymphoma (MZL)
Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease
IMBRUVICA- ON THE VERGE OF BECOMING A MEGA-BLOCKBUSTER DRUG
MARKET PERFORMANCE AND COMPETITION: ENTRESTO
CLINICAL STUDY DATA
PARADIGM-HF
MARKET PERFORMANCE AND COMPETITION IBRANCE
CLINICAL STUDY DATA
PALOMA-1
PALOMA-2
PALOMA-3
ONGOING RESEARCH
1. The PATINA trial
2. The PALLAS Trial
3. NCT02499120:
EPCLUSA
CLINICAL STUDY DATA
ASTRAL-1
ASTRAL-2 and ASTRAL-3
ASTRAL-4
ASTRAL-5
MARKET PERFORMANCE AND COMPETITORS
LYNPARZA
HARNESSING THE POTENTIAL OF PARP INHIBITORS IN OVARIAN CANCER
CLINICAL STUDY DATA
SOLO-2
Study 19
MARKET PERFORMANCE AND COMPETITION
ONGOING RESEARCH
Lynparza: Paving its way towards BRCA-Mutated Breast Cancer- the OlympiAD trial
PAOLA trial
POLO trial
PROfound trial
CONCERTO trial
UPTRAVI
CLINICAL STUDY DATA
GRIPHON trial
MARKET PERFORMANCE AND COMPETITORS
ONGOING RESEARCH
TRITON trial
TRANSIT TRIAL
INGREZZA
CLINICAL STUDY DATA
KINECT 3
Extension study of INGREZZA 40 mg and INGREZZA 80 mg (Intent-to-treat-ITT population)
MARKET PERFORMANCE AND COMPETITION
T-Forward Study
T-Force GREEN Study
T-Force GOLD study
OCALIVA
CLINICAL STUDY DATA
The POISE trial
Open-Label Extension
MARKET PERFORMANCE AND COMPETITION
FDA concern regarding incorrect dosing of Ocaliva
ONGOING RESEARCH
COBALT trial
REGENERATE trial- effect of Obeticholic Acid treatment on nonalcoholic steatohepatitis (NASH)
FLINT Trial
FACTORS TO BE CONSIDERED DURING THE PRODUCT EVALUATION PROCESS
STAGES IN THE DEVELOPMENT OF A GENERIC DRUG PRODUCT
POTENTIAL CHALLENGES IN THE VARIOUS DEVELOPMENT STAGES
OPPORTUNITY AREAS FOR GENERIC PRODUCT DEVELOPMENT
JAKAFI
MECHANISM OF ACTION
JAKAFI IN MYELOFIBROSIS (MF)
JAKAFI IN POLYCYTHEMIA VERA (PCV)
JAKAFI IN GRAFT-VERSUS-HOST DISEASE (GVHD)
CLINICAL STUDY DATA
The COMFORT-I and –II study
COMFORT-I
The primary end point
Secondary end points
COMFORT –II
RESPONSE trial
The primary end point
The secondary end points
ONGOING RESEARCH PROGRAM
ORKAMBI
CLINICAL STUDY DATA
TRAFFIC and TRANSPORT
PROGRESS STUDY
LABEL EXPANSION TO TREAT 6- TO 11-YEAR-OLD
MARKET PERFORMANCE AND COMPETITION: IMBRUVICA
AN OVERVIEW OF THE FDA APPROVAL HISTORY OF IMBRUVICA
IMBRUVICA IN CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
IMBRUVICA IN WALDENSTRÖM'S MACROGLOBULINEMIA(WM)
IMBRUVICA IN MANTLE CELL LYMPHOMA (MCL)
IMBRUVICA IN MARGINAL ZONE LYMPHOMA (MZL)
IMBRUVICA IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVHD)
CLINICAL STUDY DATA
MANTLE-CELL LYMPHOMA
The PCYC-1104
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
RESONATE TRIAL: Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia
Long-term follow-up results from the pivotal Phase 3 RESONATE trial
RESONATE-2: Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia
Updated results from the pivotal Phase 3 RESONATE-2 trial
Imbruvica in Waldenstrom's macroglobulinemia
Imbruvica for Relapsed/Refractory Marginal Zone Lymphoma (MZL)
Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease
IMBRUVICA- ON THE VERGE OF BECOMING A MEGA-BLOCKBUSTER DRUG
MARKET PERFORMANCE AND COMPETITION: ENTRESTO
CLINICAL STUDY DATA
PARADIGM-HF
MARKET PERFORMANCE AND COMPETITION IBRANCE
CLINICAL STUDY DATA
PALOMA-1
PALOMA-2
PALOMA-3
ONGOING RESEARCH
1. The PATINA trial
2. The PALLAS Trial
3. NCT02499120:
EPCLUSA
CLINICAL STUDY DATA
ASTRAL-1
ASTRAL-2 and ASTRAL-3
ASTRAL-4
ASTRAL-5
MARKET PERFORMANCE AND COMPETITORS
LYNPARZA
HARNESSING THE POTENTIAL OF PARP INHIBITORS IN OVARIAN CANCER
CLINICAL STUDY DATA
SOLO-2
Study 19
MARKET PERFORMANCE AND COMPETITION
ONGOING RESEARCH
Lynparza: Paving its way towards BRCA-Mutated Breast Cancer- the OlympiAD trial
PAOLA trial
POLO trial
PROfound trial
CONCERTO trial
UPTRAVI
CLINICAL STUDY DATA
GRIPHON trial
MARKET PERFORMANCE AND COMPETITORS
ONGOING RESEARCH
TRITON trial
TRANSIT TRIAL
INGREZZA
CLINICAL STUDY DATA
KINECT 3
Extension study of INGREZZA 40 mg and INGREZZA 80 mg (Intent-to-treat-ITT population)
MARKET PERFORMANCE AND COMPETITION
T-Forward Study
T-Force GREEN Study
T-Force GOLD study
OCALIVA
CLINICAL STUDY DATA
The POISE trial
Open-Label Extension
MARKET PERFORMANCE AND COMPETITION
FDA concern regarding incorrect dosing of Ocaliva
ONGOING RESEARCH
COBALT trial
REGENERATE trial- effect of Obeticholic Acid treatment on nonalcoholic steatohepatitis (NASH)
FLINT Trial
LIST OF FIGURES
FIGURE: 1.THE THERAPY CLASSES COVERED IN THIS REPORT
Figure 2 STAGES IN THE DEVELOPMENT OF A GENERIC DRUG PRODUCT
Figure 3 POTENTIAL CHALLENGES IN THE VARIOUS DEVELOPMENT STAGES
Figure 4 JAKAFI KEY POINTS
Figure 5 COMFORT I PRIMARY END POINT
FIGURE 6 COMFORT I SECONDARY END POINT
Figure 7 COMFORT II PRIMARY END POINT
Figure 8 RESPONSE PRIMARY END POINT
Figure 9 ORKAMBI KEY POINTS
Figure 10 EFFICACY RESULTS FROM TRAFFIC AND TRANSPORT
Figure 11 IMBRUVICA KEY POINTS
Figure 12 AN OVERVIEW OF THE FDA APPROVAL HISTORY OF IMBRUVICA
Figure 13 THE PCYC-1104 RESULTS
Figure 14 RESONATE TRIAL-PROGRESSION-FREE AND OVERALL SURVIVAL
FIGURE 15: PROGRESSION-FREE SURVIVAL WITH IBRUTINIB VERSUS CHLORAMBUCIL.
Figure 16 OVERALL SURVIVAL AND RESPONSE RATES WITH IBRUTINIB VERSUS CHLORAMBUCIL.
FIGURE 17 ENTRESTO KEY POINTS
Figure 18 PARADIGM-HF: CLINICAL ENDPOINTS
FIGURE 19 IBRANCE KEY POINTS
Figure 20 EPCLUSA KEY POINTS
Figure 21 LYNPARZA KEY POINTS
Figure 22 SOLO-2 TRIALS RESULTS
Figure 23 STUDY 19 RESULTS
Figure 24 UPTRAVI KEY POINTS
Figure 25 PRIMARY ENDPOINT:TIME TO FIRST DISEASE PROGRESSION EVENT IN THE GRIPHON TRIAL
Figure 26 GRIPHON TRIAL PRIMARY ENDPOINT EVENTS UP TO THE END OF TREATMENT
Figure 27 INGREZZA KEY POINTS
FIGURE 28 KINECT-3 RESULTS
Figure 29 Results of extension study of INGREZZA
Figure 30 OCALIVA KEY POINTS
FIGURE 31 PRIMARY COMPOSITE END POINT IN THE DOUBLE-BLIND AND OPEN-LABEL EXTENSION PHASES
FIGURE 32 ALKALINE PHOSPHATASE AND TOTAL BILIRUBIN LEVELS IN THE DOUBLE-BLIND AND OPEN-LABEL EXTENSION PHASES
FIGURE: 1.THE THERAPY CLASSES COVERED IN THIS REPORT
Figure 2 STAGES IN THE DEVELOPMENT OF A GENERIC DRUG PRODUCT
Figure 3 POTENTIAL CHALLENGES IN THE VARIOUS DEVELOPMENT STAGES
Figure 4 JAKAFI KEY POINTS
Figure 5 COMFORT I PRIMARY END POINT
FIGURE 6 COMFORT I SECONDARY END POINT
Figure 7 COMFORT II PRIMARY END POINT
Figure 8 RESPONSE PRIMARY END POINT
Figure 9 ORKAMBI KEY POINTS
Figure 10 EFFICACY RESULTS FROM TRAFFIC AND TRANSPORT
Figure 11 IMBRUVICA KEY POINTS
Figure 12 AN OVERVIEW OF THE FDA APPROVAL HISTORY OF IMBRUVICA
Figure 13 THE PCYC-1104 RESULTS
Figure 14 RESONATE TRIAL-PROGRESSION-FREE AND OVERALL SURVIVAL
FIGURE 15: PROGRESSION-FREE SURVIVAL WITH IBRUTINIB VERSUS CHLORAMBUCIL.
Figure 16 OVERALL SURVIVAL AND RESPONSE RATES WITH IBRUTINIB VERSUS CHLORAMBUCIL.
FIGURE 17 ENTRESTO KEY POINTS
Figure 18 PARADIGM-HF: CLINICAL ENDPOINTS
FIGURE 19 IBRANCE KEY POINTS
Figure 20 EPCLUSA KEY POINTS
Figure 21 LYNPARZA KEY POINTS
Figure 22 SOLO-2 TRIALS RESULTS
Figure 23 STUDY 19 RESULTS
Figure 24 UPTRAVI KEY POINTS
Figure 25 PRIMARY ENDPOINT:TIME TO FIRST DISEASE PROGRESSION EVENT IN THE GRIPHON TRIAL
Figure 26 GRIPHON TRIAL PRIMARY ENDPOINT EVENTS UP TO THE END OF TREATMENT
Figure 27 INGREZZA KEY POINTS
FIGURE 28 KINECT-3 RESULTS
Figure 29 Results of extension study of INGREZZA
Figure 30 OCALIVA KEY POINTS
FIGURE 31 PRIMARY COMPOSITE END POINT IN THE DOUBLE-BLIND AND OPEN-LABEL EXTENSION PHASES
FIGURE 32 ALKALINE PHOSPHATASE AND TOTAL BILIRUBIN LEVELS IN THE DOUBLE-BLIND AND OPEN-LABEL EXTENSION PHASES
LIST OF TABLES
Table 1 LIST OF SELECTED MOLECULES
TABLE 2 JAKAFI PATENT DETAILS
TABLE 3 ORKAMBI PATENT DETAILS
TABLE 4 IMBRUVICA PATENT DETAILS
TABLE 5 ENTRESTO PATENT DETAILS
Table 6 MAJOR TRIALS IN THE FORTIHFY PROGRAM
TABLE 7 IBRANCE PATENT DETAILS
TABLE 8 RESULTS OF PALOMA-2 TRIAL
Table 9 RESULTS OF PALOMA-3 TRIAL
TABLE 10 EPCLUSA PATENT DETAILS
Table 11 ASTRAL TRIALS- STUDY OUTCOME
TABLE 12 LYNPARZA PATENT DETAILS
TABLE 13 UPTRAVI PATENT DETAILS
TABLE 14 INGREZZA PATENT DETAILS
TABLE 15 OCALIVA PATENT DETAILS
TABLE 16-COMPETITIVE LANDSCAPE FOR THE SELECTED MOLECULES
Table 1 LIST OF SELECTED MOLECULES
TABLE 2 JAKAFI PATENT DETAILS
TABLE 3 ORKAMBI PATENT DETAILS
TABLE 4 IMBRUVICA PATENT DETAILS
TABLE 5 ENTRESTO PATENT DETAILS
Table 6 MAJOR TRIALS IN THE FORTIHFY PROGRAM
TABLE 7 IBRANCE PATENT DETAILS
TABLE 8 RESULTS OF PALOMA-2 TRIAL
Table 9 RESULTS OF PALOMA-3 TRIAL
TABLE 10 EPCLUSA PATENT DETAILS
Table 11 ASTRAL TRIALS- STUDY OUTCOME
TABLE 12 LYNPARZA PATENT DETAILS
TABLE 13 UPTRAVI PATENT DETAILS
TABLE 14 INGREZZA PATENT DETAILS
TABLE 15 OCALIVA PATENT DETAILS
TABLE 16-COMPETITIVE LANDSCAPE FOR THE SELECTED MOLECULES
