Top R&D Drug Failures - Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure

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Top R&D Drug Failures - Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure

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Top R&D Drug Failures - Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure

Summary

GBI Research, leading business intelligence provider, has released its latest research report, 'Top R&D Drug Failures - Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure', which provides insights into major drug failures during 2005–2010. The 20 drugs included in the report belong to key pharmaceutical companies and were undergoing research for a major indication. The report also includes the total expenditure of top pharmaceutical companies in R&D throughout 1996–2009, and an analysis of the financial loss faced by such companies when a drug fails in the late stages of development.

GBI Research discovered that the economic impact of drug failure during late stage development increased in relation to the escalating cost of development for new therapeutic agents. The main cause of drug failure in Phase III, when the efficacy of the drug is already evaluated, is either its safety measures or its ability to demonstrate any additional benefits in a larger population over a longer time period. Pharmaceutical companies have recently invested substantial amounts of money in R&D processes; in order to combat the threat of patent expires of blockbuster drugs, and to increase the chances of discovering a drug which could generate considerable revenue for the company. If a drug receives approval and is patented, companies' returns are significantly higher than the amount invested in R&D.

The attrition of molecules occurs at various stages of the trial during drug development process. The majority of molecules fail at the initial stages of development, such as pre-clinical studies and Phase I and II. Pharmaceutical companies face huge losses when drugs fail in the late stage of trials, such as Phase III and the post-marketing stage. According to analysis conducted during 2005–2010, it was found that the number of drugs dropped from the pipeline increased from 2003 to 2007 and furthermore decreased from 2007 to 2010. Many drugs have been discontinued during the course of clinical trials, due to safety and efficacy issues. The decision to discontinue the development of a drug is taken by the health authorities and is based on interim analysis. If the drug is not able to demonstrate any additional benefits over existing therapies, or it has issues related to patient safety, the drug fails to receive approval from health authorities.

Scope

The scope of this report includes -

- Identification of top 20 R&D drug failures

- Unmet need in efficacy and safety for all failed drugs

- Phase II results and the reasons for conducting Phase III

- The reasons for failure and lack of available options for a particular therapeutic area

- Conclusion regarding late-stage drug failures based on the analysis of the top 20 drug failures

Reasons to buy

The report will enhance your decision making capability and will allow you to -

- Build an understanding of recent top R&D late stage drug failures

- Analyze the effect of safety and efficacy parameters on major drug failures

- Identify the unmet needs for a particular indication with the highest drug failures

- Understand the most common reasons for drug failure in late stage of development

- Identify the cost involved in R&D by analyzing the expenditure done by top pharmaceutical companies

1 Table of Contents

1 Table of Contents 3

1.1 List of Tables 6

1.2 List of Figures 7

2 Introduction 8

2.1 Number of Drugs Discontinued From the Pipeline 8

2.2 Number of Drugs Discontinued by Major Pharmaceutical Companies (2005-2010) 9

2.3 R&D Expenditure by Major Pharmaceutical Companies 10

2.4 GBI Research Report Guidance 11

3 Top Phase III Drug Failures (2005–2010) 12

3.1 Semagacestat 12

3.1.1 Unmet Need for Indication 12

3.1.2 Introduction 13

3.1.3 Clinical Trial Study Details 13

3.1.4 Reasons for Failure 15

3.2 Zibotentan 15

3.2.1 Unmet Need for Indication 15

3.2.2 Introduction 16

3.2.3 Clinical Trial Study Details 16

3.2.4 Reasons for Failure 18

3.3 Vicriviroc 18

3.3.1 Unmet Need for Indication 18

3.3.2 Introduction 19

3.3.3 Clinical Trial Study Details 19

3.3.4 Reasons for Failure 20

3.4 Torcetrapib 21

3.4.1 Unmet Need for Indication 21

3.4.2 Introduction 22

3.4.3 Clinical Trial Study Details 22

3.4.4 Reasons for Failure 23

3.5 Iniparib 23

3.5.1 Unmet Need for Indication 23

3.5.2 Introduction 24

3.5.3 Clinical Trial Study Details 24

3.5.4 Reasons for Failure 25

3.6 ASA404 26

3.6.1 Unmet Need for Indication 26

3.6.2 Introduction 27

3.6.3 Clinical Trial Study Details 27

3.6.4 Reasons for Failure 28

3.7 Figitumumab 28

3.7.1 Unmet Need for Indication 29

3.7.2 Introduction 29

3.7.3 Clinical Trial Study Details 29

3.7.4 Reasons for Failure 30

3.8 Sutent 31

3.8.1 Unmet Need for Indication 31

3.8.2 Introduction 32

3.8.3 Clinical Trial Study Details 32

3.8.4 Reasons for Failure 33

3.9 Recentin 33

3.9.1 Unmet Need for Indication 34

3.9.2 Introduction 34

3.9.3 Clinical Trial Study Details 34

3.9.4 Reasons for Failure 35

3.10 Ocrelizumab 35

3.10.1 Unmet Need for Indication 36

3.10.2 Introduction 36

3.10.3 Clinical Trial Study Details 37

3.10.4 Reasons for Failure 38

3.11 GVAX 39

3.11.1 Unmet Need for Indication 39

3.11.2 Introduction 40

3.11.3 Clinical Trial Study Details 40

3.11.4 Reasons for Failure 41

3.12 Teplizumab 42

3.12.1 Unmet Need for Indication 42

3.12.2 Introduction 43

3.12.3 Clinical Trial Study Details 43

3.12.4 Reasons for Failure 44

3.13 Taspoglutide 45

3.13.1 Unmet Need for Indication 45

3.13.2 Introduction 46

3.13.3 Clinical Trial Study Details 46

3.13.4 Reasons for Failure 48

3.14 NOV002 49

3.14.1 Unmet Need for Indication 49

3.14.2 Introduction 49

3.14.3 Clinical Trial Study Details 50

3.14.4 Reasons for Failure 51

3.15 Otelixizumab 51

3.15.1 Unmet Need for Indication 52

3.15.2 Introduction 52

3.15.3 Clinical Trial Study Details 52

3.15.4 Reasons for Failure 53

3.16 Dimebon 54

3.16.1 Unmet Need for Indication 54

3.16.2 Introduction 55

3.16.3 Clinical Trial Study Details 55

3.16.4 Reasons for Failure 56

3.17 Avastin 57

3.17.1 Unmet Need for Indication 57

3.17.2 Introduction 58

3.17.3 Clinical Trial Study Details 58

3.17.4 Reasons for Failure 59

3.18 Aflibercept 60

3.18.1 Unmet Need for Indication 60

3.18.2 Introduction 60

3.18.3 Clinical Trial Study Details 61

3.18.4 Reasons for Failure 62

3.19 Cladribine 62

3.19.1 Unmet Need for Indication 62

3.19.2 Introduction 63

3.19.3 Clinical Trial Study Details 64

3.19.4 Reasons for Failure 65

3.20 Rolofylline 65

3.20.1 Unmet Need for Indication 65

3.20.2 Introduction 66

3.20.3 Clinical Trial Study Details 66

3.20.4 Reasons for Failure 67

4 Conclusion 68

5 Top R&D Drug Failures - Appendix 69

5.1 Market Definitions 69

5.2 Abbreviations 69

5.3 Research Methodology 70

5.3.1 Coverage 70

5.3.2 Secondary Research 71

5.3.3 Primary Research 71

5.3.4 Expert Panel Validation 71

5.4 Contact Us 71

5.5 Disclaimer 72

5.6 Sources 72

1.1 List of Tables

Table 1: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Products, 2005–2010 8

Table 2: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Products by Sponsor Companies, 2005–2010 9

Table 3: Top R&D Drug Failures, NINDS-ADRDA Diagnostic Criteria for Alzheimer's Disease (AD), 2011 14

Table 4: Top R&D Drug Failures, Zibotentan Phase III Outcomes, 2011 17

Table 5: Top R&D Drug Failures, ASA404 Phase II Outcomes, 2011 27

Table 6: Top R&D Drug Failures, Ocrelizumab: Phase III Clinical Trial Program In Rheumatoid Arthritis, 2011 38

Table 7: Top R&D Drug Failures, Taspoglutide List of Trials, 2005–2010 47

Table 8: Top R&D Drug Failures, Taspoglutide Trial Details, 2005–2010 48

Table 9: Top R&D Drug Failures, Treatment Related Toxicities With Avastin In Phase II Trial (%), 2011 59

Table 10: Top R&D Drug Failures, Primary Endpoint Measures, Rolofylline, 2011 67

1.2 List of Figures

Figure 1: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Products, 2005–2010 8

Figure 2: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Products by Sponsor Companies, 2005–2010 9

Figure 3: Top R&D Drug Failures, R&D Spending By Major Pharmaceutical Companies ($bn), 1996–2009 10

Figure 4: Top R&D Drug Failures, Semagacestat Overview, 2005–2010 12

Figure 5: Top R&D Drug Failures, Semagacestat Trial Overview, 2005–2010 13

Figure 6: Top R&D Drug Failures, Zibotentan Overview, 2005–2010 15

Figure 7: Top R&D Drug Failures, Zibotentan Trial Overview, 2005–2010 16

Figure 8: Top R&D Drug Failures, Vicriviroc Overview, 2005–2010 18

Figure 9: Top R&D Drug Failures, Vicriviroc Trial Overview, 2005–2010 19

Figure 10: Top R&D Drug Failures, Torcetrapib Overview, 2005–2010 21

Figure 11: Top R&D Drug Failures, Torcetrapib Trial Overview, 2005–2010 22

Figure 12: Top R&D Drug Failures, Iniparib Overview, 2005–2010 23

Figure 13: Top R&D Drug Failures, Iniparib Trial Overview, 2005–2010 24

Figure 14: Top R&D Drug Failures, ASA404 Overview, 2005–2010 26

Figure 15: Top R&D Drug Failures, ASA404 Trial Overview, 2005–2010 27

Figure 16: Top R&D Drug Failures, Figitumumab Overview, 2005–2010 28

Figure 17: Top R&D Drug Failures, Figitumumab Trial Overview, 2005–2010 29

Figure 18: Top R&D Drug Failures, Sutent Overview, 2005–2010 31

Figure 19: Top R&D Drug Failures, Sutent Trial Overview, 2005–2010 32

Figure 20: Top R&D Drug Failures, Recentin Overview, 2005–2010 33

Figure 21: Top R&D Drug Failures, Recentin Trial Overview, 2005–2010 34

Figure 22: Top R&D Drug Failures, Ocrelizumab Overview, 2005–2010 35

Figure 23: Top R&D Drug Failures, Ocrelizumab Trial Overview, 2005–2010 37

Figure 24: Top R&D Drug Failures, GVAX Overview, 2005–2010 39

Figure 25: Top R&D Drug Failures, GVAX Trial Overview, 2005–2010 40

Figure 26: Top R&D Drug Failures, Teplizumab Overview, 2005–2010 42

Figure 27: Top R&D Drug Failures, Teplizumab Trial Overview, 2005–2010 43

Figure 28: Top R&D Drug Failures, Taspoglutide Overview, 2005–2010 45

Figure 29: Top R&D Drug Failures, Taspoglutide Trial Overview, 2005–2010 46

Figure 30: Top R&D Drug Failures, NOV002 Overview, 2005–2010 49

Figure 31: Top R&D Drug Failures, NOV002 Trial Overview, 2005–2010 50

Figure 32: Top R&D Drug Failures, Otelixizumab Overview, 2005–2010 51

Figure 33: Top R&D Drug Failures, Otelixizumab Trial Overview, 2005–2010 52

Figure 34: Top R&D Drug Failures, Dimebon Overview, 2005–2010 54

Figure 35: Top R&D Drug Failures, Dimebon Trial Overview, 2005–2010 55

Figure 36: Top R&D Drug Failures, Avastin Overview, 2005–2010 57

Figure 37: Top R&D Drug Failures, Avastin Trial Overview, 2005–2010 58

Figure 38: Top R&D Drug Failures, Aflibercept Overview, 2005–2010 60

Figure 39: Top R&D Drug Failures, Aflibercept Trial Overview, 2005–2010 61

Figure 40: Top R&D Drug Failures, Cladribine Overview, 2005–2010 62

Figure 41: Top R&D Drug Failures, Cladribine Trial Overview, 2005–2010 64

Figure 42: Top R&D Drug Failures, Rolofylline Overview, 2005–2010 65

Figure 43: Top R&D Drug Failures, Rolofylline Trial Overview, 2005–2010 66

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