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.

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

2. Reasons to buy
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
Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Number of Drugs Discontinued From the Pipeline
2.2 Number of Drugs Discontinued by Major Pharmaceutical Companies (2005-2010)
2.3 R&D Expenditure by Major Pharmaceutical Companies
2.4 GBI Research Report Guidance
3 Top Phase III Drug Failures (2005-2010)
3.1 Semagacestat
3.1.1 Unmet Need for Indication
3.1.2 Introduction
3.1.3 Clinical Trial Study Details
3.1.4 Reasons for Failure
3.2 Zibotentan
3.2.1 Unmet Need for Indication
3.2.2 Introduction
3.2.3 Clinical Trial Study Details
3.2.4 Reasons for Failure
3.3 Vicriviroc
3.3.1 Unmet Need for Indication
3.3.2 Introduction
3.3.3 Clinical Trial Study Details
3.3.4 Reasons for Failure
3.4 Torcetrapib
3.4.1 Unmet Need for Indication
3.4.2 Introduction
3.4.3 Clinical Trial Study Details
3.4.4 Reasons for Failure
3.5 Iniparib
3.5.1 Unmet Need for Indication
3.5.2 Introduction
3.5.3 Clinical Trial Study Details
3.5.4 Reasons for Failure
3.6 ASA404

3. 3.6.1 Unmet Need for Indication
3.6.2 Introduction
3.6.3 Clinical Trial Study Details
3.6.4 Reasons for Failure
3.7 Figitumumab
3.7.1 Unmet Need for Indication
3.7.2 Introduction
3.7.3 Clinical Trial Study Details
3.7.4 Reasons for Failure
3.8 Sutent
3.8.1 Unmet Need for Indication
3.8.2 Introduction
3.8.3 Clinical Trial Study Details
3.8.4 Reasons for Failure
3.9 Recentin
3.9.1 Unmet Need for Indication
3.9.2 Introduction
3.9.3 Clinical Trial Study Details
3.9.4 Reasons for Failure
3.10 Ocrelizumab
3.10.1 Unmet Need for Indication
3.10.2 Introduction
3.10.3 Clinical Trial Study Details
3.10.4 Reasons for Failure
3.11 GVAX
3.11.1 Unmet Need for Indication
3.11.2 Introduction
3.11.3 Clinical Trial Study Details
3.11.4 Reasons for Failure
3.12 Teplizumab
3.12.1 Unmet Need for Indication
3.12.2 Introduction
3.12.3 Clinical Trial Study Details
3.12.4 Reasons for Failure
3.13 Taspoglutide
3.13.1 Unmet Need for Indication
3.13.2 Introduction
3.13.3 Clinical Trial Study Details
3.13.4 Reasons for Failure
3.14 NOV002
3.14.1 Unmet Need for Indication
3.14.2 Introduction
3.14.3 Clinical Trial Study Details
3.14.4 Reasons for Failure
3.15 Otelixizumab
3.15.1 Unmet Need for Indication
3.15.2 Introduction
3.15.3 Clinical Trial Study Details
3.15.4 Reasons for Failure

4. 3.16 Dimebon
3.16.1 Unmet Need for Indication
3.16.2 Introduction
3.16.3 Clinical Trial Study Details
3.16.4 Reasons for Failure
3.17 Avastin
3.17.1 Unmet Need for Indication
3.17.2 Introduction
3.17.3 Clinical Trial Study Details
3.17.4 Reasons for Failure
3.18 Aflibercept
3.18.1 Unmet Need for Indication
3.18.2 Introduction
3.18.3 Clinical Trial Study Details
3.18.4 Reasons for Failure
3.19 Cladribine
3.19.1 Unmet Need for Indication
3.19.2 Introduction
3.19.3 Clinical Trial Study Details
3.19.4 Reasons for Failure
3.20 Rolofylline
3.20.1 Unmet Need for Indication
3.20.2 Introduction
3.20.3 Clinical Trial Study Details
3.20.4 Reasons for Failure
4 Conclusion
5 Top R&D Drug Failures – Appendix
5.1 Market Definitions
5.2 Abbreviations
5.3 Research Methodology
5.3.1 Coverage
5.3.2 Secondary Research
5.3.3 Primary Research
5.3.4 Expert Panel Validation
5.4 Contact Us
5.5 Disclaimer
5.6 Sources
List of Tables
Table 1: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Products,
2005-2010
Table 2: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Products
by Sponsor Companies, 2005-2010
Table 3: Top R&D Drug Failures, NINDS-ADRDA Diagnostic Criteria for Alzheimer’s Disease
(AD), 2011
Table 4: Top R&D Drug Failures, Zibotentan Phase III Outcomes, 2011
Table 5: Top R&D Drug Failures, ASA404 Phase II Outcomes, 2011

5. Table 6: Top R&D Drug Failures, Ocrelizumab: Phase III Clinical Trial Program In
Rheumatoid Arthritis, 2011
Table 7: Top R&D Drug Failures, Taspoglutide List of Trials, 2005-2010
Table 8: Top R&D Drug Failures, Taspoglutide Trial Details, 2005-2010
Table 9: Top R&D Drug Failures, Treatment Related Toxicities With Avastin In Phase II Trial
(%), 2011
Table 10: Top R&D Drug Failures, Primary Endpoint Measures, Rolofylline, 2011
List of Figures
Figure 1: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Products,
2005-2010
Figure 2: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Products
by Sponsor Companies, 2005-2010
Figure 3: Top R&D Drug Failures, R&D Spending By Major Pharmaceutical Companies ($bn),
1996-2009
Figure 4: Top R&D Drug Failures, Semagacestat Overview, 2005-2010
Figure 5: Top R&D Drug Failures, Semagacestat Trial Overview, 2005-2010
Figure 6: Top R&D Drug Failures, Zibotentan Overview, 2005-2010
Figure 7: Top R&D Drug Failures, Zibotentan Trial Overview, 2005-2010
Figure 8: Top R&D Drug Failures, Vicriviroc Overview, 2005-2010
Figure 9: Top R&D Drug Failures, Vicriviroc Trial Overview, 2005-2010
Figure 10: Top R&D Drug Failures, Torcetrapib Overview, 2005-2010
Figure 11: Top R&D Drug Failures, Torcetrapib Trial Overview, 2005-2010
Figure 12: Top R&D Drug Failures, Iniparib Overview, 2005-2010
Figure 13: Top R&D Drug Failures, Iniparib Trial Overview, 2005-2010
Figure 14: Top R&D Drug Failures, ASA404 Overview, 2005-2010
Figure 15: Top R&D Drug Failures, ASA404 Trial Overview, 2005-2010
Figure 16: Top R&D Drug Failures, Figitumumab Overview, 2005-2010
Figure 17: Top R&D Drug Failures, Figitumumab Trial Overview, 2005-2010
Figure 18: Top R&D Drug Failures, Sutent Overview, 2005-2010
Figure 19: Top R&D Drug Failures, Sutent Trial Overview, 2005-2010
Figure 20: Top R&D Drug Failures, Recentin Overview, 2005-2010
Figure 21: Top R&D Drug Failures, Recentin Trial Overview, 2005-2010
Figure 22: Top R&D Drug Failures, Ocrelizumab Overview, 2005-2010
Figure 23: Top R&D Drug Failures, Ocrelizumab Trial Overview, 2005-2010
Figure 24: Top R&D Drug Failures, GVAX Overview, 2005-2010
Figure 25: Top R&D Drug Failures, GVAX Trial Overview, 2005-2010
Figure 26: Top R&D Drug Failures, Teplizumab Overview, 2005-2010
Figure 27: Top R&D Drug Failures, Teplizumab Trial Overview, 2005-2010
Figure 28: Top R&D Drug Failures, Taspoglutide Overview, 2005-2010
Figure 29: Top R&D Drug Failures, Taspoglutide Trial Overview, 2005-2010
Figure 30: Top R&D Drug Failures, NOV002 Overview, 2005-2010
Figure 31: Top R&D Drug Failures, NOV002 Trial Overview, 2005-2010
Figure 32: Top R&D Drug Failures, Otelixizumab Overview, 2005-2010
Figure 33: Top R&D Drug Failures, Otelixizumab Trial Overview, 2005-2010
Figure 34: Top R&D Drug Failures, Dimebon Overview, 2005-2010
Figure 35: Top R&D Drug Failures, Dimebon Trial Overview, 2005-2010
Figure 36: Top R&D Drug Failures, Avastin Overview, 2005-2010
Figure 37: Top R&D Drug Failures, Avastin Trial Overview, 2005-2010

6. Figure 38: Top R&D Drug Failures, Aflibercept Overview, 2005-2010
Figure 39: Top R&D Drug Failures, Aflibercept Trial Overview, 2005-2010
Figure 40: Top R&D Drug Failures, Cladribine Overview, 2005-2010
Figure 41: Top R&D Drug Failures, Cladribine Trial Overview, 2005-2010
Figure 42: Top R&D Drug Failures, Rolofylline Overview, 2005-2010
Figure 43: Top R&D Drug Failures, Rolofylline Trial Overview, 2005-2010
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