Your SlideShare is downloading. ×
ReportsnReports – Top R&D Drug Failures – Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure
ReportsnReports – Top R&D Drug Failures – Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure
ReportsnReports – Top R&D Drug Failures – Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure
ReportsnReports – Top R&D Drug Failures – Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure
ReportsnReports – Top R&D Drug Failures – Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure
ReportsnReports – Top R&D Drug Failures – Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×
Saving this for later? Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime – even offline.
Text the download link to your phone
Standard text messaging rates apply

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

435

Published on

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 …

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.

Published in: Health & Medicine, Business
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
435
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
6
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. Top R&D Drug Failures – Toxicity and Serious Adverse Events in Late Stage DrugDevelopment are the Major Causes of Drug FailureGBI Research, leading business intelligence provider, has released its latest research report,‘Top R&D Drug Failures – Toxicity and Serious Adverse Events in Late Stage DrugDevelopment are the Major Causes of Drug Failure’, which provides insights into major drugfailures during 2005-2010. The 20 drugs included in the report belong to keypharmaceutical companies and were undergoing research for a major indication. The reportalso includes the total expenditure of top pharmaceutical companies in R&D throughout1996-2009, and an analysis of the financial loss faced by such companies when a drug failsin the late stages of development.Buy Now: Top R&D Drug MarketBrowse All: Latest Market Research ReportsGBI Research discovered that the economic impact of drug failure during late stagedevelopment increased in relation to the escalating cost of development for new therapeuticagents. The main cause of drug failure in Phase III, when the efficacy of the drug is alreadyevaluated, is either its safety measures or its ability to demonstrate any additional benefitsin a larger population over a longer time period. Pharmaceutical companies have recentlyinvested substantial amounts of money in R&D processes; in order to combat the threat ofpatent expires of blockbuster drugs, and to increase the chances of discovering a drugwhich could generate considerable revenue for the company. If a drug receives approvaland is patented, companies’ returns are significantly higher than the amount invested inR&D.The attrition of molecules occurs at various stages of the trial during drug developmentprocess. 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 drugsfail in the late stage of trials, such as Phase III and the post-marketing stage. According toanalysis conducted during 2005-2010, it was found that the number of drugs dropped fromthe 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 andefficacy issues. The decision to discontinue the development of a drug is taken by the healthauthorities and is based on interim analysis. If the drug is not able to demonstrate anyadditional benefits over existing therapies, or it has issues related to patient safety, thedrug fails to receive approval from health authorities.ScopeIdentification of top 20 R&D drug failuresUnmet need in efficacy and safety for all failed drugsPhase II results and the reasons for conducting Phase IIIThe reasons for failure and lack of available options for a particular therapeutic areaConclusion regarding late-stage drug failures based on the analysis of the top 20 drugfailures
  • 2. Reasons to buyBuild an understanding of recent top R&D late stage drug failuresAnalyze the effect of safety and efficacy parameters on major drug failuresIdentify the unmet needs for a particular indication with the highest drug failuresUnderstand the most common reasons for drug failure in late stage of developmentIdentify the cost involved in R&D by analyzing the expenditure done by top pharmaceuticalcompaniesTable of Contents1 Table of Contents1.1 List of Tables1.2 List of Figures2 Introduction2.1 Number of Drugs Discontinued From the Pipeline2.2 Number of Drugs Discontinued by Major Pharmaceutical Companies (2005-2010)2.3 R&D Expenditure by Major Pharmaceutical Companies2.4 GBI Research Report Guidance3 Top Phase III Drug Failures (2005-2010)3.1 Semagacestat3.1.1 Unmet Need for Indication3.1.2 Introduction3.1.3 Clinical Trial Study Details3.1.4 Reasons for Failure3.2 Zibotentan3.2.1 Unmet Need for Indication3.2.2 Introduction3.2.3 Clinical Trial Study Details3.2.4 Reasons for Failure3.3 Vicriviroc3.3.1 Unmet Need for Indication3.3.2 Introduction3.3.3 Clinical Trial Study Details3.3.4 Reasons for Failure3.4 Torcetrapib3.4.1 Unmet Need for Indication3.4.2 Introduction3.4.3 Clinical Trial Study Details3.4.4 Reasons for Failure3.5 Iniparib3.5.1 Unmet Need for Indication3.5.2 Introduction3.5.3 Clinical Trial Study Details3.5.4 Reasons for Failure3.6 ASA404
  • 3. 3.6.1 Unmet Need for Indication3.6.2 Introduction3.6.3 Clinical Trial Study Details3.6.4 Reasons for Failure3.7 Figitumumab3.7.1 Unmet Need for Indication3.7.2 Introduction3.7.3 Clinical Trial Study Details3.7.4 Reasons for Failure3.8 Sutent3.8.1 Unmet Need for Indication3.8.2 Introduction3.8.3 Clinical Trial Study Details3.8.4 Reasons for Failure3.9 Recentin3.9.1 Unmet Need for Indication3.9.2 Introduction3.9.3 Clinical Trial Study Details3.9.4 Reasons for Failure3.10 Ocrelizumab3.10.1 Unmet Need for Indication3.10.2 Introduction3.10.3 Clinical Trial Study Details3.10.4 Reasons for Failure3.11 GVAX3.11.1 Unmet Need for Indication3.11.2 Introduction3.11.3 Clinical Trial Study Details3.11.4 Reasons for Failure3.12 Teplizumab3.12.1 Unmet Need for Indication3.12.2 Introduction3.12.3 Clinical Trial Study Details3.12.4 Reasons for Failure3.13 Taspoglutide3.13.1 Unmet Need for Indication3.13.2 Introduction3.13.3 Clinical Trial Study Details3.13.4 Reasons for Failure3.14 NOV0023.14.1 Unmet Need for Indication3.14.2 Introduction3.14.3 Clinical Trial Study Details3.14.4 Reasons for Failure3.15 Otelixizumab3.15.1 Unmet Need for Indication3.15.2 Introduction3.15.3 Clinical Trial Study Details3.15.4 Reasons for Failure
  • 4. 3.16 Dimebon3.16.1 Unmet Need for Indication3.16.2 Introduction3.16.3 Clinical Trial Study Details3.16.4 Reasons for Failure3.17 Avastin3.17.1 Unmet Need for Indication3.17.2 Introduction3.17.3 Clinical Trial Study Details3.17.4 Reasons for Failure3.18 Aflibercept3.18.1 Unmet Need for Indication3.18.2 Introduction3.18.3 Clinical Trial Study Details3.18.4 Reasons for Failure3.19 Cladribine3.19.1 Unmet Need for Indication3.19.2 Introduction3.19.3 Clinical Trial Study Details3.19.4 Reasons for Failure3.20 Rolofylline3.20.1 Unmet Need for Indication3.20.2 Introduction3.20.3 Clinical Trial Study Details3.20.4 Reasons for Failure4 Conclusion5 Top R&D Drug Failures – Appendix5.1 Market Definitions5.2 Abbreviations5.3 Research Methodology5.3.1 Coverage5.3.2 Secondary Research5.3.3 Primary Research5.3.4 Expert Panel Validation5.4 Contact Us5.5 Disclaimer5.6 SourcesList of TablesTable 1: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Products,2005-2010Table 2: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Productsby Sponsor Companies, 2005-2010Table 3: Top R&D Drug Failures, NINDS-ADRDA Diagnostic Criteria for Alzheimer’s Disease(AD), 2011Table 4: Top R&D Drug Failures, Zibotentan Phase III Outcomes, 2011Table 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 InRheumatoid Arthritis, 2011Table 7: Top R&D Drug Failures, Taspoglutide List of Trials, 2005-2010Table 8: Top R&D Drug Failures, Taspoglutide Trial Details, 2005-2010Table 9: Top R&D Drug Failures, Treatment Related Toxicities With Avastin In Phase II Trial(%), 2011Table 10: Top R&D Drug Failures, Primary Endpoint Measures, Rolofylline, 2011List of FiguresFigure 1: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Products,2005-2010Figure 2: Top R&D Drug Failures, Number of Drugs Discontinued/ Inactive Pipeline Productsby Sponsor Companies, 2005-2010Figure 3: Top R&D Drug Failures, R&D Spending By Major Pharmaceutical Companies ($bn),1996-2009Figure 4: Top R&D Drug Failures, Semagacestat Overview, 2005-2010Figure 5: Top R&D Drug Failures, Semagacestat Trial Overview, 2005-2010Figure 6: Top R&D Drug Failures, Zibotentan Overview, 2005-2010Figure 7: Top R&D Drug Failures, Zibotentan Trial Overview, 2005-2010Figure 8: Top R&D Drug Failures, Vicriviroc Overview, 2005-2010Figure 9: Top R&D Drug Failures, Vicriviroc Trial Overview, 2005-2010Figure 10: Top R&D Drug Failures, Torcetrapib Overview, 2005-2010Figure 11: Top R&D Drug Failures, Torcetrapib Trial Overview, 2005-2010Figure 12: Top R&D Drug Failures, Iniparib Overview, 2005-2010Figure 13: Top R&D Drug Failures, Iniparib Trial Overview, 2005-2010Figure 14: Top R&D Drug Failures, ASA404 Overview, 2005-2010Figure 15: Top R&D Drug Failures, ASA404 Trial Overview, 2005-2010Figure 16: Top R&D Drug Failures, Figitumumab Overview, 2005-2010Figure 17: Top R&D Drug Failures, Figitumumab Trial Overview, 2005-2010Figure 18: Top R&D Drug Failures, Sutent Overview, 2005-2010Figure 19: Top R&D Drug Failures, Sutent Trial Overview, 2005-2010Figure 20: Top R&D Drug Failures, Recentin Overview, 2005-2010Figure 21: Top R&D Drug Failures, Recentin Trial Overview, 2005-2010Figure 22: Top R&D Drug Failures, Ocrelizumab Overview, 2005-2010Figure 23: Top R&D Drug Failures, Ocrelizumab Trial Overview, 2005-2010Figure 24: Top R&D Drug Failures, GVAX Overview, 2005-2010Figure 25: Top R&D Drug Failures, GVAX Trial Overview, 2005-2010Figure 26: Top R&D Drug Failures, Teplizumab Overview, 2005-2010Figure 27: Top R&D Drug Failures, Teplizumab Trial Overview, 2005-2010Figure 28: Top R&D Drug Failures, Taspoglutide Overview, 2005-2010Figure 29: Top R&D Drug Failures, Taspoglutide Trial Overview, 2005-2010Figure 30: Top R&D Drug Failures, NOV002 Overview, 2005-2010Figure 31: Top R&D Drug Failures, NOV002 Trial Overview, 2005-2010Figure 32: Top R&D Drug Failures, Otelixizumab Overview, 2005-2010Figure 33: Top R&D Drug Failures, Otelixizumab Trial Overview, 2005-2010Figure 34: Top R&D Drug Failures, Dimebon Overview, 2005-2010Figure 35: Top R&D Drug Failures, Dimebon Trial Overview, 2005-2010Figure 36: Top R&D Drug Failures, Avastin Overview, 2005-2010Figure 37: Top R&D Drug Failures, Avastin Trial Overview, 2005-2010
  • 6. Figure 38: Top R&D Drug Failures, Aflibercept Overview, 2005-2010Figure 39: Top R&D Drug Failures, Aflibercept Trial Overview, 2005-2010Figure 40: Top R&D Drug Failures, Cladribine Overview, 2005-2010Figure 41: Top R&D Drug Failures, Cladribine Trial Overview, 2005-2010Figure 42: Top R&D Drug Failures, Rolofylline Overview, 2005-2010Figure 43: Top R&D Drug Failures, Rolofylline Trial Overview, 2005-2010Latest Market Research Reports:Research Report on Global and Chinese Tablet Computer Markets, 2011-2012Research Report on Chinese Natural Rubber Industry, 2011-2012Cancer Diagnostic Testing World MarketsCompanion Diagnostics in Personalized Medicine and Cancer TherapyMolecular Diagnostics in Cancer TestingMolecular Diagnostics in Infectious Disease TestingMolecular Diagnostics MarketsPoint of Care Diagnostic Testing World MarketsPositron Emission Tomography (PET) MarketsAbout Us:ReportsnReports is an online library of over 75,000 market research reports and in-depthmarket research studies & analysis of over 5000 micro markets. We provide 24/7 online andoffline support to our customers. Get in touch with us for your needs of market researchreports.Follow us on Twitter: http://twitter.com/marketsreportsOur Facebook Page: http://www.facebook.com/pages/ReportsnReports/191441427571689Contact:Mr. Priyank7557 Rambler road,Suite 727, Dallas, TX 75231Tel: +1-888-989-8004 EXT 106E-mail: sales@reportsandreports.comhttp://www.reportsnreports.comBlog: http://www.reportsnreportsblog.com

×