Drug Repositioning Strategies

Content

• Drug Repositioning Strategies
• Executive Summary
  • Introduction
  • Repositioning pharma's failed compounds
  • Repositioning marketed compounds
  • Drug repositioning through reformulation
  • Intellectual Property and regulatory issues
  • Challenges of drug repositioning
  • The future of drug repositioning
• Chapter 1 Introduction
  • Summary
  • Introduction
  • Why reposition?
  • The aims of repositioning
  • What has made repositioning possible?
  • Structure of the report
• Chapter 2 Repositioning failed compounds
  • Summary
  • Introduction
  • Technology platforms for indications discovery
  • Gene Logic
  • Sosei
  • Melior Discovery and Melior Pharmaceuticals
  • KineMed
  • BrainCells Inc and Dynogen
  • Repositioning - the Synosis business model
  • Pharmacogenomics
  • Conclusions
• Chapter 3 Repositioning marketed
  • compounds
  • Summary
  • Introduction
  • Repositioning strategies
  • Indications discovery with new technologies
  • Bionaut Pharmaceuticals
  • DanioLabs and VASTox
  • Applying a therapeutic focus
  • Mining databases for new indications
  • Drug combinations
  • Repositioning in the public sector
  • Screening technologies
  • Molecular libraries
  • Repositioning based on advancing knowledge of disease
  • Conclusions
• Chapter 4 Drug repositioning through
  • reformulation
  • Summary
  • Introduction
  • Controlled delivery and chronotherapeutics
  • Non-invasive delivery routes
  • Inhaled delivery
  • Intranasal delivery
  • Transdermal delivery
  • Pro-drugs
  • Targeted delivery
  • nab??technology
  • Dendrimers
  • BioSilicon??
  • Conclusions
• Chapter 5 Intellectual Property and
  • regulatory issues
  • Summary
  • Introduction
  • Patent issues
  • Regulatory considerations
  • Filing routes
  • Other issues
  • Non-patent market exclusivity
  • The non-approval route
  • Pharmacogenomics
  • Conclusions
• Chapter 6 Challenges of drug repositioning
  • Summary
  • Introduction
  • Challenges and obstacles to successful drug repositioning
  • Proof of concept clinical trials
  • New drug targets with novel mechanisms of action
  • Safety remains a key issue for early stage stalled drugs
  • Data and IP issues
  • Development of combination products
  • Indications discovery as part of a long-term lifecycle management program
  • Reformulation
• Chapter 7 The future of repositioning
  • Summary
  • Introduction
  • The future for repositioning
  • Business models and the future
  • Repositioning marketed drugs
  • Market size estimates
  • Impact of repositioning on R&D
  • Future financial rewards of repositioning marketed drugs
  • Market potential of reformulated drugs
  • Conclusions
  • Bibliography
  • Glossary
  • Index
  • Endnotes
• List of Figures
  • Figure 1.1: What is drug repositioning?
  • Figure 1.2: Number of new drugs approved each year: 1995-2005
  • Figure 1.3: Risk from patent expiry in the next 10 years
  • Figure 1.4: Drivers for drug repositioning
  • Figure 1.5: Timelines for repositioning vs de novo drug discovery and development
  • Figure 1.6: Success rates of the different drug development stages for new indications and line extensions compared to new chemical entities
  • Figure 2.7: Drug failure by phase
  • Figure 2.8: Approaches to drug repositioning
  • Figure 2.9: Technologies for repositioning pharma's 'failed' compounds
  • Figure 2.10: Technology platforms for finding new indications
  • Figure 2.11: Sosei's pipeline of drugs generated through repositioning
  • Figure 2.12: Melior Discovery's pipeline of repositioned drugs
  • Figure 3.13: CombinatoRx drug discovery method
  • Figure 4.14: Why reformulate?
  • Figure 4.15: Alza's three controlled release delivery systems
  • Figure 4.16: Construction of a dendrimer
  • Figure 7.17: Pharma's drug repositioning deals
• List of Tables
  • Table 1.1: Examples of repositioned compounds
  • Table 2.2: Attributes of the drug repositioning technology platforms
  • Table 2.3: Sosei's technology collaborations
  • Table 2.4: Indications covered by Melior Discovery's theraTRACESM indications discovery platform
  • Table 2.5: KineMed's collaborations for drug repositioning
  • Table 2.6: Improving efficacy through pharmacogenomics
  • Table 2.7: Summary of repositioning companies' business positions in March 2007
  • Table 3.8: Bionaut's development pipeline
  • Table 3.9: DanioLab's development pipeline
  • Table 3.10: Repositioning companies with a therapeutic focus
  • Table 3.11: Opportunities for drug repositioning with data mining
  • Table 3.12: Selected combination products under development by repositioning companies
  • Table 3.13: Selected public-sector small-molecule screening resources
  • Table 3.14: Commercial and publicly available molecular libraries for drug repositioning
  • Table 3.15: Selected academic drug repositioning projects
  • Table 3.16: Summary of repositioning companies' drug development pipelines
  • Table 4.17: Examples of manufacturers of oral controlled release formulations
  • Table 4.18: Egalet, SkyePharma, Penwest and Elan - pipelines of repositioned drugs using controlled release formulations
  • Table 4.19: Inhaled insulin products under development
  • Table 4.20: Nektar, Vectura, Aradigm: inhaled product development pipelines for non-respiratory therapeutic areas
  • Table 4.21: Repositioning projects from Altea Therapeutics
  • Table 4.22: Companies and approaches to pro-drug products
  • Table 4.23: XenoPort and Heidelberg Pharma's product pipelines
  • Table 7.24: Global drug delivery market value forecast: $ billion, 2005-2010