Drug Repositioning Strategies: Innovative strategies to boost pipeline productivity

Table of Contents

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