新薬再創出戦略：パイプライン生産性向上のための革新的戦略

Abstract

Drug repositioning is regarded as the pharma industry' s solution to falling R&D productivity and weakening product pipelines, successful repositioned drugs such as raloxifene ( Evista; Lilly), thalidomide (Thalomid; Celegene), (Exubera; Pfizer/Nektar)have enabled innovative companies to adopt lower risk strategies to optimize product pipelines. Drug Repositioning Strategies is a new report that provides in-depth analysis of leading pharma companies that are using novel technologies to reposition failed, marketed or reformulated compounds. This report analyzes strategies that are currently being employed by the leading players and the associated opportunities and challenges arising from them, enabling you to understand trends in the market and optimize your R&D pipeline. Use this report to examine current approaches to drug repositioning and identify successful technologies and business models that can help your organization deliver enhanced clinical and commercial output.

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