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

Drug Repositioning Strategies: Innovative strategies to boost pipeline productivity

発行	Business Insights
出版日	2007年06月	商品コード	52804
ページ情報	英文
価格	US$ 2,875 換算 ¥ 231,351 (税抜) PDF by E-mail (Single User License) US$ 10,782 換算 ¥ 867,627 (税抜) PDF by E-mail (Global License)

原文目次

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.

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