Drug Repositioning Strategies
Innovative strategies to boost pipeline productivity
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| Overview: | |
| 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 | |
| Keywords: What impact will drug repositioning have on the pharma industry’s product pipelines? • Which companies are providing high-quality indication discovery services for failed compounds? • How is drug | |
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By Dr Cheryl Lee Barton / Publication Date: 1st June 2007
Contents:
Table of Contents
Drug Repositioning Strategies
Executive Summary 9
Introduction 9
Repositioning pharma’s failed compounds 10
Repositioning marketed compounds 11
Drug repositioning through reformulation 12
Intellectual Property and regulatory issues 13
Challenges of drug repositioning 14
The future of drug repositioning 14
Chapter 1 Introduction 17
Summary 17
Introduction 18
Why reposition? 20
The aims of repositioning 23
What has made repositioning possible? 25
Structure of the report 26
Chapter 2 Repositioning failed compounds 29
Summary 29
Introduction 30
Technology platforms for indications discovery 32
Gene Logic 33
Sosei 36
Melior Discovery and Melior Pharmaceuticals 39
KineMed 41
BrainCells Inc and Dynogen 42
iv
Repositioning – the Synosis business model 43
Pharmacogenomics 45
Conclusions 46
Chapter 3 Repositioning marketed
compounds 49
Summary 49
Introduction 50
Repositioning strategies 51
Indications discovery with new technologies 51
Bionaut Pharmaceuticals 51
DanioLabs and VASTox 52
Applying a therapeutic focus 54
Mining databases for new indications 56
Drug combinations 58
Repositioning in the public sector 62
Screening technologies 62
Molecular libraries 65
Repositioning based on advancing knowledge of disease 66
Conclusions 68
Chapter 4 Drug repositioning through
reformulation 71
Summary 71
Introduction 72
Controlled delivery and chronotherapeutics 74
Non-invasive delivery routes 79
Inhaled delivery 79
Intranasal delivery 82
Transdermal delivery 83
Pro-drugs 84
Targeted delivery 87
nab™ technology 87
Dendrimers 87
BioSilicon™ 88
Conclusions 89
v
Chapter 5 Intellectual Property and
regulatory issues 91
Summary 91
Introduction 92
Patent issues 92
Regulatory considerations 94
Filing routes 94
Other issues 95
Non-patent market exclusivity 96
The non-approval route 97
Pharmacogenomics 97
Conclusions 99
Chapter 6 Challenges of drug repositioning 101
Summary 101
Introduction 102
Challenges and obstacles to successful drug repositioning 102
Proof of concept clinical trials 102
New drug targets with novel mechanisms of action 102
Safety remains a key issue for early stage stalled drugs 103
Data and IP issues 104
Development of combination products 104
Indications discovery as part of a long-term lifecycle management program 104
Reformulation 105
Chapter 7 The future of repositioning 107
Summary 107
Introduction 108
The future for repositioning 108
Business models and the future 111
Repositioning marketed drugs 112
Market size estimates 113
Impact of repositioning on R&D 113
Future financial rewards of repositioning marketed drugs 114
Market potential of reformulated drugs 116
Conclusions 117
vi
Bibliography 118
Glossary 120
Index 123
Endnotes 12
List of Tables:
List of Figures
Figure 1.1: What is drug repositioning? 18
Figure 1.2: Number of new drugs approved each year: 1995-2005 20
Figure 1.3: Risk from patent expiry in the next 10 years 22
Figure 1.4: Drivers for drug repositioning 23
Figure 1.5: Timelines for repositioning vs de novo drug discovery and development 24
Figure 1.6: Success rates of the different drug development stages for new indications and line
extensions compared to new chemical entities 25
Figure 2.7: Drug failure by phase 30
Figure 2.8: Approaches to drug repositioning 31
Figure 2.9: Technologies for repositioning pharma’s ‘failed’ compounds 32
Figure 2.10: Technology platforms for finding new indications 34
Figure 2.11: Sosei’s pipeline of drugs generated through repositioning 38
Figure 2.12: Melior Discovery’s pipeline of repositioned drugs 40
Figure 3.13: CombinatoRx drug discovery method 59
Figure 4.14: Why reformulate? 73
Figure 4.15: Alza’s three controlled release delivery systems 75
Figure 4.16: Construction of a dendrimer 88
Figure 7.17: Pharma’s drug repositioning deals 110
vii
List of Tables
Table 1.1: Examples of repositioned compounds 19
Table 2.2: Attributes of the drug repositioning technology platforms 33
Table 2.3: Sosei’s technology collaborations 37
Table 2.4: Indications covered by Melior Discovery’s theraTRACESM indications discovery
platform 39
Table 2.5: KineMed’s collaborations for drug repositioning 41
Table 2.6: Improving efficacy through pharmacogenomics 45
Table 2.7: Summary of repositioning companies’ business positions in March 2007 47
Table 3.8: Bionaut’s development pipeline 52
Table 3.9: DanioLab’s development pipeline 53
Table 3.10: Repositioning companies with a therapeutic focus 55
Table 3.11: Opportunities for drug repositioning with data mining 57
Table 3.12: Selected combination products under development by repositioning companies 61
Table 3.13: Selected public-sector small-molecule screening resources 63
Table 3.14: Commercial and publicly available molecular libraries for drug repositioning 65
Table 3.15: Selected academic drug repositioning projects 67
Table 3.16: Summary of repositioning companies’ drug development pipelines 68
Table 4.17: Examples of manufacturers of oral controlled release formulations 76
Table 4.18: Egalet, SkyePharma, Penwest and Elan – pipelines of repositioned drugs using
controlled release formulations 77
Table 4.19: Inhaled insulin products under development 80
Table 4.20: Nektar, Vectura, Aradigm: inhaled product development pipelines for non-respiratory
therapeutic areas 81
Table 4.21: Repositioning projects from Altea Therapeutics 83
Table 4.22: Companies and approaches to pro-drug products 85
Table 4.23: XenoPort and Heidelberg Pharma’s product pipelines 86
Table 7.24: Global drug delivery market value forecast: $ billion, 2005-2010 116