Examine Drug Repositioning Strategies Employed by the Leading Players in the Pharmaceutical Market.
Drug Repositioning Strategies: Innovative strategies to boost pipeline productivity
Drug repositioning is regarded as the pharma industry's solution to falling R&D productivity and weakening product pipelines, successfully 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.
* The number of deals between pharma and external drug repositioning partners has risen over the past 3 years. Companies with an active interest in this area include Bayer, Roche, Merck, Organon, Eli Lilly, Pfizer and Novartis.
* Repositioning marketed products for new indications will remain the most attractive repositioning strategy. The common approaches include drug combinations, broad indications discovery and the application of novel delivery technologies.
* Technologies that enable targeted delivery, alternative delivery routes, controlled delivery and prodrugs represent a large and growing market. Companies active in these areas will continue to be involved in repositioning projects for the foreseeable future
* As more clinical data for stalled drug candidates becomes available in the next five years, many failed compounds will migrate along the product development pipeline. This will drive the repositioning efforts of a number of pharma companies.
Key questions answered
* 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 repositioning being used to optimize drug pipelines?
* Which companies are utilizing libraries of marketed and off patent compounds for indications discovery?
* When will the first drugs developed by drug repositioning enter the marketplace?
Key issues examined in this report
* In spite of big pharma's productivity crisis in developing new products, drug repositioning is currently being utilized in a limited capacity. How and when will this strategy drive up the ROI on compounds that failed as late as Phase 2 or 3?
* The realization that drugs often have activity in more than one indication is growing. New technologies, presented in this report, are being utilized successfully for indications discovery- the first step of the drug repositioning process for both failed and marketed compounds.
* A large number of marketed drugs are due to come off patent in the next few years, providing a good supply of compounds for specialty pharma companies to test for activity on proprietary technology platforms
* Reformulation offers the potential for safer, more efficacious products that are easier for patients to use. This improves compliance with treatment regimes and increases patient satisfaction, while lowering the overall cost of treatment.
Table of Contents
Drug Repositioning Strategies Executive Summary 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
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
Technology platforms for indications discovery 32
Gene Logic 33
Melior Discovery and Melior Pharmaceuticals 39
BrainCells Inc and Dynogen 42
Repositioning - the Synosis business model 43
Chapter 3 Repositioning marketed compounds 49
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
Chapter 4 Drug repositioning through reformulation 71
Controlled delivery and chronotherapeutics 74
Non-invasive delivery routes 79
Inhaled delivery 79
Intranasal delivery 82
Transdermal delivery 83
Targeted delivery 87
nab technology 87
Chapter 5 Intellectual Property and regulatory issues 91
Patent issues 92
Regulatory considerations 94
Filing routes 94
Other issues 95
Non-patent market exclusivity 96
The non-approval route 97
Chapter 6 Challenges of drug repositioning 101
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
Chapter 7 The future of repositioning 107
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
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|Date:||Jun 7, 2007|
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