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Examine Drug Repositioning Strategies Employed by the Leading Players in the Pharmaceutical Market.

LYON, France -- announces that a new market research report related to the worldwide pharmaceutical industry is now available to its catalogue.

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

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

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

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

Bibliography 118

Glossary 120

Index 123

Endnotes 123

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Date:Jun 7, 2007
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