Drug Repositioning Strategies: Innovative Strategies to Boost Pipeline Productivity

Published by: Business Insights

Published: Jun. 1, 2007 - 129 Pages

Table of Contents

Drug Repositioning Strategies

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

Abstract

• 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.

• 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?

• 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.

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