Drug Repositioning Strategies - Serendipity by design : Market Research Report

Drug Repositioning Strategies - Serendipity by design

Published by: Datamonitor

Published: May. 8, 2008 - 93 Pages

CHAPTER 1 EXECUTIVE SUMMARY: Scope of the report; Key findings
CHAPTER 2 OVERVIEW OF DRUG REPOSITIONING: Drug repositioning as a phenomenon distinct from lifecycle management; The basis of repositioning; The motives for repositioning; Increased R&D investment has had little impact on productivity; Greater hurdles to obtaining drug approval; Late-stage failures; Drug repositioning as a means of reducing risk, cost and time-to-market; Conventional de novo drug development; The development of a repositioned drug is accelerated relative to a conventional candidate; A growing trend toward systematic rather than serendipitous repositioning; Viagra (sildenafil) - from angina to impotence in one serendipitous leap; Duloxetine's dual role established through informed insight; The success of sildenafil and duloxetine was facilitated by the prevailing market environment; Informed insight could lead to diabetes drug for epilepsy; Thalidomide represents an unusual form of drug repositioning; Repositioning technologies; The resistors to repositioning; Most repositioned drugs are old, with little patent protection; Repositioned drugs tend to be protected by method of use patents; Seeking drug approval for marketed drugs; Prior safety and toxicology data may be incomplete or inadequate; Repositioning a drug for which primary indication use is still active; Acquiring discontinued drugs
CHAPTER 3 KEY PLAYERS IN DRUG REPOSITIONING: Ore Pharmaceuticals - one of the most established players in drug repositioning; Ore Pharmaceuticals's corporate history; Ore Pharmaceuticals's screening process is a composite of several technology platforms; In vivo spatial mapping of drug action and biomarker changes; Cellular and molecular characterization of drug action; In silico approach further validates link between drug and disease; Successful candidates returned to innovator; Celentyx - a new player on the repositioning block; Novel immune functions for old drugs; Celentyx uses cell-based assays to find new indications; CombinatoRx - combines old drugs for new indications; High-throughput combinatorial methodology; CombinatoRx's early-stage pipeline; CRx-102 ready for Phase III development; CombinatoRx receives method of use patent for psoriasis drug; Melior - systemizing serendipity; High-throughput in vivo drug screening; Melior has three early-stage pipeline drugs; Melior has formed collaborations with several Big Pharma players; Sosei - a pioneer drug repositioning company; Sosei's corporate history; Sosei grows its pipeline through partnership; KineMed - pathways to repositioning; KineMed's proprietary technology to assess drug-induced signal transduction flux; Pipeline growth through collaboration; Dynogen - a company with a narrow therapeutic focus; Pipeline of drugs with a gastrointestinal or genitourinary focus; Dynogen's partnerships and collaborations; Other repositioning companies; Synosia; DanioLabs; Pharnext; Arachnova
CHAPTER 4 DRUG REPOSITIONING CASE STUDIES: Drugs repositioned through serendipity; Mozobil (plerixafor) - the repositioning of a discontinued drug; Stem cell mobilization for cancer patients; Blind screen throws up antibiotics to treat neurological disease; Ceftriaxone as the most potent neuroprotector; Raloxifene - a marriage of serendipity and informed insight; One drug, two mechanisms of action; Drugs repositioned through informed insight; Rituximab - rational repositioning for multiple indications; Approval for rheumatoid arthritis; Off-label use for systemic lupus erythematosus but failure in clinical trials; In development for multiple sclerosis; The risks of repositioning; HIV protease inhibitor to treat cancer; Viracept (nelfinavir) most promising of the protease inhibitors; Maraviroc; Etanercept - from inflammation to neurodegeneration; Repositioning which does not fall neatly into either class; Rapamycin, antifungal, immunosuppressant and cancer treatment; Antiangiogenic properties of rapamycin; Rapamycin analog Certican (everolimus) in development for cancer; Avastin - reverse repositioning
CHAPTER 5 REPOSITIONING GOING FORWARD: Prospect of internal repositioning by innovators; Relationship between innovators and repositioners; Acquisition of repositioning companies by innovators; Repositioning companies fueling their own development process; Competition to acquire drug candidates could lead to consolidation; One drug, too many indications?; Emerging approaches - public sector funded small molecule based screening sectors; Optimization of repositioning; Combinatorial development the way forward
CHAPTER 6 BIBLIOGRAPHY: Publications and online articles; Conference literature; Datamonitor resources
APPENDIX: Abbreviations
List of Tables: Table 1: Breakdown of R&D investment for US Pharma, 2005; Table 2: Ore Pharmaceuticals's alliance profile, 2005-07; Table 3: CombinatoRx's recent alliances, 2006-07
List of Figures: Figure 1: Ways to reposition drugs; Figure 2: Weak pipelines drive adoption of drug repositioning; Figure 3: R&D investment and productivity out of synch, 1996-2006; Figure 4: Drug repositioning versus de novo drug development; Figure 5: The innovative drug development process; Figure 6: Drug repositioning as a means of streamlining the development process; Figure 7: Methods used to identify suitable drug candidates for repositioning; Figure 8: Major issues impacting on the repositioning process; Figure 9: Summary of some of the major companies involved in repositioning; Figure 10: Ore Pharmaceuticals's multidisciplinary drug technology platform; Figure 11: Outline of Celentyx's drug repositioning plan; Figure 12: CombinatoRx's drug development pipeline, 2008; Figure 13: Melior's drug development pipeline, 2008; Figure 14: Sosei's drug development pipeline, 2008; Figure 15: KineMed's metabolic pathway plan, 2008; Figure 16: Dynogen's drug development pipeline, 2008; Figure 17: Plerixafor's action in HIV and stem cell mobilization; Figure 18: Antibiotic and neuroprotective actions of ceftriaxone; Figure 19: Raloxifene's action in osteoporosis and breast cancer; Figure 20: Rituximab approved and/in development for several indications; Figure 21: Protease inhibitor nelfinavir in cancer; Figure 22: Maraviroc in HIV and rheumatoid arthritis; Figure 23: Etanercept in Alzheimer's disease; Figure 24: Rapamycin pathways in cancer and immunosuppression; Figure 25: Avastin versus Lucentis for age-related macular degeneration; Figure 26: Issues impacting drug repositioning in the future

Abstract

Introduction

Drug repositioning has several advantages over traditional discovery-reduced cost, risk and time to market-compared with traditional discovery, providing an attractive prospect for Big Pharma, scrambling to fill pipelines in an increasingly harsh market environment. As competition to inlicense candidates drives the price of this strategy up, repositioning presents a cost effective alternative.

Scope

An outline of what drug repositioning is, and what is driving it.

An overview of the key players in the repositioning industry their methodologies and specialities.

Case-studies describing a number of drugs which are or have been repositioned.

An insight into how repositioning will change going forward.

Report Highlights

Despite increasing R&D investment, productivity has been declining, at a time when Big Pharma is contending with late-stage pipeline failures and more rigorous drug approval procedures, in addition to external challenges in the form of generic competition and pricing pressures.

The cost savings, accelerated path to market, and lower risks that repositioning brings relative to traditional discovery are attractive to Big Pharma, which has thus far been filling pipeline gaps by in-licensing, a practice which has become more expensive as competition for candidates increases.

The companies involved in repositioning currently differ greatly in the methodologies used, in addition to their disease focus, however as the strategy gains traction, the industry is likely to undergo considerable consolidation.

Reasons to Purchase

Understand what drug repositioning is, and why it is important.

Become aware of who the key players in drug repositioning are and how they operate.

Gain an insight into how drugs have been, and are being repositioned.

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Drug Repositioning Strategies - Serendipity by design

Table of Contents

Abstract