Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the report
- Key findings
- CHAPTER 2 OVERVIEW OF DRUG REPOSITIONING
- Drug repositioning as a phenomenon distinct from lifecyclemanagement
- The basis of repositioning
- The motives for repositioning
- Increased R&D investment has had little impact onproductivity
- Greater hurdles to obtaining drug approval
- Late-stage failures
- Drug repositioning as a means of reducing risk, cost andtime-to-market
- Conventional de novo drug development
- The development of a repositioned drug is acceleratedrelative to a
conventional candidate
- A growing trend toward systematic rather thanserendipitous repositioning
- Viagra (sildenafil) - from angina to impotence in oneserendipitous leap
- Duloxetine' s dual role established through informedinsight
- The success of sildenafil and duloxetine was facilitatedby the
prevailing market environment
- Informed insight could lead to diabetes drug for epilepsy
- Thalidomide represents an unusual form of drugrepositioning
- Repositioning technologies
- The resistors to repositioning
- Most repositioned drugs are old, with little patentprotection
- Repositioned drugs tend to be protected by method of usepatents
- Seeking drug approval for marketed drugs
- Prior safety and toxicology data may be incomplete orinadequate
- Repositioning a drug for which primary indication use isstill active
- Acquiring discontinued drugs
- CHAPTER 3 KEY PLAYERS IN DRUG REPOSITIONING
- Ore Pharmaceuticals - one of the most established playersin drug
repositioning
- Ore Pharmaceuticals' s corporate history
- Ore Pharmaceuticals' s screening process is a composite ofseveral
technology platforms
- In vivo spatial mapping of drug action and biomarkerchanges
- Cellular and molecular characterization of drug action
- In silico approach further validates link between drug anddisease
- 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 psoriasisdrug
- Melior - systemizing serendipity
- High-throughput in vivo drug screening
- Melior has three early-stage pipeline drugs
- Melior has formed collaborations with several Big Pharmaplayers
- 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-inducedsignal
transduction flux
- Pipeline growth through collaboration
- Dynogen - a company with a narrow therapeutic focus
- Pipeline of drugs with a gastrointestinal or genitourinaryfocus
- 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 discontinueddrug
- Stem cell mobilization for cancer patients
- Blind screen throws up antibiotics to treat neurologicaldisease
- Ceftriaxone as the most potent neuroprotector
- Raloxifene - a marriage of serendipity and informedinsight
- One drug, two mechanisms of action
- Drugs repositioned through informed insight
- Rituximab - rational repositioning for multipleindications
- Approval for rheumatoid arthritis
- Off-label use for systemic lupus erythematosus but failurein
clinical trials
- In development for multiple sclerosis
- The risks of repositioning
- HIV protease inhibitor to treat cancer
- Viracept (nelfinavir) most promising of the proteaseinhibitors
- Maraviroc
- Etanercept - from inflammation to neurodegeneration
- Repositioning which does not fall neatly into either class
- Rapamycin, antifungal, immunosuppressant and cancertreatment
- Antiangiogenic properties of rapamycin
- Rapamycin analog Certican (everolimus) in development forcancer
- 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 developmentprocess
- Competition to acquire drug candidates could lead toconsolidation
- One drug, too many indications?
- Emerging approaches - public sector funded small moleculebased screening
sectors
- Optimization of repositioning
- Combinatorial development the way forward
- CHAPTER 6 BIBLIOGRAPHY
- Publications and online articles
- Conference literature
- Datamonitor resources
- APPENDIX
- 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 drugrepositioning
- Figure 3: R&D investment and productivity out ofsynch, 1996-2006
- Figure 4: Drug repositioning versus de novo drugdevelopment
- Figure 5: The innovative drug development process
- Figure 6: Drug repositioning as a means of streamliningthe development
process
- Figure 7: Methods used to identify suitable drugcandidates for
repositioning
- Figure 8: Major issues impacting on the repositioningprocess
- Figure 9: Summary of some of the major companiesinvolved in repositioning
- Figure 10: Ore Pharmaceuticals' s multidisciplinary drugtechnology
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 cellmobilization
- Figure 18: Antibiotic and neuroprotective actions ofceftriaxone
- Figure 19: Raloxifene' s action in osteoporosis andbreast cancer
- Figure 20: Rituximab approved and/in development forseveral 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 andimmunosuppression
- Figure 25: Avastin versus Lucentis for age-relatedmacular degeneration
- Figure 26: Issues impacting drug repositioning in thefuture
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