Drug Repositioning

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Drug repositioning has become a matter of intense interest during the past few years. It is an approach to drug development that calls for reinvestigation of candidates that did not succeed in advanced clinical trials (for reasons other than safety) for potential use in other therapeutic indications.Discussed in this Report: Intellectual property coverage for new uses of known drugs Tool sets for identifying repositioning opportunities and business strategies Applicable legal frameworks and regulatory timelines for repositioned drugs Case studies of compound repositioning and approaches taken Activities of selected key companies in the drug repositioning business Financial aspects and economic potential of drug repositioning Drug repositioning is also known as drug repurposing, reprofiling, or retasking. In “on-target repurposing,” a drug’s known phar-macological mechanism is applied to a different therapeutic indication than that for which it was initially developed. Even more innovative is “off-target repurposing,” which looks for pharmacological mechanisms that have not yet been described for a known molecule. In either case, having previously failed during clinical development is not a criterion for repositioning; the avenue is equally open to drugs that are or have been marketed.Drug repurposing can have very different commercial implications. These will depend on where the drug comes from, how much accessible data exist, and how well the repurposer can exploit the new value chain created by a successfully repurposed drug. This will to a large extent depend on what sort of intellectual property can be secured for the drug’s new use, as examined in Chapter 2 of Drug Repositioning: Extracting Value from Prior R&D Investments. The repurposer fights an uphill battle against examiners who will scrutinize the prior art for“obviousness,” i.e., any public facts that can be construed to have anticipated the new medical use of a known drug.Together with expert knowledge in pharmacology, state-of-the-art genomic, proteomic, animal model, and bioinformatics tech-nologies are employed to identify repurposing opportunities and business strategies. These more technology-oriented aspects are discussed in Chapter 3, followed by an outline of the regulatory environment for repurposing in Chapter 4. Here, we discuss the applicable legal framework and show that while repurposing can remove the initial 1-1.5 years of preclinical and Phase I de-velopment time (the latter only if no new formulation has to be developed and tested), the later stages of the regulatory review process for repurposed drugs are the same as with new chemical entities. Chapter 5 discusses exemplary cases of drug reposi-tioning and the approaches taken, depending on the intended goal.Drug repurposing has become a new business segment for the life science services industry. Chapter 6 profiles selected key companies that offer platform-based services to identify repurposing opportunities. For the decade ahead to 2020, we predict that cutting-edge repurposing technology will see increasing integration as a standard process of resource utilization, de-risking and acceleration of drug development. In this chapter we also discuss the internal repurposing efforts of Pfizer, Novartis, and Eli Lilly and how these programs tie into their overall development strategies. Drug Repositioning: Extracting Added Value from Prior R&D Investments concludes with a discussion of the financial aspects, considering the benefits of repurposing for larger, smaller, and startup companies.  

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Drug Repositioning

  1. 1. Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!Drug RepositioningPublished on July 2010 Report SummaryDrug repositioning has become a matter of intense interest during the past few years. It is an approach to drug development that callsfor reinvestigation of candidates that did not succeed in advanced clinical trials (for reasons other than safety) for potential use inother therapeutic indications.Discussed in this Report: Intellectual property coverage for new uses of known drugs Tool sets for identifying repositioningopportunities and business strategies Applicable legal frameworks and regulatory timelines for repositioned drugs Case studies ofcompound repositioning and approaches taken Activities of selected key companies in the drug repositioning business Financialaspects and economic potential of drug repositioning Drug repositioning is also known as drug repurposing, reprofiling, or retasking.In “on-target repurposing,” a drug’s known phar-macological mechanism is applied to a different therapeuticindication than that for which it was initially developed. Even more innovative is “off-target repurposing,” which looks forpharmacological mechanisms that have not yet been described for a known molecule. In either case, having previously failed duringclinical development is not a criterion for repositioning; the avenue is equally open to drugs that are or have been marketed.Drug repurposing can have very different commercial implications. These will depend on where the drug comes from, how muchaccessible data exist, and how well the repurposer can exploit the new value chain created by a successfully repurposed drug. Thiswill to a large extent depend on what sort of intellectual property can be secured for the drug’s new use, as examined inChapter 2 of Drug Repositioning: Extracting Value from Prior R&D Investments. The repurposer fights an uphill battle againstexaminers who will scrutinize the prior art for“obviousness,” i.e., any public facts that can be construed to haveanticipated the new medical use of a known drug.Together with expert knowledge in pharmacology, state-of-the-art genomic, proteomic, animal model, and bioinformaticstech-nologies are employed to identify repurposing opportunities and business strategies. These more technology-oriented aspectsare discussed in Chapter 3, followed by an outline of the regulatory environment for repurposing in Chapter 4. Here, we discuss theapplicable legal framework and show that while repurposing can remove the initial 1-1.5 years of preclinical and Phase Ide-velopment time (the latter only if no new formulation has to be developed and tested), the later stages of the regulatory reviewprocess for repurposed drugs are the same as with new chemical entities. Chapter 5 discusses exemplary cases of drugreposi-tioning and the approaches taken, depending on the intended goal.Drug repurposing has become a new business segment for the life science services industry. Chapter 6 profiles selected keycompanies that offer platform-based services to identify repurposing opportunities. For the decade ahead to 2020, we predict thatcutting-edge repurposing technology will see increasing integration as a standard process of resource utilization, de-risking andacceleration of drug development. In this chapter we also discuss the internal repurposing efforts of Pfizer, Novartis, and Eli Lilly andhow these programs tie into their overall development strategies. Drug Repositioning: Extracting Added Value from Prior R&DInvestments concludes with a discussion of the financial aspects, considering the benefits of repurposing for larger, smaller, andstartup companies.Drug Repositioning (From Slideshare) Page 1/5
  2. 2. Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email! Table of ContentChapter 1 INTRODUCTION: A SECOND LIFE FOR DRUGS AND DRUG CANDIDATES 1.1. Targets and Agents: Approachingthe Limits1.2. Human Physiology as a Network of Interdependencies1.3. Leveraging Drug Repurposing To Turn the Tables onPipeline Erosion1.4. Finding Another Disease To Treat: On-Target and Off-TargetChapter 2 DRUG REPOSITIONING AND INTELLECTUAL PROPERTY 2.1. Considerations Regarding the PatentabilityCriteria2.2. Searching Prior Art to Assess Repurposing Opportunities2.3. Searching For Intellectual Property Gaps2.4. DataSupport: An Indispensable Requirement for Second Use Patenting2.5. Case Study: Developer Actelion Claims Bosentan for OvarianCancerChapter 3 THE STRATEGIC CONCEPT, THE SCIENCE, AND THE TOOLS OF THE THERAPEUTIC SWITCH 3.1. WhatStrategic Considerations Make a Compound a Repositioning Candidate3.2. Identification of Repurposing OpportunitiesKnow theScienceKnow the ResourcesHypothesis-Driven Approaches3.3. Targeted High-Throughput Screening and Inverse High-ContentScreeningPhenotypic Screening: Parameter-Free High-Content ScreeningMultiplexing Animal Tests3.4. Putting Informatics toWorkCase Study for Gene Expression: VVP808Case Study for Virtual Screening and In Silico Docking: SOSA andEntacaponeCase Study for Systems Biology: OptimataData Mining and Ligand-Similarity ApproachesNew Opportunities ThroughGrid Computing3.5. Repurposing Aided By Drug Reformulation and New Forms of Delivery3.6. Repurposing for Biodefense: AStrategy Outside of the MainstreamChapter 4 REPOSITIONED DRUGS AND REGULATORY AUTHORITIES 4.1. The FDA’s 505(b)(2) New DrugApplication4.2. The EMEA “Hybrid Application”Chapter 5 EXAMPLES OF DRUG REPURPOSING 5.1. Successfully Repositioned Compounds That Were Never Marketed ForTheir Original Development Targets or Were Withdrawn From the MarketPfizer’s Sildenafil: From Failed Antihypertensive, toLifestyle Drug, to Orphan DiseaseThalidomide: A Colossal Tragedy and a New BeginningAzidothymidine: A Cancer DrugCandidate Repurposed as an HIV Therapeutic and Vice Versa5.2. Drugs That Were Moderately Successful and Were (Or AreBeing) RepurposedGalantamine: Transformed Into an Alzheimer’s Drug, With More PerspectivesCicletanine: AnAntihypertensive for Pulmonary Hypertension…And DiabetesRopinirole and Pramipexole: Parkinson’s Drugs forRestless Leg SyndromeBenzbromarone: A Potentially Problematic Gout Drug Applied To MRSA InfectionsClioquinol: An OldAntiprotozoal As a Lead Compound for NeuroprotectionAstemizole: A Problematic Antihistamine with Significant AlternativePerspectives5.3. Successful Primary-Use Drugs in Repurposing ScenariosMilnacipran and Duloxetine: Two Antidepressants NowApproved for FibromyalgiaFinasteride: From Prostate to Hair LossImatinib for Diabetes and Rheumatoid Arthritis5.4. Failed, andFailed Again…Perhaps For the Wrong ReasonsMCI-225: From Psychiatry Drug Candidate, to Gastrointestinal and UrinaryTract AgentChapter 6 COMPANIES IN THE DRUG REPURPOSING BUSINESS 6.1. Business Models Centered On Drug Repurposing:Different From Those for Discovery6.2. The Small, Drug-Repurposing SpecialistsSosei Group Corp.CombinatoRx, Inc.OrePharmaceutical Holdings, Inc.Biovista, Inc.Melior Discovery, Inc.Numedicus Ltd.Vifor Pharma/Galenica GroupAureusPharmaHorizon Discovery Ltd.Tangent Reprofiling Ltd.Anaxomics Biotech SLSOM Biotech SLSWITCHBIOTECHLLCCelentyx Ltd.Almac Group Ltd.6.3. “Big Pharma” And Drug RepositioningPfizerNovartisEli Lilly6.4. PublicEfforts to Facilitate Drug RepurposingChapter 7 THE ECONOMIC POTENTIAL OF DRUG REPURPOSING 7.1. Cost Savings of Repurposing In Discovery andDrug Repositioning (From Slideshare) Page 2/5
  3. 3. Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!Development7.2. Acceleration of Drug Development: Time Equals Sales7.3. The Benefits of De-Risking7.4. The RepurposingService Provider’s Perspective7.5. Summary and OutlookReferencesCompany Index with Web AddressesDrug Repositioning (From Slideshare) Page 3/5
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