Drug Repositioning: New Technologies, Business Models & Strategies forSuccessful DevelopmentReportsnReports.com adds Arrow...
   What are the major rewards offered by strategic drug repositioning?   What are the major challenges involved in this ...
3.9 Reformulation and Alternative Delivery Strategies3.10 Technology Selection Considerations4 THE MAJOR CHALLENGES OF DRU...
7.1.2 Reducing R&D Expenditure7.1.3 Derisking R&D7.1.4 Enhancing Product Life Cycle Management7.1.5 Reviving Failed Drug C...
Figure   15:   Comparison of Traditional De Novo R&D versus Drug RepositioningFigure   16:   Risk: Reward Ratio Comparison...
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ReportsnReports – Drug Repositioning: New Technologies, Business Models & Strategies for Successful Development

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Drug repositioning market offers the possibility of breathing new life into pharmaceutical R&D. By recycling drug data, repositioning promises to boost production, accelerate and derisk R&D, and enhance product life-cycle management.

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ReportsnReports – Drug Repositioning: New Technologies, Business Models & Strategies for Successful Development

  1. 1. Drug Repositioning: New Technologies, Business Models & Strategies forSuccessful DevelopmentReportsnReports.com adds Arrowhead Publishers Market Research Report “DrugRepositioning: New Technologies, Business Models & Strategies for SuccessfulDevelopment’’ to its store.Drug repositioning market offers the possibility of breathing new life into pharmaceuticalR&D. By recycling drug data, repositioning promises to boost production, accelerate andderisk R&D, and enhance product life-cycle management.The promise of drug repositioning is now driving Big Pharma and Biotech to focus over 50%of its R&D activity into the approach. As the benefits of drug repositioning are being realizedby industry; it is vital that stakeholders successfully navigate this challenging yet rewardingR&D paradigm.This in-depth report delivers:Analysis of the scientific and technological strategies driving drug repositioning, successfulbusiness models, the role of Big Pharma and the financial reward of strategic drugrepositioningIdentification of the major challenges within strategic drug repositioning – examining theproof-of-concept clinical trial, regulatory hurdles, intellectual property barriers, selection ofscreening technologies and company organizationClinical and commercial analysis of classic and recently-approved repositioned products andkey Phase III candidatesReport highlights:With around 2,000 Phase II and Phase III failed pipeline candidates typically sitting idle in atypical pharma drug library, drug repositioning may resurrect abandoned R&D programs.Success will recoup R&D costs and provide novel, high-value product life-cyclemanagement.Arrowhead has identified over 50 specialist drug repositioning companies offering uniquescreening technologies. It is essential that players adopt a multi-disciplined approach byforming collaborations with specialists to gain valid, fast results to unveil new commercialopportunities.This report will enable you to: Assess opportunities and risks influencing strategic drug repositioning R&D Identify key repositioned products in late-phase development based on sales forecasts to 2016, to maximize your product’s commercial potential Gain an impartial perspective of strategies that can be used to enhance your product’s performance in the drug repositioning arenaKey questions answered by this report: Why is there a need for drug repositioning in the biopharmaceutical industry?
  2. 2.  What are the major rewards offered by strategic drug repositioning? What are the major challenges involved in this paradigm; and how can they be overcome? Who are the key specialist players involved in the market and what business models are they utilizing? What lessons can investors learn from established repositioned brands? What products have recently gained FDA approval and what developmental pathway did they take? How can players optimize strategic drug repositioning to maximize commercial success? What are the key leading products and pipeline candidates in the market? How much revenue will the leading products and key pipeline agents reach by 2016? What financial rewards does the strategy provide? What recommendations does Arrowhead provide for successful repositioning? What does the future hold for the drug repositioning market?TABLE OF CONTENTS1 EXECUTIVE SUMMARY1.1 Scope of Drug Repositioning1.2 Methodology OF Drug Repositioning1.3 The Need for Drug Repositioning1.4 Key Challenges Involved in Drug Repositioning1.5 Successful Drug Repositioning Business Models1.6 Financial Analysis of the Drug Repositioning Market2 INTRODUCTION TO THE DRUG REPOSITIONING CONCEPT2.1 What is Drug Repositioning?2.1.1 The Definition of Drug Repositioning2.1.2 The Aims of Drug Repositioning2.1.3 The History of Drug Repositioning2.2 The Need for Drug Repositioning2.2.1 Lack of Highly Effective Products for Numerous Indications2.2.2 Safer Drugs are Needed2.2.3 The Cost of R&D May be Greater than Thought2.2.4 Industry Pipelines are Weak with Small Growth Rates2.2.5 Low Attrition Rates in R&D2.2.6 The Number of NME’s Submissions are Falling, Leading to Fewer FDA Approvals2.2.7 Patent Expiries to Rise Over the Coming Years2.3 Repositioned Drug Products with New Indications3 SCIENTIFIC AND TECHNOLOGICAL STRATEGIES DRIVING DRUG REPOSITIONING3.1.1 The Science of Drug Repositiong: On and Off Targeting3.2 Overview of the Strategic Drug Repositioning R&D Process3.3 Technological Advances are Driving Drug Repositioning3.3.1 Technological Strategies Identifying Repositioning Opportunities3.4 In Vivo Screening3.5 In Vitro Screening3.6 Informatics in Drug Repositioning3.7 Pharmacogenomics in Drug Repositioning3.8 Network-based Drug Repositioning
  3. 3. 3.9 Reformulation and Alternative Delivery Strategies3.10 Technology Selection Considerations4 THE MAJOR CHALLENGES OF DRUG REPOSITIONING R&D4.1 Overview of the Major Challenges Involved in Drug Repositioning R&D4.2 The Proof-of-Concept Clinical Trial4.2.1 Proof-of-Concept Trial Design Considerations4.3 Intellectual Property Challenges4.4 Drug Repositioning IP Considerations4.4.1 Maximizing IP and Market Exclusivity Rights4.4.2 Finding IP Drug Repositoning Opportunities4.5 Regulatory Challenges4.5.1 The FDA’s 505(b)(2) NDA4.5.2 The EMEA’s Hybrid Application5 BUSINESS MODELS OF KEY SPECIALIST DRUG REPOSITIONING PLAYERS ANDTHE ROLE OF BIG PHARMA5.1 Biovista5.2 Gene Logic5.3 Kinemed5.4 Melior Discovery5.5 SOM Biotech5.6 Sosei5.7 Zalicus5.8 Big Pharma’s Business Model in Drug Repositioning5.8.1 Pfizer’s Indication Discovery Unit5.8.2 Big Pharma In-House Drug Repositioning Considerations6 CASE STUDIES OF REPOSITIONED DRUGS: PIVOTAL PRODUCTS, NEWAPPROVALS AND KEY PIPELINE CANDIDATES6.1 Pivotal Repositioned Products6.1.1 Case Study of Pfizer’s Viagra (sidenafil)6.1.2 Case Study of Eli Lilly’s Cymbalta (duloxetine)6.1.3 Case Study of Celgene’s Thalomid (thalidomide)6.2 Newly FDA Approved Repositioned Products6.2.1 Case Study of Somaxon’s Silenor (doxepin)6.2.2 Case Study of Mobius’ Mitosol (mitomycin)6.2.3 Case Study of Avanir’s Nuedexta (dextramethorphan/quinidine)6.2.4 Case Study of Allergan’s Botox (onabotulinumtoxinA)6.3 The Drug Repositioning Pipeline6.3.1 Case Study of Ampio Pharma’s Zertane6.3.2 Case Study of Novartis/Sosei/Vectura’s NVA237 (glycopyrronium bromide)6.3.3 Case Study of Novartis/Sosei/Vectura’s Arcapta Neohaler (glycopyrromium bromide,indacaterol; QAB149)6.3.4 Case Study of Corcept Therapeutic’s Corlux (mifepristone)7 THE MARKET IMPACT OF DRUG REPOSITIONING7.1 The Potential Benefits of Drug Repositioning7.1.1 Accelerating R&D
  4. 4. 7.1.2 Reducing R&D Expenditure7.1.3 Derisking R&D7.1.4 Enhancing Product Life Cycle Management7.1.5 Reviving Failed Drug Candidates and Market Withdrawn Drugs7.1.6 Boosting Industry Productivity7.2 The Economics of Drug Repositioning7.2.1 Orphan Drug Status and Drug Repositioning7.2.2 Geographic Drug Repositioning7.3 SWOT Analysis of the Drug Repositioning Market, 20117.4 The Future of Drug Repositioning7.4.1 The Increasing Role of Biotech in Drug Repositioning7.5 Financial Forecast of the Drug Repositioning Market7.6 Arrowhead’s Recommendations for Successful Drug Repositioning7.7 Conclusion8 BIBLIOGRAPHYLIST OF TABLESTable 1: Leading Causes of Mortality in the US, 2001Table 2: Top-Selling Products Facing Patent Expiry in 2011-2016Table 3: Repositioned Branded Products with a New IndicationTable 4: Summary of Specialized Drug Repositioning Companies May 2011Table 5: Biovista’s Pipeline, May 2011Table 6: SOM Biotech’s Pipeline, May 2011Table 7: Sosei’s Pipeline, May 2011Table 8: Zalicus’ Pipeline, May 2011Table 9: Repositioned Drug Products FDA Approved 2010-May 2011Table 10: Phase III and Phase II Specialized Drug Repositioners Pipeline, May 2011Table 11: Key Drugs Withdrawn by the FDA, 2000-2010Table 12: Repositioned Branded Drugs Revenue History 2005-2010 ($ million)Table 13: Repositioned Branded Drugs Revenue Forecast 2011-2016 ($ million)LIST OF FIGURESFigure 1: US Biopharmaceutical Industry Productivity, 2000-2010Figure 2: Key Challenges in Drug RepositioningFigure 3: Comparison of the Branded Repositioned Drug Market, 2011 and 2016 ($ billion)Figure 4: Patient Response Rate to Drug Medication by Therapeutic AreaFigure 5: Cumulative Cost per step in Developing a New Drug Application (NDA)Figure 6: Attrition Rate of New Candidates in the Drug Development ProcessFigure 7: Comparison of the Number of NME’s Submitted and Approved by the FDA, 2000-2010.Figure 8: The Two Scientific Concepts of Drug RepositioningFigure 9: Summary of the Drug Repositioning Developmental ProcessFigure 10: The Virtual Discovery Drug Repositioning StrategyFigure 11: The Favored Targeting Drug Repositioning StrategyFigure 12: The Model Insight Drug Repositioning StrategyFigure 13: The Agnostic Screening Drug Repositioning StrategyFigure 14: The Reformulation/Alternative Delivery Drug Repositioning Strategy
  5. 5. Figure 15: Comparison of Traditional De Novo R&D versus Drug RepositioningFigure 16: Risk: Reward Ratio Comparison of Drug Development StrategiesFigure 17: Product Life Cycle Management Enhancement by Drug RepositioningFigure 18: SWOT Analysis of the Drug Repositioning Market, 2011Figure 19: Repositioned Branded Drug Revenue Forecast, 2006-2016 ($ billion)Latest Market Research Reports:  North American Fire and Life Safety Market  Brazilian Industrial Protective Footwear Market  VEGF Inhibition: Therapy-Indicating and Prognostic Biomarkers, 2011  On-Trade Alcoholic Drinking Trends: Differentiating consumer on-trade drinking occasions to capitalize on value generating opportunities  Recycling Equipment Market in Singapore – Singapore recycling equipment marketAbout Us:ReportsnReports is an online library of over 75,000 market research reports and in-depthmarket research studies & analysis of over 5000 micro markets. We provide 24/7 online andoffline support to our customers. Get in touch with us for your needs of market researchreports.Follow us on Twitter: http://twitter.com/marketsreportsOur Facebook Page: http://www.facebook.com/pages/ReportsnReports/191441427571689Contact:Mr. Priyank7557 Rambler road,Suite 727, Dallas, TX 75231Tel: + 1 888 391 5441E-mail: sales@reportsandreports.comhttp://www.reportsnreports.comVisit Our Blog : Market Research Reports

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