Drug Repositioning: New Technologies, Business Models & Strategies for Successful Development
Big Pharma’s 2012 colossal patent cliff looms. Thirteen blockbuster drugs are set to lose US patent protection; costing industry 70% in lost revenues. Furthermore, despite record R&D investment, biopharmaceutical productivity remains in decline. Drug repositioning 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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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 realized by industry; it is vital that stakeholders successfully navigate this challenging yet rewarding R&D paradigm.
This in-depth report delivers:
- Analysis of the scientific and technological strategies driving drug repositioning, successful business models, the role of Big Pharma and the financial reward of strategic drug repositioning
- Identification of the major challenges within strategic drug repositioning - examining the proof-of-concept clinical trial, regulatory hurdles, intellectual property barriers, selection of screening technologies and company organization
- Clinical and commercial analysis of classic and recently-approved repositioned products and key Phase III candidates
Report highlights:
With around 2,000 Phase II and Phase III failed pipeline candidates typically sitting idle in a typical pharma drug library, drug repositioning may resurrect abandoned R&D programs. Success will recoup R&D costs and provide novel, high-value product life-cycle management.
Arrowhead has identified over 50 specialist drug repositioning companies offering unique screening technologies. It is essential that players adopt a multi-disciplined approach by forming collaborations with specialists to gain valid, fast results to unveil new commercial opportunities.
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 arena
Key questions answered by this report:
- Why is there a need for drug repositioning in the biopharmaceutical industry?
- 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 CONTENTS
1 EXECUTIVE SUMMARY
1.1 Scope of Drug Repositioning
1.2 Methodology OF Drug Repositioning
1.3 The Need for Drug Repositioning
1.4 Key Challenges Involved in Drug Repositioning
1.5 Successful Drug Repositioning Business Models
1.6 Financial Analysis of the Drug Repositioning Market
2 INTRODUCTION TO THE DRUG REPOSITIONING CONCEPT
2.1 What is Drug Repositioning?
2.1.1 The Definition of Drug Repositioning
2.1.2 The Aims of Drug Repositioning
2.1.3 The History of Drug Repositioning
2.2 The Need for Drug Repositioning
2.2.1 Lack of Highly Effective Products for Numerous Indications
2.2.2 Safer Drugs are Needed
2.2.3 The Cost of R&D May be Greater than Thought
2.2.4 Industry Pipelines are Weak with Small Growth Rates
2.2.5 Low Attrition Rates in R&D
2.2.6 The Number of NME’s Submissions are Falling, Leading to Fewer FDA Approvals
2.2.7 Patent Expiries to Rise Over the Coming Years
2.3 Repositioned Drug Products with New Indications
3 SCIENTIFIC AND TECHNOLOGICAL STRATEGIES DRIVING DRUG REPOSITIONING
3.1.1 The Science of Drug Repositiong: On and Off Targeting
3.2 Overview of the Strategic Drug Repositioning R&D Process
3.3 Technological Advances are Driving Drug Repositioning
3.3.1 Technological Strategies Identifying Repositioning Opportunities
3.4 In Vivo Screening
3.5 In Vitro Screening
3.6 Informatics in Drug Repositioning
3.7 Pharmacogenomics in Drug Repositioning
3.8 Network-based Drug Repositioning
3.9 Reformulation and Alternative Delivery Strategies
3.10 Technology Selection Considerations
4 THE MAJOR CHALLENGES OF DRUG REPOSITIONING R&D
4.1 Overview of the Major Challenges Involved in Drug Repositioning R&D
4.2 The Proof-of-Concept Clinical Trial
4.2.1 Proof-of-Concept Trial Design Considerations
4.3 Intellectual Property Challenges
4.4 Drug Repositioning IP Considerations
4.4.1 Maximizing IP and Market Exclusivity Rights
4.4.2 Finding IP Drug Repositoning Opportunities
4.5 Regulatory Challenges
4.5.1 The FDA’s 505(b)(2) NDA
4.5.2 The EMEA’s Hybrid Application
5 BUSINESS MODELS OF KEY SPECIALIST DRUG REPOSITIONING PLAYERS AND THE ROLE OF BIG PHARMA
5.1 Biovista
5.2 Gene Logic
5.3 Kinemed
5.4 Melior Discovery
5.5 SOM Biotech
5.6 Sosei
5.7 Zalicus
5.8 Big Pharma's Business Model in Drug Repositioning
5.8.1 Pfizer’s Indication Discovery Unit
5.8.2 Big Pharma In-House Drug Repositioning Considerations
6 CASE STUDIES OF REPOSITIONED DRUGS: PIVOTAL PRODUCTS, NEW APPROVALS AND KEY PIPELINE CANDIDATES
6.1 Pivotal Repositioned Products
6.1.1 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 Products
6.2.1 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 Pipeline
6.3.1 Case Study of Ampio Pharma’s Zertane
6.3.2 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 REPOSITIONING
7.1 The Potential Benefits of Drug Repositioning
7.1.1 Accelerating R&D
7.1.2 Reducing R&D Expenditure
7.1.3 Derisking R&D
7.1.4 Enhancing Product Life Cycle Management
7.1.5 Reviving Failed Drug Candidates and Market Withdrawn Drugs
7.1.6 Boosting Industry Productivity
7.2 The Economics of Drug Repositioning
7.2.1 Orphan Drug Status and Drug Repositioning
7.2.2 Geographic Drug Repositioning
7.3 SWOT Analysis of the Drug Repositioning Market, 2011
7.4 The Future of Drug Repositioning
7.4.1 The Increasing Role of Biotech in Drug Repositioning
7.5 Financial Forecast of the Drug Repositioning Market
7.6 Arrowhead's Recommendations for Successful Drug Repositioning
7.7 Conclusion
8 BIBLIOGRAPHY
LIST OF TABLES
Table 1: Leading Causes of Mortality in the US, 2001
Table 2: Top-Selling Products Facing Patent Expiry in 2011-2016
Table 3: Repositioned Branded Products with a New Indication
Table 4: Summary of Specialized Drug Repositioning Companies May 2011
Table 5: Biovista’s Pipeline, May 2011
Table 6: SOM Biotech’s Pipeline, May 2011
Table 7: Sosei’s Pipeline, May 2011
Table 8: Zalicus’ Pipeline, May 2011
Table 9: Repositioned Drug Products FDA Approved 2010-May 2011
Table 10: Phase III and Phase II Specialized Drug Repositioners Pipeline, May 2011
Table 11: Key Drugs Withdrawn by the FDA, 2000-2010
Table 12: Repositioned Branded Drugs Revenue History 2005-2010 ($ million)
Table 13: Repositioned Branded Drugs Revenue Forecast 2011-2016 ($ million)
LIST OF FIGURES
Figure 1: US Biopharmaceutical Industry Productivity, 2000-2010
Figure 2: Key Challenges in Drug Repositioning
Figure 3: Comparison of the Branded Repositioned Drug Market, 2011 and 2016 ($ billion)
Figure 4: Patient Response Rate to Drug Medication by Therapeutic Area
Figure 5: Cumulative Cost per step in Developing a New Drug Application (NDA)
Figure 6: Attrition Rate of New Candidates in the Drug Development Process
Figure 7: Comparison of the Number of NME’s Submitted and Approved by the FDA, 2000-2010.
Figure 8: The Two Scientific Concepts of Drug Repositioning
Figure 9: Summary of the Drug Repositioning Developmental Process
Figure 10: The Virtual Discovery Drug Repositioning Strategy
Figure 11: The Favored Targeting Drug Repositioning Strategy
Figure 12: The Model Insight Drug Repositioning Strategy
Figure 13: The Agnostic Screening Drug Repositioning Strategy
Figure 14: The Reformulation/Alternative Delivery Drug Repositioning Strategy
Figure 15: Comparison of Traditional De Novo R&D versus Drug Repositioning
Figure 16: Risk: Reward Ratio Comparison of Drug Development Strategies
Figure 17: Product Life Cycle Management Enhancement by Drug Repositioning
Figure 18: SWOT Analysis of the Drug Repositioning Market, 2011
Figure 19: Repositioned Branded Drug Revenue Forecast, 2006-2016 ($ billion)