Indication Expansion

Summary

Due to shrinking pipelines and rising financial pressures on pharmaceutical companies, indication expansion is an increasingly attractive strategy to expand patient potential and extend market exclusivity.

Indication Expansion is a new report that provides in-depth case studies analyzing successful recent indication expansions and emerging trends. This report will enable you to avoid potential pitfalls whilst gaining a comprehensive review of how to delay generic competition and boost revenue growth.

Use the case studies in this report to identify best practice examples of indication expansion strategies and ensure that you can implement these into your current processes to maximize the lifecycle of your products.

Key findings of the report...

• Indication expansion is a common lifecycle management strategy, with more than three quarters of the 50 top selling brands in 2006 having had at least one additional indication approved since their initial launch in the US.
• Pediatric market exclusivity can be extremely cost effective; blockbuster drugs generate more than $2.7m per day for each $1bn in annual sales but pediatric testing typically costs just $4m per drug.
• Pfizer is continuing to expand Celebrex's indications, filing in April 2006 with the EU for permission to market Celebrex for ankylosing spondylitis and filing in June 2006 with the FDA for permission to market the drug for juvenile rheumatoid arthritis.
• In December 2005, Abbott obtained FDA approval to market Depakote ER for mania associated with bipolar disorder, as a response to patent expiration in 2008. Sales of the drug rose by 20% in 2006 to an estimated $1.2bn.
• Combination therapy can provide medical benefits that enhance the performance of certain products, such as with TAP Pharmaceutical's Prevacid NapraPAC. NapraPAC was the second successful combination product for Prevacid, with the first, Prevpac, launched in 1999.

Key questions answered in this report

• What type of drug is best suited to indication expansion?
• What are the financial advantages to indication expansion?
• Why would a drug developer pursue several types of indication expansion?
• Which indication expansion strategy typically offers the greatest benefit, albeit with the greatest limitations?
• Why are some companies removing indications from their labeling?
• What emerging trend are companies using to identify uses for discarded compounds?
• Why might pediatric exclusivity be discontinued in the U.S.?

Top five reasons to order your copy today

• Understand the factors driving growth of indication expansion, and take advantage of future market trends.
• Develop indication expansion strategies by implementing best practice processes outlined in each case study.
• Identify emerging expansion trends including repositioning and indication removal.
• Gain access to analysis of the future of pediatric exclusivity and ensure your product pipeline is aligned with future market opportunity.
• Assess which companies are implementing successful indication expansion strategies and which therapy areas are the most popular.

Contents

• Executive Summary
  • Introduction
  • Extension to related indications
  • Extension to new applications
  • Pediatric and special population extensions
  • Extension of usage conditions
  • Comparison of indication expansion strategies
• Chapter 1 Introduction
  • Summary
  • The importance of indication expansion
  • When an indication expansion is appropriate
  • Types of indication expansion
  • Expanded drug usage conditions
  • Extension to related indications
  • Extension to additional indications
  • Prerequisites for a successful indication expansion
  • Objectives of indication expansion
  • Benefits of indication expansion
  • Building additional revenue streams for a drug
  • Mitigating the effects of patent expiration
  • The value of patents
  • Types of patents
  • Cost containment and the rise of generics
  • United States
  • United Kingdom
  • Germany
  • France
  • Italy
  • Spain
  • Impact on drug revenues
  • Expiring patents on blockbusters
  • Patent challenges
  • Case study: Lipitor
  • Limitations of indication expansion
  • Trends in indication expansion
  • Indication Removal
  • Conclusion
• Chapter 2 Extension To Related Indications
  • Summary
  • Introduction
  • Treatment-prevention extensions
  • Disease severity extensions
  • Case study: Aricept
  • Extensions to disease variants
  • Case study: Hycamtin
  • When an indication extension is appropriate
  • Objectives of indication extension
  • Benefits of indication extension
  • Limitations of indication extension
  • Conclusion
• Chapter 3 Extension To New Applications
  • Summary
  • Introduction
  • When a new application extension is appropriate
  • New application extensions within drug families
  • Case study: Acomplia
  • Objectives of new application extension
  • Benefits of new application extension
  • Repositioning
  • Case Study: Lyrica
  • Case Study: Botox
  • Limitations of new application extension
  • Conclusion
• Chapter 4 Pediatric And Special Population
  • extensions
  • Summary
  • Introduction
  • Pediatric extensions
  • Gender-based extensions
  • Geriatric extensions
  • When a pediatric or special population extension is appropriate
  • Objectives of pediatric and special population extensions
  • Benefits of pediatric and special population extensions
  • United States
  • Pediatric Research Equity Act of 2003
  • Chances of Pediatric Exclusivity Renewal in 2007
  • Europe
  • Case study: Claritin and Zyrtec
  • Limitations of pediatric and special population extensions
  • Case study: Norvasc
  • Conclusion
• Chapter 5 Extension Of USAge Conditions
  • Summary
  • Introduction
  • Monotherapy extensions
  • Case Study: Topamax
  • Combination therapy extensions
  • Other usage extensions
  • When a usage extension is appropriate
  • Objectives of usage extension
  • Benefits of usage extension
  • Case study: Femara
  • Limitations of usage extension
  • Case study: torcetrapib
  • Conclusion
• Chapter 6 Comparison Of Indication
  • expansion strategies
  • Summary
  • Introduction
  • Conditions under which each indication expansion strategy is
  • appropriate
  • Comparative benefits of each indication expansion strategy
  • Comparative limitations of each indication expansion strategy
  • Combining indication expansion strategies
  • Case Study: Singulair
  • Case Study: Taxotere
  • Conclusion
• Chapter 7 Appendix
  • Research methodology
  • Index
• List Of Figures
  • Figure 2.1: Breakdown of new indication launches by therapeutic Area, 2005
  • Figure 2.2: Comparison of drug development costs by strategy
  • Figure 3.3: Disease characteristics supporting indication extension for disease variants
  • Figure 4.4: Botox indications and revenues, 2000 - 2006
  • Figure 4.5: Pricing opportunities and threats for a new drug indication
  • Figure 5.6: Timeline of Zyrtec & Claritin US pediatric extensions, 1994 - 2006
  • Figure 7.7: Comparative appropriateness of indication expansion strategies
  • Figure 7.8: Comparative benefits of indication expansion strategies
  • Figure 7.9: Comparative limitations of indication expansion strategies
  • Figure 7.10: Benefits vs. limitations for indication expansion strategies
  • Figure 7.11: Singulair indications and revenues, 2002 - 2006
• List Of Tables
  • Table 2.1: Selected indication expansions for US commercialized drugs
  • Table 2.2: Revenues and patent expirations for selected companies' blockbusters, 2006
  • Table 3.3: Selected indication extensions for US commercialized drugs
  • Table 3.4: Impact on global revenues of indication extensions of selected drugs
  • Table 3.5: Selected indication extension initiatives for US commercialized drugs, 2007
  • Table 4.6: Selected new application extensions for US commercialized drugs
  • Table 4.7: Approved and non-approved indications for anti-depressants in the US, 2007
  • Table 4.8: Impact on global revenues of new additional extensions of selected drugs
  • Table 4.9: Selected repositioning specialists
  • Table 4.10: Selected new application extension initiatives for US commercialized drugs
  • Table 5.11: Selected new application extension initiatives for US commercialized drugs
  • Table 5.12: Non-approved pediatric usage for US commercialized drugs
  • Table 6.13: Selected usage extensions for US commercialized drugs
  • Table 6.14: Selected usage extension initiatives for US commercialized drugs, 2007
  • Table 7.15: Taxotere indication expansions, 1999 - 2006