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Indication Expansion - Opportunities for successful lifecycle management

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Report 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.

Table of Contents

Executive Summary 10
Introduction 10
Extension to related indications 11
Extension to new applications 12
Pediatric and special population extensions 13
Extension of usage conditions 14
Comparison of indication expansion strategies 15
Chapter 1 Introduction 18
Summary 18
The importance of indication expansion 19
When an indication expansion is appropriate 19
Types of indication expansion 22
Expanded drug usage conditions 22
Extension to related indications 23
Extension to additional indications 23
Prerequisites for a successful indication expansion 25
Objectives of indication expansion 26
Benefits of indication expansion 27
Building additional revenue streams for a drug 29
Mitigating the effects of patent expiration 30
The value of patents 30
Types of patents 31
Cost containment and the rise of generics 32
United States 32
United Kingdom 35
Germany 36
France 36
Italy 37
Spain 37
Impact on drug revenues 38
Expiring patents on blockbusters 39
Patent challenges 40
Case study: Lipitor 40
Limitations of indication expansion 42
Trends in indication expansion 44
Indication Removal 45
Conclusion 45
Chapter 2 Extension to related indications 48
Summary 48
Introduction 49
Treatment-prevention extensions 49
Disease severity extensions 50
Case study: Aricept 52
Extensions to disease variants 53
Case study: Hycamtin 56
When an indication extension is appropriate 57
Objectives of indication extension 58
Benefits of indication extension 59
Limitations of indication extension 62
Conclusion 64
Chapter 3 Extension to new applications 66
Summary 66
Introduction 67
When a new application extension is appropriate 69
New application extensions within drug families 70
Case study: Acomplia 70
Objectives of new application extension 73
Benefits of new application extension 74
Repositioning 75
Case Study: Lyrica 77
Case Study: Botox 79
Limitations of new application extension 82
Conclusion 85
Chapter 4 Pediatric and special population
extensions 88
Summary 88
Introduction 89
Pediatric extensions 91
Gender-based extensions 93
Geriatric extensions 93
When a pediatric or special population extension is appropriate 95
Objectives of pediatric and special population extensions 95
Benefits of pediatric and special population extensions 96
United States 97
Pediatric Research Equity Act of 2003 98
Chances of Pediatric Exclusivity Renewal in 2007 99
Europe 100
Case study: Claritin and Zyrtec 100
Limitations of pediatric and special population extensions 102
Case study: Norvasc 103
Conclusion 105
Chapter 5 Extension of usage conditions 108
Summary 108
Introduction 109
Monotherapy extensions 111
Case Study: Topamax 112
Combination therapy extensions 113
Other usage extensions 115
When a usage extension is appropriate 116
Objectives of usage extension 119
Benefits of usage extension 119
Case study: Femara 120
Limitations of usage extension 122
Case study: torcetrapib 122
Conclusion 124
Chapter 6 Comparison of indication
expansion strategies 126
Summary 126
Introduction 127
Conditions under which each indication expansion strategy is
appropriate 127
Comparative benefits of each indication expansion strategy 129
Comparative limitations of each indication expansion strategy 131
Combining indication expansion strategies 133
Case Study: Singulair 134
Case Study: Taxotere 136
Conclusion 139
Chapter 7 Appendix 142
Research methodology 142
Index 143
List of Figures
Figure 2.1: Breakdown of new indication launches by therapeutic Area, 2005 21
Figure 2.2: Comparison of drug development costs by strategy 28
Figure 3.3: Disease characteristics supporting indication extension for disease variants 55
Figure 4.4: Botox indications and revenues, 2000 – 2006 81
Figure 4.5: Pricing opportunities and threats for a new drug indication 84
Figure 5.6: Timeline of Zyrtec & Claritin US pediatric extensions, 1994 – 2006 101
Figure 7.7: Comparative appropriateness of indication expansion strategies 128
Figure 7.8: Comparative benefits of indication expansion strategies 130
Figure 7.9: Comparative limitations of indication expansion strategies 132
Figure 7.10: Benefits vs. limitations for indication expansion strategies 133
Figure 7.11: Singulair indications and revenues, 2002 – 2006 136
List of Tables
Table 2.1: Selected indication expansions for US commercialized drugs 20
Table 2.2: Revenues and patent expirations for selected companies’ blockbusters, 2006 39
Table 3.3: Selected indication extensions for US commercialized drugs 51
Table 3.4: Impact on global revenues of indication extensions of selected drugs 60
Table 3.5: Selected indication extension initiatives for US commercialized drugs, 2007 62
Table 4.6: Selected new application extensions for US commercialized drugs 68
Table 4.7: Approved and non-approved indications for anti-depressants in the US, 2007 71
Table 4.8: Impact on global revenues of new additional extensions of selected drugs 75
Table 4.9: Selected repositioning specialists 77
Table 4.10: Selected new application extension initiatives for US commercialized drugs 79
Table 5.11: Selected new application extension initiatives for US commercialized drugs 90
Table 5.12: Non-approved pediatric usage for US commercialized drugs 92
Table 6.13: Selected usage extensions for US commercialized drugs 110
Table 6.14: Selected usage extension initiatives for US commercialized drugs, 2007 118
Table 7.15: Taxotere indication expansions, 1999 - 2006 138