Market Report Source

Overview

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 $4mn 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

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