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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.

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