Lifecycle Management Strategies: Indication Expansion - Early planning is necessary for success

NEW YORK, Dec. 31, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Lifecycle Management Strategies: Indication Expansion – Early planning is necessary for success

http://www.reportlinker.com/p01055537/Lifecycle-Management-Strategies-Indication-Expansion-–-Early-planning-is-necessary-for-success.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

Indication expansion is one of the most successful developmental lifecycle management strategies. However, it is also one of the most costly, requiring long and expensive clinical trials to be conducted, and therefore carries higher risks.Analysis of success drivers and resistors of indication expansion as a lifecycle management strategy.Discussion of the factors that influence the order of launch of a product in different indications.Case study analysis of recent successful and unsuccessful indication expansion strategies.Developing and patenting the use of a drug in an additional indication is an attractive lifecycle management strategy for pharma, not least because it can result in higher sales in the mid-stages of a drug's lifecycle, affording additional market exclusivity as well as patent protection and thus a longer lifecycle.Companies may decide to launch the drug approved for a new primary indication as a separate brand. However, its positioning needs to be clear, especially in a large portfolio where multiple brands exist (brand, generic, over-the-counter).Getting the order of entry right is critical and companies developing indication extensions are faced with a choice between quickest approval or fastest uptake. Also, market exclusivity is triggered by launch in the first indication, thus shortening the time a product may be on the market for a larger patient population that may be approved later.What are the advantages and disadvantages of launching a drug in additional indications early in the product lifecycle?How can off-label generics use undercut sales in additional indications and how can this be overcome?What factors influence the order of product launch in diifferent indications?

OVERVIEW

Catalyst

Summary

EXECUTIVE SUMMARY

INDICATION EXPANSION OVERVIEW

What is indication expansion?

Drivers and resistors

Generics off-label use

Same or separate branding

Early or late indication expansion

Selecting the order of indication launch and development

Case study summary

INDICATION EXPANSION CASE STUDIES

Girosa (flibanserin; Boehringer Ingelheim) – level of acceptable risk-benefit ratio varies with indications

Lesson

Background

Impact

Latisse (bimatoprost ophthalmic solution; Allergan) – new use found through spotting side effects

Lesson

Background

Impact

Nasonex (mometasone fuorate; Merck & Co.) – repurposing a compound with reformulation and easy to use device to create a strong opportunity

Lesson

Background

Impact

Cymbalta (duloxetine; Eli Lilly) – an ambitious indication expansion strategy drives franchise growth

Lesson

Background

Impact

Rituxan/MabThera (rituximab; Roche) – early monoclonal antibody finds added life from expanded uses

Lesson

Background

Impact

BIBLIOGRAPHY

Online sources and journal articles

TABLES

Table: Indication expansion case study summary

FIGURES

Figure: Success drivers and resistors of indication expansion as an LCM strategy

Figure: Early versus late launch of new indication

Figure: Multiple options exist for indication expansion

Figure: Latisse and Lumigan global sales, 2004-17

Figure: Global sales of Nasonex and Asmanex, 2002–17

Figure: Global sales of Cymbalta and Effexor, 2003–17

Figure: Global sales of Rituxan in the oncology setting vs the immunology and inflammation setting, 2002–17

Companies Mentioned

Devoteam SA, GlaxoSmithKline Plc, Hutchison 3G UK Limited, Janssen Pharmaceuticals, Inc., Sanofi

To order this report:

Drug_and_Medication Industry: Lifecycle Management Strategies: Indication Expansion – Early planning is necessary for success

Contact Nicolas: nicolasbombourg@reportlinker.com
US: (805)-652-2626
Intl: +1 805-652-2626

SOURCE Reportlinker



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