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

• Publication date: November 2012
• Report size: 25 pages

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....

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?

Global Drug And Medication Industry

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