Generic Series: Optimizing Brand Lifecycle Management Winning Strategies to Maximize Revenue in the Face of Growing Generic Competition

Published by: Datamonitor

Published: Jul. 15, 2008 - 148 Pages

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the report

Key findings

CHAPTER 2 INTRODUCTION TO LIFECYCLE MANAGEMENT

What is lifecycle management?

Why is lifecycle management so important now?

Patent expiries and thinning pipelines are compounded by tougher pricing and reimbursement conditions

Payers are stimulating generics use to cut costs

Faster brand erosion post generics entry

Growing competition and harder molecule differentiation

Other stakeholders are increasingly important

CHAPTER 3 CRITICAL CONSIDERATIONS FOR PRODUCT LIFECYCLE MANAGEMENT

What is the purpose?

Be realistic about your expectations

Counter-generic strategies are under growing public scrutiny

Timing of execution is critical but few companies consider LCM early enough

Think ahead

Lifecycle management is a continuous process

Capturing internal knowledge

What is the best method?

Formal or informal approach to lifecycle management?

Marketing- or development-driven LCM?

Internal company issues impact the choice of LCM strategy

Portfolio-led lifecycle management

What resources are required and what is available?

Understanding each market is crucial

Strong market intelligence is important

Focus on fulfilling the unmet need

Make sure you have a clear message and keep things simple

Product characteristics determine the choice of LCM strategy

Local versus global LCM drive and execution

Flexibility and creativity

LCM tactics can act synergistically

CHAPTER 4 SELECTING THE RIGHT LIFECYCLE MANAGEMENT STRATEGY

Commercial lifecycle management strategies

Authorized/own generics

Strategic pricing

Brand loyalty programs and increasing share of voice

Rx-to-OTC switching

Divestiture or market exit

Geographical expansion

Brand protection in non-exclusive markets

Developmental lifecycle management strategies

Reformulations and second generation products

Fixed dose combinations

New delivery devices

Indication expansion

Manufacturing process-based LCM

Legal and regulatory strategies

Patent litigation

Regulatory exclusivity

CHAPTER 5 CASE STUDIES OF RECENT LIFECYCLE MANAGEMENT STRATEGIES USED BY BIOPHARMA

Fosamax Plus D’s success was determined by market characteristics and timing of launch

Fosamax Plus D’s late launch proved fatal for Merck & Co’s alendronate franchise in Germany and the UK…

…while early launch resulted in a more successful brand protection in France and Italy

US - launching too early?

Will the second strategy to minimize losses work?

Novartis’s inability to defend its patent for combination drug Lotrel resulted in tremendous loss of sales after Teva’s challenge

Biaxin XL - a reformulation offering true benefits

Ambien CR - a moderately successful reformulation strategy

Actiq and Fentora - a mix of strategies gives mixed success to Cephalon

Mixed success for authorized and own generics

Merck & Co’s Zocor - authorized generic launched during 180-days exclusivity

Pfizer’s Zoloft - own generic launched during 180-day exclusivity

Pfizer Zithromax - successful own generic

Own generics in Europe

Oxycontin legal strategy was a success

The FDA rejected an abuse-proof tablet formulation for Oxycontin

Voltaren - success in uprotected markets is driving sales growth even after patent expiry

Strong differentiation of Aclasta from Zometa is the basis for success of this indication expansion strategy

Not only generic defense

Keppra - a case of good or bad lifecycle management?

Human growth hormones - a lifetime of lifecycle management?

Osteoporosis market - a move to intermittent dosage early in the product lifecycle

CHAPTER 6 BIBLIOGRAPHY

Publications and online articles

Conference literature

Datamonitor resources

Appendix

Glossary of Terms

LIST OF FIGURES

Figure 1: Different stages of a drug lifecycle

Figure 2: Product lifecycles are getting shorter

Figure 3: A range of factors are impacting drug lifecycles

Figure 4: $102 billion worth of branded drugs from the top 50 Pharma companies face patent expiry from 2008 to 2012

Figure 5: Decline in the number of NMEs and new BLAs approved by the FDA, 1993-2006

Figure 6: Payers are introducing a range of measures designed to curb drug spending

Figure 7: Payers and governments have introduced a range of measures aimed at increasing generics use

Figure 8: Various factors impacting brand erosion at patent expiry

Figure 9: Entry of generic simvastatin resulting in significant reduction of Lipitor sales in Germany

Figure 10: Lifecycle management can have a different purpose

Figure 11: Early and mid-phase LCM strategies tend to have a two-fold effect on ROI

Figure 12: Late-phase strategies target sales in the mature and declining phases of a drug’s lifecycle

Figure 13: Developmental, commercial and legal LCM tactics

Figure 14: Depending on the stage of the lifecycle many or only few LCM strategies may be available

Figure 15: Key questions that need to be answered at each stage of the lifecycle

Figure 16: LCM strategy selection is a continuous process

Figure 17: A variety of functions need to be involved in the choice and design of LCM strategies

Figure 18: Marketing- versus development-driven LCM

Figure 19: A range of internal factors impact the company’s choice of LCM strategy

Figure 20: Resources required for different LCM strategies

Figure 21: Individual market characteristics impact LCM tactic selection

Figure 22: LCM strategies have varying levels of success depending on individual market conditions

Figure 23: Product characteristics also impact the choice of LCM tactics

Figure 24: Global versus local LCM - the focus changes across the product lifecycle

Figure 25: Commercial LCM strategies tend to have the greatest impact post-patent expiry

Figure 26: Success drivers and resistors of employing an own/authorized/licensed generic strategy

Figure 27: Authorized generics agreements can be either co-operative or competitive in nature

Figure 28: Pros and cons for generics companies of entering into authorized generic agreements

Figure 29: Pricing strategies at patent expiry

Figure 30: Success drivers and resistors of brand loyalty programs and increasing share of voice

Figure 31: Drivers and resistors of Rx-to-OTC switching

Figure 32: Drivers and resistors of Rx-to-OTC switching in the seven major markets

Figure 33: Advantages and disadvantages of divestiture as an LCM strategy

Figure 34: Success drivers and resistors of geographical expansion as an LCM tactic

Figure 35: Protected vs unprotected markets

Figure 36: Two types of unprotected markets exist

Figure 37: Routes for brand differentiation in unprotected markets

Figure 38: Developmental lifecycle management strategies can boost sales in both mid and late stages of the lifecycle

Figure 39: Reformulation and second generation products are developed with different aims depending on the stage of the lifecycle

Figure 40: Success drivers and resistors of reformulation as an LCM strategy

Figure 41: Success drivers and resistors of second generation product development and launch as an LCM strategy

Figure 42: Drivers and resistors of launching fixed dose combinations (FDCs) as an LCM strategy

Figure 43: Advantages and disadvantages of single or multiple indication FDCs

Figure 44: Success drivers and resistors to launching new delivery devices

Figure 45: Success drivers and resistors of indication expansion as an LCM strategy

Figure 46: Early versus late launch of new indication

Figure 47: Multiple options exist for indication expansion

Figure 48: Legal and regulatory strategies tend to extend the protected life of a drug

Figure 49: Success drivers and resistors of legal and regulatory LCM strategies

Figure 50: Critical considerations for legal and regulatory LCM strategies

Figure 51: The length of market exclusivity achievable in the US is different from the EU

Figure 52: UK sales of Fosamax suffered extensive generic erosion post patent expiry, Q4 2004-Q4 2007

Figure 53: Late launch of Fosavance resulted in failure to protect Merck & Co’s alendronate franchise in Germany, Q1 2005-Q4 2007

Figure 54: Fosavance proved to be a successful LCM strategy in France and Italy, Q1 2005-Q4 2007

Figure 55: Despite its late launch Fosavance achieved high sales in Spain, Q3 2005-Q4 2007

Figure 56: Fosamax Plus D was launched 3 years prior to patent expiry in the US, Q1 2005-Q4 2007

Figure 57: Novartis lost almost a half of its Lotrel sales (brand and own generic) after just one generic entrant

Figure 58: Biaxin XL proved to be a successful reformulation strategy for Abbott in the short term, 2003-07

Figure 59: Sanofi-Aventis focused most of its promotional efforts on Ambien CR following its launch, Q1 2005-Q4 2007

Figure 60: Ambien CR managed to retain some of Sanofi-Aventis’s Ambien franchise following generic entry, Q2 2005-Q4 2007

Figure 61: Fentora is only moderately successful in protecting Cephalon’s fentanyl franchise, Q2 2006-Q4 2007

Figure 62: Cephalon increased the price of Actiq to drive Fentora uptake

Figure 63: Cephalon directed all the promotional activities from Actiq to Fentora after its launch

Figure 64: Teva and Ranbaxy grabbed the biggest share of the generic simvastatin market despite Dr Reddy’s authorized generic, Q1 2006-Q4 2007

Figure 65: Pfizer’s own generic Zoloft diminished the impact of generics entry on the product franchise, Q1 2006-Q4 2007

Figure 66: Pfizer’s generic Zithromax was a success despite the lack of 180-days exclusivity for any generics player, 2005-07

Figure 67: Early entry enabled Winthrop to hold onto its share of market even after further generic companies entered the market, Q32003-Q42007

Figure 68: Purdue’s legal in resulted in return to growth for Oxycontin, Q4 2003-Q4 2007

Figure 69: Sales of Voltaren are still growing (2003-2007)

Figure 70: Novartis employed a range of commercial and development lifecycle management strategies for Voltaren

Figure 71: Zometa’s sales in the six major markets (2003-2007)

Figure 72: Aclasta had a strong uptake, especially in the US (2007)

Figure 73: Keppra’s sales are still growing even close to patent expiry

Figure 74: US sales of Boniva (2005-2007)

LIST OF TABLES

Table 1: The impact of generics entry on brand franchises varies across the US and 5EU markets

Table 2: Keppra received approval for several different indications and patient populations

Abstract

• Review of key reasons why lifecycle management is important now
• Analysis of key considerations Pharma need to take care of when devising lifecycle management strategies
• Discussion of most commonly used lifecycle management strategies
• Case study analysis of successful and unsuccessful lifecycle management strategies employed by Pharma

• Identify critical considerations for creating the optimal lifecycle management plan
• Understand when the different lifecycle management strategies are most appropriate
• Gain insight into recent successful and unsuccessful lifecycle management strategies

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