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
- Reformulation/dosage change/Route of administration (ROA) change
- Second generation products
- Fixed dose combinations
- Achieving protection for FDC products is critical
- Have a clear message and keep it simple
- 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
- Fosamax patent was reinstated in Europe but is it having an effect?
- 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
- Pfizer' s reformulation strategy was a failure
- Pfizer' s own generic azithromycin is still the best selling generic
in the US
- Own generics in Europe
- Sanofi-Aventis' s launched generic Ambien/Stilnox through Winthrop
- 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?
- Indication expansion and development of follow-on products
demonstrate commitment to the epilepsy market
- Brand loyalty programs
- A variety of formulations
- Human growth hormones - a lifetime of lifecycle management?
- Pfizer used a comprehensive approach for Genotropin brand 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
- 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
- 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)
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