Amgen Inc.: PharmaVitae Profile

This analysis examines the historical and forecast performance for Amgen in the ethical pharmaceutical sector. The profile encompasses global company strategy, portfolio and pipeline analysis and assessment of financial performance, with 1-6 year sales forecasts for key drugs. An interactive forecasting and analysis tool provides continually updated quantitative and qualitative information.

Report Highlights

[Fade out the market survey infos]

CHAPTER 1 EXECUTIVE SUMMARY 5
Scope of the report 5
Key findings 6
CHAPTER 2 INTRODUCTION TO LIFECYCLE MANAGEMENT 18
What is lifecycle management? 18
Why is lifecycle management so important now? 19
Patent expiries and thinning pipelines are compounded by tougher pricing and reimbursement conditions 20
Payers are stimulating generics use to cut costs 22
Faster brand erosion post generics entry 25
Growing competition and harder molecule differentiation 28
Other stakeholders are increasingly important 30
CHAPTER 3 CRITICAL CONSIDERATIONS FOR PRODUCT LIFECYCLE MANAGEMENT 32
What is the purpose? 32
Be realistic about your expectations 35
Counter-generic strategies are under growing public scrutiny 35
Timing of execution is critical but few companies consider LCM early enough 36
Think ahead 38
Lifecycle management is a continuous process 39
Capturing internal knowledge 40
What is the best method? 41
Formal or informal approach to lifecycle management? 41
Marketing- or development-driven LCM? 43
Internal company issues impact the choice of LCM strategy 44
Portfolio-led lifecycle management 45
What resources are required and what is available? 47
Understanding each market is crucial 48
Strong market intelligence is important 49
Focus on fulfilling the unmet need 50
Make sure you have a clear message and keep things simple 50
Product characteristics determine the choice of LCM strategy 50
Local versus global LCM drive and execution 51
Flexibility and creativity 53
LCM tactics can act synergistically 53
CHAPTER 4 SELECTING THE RIGHT LIFECYCLE MANAGEMENT STRATEGY 55
Commercial lifecycle management strategies 55
Authorized/own generics 56
Strategic pricing 60
Brand loyalty programs and increasing share of voice 61
Rx-to-OTC switching 63
Divestiture or market exit 65
Geographical expansion 66
Brand protection in non-exclusive markets 67
Developmental lifecycle management strategies 71
Reformulations and second generation products 72
Fixed dose combinations 76
New delivery devices 81
Indication expansion 82
Manufacturing process-based LCM 85
Legal and regulatory strategies 86
Patent litigation 89
Regulatory exclusivity 90
CHAPTER 5 CASE STUDIES OF RECENT LIFECYCLE MANAGEMENT STRATEGIES USED BY BIOPHARMA 96
Fosamax Plus D’s success was determined by market characteristics and timing of launch 96
Fosamax Plus D’s late launch proved fatal for Merck & Co’s alendronate franchise in Germany and the UK… 97
…while early launch resulted in a more successful brand protection in France and Italy 99
US – launching too early? 102
Will the second strategy to minimize losses work? 103
Novartis’s inability to defend its patent for combination drug Lotrel resulted in tremendous loss of sales after Teva’s challenge 104
Biaxin XL – a reformulation offering true benefits 106
Ambien CR – a moderately successful reformulation strategy 108
Actiq and Fentora – a mix of strategies gives mixed success to Cephalon 111
Mixed success for authorized and own generics 116
Merck & Co’s Zocor – authorized generic launched during 180-days exclusivity 116
Pfizer’s Zoloft – own generic launched during 180-day exclusivity 119
Pfizer Zithromax – successful own generic 121
Own generics in Europe 124
Oxycontin legal strategy was a success 126
The FDA rejected an abuse-proof tablet formulation for Oxycontin 129
Voltaren – success in uprotected markets is driving sales growth even after patent expiry 130
Strong differentiation of Aclasta from Zometa is the basis for success of this indication expansion strategy 132
Not only generic defense 134
Keppra – a case of good or bad lifecycle management? 134
Human growth hormones – a lifetime of lifecycle management? 138
Osteoporosis market – a move to intermittent dosage early in the product lifecycle 140
CHAPTER 6 BIBLIOGRAPHY 143
Publications and online articles 143
Conference literature 146
Datamonitor resources 147
Appendix 149
Glossary of Terms 149
[Fade out table of contents]

Table 1: Amgen – PharmaVitae forecasts at a glance 9
Table 2: Amgen’s total costs outpacing revenue growth 13
Table 3: Amgen key product developments, 2008 32
Table 4: Amgen product deals and alliances, 2008 33
Table 5: Amgen technology deals and alliances, 2008 34
Table 6: Amgen M&A activity, 2008 34
Table 7: Amgen company announcements, 2008 35
Table 8: Amgen future product milestones, 2008–10 37
Table 9: Amgen product portfolio overview ($m), 2001–07 51
Table 10: Amgen product portfolio overview ($m), 2007–13 54
Table 11: Amgen, therapy portfolio overview ($m), 2001–07 60
Table 12: Amgen, therapy portfolio overview ($m), 2007–13 62
Table 13: Amgen, portfolio overview by geographic region ($m), 2001–07 68
Table 14: Amgen, portfolio overview by geographic region ($m), 2007–13 70
Table 15: Amgen, launch portfolio overview ($m), 2007–13 75
Table 16: Amgen, core portfolio overview ($m), 2007–13 77
Table 17: Amgen, expiry portfolio overview ($m), 2007–13 79
Table 18: Amgen, portfolio overview by molecule type ($m), 2001–07 83
Table 19: Amgen, product portfolio overview by molecule type ($m), 2007–13 85
Table 20: Amgen, product portfolio overview by source ($m), 2001–07 89
Table 21: Amgen, product portfolio overview by source ($m), 2007–13 90
Table 22: Amgen, sales by business unit ($m), 2001–07 94
Table 23: Amgen profit and loss account ($m), 2001–07 96
Table 24: Amgen balance sheet ($m), 2001–07 99
Table 25: Amgen operating revenue/cost analysis ($m), 2001–07 103
Table 26: Amgen operating cost ratio analysis (% of total revenues), 2001–07 105
Table 27: Amgen operating cost ratio analysis (% of total revenues), 2007–13 106
Table 28: Amgen operating revenue/cost analysis ($m), 2007–13 109
Table 29: Amgen capital employed ($m), 2001–07 111
Table 30: Amgen EBIT return on capital employed ($m), 2001–07 113
Table 31: Amgen pre-tax return/Capital employed driver analysis (%), 2001–07 114
Table 32: Amgen market capitalization ($ billion), 2001–07 115
Table 33: Amgen total shareholder returns (annual %), 2001–07 118
Table 34: Key products overview 121
Table 35: Neulasta: overview 123
Table 36: Neulasta: sales forecast ($m), 2007–13 123
Table 37: Aranesp: overview 127
Table 38: Aranesp (oncology): sales forecast ($m), 2007–13 128
Table 39: Aranesp (hematology): sales forecast ($m), 2007–13 128
Table 40: Enbrel: overview 132
Table 41: Enbrel: sales forecast ($m), 2007–13 132
Table 42: Remicade vs. Enbrel key approvals 133
Table 43: Remicade vs. Enbrel vs. Humira key approvals 135
Table 44: Epogen: overview 136
Table 45: Epogen (hematology): sales forecast ($m), 2007–13 137
Table 46: Epogen (oncology): sales forecast ($m), 2007–13 137
Table 47: denosumab: overview 140
Table 48: denosumab (musculoskeletal): sales forecast ($m), 2007–13 140
Table 49: denosumab (oncology): sales forecast ($m), 2007–13 141
Table 50: Amgen’s R&D pipeline (Phase I–registration) 144
Figure 1: Amgen prescription pharmaceutical performance, sales ($m) and growth rate (%), 2001–13 6
Figure 2: Amgen’s financial performance ($m), 2001–13 8
Figure 3: Overview of Amgen’s strong historical sales growth 10
Figure 4: Amgen’s switching strategy from high sales growth to controlled cost expenditure ($m), 2001–13 15
Figure 5: Amgen SWOT analysis 17
Figure 6: Amgen timeline 40
Figure 7: M&A/divestment history 41
Figure 8: Current corporate structure 44
Figure 9: Amgen prescription pharmaceutical performance, sales ($m) and growth rate (%), 2001–13 48
Figure 10: Amgen key sales growth driver & resistors ($m), 2001–07 52
Figure 11: Amgen key sales growth drivers & resistors ($m), 2007–13 55
Figure 12: Amgen prescription pharmaceutical sales by therapy area ($m), 2001–13 59
Figure 13: Amgen prescription pharma sales by therapy area (% of total), 2001–13 65
Figure 14: Amgen prescription pharmaceutical sales by geographic region ($m), 2001–13 67
Figure 15: Amgen drivers and resistors by geographic region ($m), 2001–07 68
Figure 16: Amgen drivers and resistors by geographic region ($m), 2007–13 70
Figure 17: Amgen prescription pharmaceutical sales by geographic region (% of total), 2001–13 72
Figure 18: Amgen launch/core/expiry configuration ($m), 2007–13 80
Figure 19: Amgen prescription pharmaceutical sales by molecule type ($m), 2001–13 83
Figure 20: Amgen growth drivers & resistors by molecule type ($m), 2007–13 85
Figure 21: Amgen prescription pharmaceutical sales by source ($m), 2001–13 88
Figure 22: Amgen growth drivers & resistors by source ($m), 2001–07 89
Figure 23: Amgen growth drivers & resistors by source ($m), 2007–13 91
Figure 24: Amgen operating revenue/cost analysis ($m), 2001–13 102
Figure 25: Amgen operating cost ratio analysis (% of total revenues), 2001–13 108
Figure 26: Amgen return on capital employed, EBIT margin and capital turnover, 2001–07 110
Figure 27: Return on capital employed formula 114
Figure 28: Amgen market capitalization ($ billion), 2001–07 117
Figure 29: Amgen total shareholder returns vs. S&P 500 ($m), 2001–07 119
[Fade out list of tables / figures]