Commercial Insight: Osteoporosis & HRT - HRT is down for the count, but can osteoporosis players pick up the pieces?

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY 3

• Scope of the analysis 3
• Datamonitor insight into the osteoporosis market 3
• Effective detailing 7
• Phase IV/extension studies 8
• Additional indications 8
• Summary 10
• Key metrics 12

CHAPTER 2 MARKET SEGMENTATION & DEFINITION 24

• Strategic scoping & focus 25
• Market definition 26
• A11C: vitamin A and D (including combinations of the two) 26
• Advantages of vitamin D therapy 27
• Disadvantages of vitamin D therapy 27
• H4A: calcitonins 28
• Advantages of calcitonins 29
• Disadvantages of calcitonins 30
• H05AA: parathyroid hormones and analogues 30
• Advantages of PTH 31
• Disadvantages of PTH 31
• G3C and G3F: estrogens and estrogen/progestogen combinations 32
• Advantages of estrogen hormone therapy 33
• Disadvantages of estrogen hormone therapy 33
• G3H: other sex hormones and similar products: SERMs 34
• Advantages of SERMs 35
• Disadvantages of SERMs 35
• M5B: bone calcium regulators 35
• Advantages of bisphosphonates 36
• Disadvantages of bisphosphonates 36
• Definition of gold-standard drug 37
• Fosamax: the gold standard in osteoporosis 37
• Associated pharmaceutical markets 39
• Paget's disease of bone 39
• Bisphosphonates as cancer adjunct therapies: hypercalcemia of malignancy and bone metastases 40

CHAPTER 3 GLOBAL MARKET OVERVIEW 42

• Key findings 42
• Global osteoporosis market analysis 43
• Overview 43
• IMS historical perspective and implications 44
• Five-quarter performance analysis: Q1 2002 to Q1 2003 46
• The effect of the WHI on the osteoporosis market 46
• Drug contribution to market growth 48
• Global market forecast 49
• Market growth driven by pipeline drugs, today's marketed products to slow around 2007 50
• HRT market rocked again by breast cancer link: Million Women Study 51
• SERMs growth takes up HRT's decline 55
• Cautious uptake in the PTH class 56
• Forecast scenario analysis 57
• Evista shows neutral results in breast cancer prevention and CVD 57
• Fosamax patent expiry penetrates throughout the osteoporosis market 58
• Bisphosphonate class analysis 59
• Bisphosphonate market performance 59
• Bisphosphonate market forecast 62
• Long-interval, intermittent dosing 63
• Generic penetration 64
• Bisphosphonate R&D drugs 64
• Brand analysis 65
• Fosamax analysis 65
• Fosamax: 12-month event screen 67
• Fosamax strategic analysis 68
• Leading with the hip: positioning Fosamax in an increasingly competitive market 68
• Fosamax forecasts to 2011 71
• Phase IV trial results vs. Evista/Actonel 73
• Launch of novel bisphosphonates 74
• Actonel analysis 74
• Actonel 12-month event screen 75
• Actonel strategic analysis 77
• Actonel forecasts to 2011 81
• SERM class analysis 83
• SERM market performance 83
• SERM market forecast 83
• Additional indications 84
• SERM R&D drugs 85
• Brand analysis 85
• Evista analysis 85
• Evista 12-month event screen 87
• Evista strategic analysis 88
• Evista forecasts to 2011 91
• Parathyroid hormone class analysis 93
• PTH R&D drugs 93
• Brand analysis 93
• Forteo analysis 93
• Forteo 12-month event screen 95
• Forteo strategic analysis 96
• Drive diagnosis rates through disease awareness campaigns 96
• Continue trials for hip fracture risk reduction 97
• Forteo forecasts to 2011 98
• Calcitonin class analysis 100
• Calcitonin market performance 100
• Brand analysis 100
• Miacalcin analysis 100
• Miacalcin 12-month event screen 102
• Miacalcin strategic analysis 103
• Miacalcin forecasts to 2011 104
• Hormone therapy class analysis 105
• Hormone therapy market performance 105
• Brand analysis 107
• Premarin family analysis 107
• Premarin family 12-month event screen 107
• Premarin family strategic analysis 109
• Switching to low-dose Prempro/Premarin 109
• Competitive pricing of low-dose products 110
• Hormone therapy market forecasts to 2011 111
• Osteoporosis pipeline drug overview and forecasts 113
• Pipeline profiles 114
• Boniva 114
• Zometa 114
• Lasofoxifene 115
• Bazedoxifene 115
• Protos 116
• Preos 117
• Osteoporosis pipeline drug forecast to 2011 118

CHAPTER 4 PORTFOLIO AND LIFECYCLE MANAGEMENT 119

• Key findings 119
• Market attractiveness 120
• Comparative attractiveness of the osteoporosis market 120
• Class attractiveness in the osteoporosis market 123
• Bisphosphonate class attractiveness 124
• SERM class attractiveness 125
• Calcitonin class attractiveness 126
• Positioning of the major osteoporosis players 126
• Merck's potential patent woes 128
• Inclusion of the leading HRT player in osteoporosis positioning 130
• Osteoporosis and the major HRT players 131
• Performance of the major players from 2001 to 2002 133
• Pipeline activity and implications in the osteoporosis market 137
• Lifecycle management in osteoporosis 138
• The osteoporosis product lifecycle 138
• Launch strategy and market penetration 141
• Fosamax: how Merck seeded the market for optimal penetration 141
• Promotional activity: sampling and advertising 143
• Actonel: geographical licensing and co-marketing activity 145
• Accessing the Japanese market: Fosamax and Actonel 146
• Outsourcing sales capability with Evista 146
• eDetailing in osteoporosis 147
• Aventis 147
• Forteo: doing the best with what you've got 148
• Optimizing peak sales 149
• Additional indications: Fosamax leagues ahead of the pack 149
• Heavy Phase IV activity among top three drugs 149
• Combination trials with Forteo, Evista and Fosamax 151
• Alternative peak sale optimization strategies 152
• Summary 154

CHAPTER 5 STRATEGIC PRODUCT POSITIONING 155

• Physician targeting strategies 155
• Merck and Lilly promotional strategy in osteoporosis 155
• Best practice promotion in osteoporosis 157
• Patient targeting and influence 158
• Brand imaging 158
• Fosamax 158
• Actonel 162
• Evista 164
• Miacalcin 165
• Premarin family products 166
• Forteo 167
• Patient advocacy initiatives 168
• Merck sponsorship of the US NORA program 168
• Alliance for Better Bone Health 169
• International Osteoporosis Foundation patient group grants: Merck and Lilly 169
• Pricing and reimbursement 170
• Regulatory interventions 170
• NICE guidelines on osteoporosis 170
• Key Phase IV and post-marketing trial results 170
• Fosamax 170
• Actonel 172
• Evista 172
• Cost-containment initiatives 173
• Formulary status of osteoporosis medications 173
• Medicare: the elderly and discounted drug access 174
• Assessments of osteoporosis screening programs and treatment cost effectiveness 175
• Pricing data for key products in the major markets 176
• Case study: what is the rationale behind the price of Forteo? 179
• Osteoporosis product value analysis 180

APPENDIX A - MARKET DATA 182

• Global osteoporosis market data 182
• Bisphosphonate market data 182
• SERM class market data 183
• Calcitonin class market data 183
• Leading osteoporosis drugs historical data 184

Appendix B 185

• List of tables 185
• List of figures 187
• Bibliography 189
• Epidemiology 189
• Clinical trial data 190

About Datamonitor 190

• About Datamonitor Healthcare 190
• Datamonitor Healthcare's research and analysis methodologies 191
• Datamonitor Healthcare's therapy area capabilities 191
• About the Women's Health analysis team 192
• Datamonitor Healthcare's Consulting expertise 193
• Datamonitor's Therapeutic Consulting expertise 194
• Key therapy team members 194
• David Abramson, Therapeutic Lead Consultant 194
• Disclaimer 196