Pipeline Insight: Osteoporosis - Intermittent Dosing and Multiple Indications Drive Market Growth

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Publication Date: 2004-01-28

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Introduction
Osteoporosis therapy has been largely focused on antiresorptive drugs that reduce the rate of bone loss. The condition is the focus of attention of significant R&D activity, with drugs in development both in existing classes offering advantages over marketed products and novel drugs exploiting genomics programs and a deeper understanding of bone biology.

Scope

Epidemiology of osteoporosis in the seven major markets by disease severity, identification of niche populations and unmet needs
Detailed profiles of drugs in Phase II and above. Analysis examines clinical data, patient potential, marketing factors, satisfaction of unmet needs
Primary research with key osteoporosis opinion leaders providing insight on future market entrants and innovative R&D projects in the disease area
Pharma Market Forecast model shows market potential with global sales forecasts for key pipeline drugs, currently marketed products and classes

Highlights
Novel bisphosphonates, Zometa and Boniva, with their novel dosing regimens and delivery methods, will lead growth in the osteoporosis market, as R&D osteoporosis drugs will reach sales of $4.7 billion by 2011.

Driven by new market leader Evista, which will lead Pfizer's lasofoxifene and Wyeth's bazedoxifene by targeting multiple indications, the SERMs drug class will be valued at $4.2 billion by 2011.

The osteoporosis early stage pipeline consists largely of drug candidates in new therapeutic classes, in particular cathepsin K inhibitors, osteoprotegerin and calcilytics. While these drugs have the potential to change the face of osteoporosis treatment in the long term, innovative approaches will likely be costly to patients, limiting potential.

Why you should buy this report

Validate internal forecasts against drug/class sales model and assess market potential for pipeline products
Analyze competitive environment at time of product launch to inform best strategy for market entry
Highlight key R&D trends and company involvement in the market to inform licensing decisions and identify potential partners based on R&D activity

CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the osteoporosis market - page 4
  - Innovative bisphosphonates, Zometa (zoledronate) and Boniva (ibandonrate), with their novel dosing regimens and delivery methods, will drive growth in the osteoporosis market, as sales will reach $10.4 billion by 2011 - page 5
  - Driven by new market leader Evista (raloxifene), which will stay one step ahead of lead Pfizer's lasofoxifene and Wyeth's bazedoxifene by targeting multiple indications, the SERMs drug class will be valued at $4.2 billion by 2011 - page 8
  - The osteoporosis early stage pipeline consists largely of drug candidates in new therapeutic classes, in particular cathepsin K inhibitors, osteoprotegerin and calcilytics. While these drugs have the potential to change the face of osteoporosis treatment in the long term, innovative approaches will likely be costly to patients, limiting potential - page 10
  - Summary - page 12
- Key metrics - page 14
TABLE OF CONTENTS - page 15
CHAPTER 2 PATIENT POTENTIAL - page 30
- Definition of osteoporosis - page 30
  - Etiology of osteoporosis - page 31
- Epidemiology of osteoporosis - page 37
  - Methodological difficulties in assessing prevalence - page 38
  - Prevalence of osteoporosis and osteopenia in postmenopausal women - page 39
- Segmentation of osteoporosis - page 46
  - Prevalence of osteoporosis and osteopenia in men - page 47
  - Osteoporosis population forecast - page 52
  - Osteoporotic fractures, their implications and minor risk groups - page 53
  - Niche populations - page 60
- Unmet need in osteoporosis - page 65
  - Clinical unmet need - page 65
CHAPTER 3 R&D APPROACH - page 72
- Classification of pipeline products - page 73
  - Bisphosphonates - page 73
  - SERMs - page 75
  - Calcitonins - page 76
  - Parathyroid hormone and analogues - page 77
  - Hormone therapy - page 78
- Clinical trial design in osteoporosis - page 79
  - Clinical trial guidelines - page 79
  - Trial design and implementation in osteoporosis: the future? - page 82
- Clinical trial endpoints in osteoporosis - page 84
  - Fracture rate - page 84
  - Changes in BMD - page 86
  - Biochemical markers of bone turnover - page 88
  - Changes in bone microarchitecture - page 90
CHAPTER 4 OSTEOPOROSIS PIPELINE ANALYSIS - page 91
- Pipeline overview - page 92
- Key companies involved in the osteoporosis pipeline - page 94
  - Novartis - page 94
  - GSK - page 96
  - Merck - a notable absentee - page 97
- Strategies for success in osteoporosis - page 98
  - Dosing variations in the bisphosphonate class - page 98
  - Multiple indications strategy in osteoporosis - page 99
CHAPTER 5 BISPHOSPHONATE LATE-STAGE DRUG ANALYSIS & FORECASTS - page 101
- Overview for the bisphosphonate class - page 102
  - Pipeline summary - page 102
  - Definition of current comparator therapy - page 102
- Comparative analysis - page 104
  - Bonviva (ibandronate) - page 104
  - Forecasts to 2011 - page 118
- Zometa (zoledronate) - page 119
  - Forecasts to 2011 - page 127
- Other late stage drugs - page 128
  - Minodronate - page 128
  - Apomine - page 128
  - Clodronate - page 129
- Comparison of key compounds in the bisphosphonate class - page 131
  - Unmet needs - page 131
  - Marketing strength - page 134
  - Comparative forecasts - page 135
CHAPTER 6 SERMS LATE-STAGE ANALYSIS AND FORECASTS - page 136
- Overview table - page 137
- Definition of current comparator therapy - page 137
- Comparative analysis - page 139
  - Lasofoxifene - page 140
  - Forecasts to 2011 - page 144
- Bazedoxifene - page 145
  - Drug overview - page 145
  - Forecasts to 2011 - page 150
- Other late stage drugs - page 151
  - Ospemifene - page 151
- Comparison of key compounds in the SERM class - page 152
  - Unmet needs - page 152
  - Marketing strength - page 154
  - Comparative forecasts - page 155
CHAPTER 7 CALCITONIN LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 156
- Definition of current comparator therapy - page 158
  - Overview - page 158
- Comparative analysis - page 160
  - Fortical - page 160
  - Forecasts to 2011 - page 164
- Other drugs in the calcitonin class - page 165
  - SMC021 - page 165
  - rsCT - page 167
CHAPTER 8 PTH LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 168
- Overview for PTH class - page 169
  - Definition of current comparator therapy - page 169
- Comparative analysis - page 171
  - Preos (rhPTH 1-84) - page 171
  - Satisfaction of unmet needs - page 177
- Forecasts to 2011 - page 179
- Other drugs in the PTH class - page 180
  - Asahi teriparatide/PTH (1(34) - page 180
- Comparative forecasts - page 180
CHAPTER 9 'OTHER' DRUGS LATE STAGE ANALYSIS AND FORECASTS - page 181
- Comparative analysis - page 182
  - Strontium ranelate - page 182
- Forecasts to 2011 - page 192
- Additional drugs in the 'other' class - page 192
  - Nitroflurbiprofen - page 192
  - Osteoprotegerin - page 194
  - SomataKine (IGF 9606) - page 195
CHAPTER 10 INNOVATIVE EARLY-STAGE PROJECTS - page 199
- Key phase I and preclinical compounds in osteoporosis - page 199
- Cathepsin K inhibitors - page 200
  - Novartis - AAE581 - page 200
  - GSK - SB-462795 - page 201
  - Merck/Celera - page 202
- Calcilytics - page 202
  - GSK/NPS - 423557 - page 202
- Calcitonin - page 203
  - Nobex/Elan - Oratonin - page 203
- PTH - page 204
  - Unigene/GSK - page 204
- Src kinase inhibitors - page 204
  - Ariad - page 204
- PPAR gamma modulators - page 205
  - GSK/Bayer - page 205
- Vitronectin receptor antagonists - page 206
  - GSK - SB 273005 - page 206
- Long-acting proteins - page 206
  - Human Genome Sciences - page 206
- Wyeth looking away from hormones to new horizons? - page 207
- Key research impacts on osteoporosis - page 208
  - Impacts of clinical trial issues - page 209
CHAPTER 11 OPINION LEADER TRANSCRIPTS - page 211
- Key opinion leader 1 - Belgium - page 211
  - Unmet needs - page 211
  - Pipeline - page 212
  - Novel drug targets - page 218
  - Clinical trial design - page 219
- Key opinion leader 2 - US - page 222
  - Unmet needs - page 222
  - Clinical trial design - page 230
- Key opinion leader 3 - US - page 234
  - Unmet needs - page 234
  - Pipeline - page 235
  - Novel drug targets - page 241
  - Clinical trial design - page 242
- Key opinion leader 4 - US - page 244
  - Unmet needs - page 244
  - Pipeline - page 246
  - Novel drug targets - page 251
  - Clinical trial design - page 253
- Contributing experts - page 257
- Bibliography - page 257
  - Epidemiology - page 257
  - Clinical trial data - page 262
- Report methodology - page 264

List of Tables
Table 1: Key parameters of the osteoporosis market - page 14
Table 2: Forecast key pipeline products in osteoporosis to 2011 - page 14
Table 3: Causes of secondary (Type III) osteoporosis - page 32
Table 4: WHO classification of osteoporotic bone loss - page 38
Table 5: Epidemiology overview of osteoporosis - page 40
Table 6: Prevalence of osteopenia and osteoporosis in postmenopausal women across the seven major markets, 2003 - page 41
Table 7: Prevalence of osteopenia and osteoporosis in men over 50 in the seven major markets, 2003 - page 48
Table 8: Estimated forecast of the osteoporosis and osteopenia populations over 50 years in the seven major markets, 000s, 2003(11 - page 53
Table 9: Prevalence of vertebral fractures in men and women over 50 in the seven major markets, 2003 - page 55
Table 10: Overview of currently marketed bisphosphonates indicated for use in osteoporosis - page 73
Table 11: Overview of currently marketed SERMs indicated for use in osteoporosis - page 75
Table 12: Overview of currently marketed SERMs indicated for use in osteoporosis - page 77
Table 13: Quantitative measures used for clinical efficacy endpoints in osteoporosis - page 84
Table 14: R&D pipeline in osteoporosis, 2003 - page 93
Table 16: Key bisphosphonate products in late-stage R&D pipeline 2003 - page 102
Table 17: Defining the gold standard: key clinical trial results for Fosamax - page 103
Table 18: Dose ranging study results for 20mg and placebo with ibandronate, % change from baseline - page 106
Table 19: Results at 2 and 3-years in study comparing 3-monthly i.v. ibandronate, and daily oral alfacalcidol, % BMD relative to baseline, 2003 - page 108
Table 20: Novartis's HORIZON trial design, 2003 - page 120
Table 21: Difference between two treatment groups at 48 months, mean % change in BMD from baseline - page 130
Table 22: Global sales forecasts for the bisphosphonate class, 2003(11 - page 135
Table 23: Overview of the SERMs in late stage development for the prevention or treatment of osteoporosis - page 137
Table 24: Evista: key facts - page 138
Table 25: Global sales forecasts for the SERM class, 2003(11 - page 155
Table 26: Overview of the calcitonins in late stage development for the prevention or treatment of osteoporosis - page 157
Table 27: Miacalcin: key facts - page 159
Table 28: Global sales forecast for the calcitonin class, 2003(11 - page 165
Table 29: Summary of the PTH drugs in late stage development for osteoporosis - page 169
Table 30: Forteo: key facts - page 170
Table 31: Results of PATH trial, %, 2003 - page 172
Table 32: Global sales forecast for the PTH class, 2003(11 - page 180
Table 33: Summary of other late stage drugs in development for osteoporosis, 2003 - page 182
Table 34: Study population, design and end points. - page 184
Table 35: PREVOS change in BMD results, % from baseline - page 184
Table 36: STRATOS mean annual change in BMD, % from baseline - page 185
Table 37: Drugs in phase I and preclinical development for osteoporosis, 2003 - page 199

List of Figures
Figure 1: Summary of osteoporosis pipeline by development phase, mechanism of action and company category, 2003 - page 12
Figure 2: Drug launches and events in the osteoporosis market from 2003 - page 13
Figure 3: Schematic of key current and pipeline drugs, their targets and their effect on bone formation and resorption - page 34
Figure 4: Osteoporosis drugs and their overlap into other indications - page 36
Figure 5: Prevalence of osteopenia and osteoporosis in postmenopausal women across the seven major markets, 2003 - page 42
Figure 6: Prevalence of osteopenia and osteoporosis in men over 50 in the seven major markets, 2003 - page 49
Figure 7: Prevalence of vertebral fractures in men and women over 50 in the seven major markets, 2003 - page 56
Figure 8: Clinical unmet needs in osteoporosis - page 65
Figure 9: Boniva satisfaction of unmet needs in osteoporosis - comparative analysis vs. Fosamax - page 115
Figure 10: Global market forecast and events for Boniva, 2005(2011 - page 118
Figure 11: Zometa satisfaction of unmet needs - comparative analysis vs. Fosamax - page 125
Figure 12: Global market forecast and events for Zometa to 2011 - page 127
Figure 13: Comparison of key compounds in the bisphosphonate class currently in late stage development, 2003 - page 132
Figure 14: Comparative analysis of lasofoxifene and Evista - page 143
Figure 15: Global market forecast and events for lasofoxifene to 2011 - page 144
Figure 16: Bazedoxifene satisfaction of unmet needs - comparative analysis vs. Evista - page 148
Figure 17: Global market forecasts and events for bazedoxifene to 2011 - page 150
Figure 18: Comparison of key compounds in the SERM class currently in late stage development, 2003 - page 153
Figure 19: Fortical satisfaction of unmet needs - comparative analysis vs. Miacalcin - page 163
Figure 20: Global market forecasts and events for Fortical to 2011 - page 164
Figure 21: Preos satisfaction of unmet needs - comparative analysis vs. Forteo - page 177
Figure 22: Global market forecast and events for Preos to 2011 - page 179
Figure 23: Protos satisfaction of unmet needs - comparative analysis with Fosamax - page 190
Figure 24: Global market forecast and events for Protos to 2011 - page 192

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Pipeline Insight: Osteoporosis - Intermittent Dosing and Multiple Indications Drive Market Growth

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