Commercial and Pipeline Insight: Opioids - Short acting and anti-abuse technologies set to fragment and grow the market

Commercial and Pipeline Insight: Opioids - Short acting and anti-abuse technologies set to fragment and grow the market
ABOUT DATAMONITOR HEALTHCARE 2

About the CNS pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3

Scope of the analysis 3

Contributing experts 3

Datamonitor insight into the opioid market 4

Related reports 6

CHAPTER 2 MARKET OVERVIEW AND POTENTIAL 8

Market overview and pain definition 9

Definition of opioid market 9

Market potential 10

Epidemiology of pain 10

Incidence 10

The burden of pain on every day life 10

Commonly-reported pain conditions 10

Definition of pain 11

Nociceptive pain 11

Neuropathic pain 12

Types of pain treated with opioids 13

Diagnosis of pain 14

Treatment of pain 15

Acute pain and cancer pain 15

Chronic non-cancer pain 16

Unmet need in pain treatment 17

Need to reduce the abuse and overdosing potential of opioids 18

Need to minimize opioid-related adverse events 19

Improved short-acting opioids 20

Current market value and future market forecasts 26

Current market dynamics 26

OxyContin dominates the opioid market 26

The US generated more revenue from opioid therapies than the EU and Japan combined 27

The opioid market is set to grow throughout the forecast period 29

Short-acting opioids-large growth driver 30

Anti-abuse reformulations take share from OxyContin 32

Generics are ever present 33

CHAPTER 3 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES 34

Marketed brands overview 35

Short-acting opioid brands 36

Actiq (fentanyl oral transmucosal) 36

Drug overview 36

Forecasts to 2017 36

SWOT analysis 38

Clinical trial data 38

Fentora 40

Drug overview 40

Forecasts to 2017 40

SWOT analysis 44

Patient potential 44

Marketing factors 44

Clinical trial data 45

Long-acting opioid brand 47

OxyContin (oxycodone HCl controlled-release) 47

Drug overview 47

Forecasts to 2017 48

SWOT analysis 51

Clinical trial data 51

Kadian (morphine sulfate XR) 55

Drug overview 55

Forecasts to 2017 55

SWOT analysis 57

Clinical trial data 57

Avinza (morphine sulfate XR) 59

Drug overview 59

Forecasts to 2017 59

SWOT analysis 61

Clinical trial data 61

Duragesic (fentanyl transdermal patch) 63

Drug overview 63

Forecasts to 2017 64

SWOT analysis 66

Clinical trial data 66

Opana 68

Drug overview 68

Forecasts to 2017 69

SWOT analysis 70

Clinical trial data 70

CHAPTER 4 FORECAST ANALYSIS 72

Key events 73

New product launches 74

Key drug launch assumptions 74

Product launches in Japan 75

Patent expiries 76

Data definitions, limitations and assumptions 76

Standard units 76

Japanese market data 76

Derivation of sales forecasts and pricing trends 77

Forecast methodology 77

CHAPTER 5 STRATEGIES FOR SUCCESS 78

Broaden customer base with key additional indications 79

Back pain 80

Postoperative pain 80

Neuropathic pain 81

Osteoarthritis 81

Refractory migraine 82

Opportunities for specialized niche companies to enter the market 82

Delivery reformulation 83

Anti-abuse technologies 86

CHAPTER 6 PIPELINE OVERVIEW-R&D DYNAMICS AND APPROACH 87

Pipeline overview 88

Classification of pipeline products 91

Majority of pipeline products are reformulations of existing opioids 91

Short-acting opioids 91

Oral transmucosal opioids 91

Intranasal opioids 92

Oral inhaled opioids 92

Long-acting opioids 93

Oral opioids 93

Subcutaneous opioids 93

Transdermal opioids 93

Clinical trial design 94

Actiq clinical trials set the standard 94

Actiq pivotal trial overview 94

Clinical trial endpoints in pain 100

Primary endpoints: the brief pain inventory is often used to assess pain in cancer patients 100

Secondary endpoints: economic and quality-of-life measures are important 100

CHAPTER 7 SHORT-ACTING OPIOID DRUG ANALYSIS & FORECASTS 102

Late-stage short-acting pipeline overview 103

Fentanyl based formulations 105

Rapinyl (sublingual) 106

Drug overview 106

Forecasts to 2017 106

Marketing potential 109

Patient potential 111

Satisfaction of unmet needs 111

Clinical trial data 112

BEMA fentanyl (buccal) 112

Drug overview 112

Forecasts to 2017 113

Marketing factors 116

Patient potential 117

Satisfaction of unmet needs 118

Clinical trial data 118

Instanyl (intranasal) 119

Drug overview 119

Forecasts to 2017 119

Marketing potential 121

Patient potential 122

Satisfaction of unmet needs 122

Clinical trial data 123

Nasalfent (intranasal) 123

Drug overview 123

Forecasts to 2017 123

Marketing potential 125

Patient potential 126

Satisfaction of unmet needs 126

Clinical data 126

AD-923 (sublingual spray) 127

Drug overview 127

Ongoing clinical trial program 128

Forecasts to 2017 128

HFT-290 (transdermal) 130

Morphine-based formulations 131

Rylomine (intranasal) 131

Drug overview 131

Forecasts to 2017 131

Marketing potential 133

Patient potential 134

Satisfaction of unmet needs 134

Clinical trial data 134

Buprenorphine based formulations 135

V1003 (intranasal) 135

Drug overview 135

Forecasts to 2017 136

Marketing potential 138

Patient potential 138

Clinical trial data 139

BEMA LA (buccal) 140

Drug overview 140

Clinical trial data 140

Drugs on hold 141

Taifun (inhaled) 141

Drug overview 141

Marketing potential 141

Patient potential 142

Satisfaction of unmet needs 143

Clinical trial data 143

AeroLEF (inhaled) 144

Drug overview 144

Marketing potential 145

Patient potential 146

Satisfaction of unmet needs 146

Clinical trial data 147

CHAPTER 8 LONG-ACTING OPIOID DRUG ANALYSIS & FORECASTS 149

Late-stage long-acting pipeline overview 150

Oxycodone based formulations 153

Remoxy (oxycodone) 153

Drug overview 153

Forecasts to 2017 154

Marketing potential 156

Patient potential 157

Satisfaction of unmet needs 157

Clinical trial data 157

Oxytrex (oxycodone and naltrexone) 158

Drug overview 158

Forecasts to 2017 158

Marketing potential 161

Patient potential 161

Satisfaction of unmet needs 162

Ongoing clinical trial program 162

ELI-216 (naltrexone hydrochloride, oxycodone) 162

Drug overview 162

Marketing potential 163

Patient potential 163

Ongoing clinical trial program 163

Acurox/OxyADF (oxycodone) tablet 164

Drug overview 164

Clinical trial data 165

Morphine-based formulations 167

Embeda (morphine sulfate, naltrexone hydrochloride) 167

Drug overview 167

Forecasts to 2017 167

Marketing potential 170

Patient potential 170

Satisfaction of unmet needs 171

Clinical trial data 171

Morphine-6-glucuronide (M6G) 171

Drug overview 171

Forecasts to 2017 172

Marketing potential 173

Patient potential 174

Clinical trial data 174

Egalet morphine (morphine) 176

EpiCept MP/DP (morphine, lidocaine) 177

Drug overview 177

Tramadol-based formulations 177

Tapentadol 177

Drug overview 177

Forecasts to 2017 178

Marketing potential 180

Patient potential 180

Clinical trial data 181

Tramadol ER 182

Drug overview 182

Forecasts to 2017 182

Clinical trial data 182

NS-315 (tramadol hydrochloride) 183

Drug overview 183

BVF-146 (tramadol in combination with NSAID) 183

Other 184

Ionsys (transdermal delivery system) 184

Drug overview 184

Forecasts to 2017 184

Marketing potential 185

Patient potential 185

Clinical trial data 186

Sufentanil patch 188

Drug overview 188

Forecasts to 2017 188

Clinical trial data 189

Vicodin CR 190

Drug overview 190

Forecasts to 2017 190

Hydromorphone nasal spray 192

Drug overview 192

Clinical trial data 193

Q8003IR (morphine and oxycodone) 193

Drug overview 193

Clinical trial data 194

ADL-5859 194

Drug overview 194

Clinical trial data 195

Nalbuphine ER 195

Drug overview 195

Clinical trial data 196

NRP-290 196

Drug overview 196

Clinical trial data 196

MGX-001 197

Drug overview 197

Suspended drugs 197

Titragesia (fentanyl) 197

CHAPTER 9 EARLY-STAGE PROJECTS 198

Key Phase I and earlier opioids in development 199

Phase I overview 199

TPM-01/ Morphine 200

CR665 200

Clinical trial data 200

BIBLIOGRAPHY 202

Journal papers 202

Websites 207

DM reports 215

APPENDIX 216

Report methodology 216

Contributing experts 218

About Datamonitor 218

About Datamonitor Healthcare 218

About the CNS team 219

Disclaimer 220

List of Tables

Table 1: Primary opioid-related adverse events for 130 patients initially enrolled in the trial of Actiq for cancer-related breakthrough pain 19

Table 2: Characteristics of immediate-release opioids useful for breakthrough pain 21

Table 3: Side effects experienced in OxyContin clinical trials 53

Table 4: Forecast launch dates in the US and 5EU 74

Table 5: Forecast launch dates in Japan 75

Table 6: Pivotal patent expiries for key marketed drugs in the US and 5EU 76

Table 7: Key pipeline opioids in late-stage development , 2008 89

Table 8: Characteristics of patients enrolled in the Farrar Actiq trial 96

Table 9: Key short-acting opioids in late-stage development, 2008 105

Table 10: Key long-acting opioids in late stage development, 2008 152

Table 11: Opioids in Phase development, 2008 199

Table 12: Datamonitor drug assessment parameters 217

List of Figures

Figure 1: Historical (2006) and forecast (2007-17) sales revenue for key marketed and pipeline opioids across the 7MM 6

Figure 2: Key unmet needs in the opioid market 17

Figure 3: The current versus ideal approach to breakthrough pain treatment 22

Figure 4: Onset of action versus duration of action of opioid formulations 23

Figure 5: Opioid sales revenue trend, 7MM, 2004-E2007 26

Figure 6: Estimated sales revenue generated by opioids per molecule, 2007 27

Figure 7: Opioid sales by revenue, by region and country, 2006-17 28

Figure 8: Opioid total market value in the US, Japan and 5EU split by molecule, 2006-17 29

Figure 9: Opioid total market value in the US, Japan and 5EU, 2006-17 30

Figure 10: Short-acting opioids sales revenue ($m), 7MM, 2006-17 31

Figure 11: Sales revenue ($m) of key long-acting opioids, 2006-17 32

Figure 12: Historical sales revenue (2006-07) and forecast sales revenue (2008-17) for key opioids across the 7MM 35

Figure 13: Actiq sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts 37

Figure 14: Actiq SWOT analysis 38

Figure 15: Fentora sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts 42

Figure 16: Drug assessment summary for Fentora, 2008 43

Figure 17: Fentora SWOT analysis 44

Figure 18: OxyContin sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts 49

Figure 19: Drug assessment summary for OxyContin, 2008 50

Figure 20: OxyContin SWOT analysis 51

Figure 21: Kadian sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts 56

Figure 22: Kadian SWOT analysis 57

Figure 23: Avinza sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts 60

Figure 24: Avinza SWOT analysis 61

Figure 25: Duragesic sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts 65

Figure 26: Duragesic SWOT analysis 66

Figure 27: Opana franchise sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts 69

Figure 28: Opana ER SWOT analysis 70

Figure 29: Impact of each key event on the opioid market across the seven major markets, 2007-12 73

Figure 30: Cephalon's breakthrough pain franchise, 2004-07 84

Figure 31: Cephalon's franchise as a percentage of Q1 2004 Standard Units 85

Figure 32: Drugs in development by class, 2008+ 88

Figure 33: Actiq study design 99

Figure 34: Historical (2006), estimated (2007) and forecast (2008-17) sales revenue for key short-acting pipeline opioids across the 7MM 103

Figure 35: Drug assessment summary overview of key pipeline short-acting opioids, 2008 104

Figure 36: Sales forecast for Rapinyl to 2017 in the 7MM 108

Figure 37: Drug assessment summary for Rapinyl, 2008 109

Figure 38: Sales forecast for BEMA Fentanyl to 2017 in the 7MM 115

Figure 39: Drug assessment summary for BEMA Fentanyl, 2008 116

Figure 40: Sales forecast for Instanyl to 2017 in the 7MM 120

Figure 41: Drug assessment summary for Instanyl, 2008 121

Figure 42: Sales forecast for Nasalfent to 2017 in the 7MM 124

Figure 43: Drug assessment summary for Nasalfent, 2008 125

Figure 44: Sales forecast for sublingual spray to 2017 in the 7MM 129

Figure 45: Drug assessment summary for sublingual spray, 2008 130

Figure 46: Sales forecast for Rylomine to 2017 in the 7MM 132

Figure 47: Drug assessment summary for Rylomine, 2008 133

Figure 48: Sales forecast for V1003 to 2017 in the 7MM 137

Figure 49: Drug assessment summary for V1003, 2008 138

Figure 50: Key long-acting opioid late-stage pipeline overview, 2008 150

Figure 51: Drug assessment summary overview of key pipeline long-acting opioids, 2008 151

Figure 52: Sales forecast for Remoxy to 2017 in the 7MM 155

Figure 53: Drug assessment summary for Remoxy, 2008 156

Figure 54: Sales forecast for Oxytrex to 2017 in the 7MM 160

Figure 55: Drug assessment summary for Oxytrex, 2008 161

Figure 56: Sales forecast for Embeda to 2017 in the 7MM 169

Figure 57: Drug assessment summary for Embeda, 2008 170

Figure 58: Sales forecast M6G to 2017 in the 7MM 172

Figure 59: Drug assessment summary for M6G, 2008 173

Figure 60: Sales forecast for Tapentadol to 2017 in the 7MM 179

Figure 61: Drug assessment summary for Tapentadol, 2008 180

Figure 62: Sales forecast for Ionsys to 2017 in the 7MM 185

Figure 63: Sales forecast for the Sufentanil patch to 2017 in the 7MM 189

Figure 64: Sales forecast for Vicodin CR to 2017 in the 7MM 191

Figure 65: Drug assessment summary for Vicodin CR, 2008 192

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