Commercial and Pipeline Perspectives: Obesity - Lack of Reimbursement Limits Market Potential

CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the Analysis 3
Datamonitor insight into the Obesity market 4
The obesity "epidemic" is taking place to a certain extent in all the major markets, and the rate of obesity prevalence growth is not showing any signs of slowing down in the near future 4
The anti-obesity market growth does not follow the growth of obesity prevalence. The major cause for the lack of growth in most of the major markets is lack of reimbursement for pharmacological management of obesity 5
The drugs currently available in the major markets for treatment of obesity have significant unmet needs and do not meet the expectations of obese patients 6
The pipeline drugs will be able to satisfy some of the unmet needs and will be able to expand the market. However, the growth of the market will still be marginal in comparison to the growth of obesity prevalence 7
Key metrics 8
CHAPTER 2 PATIENT POTENTIAL 26
Definition of obesity 26
Segmentation of obesity 26
Causes of obesity 29
Genetic factors 29
Environmental factors 29
Psychological factors 30
Other causes 30
Obesity as a Risk Factor 30
Obesity and overweight prevalence 31
Obesity and overweight prevalence methodology 35
US 35
Japan 36
France 36
Germany 36
Italy 37
Spain 37
UK 37
Overview of guidelines 38
NHLBI Guidelines 38
American College of Physicians guidelines 40
PRODIGY 41
Unmet needs in obesity 45
More cost-effective care 46
Increased patient knowledge and physician awareness 46
Safe and tolerable drugs 47
Drugs with greater efficacy 47
Improved patient compliance 48
CHAPTER 3 MARKET ANALYSIS 50
Overview of the global anti-obesity drug market 50
Lack of reimbursement is the key market resistor. 52
Overview of the US anti-obesity drug market 52
Reimbursement 55
DTC advertising 56
National organizations and Awareness campaigns 57
FDA’s Obesity Working Group 57
The United States Department of Health and Human Services 57
Trust for America’s Health 58
2001-2006 - The VERB Youth Media 59
2003 - Steps to a HealthierUS 59
2004 - Preventing Childhood Obesity: Health in the Balance 59
2004 - The Calories Count initiative 59
2004 - The Obesity and the Built Environment: Improving Public Health Through Community Design conference 59
2005 – Dietary Guidelines for Americans, 2005 60
2005 – "We Can!" 60
2006 - Perspectives on Marketing, Self- Regulation, and Childhood Obesity 60
2006 - Food Marketing to Children and Youth: Threat or Opportunity? 60
2006 – Shape of the Nation 60
Overview of the anti-obesity drug market in Japan 62
Overview of the anti-obesity drug market in Europe 64
France 65
Germany 67
Italy 69
Spain 71
UK 73
UK-specific awareness campaigns 75
TOAST 75
The British Dietetic Association’s Food First Program 75
National Obesity Forum 75
The International Obesity Taskforce 76
Other European initiatives 77
Food & Nutrition Action Plan 78
The European Childhood Obesity Group 78
EU platform for action "diet, physical activity and health" 79
Green Paper: "Promoting healthy diets and physical activity" 80
Anti-Obesity Charter 80
Global market forecast 82
CHAPTER 4 OBESITY PIPELINE ANALYSIS 84
The anti-obesity pipeline is mechanistically diversified 88
The anti-obesity pipeline is rich in Phase I and Phase II candidates 90
Numerous companies have their stake in the R&D landscape 91
CHAPTER 5 R&D APPROACH 94
Classification of pipeline products 94
Cannabinoid (CB1) antagonists 94
5-HT (Serotonin) Receptors 95
SNRIs 96
Lipase inhibitors 96
Alpha MSH (alpha-melanocyte-stimulating hormone) modulator 96
Clinical trial design 98
Clinical endpoints 100
Insulin sensitivity and prevention of type 2 diabetes 103
HDL and LDL cholesterol levels 104
Critique of clinical trial design in obesity 104
Strategies for achieving reimbursement 105
Sanofi-Aventis raises the bar 106
CHAPTER 6 DRUG ANALYSIS – DRUGS ON THE MARKET 109
Xenical analysis 109
Drug overview 109
Marketing support 111
The XENDOS study shows orlistat reduces risk of type 2 diabetes 112
The FDA approves the use of orlistat in adolescents 113
The European Commission approves label extension 115
Xenical may slow cancer growth 115
Chugai discontinues clinical development of orlistat in Japan 115
The European Commission approves the use of orlistat in obese adolescents 115
FDA gives conditional approval for OTC use of orlistat 115
Public Citizen petitions FDA to remove orlistat from the market 117
Trials with Orlistat (60 mg) prove efficacy and improved tolerability in weight loss and reduction in LDL cholesterol. 117
Marketing strategies 118
Promotion of long-term efficacy and safety 118
Promotion of Xenical use in obese adolescents and the reduced risk of developing type 2 diabetes 119
Provide more patient support to increase patient compliance 120
Xenical forecasts to 2015 121
Launch of Acomplia 122
Orlistat goes OTC 122
Loss of Patent Protection 122
Launch of Contrave 122
Launch of Qnexa 123
Launch of Lorcaserin 123
Launch of Cetilistat 123
Meridia analysis 124
Drug overview 124
Behavior therapy and sibutramine for the treatment of adolescent obesity 126
STORM trial shows weight-maintenance success after weight loss is positively influenced by sibutramine and leisure-time activity. 128
Sibutramine has a positive effect on clinical and metabolic parameters in obese patients with polycystic ovary syndrome (PCOS) 129
Sibutramine effective in the treatment of binge-eating disorder 129
No benefits shown in health-related quality of life study in sibutramine-treated obese patients with type 2 diabetes 130
Eisai announces the start of phase III trials in Japan 131
SCOUT study 131
Marketing strategies 132
Increase patient support strategies to improve patient compliance 132
Invest in more clinical trials for new indications 133
Conduct more trials focusing on the safety of Meridia 133
Meridia forecasts to 2015 134
Launch of Acomplia 135
Launch of Sibutramine in Japan 135
Disclosure of SCOUT results 135
Patent expiry 136
Launch of Contrave 136
Launch of Qnexa 136
Launch of Lorcaserin 136
Launch of Cetilistat 137
Acomplia analysis 138
Drug overview 138
Results of RIO-Lipids presented 139
Results of RIO-Diabetes presented 141
FDA issues approvable letter for obesity 143
EU CHMP recommends approval of rimonabant for obesity 143
Germany classifies rimonabant as lifestyle drug 144
Results of SERENADE presented 144
Marketing strategies 146
Conduct more safety studies focusing on depression 146
Promote the improvement of multiple risk factors for CV disease 147
Conduct an outcome study with prevention of diabetes as primary end point 147
Acomplia forecasts to 2015 148
Launch of Acomplia 148
Potential for a black box warning 149
Launch of Contrave 149
Launch of Qnexa 149
Launch of Lorcaserin 150
Launch of Cetilistat 150
CHAPTER 7 DRUG ANALYSIS – LATE STAGE AGENTS 151
Phase III 151
Pipeline summary 151
Contrave (bupropion+ naltrexone) 152
Drug Overview 152
Clinical Trial Data 152
Datamonitor Comments 153
Forecasts to 2015 153
Lorcaserin (APD356) 155
Drug overview 155
Clinical Trial Data 156
Datamonitor Comments 157
Forecasts to 2015 162
MK0557 (L-000753721) 163
Drug Overview 163
Clinical Trial Data 163
Datamonitor Comments 164
MK0364 (c5093) 164
Drug Overview 164
Clinical Trial Data 164
CP945598 164
Phase II – Pipeline summary 166
Phase II – most promising compounds 168
Cetilistat (ATL962) 168
Drug Overview 168
Datamonitor Comments 169
Forecasts to 2015 170
Qnexa (phentermine + topiramate; VI0521) 172
Drug Overview 172
Clinical Trial Data 172
Datamonitor Comments 173
Forecasts to 2015 173
Phase II – other compounds 175
Excalia (zonisamide +bupropion) 175
Drug Overview 175
Clinical Trial Data 175
Datamonitor Comments 176
AOD9604 177
Drug Overview 177
Clinical Trial Data 177
Datamonitor Comments 178
Surinabant (SR 147778) 178
Drug Overview 178
Clinical Trial Data 179
Datamonitor Comments 179
Recombinant Methionyl human leptin 180
Drug Overview 180
Clinical Trial Data 180
Datamonitor Comments 181
Pramlintide (AC137) 181
Drug Overview 181
Clinical Trial Data 181
Datamonitor Comments 183
S2367 183
Drug Overview 183
Clinical Trial Data 183
Datamonitor Comments 184
Oleoyl-estrone 184
Drug Overview 184
Clinical Trial Data 185
Teglicar (ST1326) 187
N5984 (KRP204) 187
CP741952 188
MK0916 188
AVE1625 189
C2735 189
MK0493 (c2624) 189
Sergliflozin (KGT1251, 869682) 189
Tesofensine (NS2330) 190
CHAPTER 8 DRUG ANALYSIS – EARLY STAGE AGENTS 191
KB2115 193
SLV319 193
PROTEIN TYROSINE PHOSPHATASE 1B INHIBITORS, SERONO 193
856464 193
AC162352 193
ANDROGEN RECEPTOR AGONISTS, GTX 194
AMG076 194
QRX431 194
BDC03 194
RESVERATROL (SRT501) 195
PRX07034 195
TM30338 195
GT389255 195
PEPTIDE YY [3-36] (OBESITY, INTRANASAL), NASTECH 196
ID1101 198
RADAFAXINE 198
FLUASTERONE 198
NGD4715 198
BVT74316 199
APPENDIX A 200
Contributing experts 200
Interviewed in 2004 200
Interviewed in 2006 200
Bibliography 202
Epidemiology sources 202
US 202
Japan 202
France 202
Germany 202
Italy 202
Spain 203
UK 203
General Sources 204
Report methodology 213
Japanese market data 213
APPENDIX B 214
About Datamonitor 214
About Datamonitor Healthcare 214
Datamonitor Healthcare’s research and analysis methodologies 215
Datamonitor Healthcare’s therapy area capabilities 215
About the Cardiovascular analysis team 216
Disclaimer 217