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Commercial and Pipeline Perspectives: Obesity - Lack of Reimbursement Limits Market PotentialPublished by: Datamonitor Published: Dec. 20, 2006 - 217 Pages Table of ContentsTABLE OF CONTENTS 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 AbstractIntroductionDatamonitor predicts a somewhat enthusiastic uptake of two agents currently in development by 2015. However, reimbursement is critical to the uptake of new medication, due to the high cost of therapy. If the reimbursable status is not achieved, the expansion of the market will not match the rate of growth of the obese population and the great potential of the obesity market will remain untapped. Scope Assessment of the patient potential for developmental anti-obesity agents over the period 2006-15 Overview of the anti-obesity R&D pipeline, with detailed information on the classes in development and comparator drugs Commercial analysis of key compounds in development regarding their ability to take away market share from the currently available drugs Sales forecasts for key late-stage developmental anti-obesity agents in the seven major markets to 2015 Highlights 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. 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. 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. The pipeline drugs 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. Reasons to Purchase Understand the key factors that will contribute to the success of the next generation of anti-obesity drugs View independent sales forecasts for products in late stage development for therapy of obesity Understand physician sentiment on clinical trial endpoints and late-stage candidate drugs for the obesity market Get Full Details About This Report >> |
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