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

Table of Contents

• ABOUT HEALTHCARE
  • About the cardiovascular pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the Analysis
    • 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 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
  • Key metrics
• CHAPTER 2 PATIENT POTENTIAL
  • Definition of obesity
  • Segmentation of obesity
  • Causes of obesity
    • Genetic factors
    • Environmental factors
    • Psychological factors
    • Other causes
  • Obesity as a Risk Factor
  • Obesity and overweight prevalence
    • Obesity and overweight prevalence methodology
      • US
      • Japan
      • France
      • Germany
      • Italy
      • Spain
      • UK
  • Overview of guidelines
    • NHLBI Guidelines
    • American College of Physicians guidelines
    • PRODIGY
  • Unmet needs in obesity
    • More cost-effective care
    • Increased patient knowledge and physician awareness
    • Safe and tolerable drugs
    • Drugs with greater efficacy
    • Improved patient compliance
• CHAPTER 3 MARKET ANALYSIS
  • Overview of the global anti-obesity drug market
    • Lack of reimbursement is the key market resistor
  • Overview of the US anti-obesity drug market
    • Reimbursement
    • DTC advertising
    • National organizations and Awareness campaigns
      • FDA' s Obesity Working Group
      • The United States Department of Health and Human Services
      • Trust for America' s Health
      • 2001-2006 - The VERB Youth Media
      • 2003 - Steps to a HealthierUS
      • 2004 - Preventing Childhood Obesity: Health in the Balance
      • 2004 - The Calories Count initiative
      • 2004 - The Obesity and the Built Environment: Improving Public Health Through Community Design conference
      • 2005 - Dietary Guidelines for Americans, 2005
      • 2005 - "We Can!"
      • 2006 - Perspectives on Marketing, Self- Regulation, and Childhood Obesity
      • 2006 - Food Marketing to Children and Youth: Threat or Opportunity?
      • 2006 - Shape of the Nation
  • Overview of the anti-obesity drug market in Japan
  • Overview of the anti-obesity drug market in Europe
    • France
    • Germany
    • Italy
    • Spain
    • UK
    • UK-specific awareness campaigns
      • TOAST
      • The British Dietetic Association' s Food First Program
      • National Obesity Forum
      • The International Obesity Taskforce
    • Other European initiatives
      • Food & Nutrition Action Plan
      • The European Childhood Obesity Group
      • EU platform for action "diet, physical activity and health"
      • Green Paper: "Promoting healthy diets and physical activity"
      • Anti-Obesity Charter
  • Global market forecast
• CHAPTER 4 OBESITY PIPELINE ANALYSIS
  • The anti-obesity pipeline is mechanistically diversified
  • The anti-obesity pipeline is rich in Phase I and Phase II candidates
  • Numerous companies have their stake in the R&D landscape
• CHAPTER 5 R&D APPROACH
  • Classification of pipeline products
    • Cannabinoid (CB1) antagonists
    • 5-HT (Serotonin) Receptors
    • SNRIs
    • Lipase inhibitors
    • Alpha MSH (alpha-melanocyte-stimulating hormone) modulator
  • Clinical trial design
  • Clinical endpoints
    • Insulin sensitivity and prevention of type 2 diabetes
    • HDL and LDL cholesterol levels
  • Critique of clinical trial design in obesity
  • Strategies for achieving reimbursement
  • Sanofi-Aventis raises the bar
• CHAPTER 6 DRUG ANALYSIS - DRUGS ON THE MARKET
  • Xenical analysis
    • Drug overview
      • Marketing support
      • The XENDOS study shows orlistat reduces risk of type 2 diabetes
      • The FDA approves the use of orlistat in adolescents
      • The European Commission approves label extension
      • Xenical may slow cancer growth
      • Chugai discontinues clinical development of orlistat in Japan
      • The European Commission approves the use of orlistat in obese adolescents
      • FDA gives conditional approval for OTC use of orlistat
      • Public Citizen petitions FDA to remove orlistat from the market
      • Trials with Orlistat (60 mg) prove efficacy and improved tolerability in weight loss and reduction in LDL cholesterol.
    • Marketing strategies
      • Promotion of long-term efficacy and safety
      • Promotion of Xenical use in obese adolescents and the reduced risk of developing type 2 diabetes
      • Provide more patient support to increase patient compliance
    • Xenical forecasts to 2015
      • Launch of Acomplia
      • Orlistat goes OTC
      • Loss of Patent Protection
      • Launch of Contrave
      • Launch of Qnexa
      • Launch of Lorcaserin
      • Launch of Cetilistat
  • Meridia analysis
    • Drug overview
      • Behavior therapy and sibutramine for the treatment of adolescent obesity
      • STORM trial shows weight-maintenance success after weight loss is positively influenced by sibutramine and leisure-time activity.
      • Sibutramine has a positive effect on clinical and metabolic parameters in obese patients with polycystic ovary syndrome (PCOS)
      • Sibutramine effective in the treatment of binge-eating disorder
      • No benefits shown in health-related quality of life study in sibutramine-treated obese patients with type 2 diabetes
      • Eisai announces the start of phase III trials in Japan
      • SCOUT study
    • Marketing strategies
      • Increase patient support strategies to improve patient compliance
      • Invest in more clinical trials for new indications
      • Conduct more trials focusing on the safety of Meridia
    • Meridia forecasts to 2015
      • Launch of Acomplia
      • Launch of Sibutramine in Japan
      • Disclosure of SCOUT results
      • Patent expiry
      • Launch of Contrave
      • Launch of Qnexa
      • Launch of Lorcaserin
      • Launch of Cetilistat
  • Acomplia analysis
    • Drug overview
      • Results of RIO-Lipids presented
      • Results of RIO-Diabetes presented
      • FDA issues approvable letter for obesity
      • EU CHMP recommends approval of rimonabant for obesity
      • Germany classifies rimonabant as lifestyle drug
      • Results of SERENADE presented
    • Marketing strategies
      • Conduct more safety studies focusing on depression
      • Promote the improvement of multiple risk factors for CV disease
      • Conduct an outcome study with prevention of diabetes as primary end point
    • Acomplia forecasts to 2015
      • Launch of Acomplia
      • Potential for a black box warning
      • Launch of Contrave
      • Launch of Qnexa
      • Launch of Lorcaserin
      • Launch of Cetilistat
• CHAPTER 7 DRUG ANALYSIS - LATE STAGE AGENTS
  • Phase III
    • Pipeline summary
    • Contrave (bupropion+ naltrexone)
      • Drug Overview
      • Clinical Trial Data
      • Datamonitor Comments
      • Forecasts to 2015
    • Lorcaserin (APD356)
      • Drug overview
      • Clinical Trial Data
      • Datamonitor Comments
      • Forecasts to 2015
    • MK0557 (L-000753721)
      • Drug Overview
      • Clinical Trial Data
      • Datamonitor Comments
    • MK0364 (c5093)
      • Drug Overview
      • Clinical Trial Data
    • CP945598
  • Phase II - Pipeline summary
  • Phase II - most promising compounds
    • Cetilistat (ATL962)
      • Drug Overview
      • Datamonitor Comments
      • Forecasts to 2015
    • Qnexa (phentermine + topiramate; VI0521)
      • Drug Overview
      • Clinical Trial Data
      • Datamonitor Comments
      • Forecasts to 2015
  • Phase II - other compounds
    • Excalia (zonisamide +bupropion)
      • Drug Overview
      • Clinical Trial Data
      • Datamonitor Comments
    • AOD9604
      • Drug Overview
      • Clinical Trial Data
      • Datamonitor Comments
    • Surinabant (SR 147778)
      • Drug Overview
      • Clinical Trial Data
      • Datamonitor Comments
    • Recombinant Methionyl human leptin
      • Drug Overview
      • Clinical Trial Data
      • Datamonitor Comments
    • Pramlintide (AC137)
      • Drug Overview
      • Clinical Trial Data
      • Datamonitor Comments
    • S2367
      • Drug Overview
      • Clinical Trial Data
      • Datamonitor Comments
    • Oleoyl-estrone
      • Drug Overview
      • Clinical Trial Data
    • Teglicar (ST1326)
    • N5984 (KRP204)
    • CP741952
    • MK0916
    • AVE1625
    • C2735
    • MK0493 (c2624)
    • Sergliflozin (KGT1251, 869682)
    • Tesofensine (NS2330)
• CHAPTER 8 DRUG ANALYSIS - EARLY STAGE AGENTS
  • KB2115
  • SLV319
  • PROTEIN TYROSINE PHOSPHATASE 1B INHIBITORS, SERONO
  • 856464
  • AC162352
  • ANDROGEN RECEPTOR AGONISTS, GTX
  • AMG076
  • QRX431
  • BDC03
  • RESVERATROL (SRT501)
  • PRX07034
  • TM30338
  • GT389255
  • PEPTIDE YY [3-36] (OBESITY, INTRANASAL), NASTECH
  • ID1101
  • RADAFAXINE
  • FLUASTERONE
  • NGD4715
  • BVT74316
• APPENDIX A
  • Contributing experts
    • Interviewed in 2004
    • Interviewed in 2006
  • Bibliography
    • Epidemiology sources
      • US
      • Japan
      • France
      • Germany
      • Italy
      • Spain
      • UK
    • General Sources
  • Report methodology
    • Japanese market data
• APPENDIX B
  • About the Cardiovascular analysis team
  • Disclaimer
  • List of Tables
    • Table 1: Prevalence of obesity in the seven major markets (000s), 2006-2015
    • Table 2: Prevalence of obesity / overweight in the seven major markets (000s), 2006-2015
    • Table 3: Global anti-obesity drug forecast, 2006-15, $m
    • Table 4: Classification of overweight, obesity by BMI, waist circumference and associated disease risk
    • Table 5: Prevalence of obesity in the seven major markets (000s), 2006-2015
    • Table 6: Prevalence of obesity / overweight in the seven major markets (000s), 2006-2015
    • Table 7: A guide to treatment selection according to the NHLBI guidelines
    • Table 8: Global anti-obesity drug forecast, 2006-15, $m
    • Table 9: Pipeline of anti-obesity compounds, 2006
    • Table 10: The pipeline for anti-obesity agents is mechanistically diversified: full listing, 2006
    • Table 11: Pipeline of anti-obesity agents by company, 2006
    • Table 12: Clinical trial design
    • Table 13: Clinical trial endpoints
    • Table 14: Phase III(b) rimonabant clinical development program
    • Table 15: Xenical: key characteristics
    • Table 16: Xenical events, 2003-06
    • Table 17: Meridia: key characteristics
    • Table 18: Meridia events, 2003-06
    • Table 19: Acomplia: key characteristics
    • Table 20: Acomplia events, 2003-6
    • Table 21: Results of the Phase III RIO-Lipids study
    • Table 22: Results of the Phase III RIO-Diabetes study
    • Table 23: Results of the SERENADE trial
    • Table 24: Key products in Phase III R&D pipeline for obesity, Oct 2006
    • Table 25: Key products in Phase II R&D pipeline for obesity, December 2006
    • Table 26: Results of phase Ib trial with Oleoyl-Estrone (kilograms)
    • Table 27: Percentage Changes after the treatment with N5984
    • Table 28: Key products in early-stage R&D pipeline for obesity, Dec 2006
  • List of Figures
    • Figure 1: Pipeline of anti-obesity compounds, 2006
    • Figure 2: Classification of overweight and obesity
    • Figure 3: Overview of obesity treatment guidelines from the NHLBI
    • Figure 4: Global anti-obesity drug sales, 2002-2005, $m
    • Figure 5: US anti-obesity drug sales, 2002-2005, $m
    • Figure 6: US anti-obesity drug sales, 2002-2005, SU (000,000)
    • Figure 7: Japan anti-obesity drug sales, 2002-2005, $m
    • Figure 8: France - anti-obesity drug sales, 2002-2005, $m
    • Figure 9: France anti-obesity drug sales, 2002-2005, SU (000,000)
    • Figure 10: Germany - anti-obesity drug sales, 2002-2005, $m
    • Figure 11: Germany - anti-obesity drug sales, 2002-2005, SU (000,000)
    • Figure 12: Italy - anti-obesity drug sales, 2002-2005, $m
    • Figure 13: Italy - anti-obesity drug sales, 2002-2005, SU (000,000)
    • Figure 14: Spain - anti-obesity drug sales, 2002-2005, $m
    • Figure 15: Spain - anti-obesity drug sales, 2002-2005, SU (000,000)
    • Figure 16: UK - anti-obesity drug sales, 2002-2005, $m
    • Figure 17: UK - anti-obesity drug sales, 2002-2005, SU (000,000)
    • Figure 18: Pipeline of anti-obesity compounds, 2006
    • Figure 19: The pipeline of anti-obesity agents is mechanistically diverse, 2006
    • Figure 20: Pipeline maturity: percentage of R&D products in each phase of development, 2006
    • Figure 21: Xenical SWOT analysis
    • Figure 22: Global sales forecasts for Xenical, 2006-15, $m
    • Figure 23: Meridia SWOT analysis
    • Figure 24: Global sales forecasts for Meridia, 2006-15
    • Figure 25: Acomplia SWOT analysis
    • Figure 26: Global sales forecasts for Acomplia, 2006-15
    • Figure 27: Global sales forecasts for Contrave, 2006-15, $m
    • Figure 28: Global sales forecasts for Lorcaserin, 2006-15, $m
    • Figure 29: Global sales forecasts for Cetilistat, 2006-15, $m
    • Figure 30: Global sales forecasts for Qnexa, 2006-15, $m