Commercial and Pipeline Perspectives: Obesity

Lack of Reimbursement Limits Market Potential

Publication Date	December 2006
Publisher	Datamonitor
Product Type	Report
Pages	217
ISBN Number	not applicable
Product Code	DAT04409

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Summary

Introduction

Datamonitor 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

Content

Chapter 1 Executive Summary
- Scope of the Analysis
- Datamonitor insight into the Obesity market
- 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 Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's research and analysis methodologies
- Datamonitor Healthcare's therapy area capabilities
- About the Cardiovascular analysis team
- Disclaimer