Commercial and Pipeline Perspectives: Obesity - Super-sized Epidemic

TABLE OF CONTENTS

ABOUT DATAMONITOR HEALTHCARE

• About the Cardiovascular pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

• Scope of the analysis
• Datamonitor insight into the anti-obesity drug market
• Summary
• Key metrics

CHAPTER 2 PATIENT POTENTIAL

• Definition of obesity
• Causes of obesity
• Obesity prevalence
• Obesity prevalence
• Obesity forecasts
• Obesity prevalence methodology
• US
• Japan
• France
• Germany
• Italy
• Spain
• UK
• Forecast methodology
• Prevalence of obesity in juveniles
• Segmentation of obesity
• Overview of guidelines
• 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 GLOBAL MARKET OVERVIEW

• Overview of the global anti-obesity drug market
• US
• REIMBURSEMENT
• DTC ADVERTISING
• National organizations
• FDA'S OBESITY WORKING GROUP
• Awareness campaigns
• THE UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Japan
• Takeda
• Europe
• European initiatives
• FOOD NUTRITION ACTION PLAN
• THE EUROPEAN CHILDHOOD OBESITY GROUP
• FRANCE
• GERMANY
• ITALY
• SPAIN
• UK
• Awareness campaigns
• TOAST
• THE BRITISH DIETETIC ASSOCIATION'S FOOD FIRST PROGRAMME, 2002-04
• NATIONAL OBESITY FORUM
• GOVERNMENT INITIATIVES
• THE INTERNATIONAL OBESITY TASKFORCE
• Global market forecast

CHAPTER 4 DRUG ANALYSIS

• 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
• 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 MAY BECOME PRESCRIPTION-FREE
• Xenical forecasts to 2012
• FDA APPROVAL OF USE OF XENICAL IN ADOLESCENTS
• LONG-TERM SAFETY DATA FROM THE XENDOS STUDY
• OTHER POSITIVE FACTORS
• LAUNCH OF ACOMPLIA
• FURTHER PRODUCT LAUNCHES AND PATENT EXPIRIES
• Meridia analysis
• Drug overview
• NO BENEFITS SHOWN IN HEALTH-RELATED QUALITY OF LIFE STUDY IN SIBUTRAMINE-TREATED OBESE PATIENTS WITH TYPE 2 DIABETES
• 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 (ESPECIALLY ON HEART)
• Meridia forecasts to 2012
• LAUNCH OF ACOMPLIA
• PATENT EXPIRY

CHAPTER 5 RD APPROACH

• Classification of pipeline products
• Cannabinoid (CB1) antagonists
• SNRIs
• Beta-3 adrenergic agonists
• Cholecystokinin agonists
• Carboxypeptidase inhibitors
• Ciliary neurotrophic factor (CNTF) agonists
• Lipase inhibitors
• Leptin agonists
• Lipid metabolism modulators
• 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

CHAPTER 6 OBESITY PIPELINE ANALYSIS

• Pipeline overview
• Key companies involved in the anti-obesity drug market
• Sanofi-Aventis
• Breakdown by type of therapy
• Key marketing opportunities
• Axokine
• AOD9604

CHAPTER 7 DRUGS IN DEVELOPMENT

• Phase III
• Pipeline summary
• Definition of current comparator therapy
• Acomplia (rimonabant)
• Drug overview
• Clinical trial data
• PHASE IIA
• PHASE IIB
• RESULTS
• PHASE III RIO-LIPIDS TRIAL
• BACKGROUND
• STUDY DESIGN
• RESULTS
• AUTHOR CONCLUSION
• DATAMONITOR COMMENTS
• Patient potential
• Marketing factors
• Satisfaction of unmet needs
• WEIGHT LOSS
• SIDE EFFECTS
• PATIENT POTENTIAL
• MARKETING STRENGTH
• OVERALL PERFORMANCE
• Forecasts to 2012
• Axokine
• Drug overview
• Clinical trial data
• BACKGROUND
• STUDY DESIGN
• RESULTS
• AUTHOR CONCLUSIONS
• DATAMONITOR COMMENTS
• PHASE II
• BACKGROUND
• STUDY DESIGN
• RESULTS
• AUTHOR CONCLUSION
• DATAMONITOR COMMENTS
• PATIENT POTENTIAL
• MARKETING FACTORS
• Satisfaction of unmet needs
• WEIGHT LOSS
• SIDE EFFECTS
• PATIENT POTENTIAL
• MARKETING STRENGTH
• OVERALL PERFORMANCE
• Forecasts to 2012
• Phase II drugs
• ATL-962
• Drug overview
• Clinical trial data
• BACKGROUND
• STUDY DESIGN
• RESULTS
• AUTHOR CONCLUSIONS
• DATAMONITOR COMMENTS
• Patient potential
• Marketing factors
• Satisfaction of unmet needs
• WEIGHT LOSS
• SIDE EFFECTS
• PATIENT POTENTIAL
• MARKETING STRENGTH
• OVERALL PERFORMANCE
• Forecasts to 2012
• 1426
• Drug overview
• Clinical trial background
• STUDY DESIGN
• RESULTS
• DATAMONITOR COMMENTS
• MARKETING FACTORS
• Satisfaction of unmet needs
• WEIGHT LOSS
• SIDE EFFECTS
• PATIENT POTENTIAL
• MARKETING STRENGTH
• OVERALL PERFORMANCE
• Forecasts to 2012
• AOD9604
• Drug overview
• Clinical trial data
• BACKGROUND
• STUDY DESIGN
• RESULTS
• AUTHOR CONCLUSIONS
• DATAMONITOR COMMENTS
• Satisfaction of unmet needs
• WEIGHT LOSS
• SIDE EFFECTS
• PATIENT POTENTIAL
• MARKETING STRENGTH
• OVERALL PERFORMANCE
• Forecast to 2012
• GI181771
• A137
• Comparison of key compounds
• 10% and 5% weight loss
• Side effects
• Patient potential
• Marketing strength
• Overall performance
• Comparative forecasts
• Innovative early-stage projects
• 1954
• C2624
• C5093
• LY377604
• Peptide YY [3-36]
• SLV319
• T71
• APD356
• S2367
• Peg Axokine
• CP 331684
• Discontinued anti-obesity agents

APPENDIX A

• Contributing experts
• Bibliography
• Epidemiology sources
• US
• Japan
• France
• Germany
• Italy
• Spain
• UK
• 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
• Key therapy team members
• Dr Allison Fleetwood
• Disclaimer
• List of Tables
• Table 1: Prevalence of obesity in the seven major markets by age (000s), 2003
• Table 2: Forecast of key pipeline products in the anti-obesity drug market in 2012
• Table 3: Prevalence of obesity in the seven major markets by age (000s), 2003
• Table 4: Prevalence of overweight in the seven major markets by age (000s), 2003
• Table 5: Forecast prevalence of obesity in the US (000s), 2003-12
• Table 6: Forecast prevalence of overweight in the US (000s), 2003-12
• Table 7: Forecast prevalence of obesity in the UK (000s), 2003-12
• Table 8: Forecast prevalence of overweight in the UK (000s), 2003-12
• Table 9: Classification of overweight, obesity by BMI, waist circumference and associated disease risk
• Table 10: A guide to treatment selection
• Table 11: Global anti-obesity drug sales 1999-2003, across the seven major markets
• Table 12: US anti-obesity drug sales from 1999-2003
• Table 13: Anti-obesity drug sales in Japan, 1999-03
• Table 14: French anti-obesity drug sales, 1999-2003
• Table 15: German anti-obesity drug sales, 1999-2003
• Table 16: Italian anti-obesity drug sales, 1999-2003
• Table 17: Spanish anti-obesity drug sales, 1999-2003
• Table 18: UK anti-obesity drug sales, 1999-2003
• Table 19: Global anti-obesity drug forecast, 2003-12
• Table 20: Xenical: key characteristics
• Table 21: Xenical events, 2003-04
• Table 22: Impacting factors on the sales of Xenical, 2003-12
• Table 23: Meridia: key characteristics
• Table 24: Meridia events, 2003-04
• Table 25: Impacting factors on the revenues of Meridia, 2003-12
• Table 26: Clinical trial designs
• Table 27: Clinical trial endpoints
• Table 28: Anti-obesity RD pipeline, June 2004
• Table 29: Companies with anti-obesity drugs in Phase I or above
• Table 30: Breakdown of the anti-obesity pipeline by type of therapy, 2004
• Table 31: Marketing position of companies with anti-obesity RD products
• Table 32: Key products in late-stage RD pipeline for obesity, June 2004
• Table 33: Results of the Phase III RIO-Lipids study
• Table 34: Impacting factors on the revenues of Acomplia, 2003-12
• Table 35: Phase III Axokine trial results
• Table 36: Comparison of Axokine trial results according to patients developing antibodies and those who did not
• Table 37: Average weight loss in pounds in Phase II of Axokine trial from baseline weight
• Table 38: Percentage of patients losing at least 5% of body weight
• Table 39: Impacting factors on the revenues of Axokine, 2006-12
• Table 40: Impacting factors on the revenues of ATL-962, 2008-12
• Table 41: Impacting factors on the revenues of 1426, 2009-12
• Table 42: Impacting factors on the revenues of AOD9604, 2009-12
• Table 43: Global sales forecasts for anti-obesity drugs, 2003-12
• Table 44: Anti-obesity agents in Phase I of development, June 2004
• Table 45: Discontinued RD anti-obesity agents
• List of Figures
• Figure 1: Impacts on the global anti-obesity market to 2012
• Figure 2: Classification of overweight and obesity
• Figure 3: Overview of obesity treatment guidelines from the NHLBI
• Figure 4: Growth and market share of anti-obesity drugs, 2002-03
• Figure 5: Xenical SWOT analysis
• Figure 6: Global sales forecasts for Xenical, 2003-12
• Figure 7: Meridia SWOT analysis
• Figure 8: Global sales forecasts for Meridia, 2003-12
• Figure 9: Rimonabant's satisfaction of unmet needs
• Figure 10: Global sales forecasts for Acomplia, 2003-12
• Figure 11: Phase III Axokine trial design
• Figure 12: Axokine Phase II trial design
• Figure 13: Axokine's satisfaction of unmet needs
• Figure 14: Global sales forecasts for Axokine, 2006-12
• Figure 15: ATL-962 Phase II trial designs
• Figure 16: ATL-962's satisfaction of unmet needs
• Figure 17: Global sales forecasts for ATL-962, 2008-12
• Figure 18: 1426's satisfaction of unmet needs
• Figure 19: Global sales forecasts for 1426, 2003-12
• Figure 20: AOD9604's satisfaction of unmet needs
• Figure 21: Global sales forecasts for AOD9604, 2003-12
• Figure 22: Comparison of key RD products in anti-obesity pipeline
• Figure 23: Comparative sales forecasts for the key therapies in the anti-obesity drug market, 2003-12