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Obesity Therapeutics to 2019 - Safety Concerns Hinder Drug Performance Despite Large Market Opportunity

NEW YORK, Sept. 16, 2013 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Obesity Therapeutics to 2019 - Safety Concerns Hinder Drug Performance Despite Large Market Opportunity

Obesity Therapeutics to 2019 - Safety Concerns Hinder Drug Performance Despite Large Market Opportunity Summary

GBI Research, the leading business intelligence provider, has released its latest research, "Obesity Therapeutics to 2019 - Safety Concerns Hinder Drug Performance Despite Large Market Opportunity". Obesity is often described as a global endemic, with incidence dramatically increasing over the past decades, particularly in developed countries. Being overweight or obese is a major risk factor in the development of many chronic diseases, including cardiovascular diseases, cancer, and diabetes, of which treatment incurs extensive economic and healthcare costs. Numerous anti-obesity drugs have been approved in the past decade, including Knoll Pharmaceutical's Meridia (sibutramine) and Acomplia (rimonabant), only for them to be removed from the market due to evidence of suicidal thoughts, depression and cardiovascular problems with their long-term use. As such, healthcare professionals have a negative perception of such drugs and do not widely prescribe them, a major barrier to the growth of the anti-obesity therapeutics market.

Only orlistat is currently deemed safe for the long-term treatment of obesity; being proven to produce a placebo-adjusted weight-loss average of a limited 3kg. Two anti-obesity drugs were approved in June and July 2012, and GBI Research believes that only one, Vivus' Qsymia, has a strong enough safety and efficacy (average placebo-adjusted weight loss of 5kg at the medium dose) profile to make a significant impact on the market, providing it is proven safe in long-term-use studies. If proven safe, GBI Research expects the sales of Qsymia and other drugs expected to be approved over the forecast period to increase the market size to $2.7 billion. Although moderate, this is significantly below the market potential given the size of the prevalence population. Optimally safe and effective anti-obesity drugs which overcome healthcare professionals' negative opinions will have to be developed if the size of the market is ever to reflect the prevalence of obesity.

Scope - The report analyzes the incidence of obesity, current treatment options, pipeline and market forecasts, and deals surrounding anti-obesity drugs.

- A brief introduction to obesity; detailed analysis of recent, current and projected incidence trends; co-morbidities; economic implications of their treatment; and the current treatment options

- Analysis of the currently marketed anti-obesity drugs, including recent sales figures, safety and efficacy data, and a discussion of each drug's expected performance within the forecast period

- Comprehensive reviews of the pipeline for anti-obesity drugs, including analysis by molecule type and mechanism of action

- Statistical analysis of clinical trial duration, size, and failure rate by Phase and molecule type

- An in-depth forecast model for the anti-obesity drugs market in the US, UK, France, Germany, Italy, Spain and Japan. Each model is based on the anticipated market performance of marketed drugs and those expected to be approved within the forecast period, and takes into account drug cost, efficacy, safety, and likely prescription volumes.

- A detailed discussion of the drivers and barriers for this immature market.

Reasons to buy The report will enhance your decision-making capability by allowing you to -

- Understand the large number of potential molecular targets for the development of an anti-obesity drug, as well as the strengths, weaknesses, and risks of each drug type

- Gain an in-depth view of the current status of the anti-obesity drug pipeline, including the most common molecular targets and molecule types in development

- Observe the trends in clinical trial duration and size by Phase, molecule type and mechanism of action, and use the clinical trial failure rate analysis to assess the risk profiles of current and future developmental programs

- Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the anti-obesity drugs market

- Analyze current and past deals surrounding anti-obesity drugs, including their value, year of deal and in depth details of the highest value deals.

1 Table of Contents

1.1 List of Tables 71.2 List of Figures 82 Introduction 92.1 Etiology and Pathophysiology 92.2 Classification 92.3 Epidemiology 102.3.1 The US 102.3.2 Obesity in the Top Five European Markets 102.3.3 Japan 102.4 Comorbidities 112.4.1 Type 2 Diabetes 112.4.2 Hypertension 112.4.3 Dyslipidemia 112.4.4 Respiratory Problems 122.4.5 Osteoarthritis 122.4.6 Cancer Risk 122.5 Economic Burden 122.6 Current Therapy Options 122.6.1 Lifestyle and Behavioral Modifications 122.6.2 Bariatric Surgery 132.6.3 Pharmacotherapy 132.6.4 Treatment Algorithms and Prescription Habits 152.6.5 Method of Determining Treatment Effectiveness 162.7 Why Develop Therapeutic Anti-obesity Drugs? 163 Marketed Products 183.1 Amphetamine-like Drugs 183.1.1 Overview 183.1.2 Efficacy Profile 193.1.3 Safety Profile 193.2 Qsymia, Vivus, Inc. 193.2.1 Overview 193.2.2 Efficacy Profile 203.2.3 Safety Profile 213.2.4 Discussion 223.3 Orlistat 223.3.1 Overview 223.3.2 Efficacy Profile 233.3.3 Safety Profile 253.3.4 Discussion 253.4 Belviq, Arena Pharmaceuticals 263.4.1 Introduction 263.4.2 Efficacy Profile 263.4.3 Safety Profile 273.4.4 Discussion 273.5 Low Long-term Success Rate of Marketed Anti-Obesity Drugs 283.6 Discussion 294 Pipeline 334.1 Overview of Pipeline by Phase, Molecule Type and Molecular Target 334.2 Clinical Trial Duration and Size 364.2.1 Clinical Trial Duration 364.2.2 Clinical Trial Size 384.3 Clinical Trial Failure, Attrition Rate and Reasons for Clinical Trial Failure 394.4 Primary and Secondary Endpoints 414.5 Late-stage Drugs of the Developmental Pipeline 434.5.1 Contrave, Orexigen Therapeutics 434.5.2 Cametor, Norgine BV 454.5.3 Victoza, Novo Nordisk 474.5.4 Tesofensine (NeuroSearch) 504.6 Discussion 515 Market Forecasts 545.1 Global Market 545.2 The US 565.2.1 Epidemiology and Treatment Usage Patterns 565.2.2 Annual Cost of Therapy 565.2.3 Market Size 565.3 Europe 585.3.1 Treatment Usage Patterns 585.3.2 Annual Cost of Therapy 605.3.3 Market Size 615.4 Japan 635.4.1 Treatment Usage Patterns 635.4.2 Annual Cost of Therapy 635.4.3 Market Forecast 635.5 Discussion 645.6 Drivers and Barriers of the Anti-obesity Market 655.7 Obesity Market Drivers 655.7.1 Obesity is a Very Prevalent Disease with Large Potential Target Populations Globally 655.7.2 Recent Approval of Qsymia to Drive Market Growth Providing its Long-term Safety is Proved 655.7.3 Diversification of Molecular Targets 655.8 Obesity Market Barriers 665.8.1 Low Treatment Rate 665.8.2 Reimbursement Issues 666 Licensing and Co-Development Deals 676.1 Licensing Deals 676.1.1 EMD Serono Enters into Collaboration and Licensing Agreement with Theratechnologies 686.1.2 Amylin Pharma Enters into Licensing Agreement with Takeda Pharma 686.1.3 Palatin Technologies Extends License Agreement with AstraZeneca 696.1.4 Zealand Pharma Enters into Licensing and Collaboration Agreement with Boehringer Ingelheim 696.2 Co-development Deals 706.2.1 Isis Enters into Collaboration Agreement with Ortho-McNeil 716.2.2 Orexigen Therapeutics Enters into Co-development Agreement with Takeda Pharma for Contrave 717 Appendix 727.1 References 727.2 Abbreviations 767.3 All Pipeline Drugs by Phase 797.3.1 Discovery 797.3.2 Preclinical 807.3.3 Phase I 847.3.4 Phase II 857.3.5 Phase III 867.3.6 Pre-Registration 867.4 Market Forecasts to 2019 877.4.1 Global 877.4.2 The US 877.4.3 UK 887.4.4 France 887.4.5 Germany 887.4.6 Italy 897.4.7 Spain 897.4.8 Japan 897.5 Methodology 907.6 Secondary Research 907.7 Therapeutic Landscape 907.8 Epidemiology-Based Forecasting 917.9 Market Size by Geography 927.10 Pipeline Analysis 937.11 Contact Us 937.12 Disclaimer 93

1.1 List of Tables

Table 1: BMI Classifications 10Table 2: Key Components of Pathways Thought to be Related to Obesity 14Table 3: Treatment Options Dependent on BMI 16Table 4: Obesity Therapeutics, Leading Brand Names of Phentermine 18Table 5: Efficacy Results* for Qsymia at 52 Weeks 21Table 6: Changes in Key Safety Parameters in Patients Treated with Qsymia 21Table 7: Sales Data for Xenical ($m), 2008–2011 23Table 8: Efficacy Results for Orlistat as an Initial and Maintenance Therapy 24Table 9: Safety Results of Orlistat 25Table 10: Efficacy Results for Belviq 27Table 11: Placebo-adjusted Safety Results for Belviq 27Table 12: Obesity Therapeutics Market, Global, Common Molecular Targets in the Obesity Pipeline 35Table 13: Obesity Therapeutics Market, Global, Average Clinical Trial Size for the Most Common Modes of Action Amongst Pipeline Drugs, 2006–2013 38Table 14: Obesity Therapeutics Market, Global, Average Clinical Trial Duration for the Main Modes of Action Amongst Pipeline Drugs, 2013 38Table 15: Contrave, Phase III Clinical Trial Results 43Table 16: Contrave, Efficacy Results, Phase III Clinical Trial 44Table 17: Cametor, Efficacy Results of a Phase II Clinical Trial 45Table 18: Cametor, Safety and Efficacy Results, Phase III Clinical Trial 46Table 19: Victoza, Clinical Trial Results, Phase III Clinical Trial, 2009 48Table 20: Victoza, Clinical Trial Results, Phase III Clinical Trial, 2009 49Table 21: Victoza ,Safety and Efficacy Results, Phase III Clinical Trial, 2009 49Table 22: Obesity Therapeutics Market, Europe, Current Prevalence Rate of the Population Which is Obese or Overweight, 2012–2019 58Table 23: Obesity Therapeutics Market: Global, Developmental Pipeline, Discovery Phase 79Table 24: Obesity Therapeutics Market: Global, Developmental Pipeline, Preclinical Phase 80Table 25: Obesity Therapeutics Market: Global, Developmental Pipeline, Phase I 84Table 26: Obesity Therapeutics Market: Global, Developmental Pipeline, Phase II 85Table 27: Obesity Therapeutics Market: Global, Developmental Pipeline, Phase III 86Table 28: Obesity Pharmacotherapy Market: Global, Developmental Pipeline, Pre-Registration 86Table 29: Obesity Therapeutics Market, Global, Market Forecasts, 2012–2019 87Table 30: Obesity Therapeutics Market, US, Market Forecasts, 2012–2019 87Table 31: Obesity Therapeutics Market, UK, Market Forecasts, 2012–2019 88Table 32: Obesity Therapeutics Market, France, Market Forecasts, 2012–2019 88Table 33: Obesity Therapeutics Market, Germany, Market Forecasts, 2012–2019 88Table 34: Obesity Therapeutics Market, Italy, Market Forecasts, 2012–2019 89Table 35: Obesity Therapeutics Market, Spain, Market Forecasts, 2012–2019 89Table 36: Obesity Therapeutics Market, Japan, Market Forecasts, 2012–2019 89

1.2 List of Figures

Figure 1: Obesity, Global, Prevalence (%), 1990–2010 11Figure 2: Effects of Topiramate on Food Intake 20Figure 3: Obesity Therapeutics Market, Obesity Drug Approvals and Market Removals 29Figure 4: Obesity Therapeutics Market, Heat Map Comparing the Safety and Efficacy of Marketed Drugs 31Figure 5: Obesity Therapeutics Market, Heat Map Comparing the Performance of Marketed Drugs in Major Safety Parameters 32Figure 6: Obesity Therapeutics Market, Global, Pipeline by Phase and Molecule Type and Molecular Target 34Figure 7: Obesity Therapeutics Market, Global, Clinical Trial Duration by Phase and Molecule Type, 2006–2013 37Figure 8: Obesity Therapeutics Market: Global, Clinical Trial Size by Phase and Molecule Type, 2006–2013 39Figure 9: Obesity Therapeutics Market, Global, Clinical Trial Failure and Attrition Rates by Phase and Molecule Type, 2006–2013 40Figure 10: Obesity Therapeutics Market, Global, Clinical Trial Primary and Secondary Endpoints, 2006–2013 42Figure 11: Heat Map Comparing the Safety and Efficacy of Marketed and Key Pipeline Drugs 52Figure 12: Heat Map Comparing the Performance of Marketed and Key Pipeline Drugs in Major Safety Parameters 53Figure 13: Obesity Therapeutics Market, Global, Epidata and Market Forecasts, 2012–2019 55Figure 14: Obesity Therapeutics Market, US, Epidata and Market Forecasts, 2012–2019 57Figure 15: Obesity Therapeutics Market, Europe, Treatment Patterns, 2012–2019 59Figure 16: Obesity Therapeutics Market, Europe, Annual Cost of Therapy, 2012–2019 60Figure 17: Obesity Therapeutics Market, Europe, Market Forecasts, 2012–2019 62Figure 18: Obesity Therapeutics Market, Japan, Epidata and Market Forecast, 2012–2019 64Figure 19: Obesity Therapeutics Market, Global, Status, Value and Number of Licensing Deals, 2006–2013 67Figure 20: Obesity Therapeutics Market, Global, Licensing Deals by Phase, Molecule Type and Value, 2006–2013 68Figure 21: Obesity Therapeutics Market, Global, Status, Value and Number of Co-development Deals, 2006–2011 70Figure 22: Obesity Market, Global, GBI Research Market Sizing Model 92

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