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Published by: CHI Insight Pharma Reports
Published: Sep. 23, 2008 - 104 Pages
Table of Contents
- Chapter 1
- INTRODUCTION: ARE OBESITY DRUGS NEEDED?
- 1.1. The Growing Worldwide Obesity Epidemic
- 1.2. Definition of Obesity
- 1.3. Obesity as a Factor in the Pathogenesis of Major Diseases, Especially Diabetes and Cardiovascular Disease
- 1.4. Social and Economic Change as Drivers of the Obesity Epidemic
- 1.5. Difficulty of Maintaining Long-Term Weight Loss Through Diet and Exercise Alone
- 1.6. Guidelines for the Treatment of Obesity, and the Role of Drugs and Surgery
- American College of Physicians (ACP) Guidelines
- Obesity Drugs
- Lifestyle Modification and the Efficacy of Obesity Drugs
- The Role of Bariatric Surgery in the ACP Guidelines
- 1.7. Obesity as a Disease, Not the Result of Lack of Willpower
- Genetic and Physiological Factors in Obesity
- Small Population Studies to Examine the Interaction of Environmental and Genetic Factors in Obesity
- 1.8. Basic Research Suggesting that Drugs Are Needed in Obesity Treatment
- Chapter 2
- DIFFICULTIES IN SUCCESSFUL DEVELOPMENT OF OBESITY DRUGS
- 2.1. Barriers to Successful Development of Obesity Drugs
- The Societal Perception of Obesity as a “Lifestyle Issue”
- Reimbursement
- Consumer Payment Out-of-Pocket
- The Poorly Understood Complexity of the Physiology of Control of Body Weight and Fat Mass
- 2.2. The Complex Genetics of Human Obesity
- 2.3. Continuing Safety Issues Connected with Obesity Drugs
- Chapter 3
- CURRENT DRUGS AND THEIR INADEQUACIES
- 3.1. Sibutramine
- 3.2. Orlistat (Xenical)
- 3.3. Lack of Sufficiently Safe and Effective Obesity Drugs on the Market Today
- Chapter 4
- HISTORY OF FAILURE IN THE OBESITY DRUG FIELD
- 4.1. Fenfluramine, Dexfenfluramine, and Fenfluramine/Phentermine
- 4.2. Recombinant Leptin and Recombinant Ciliary Neurotrophic Growth Factor
- 4.3. Rimonabant
- Chapter 5
- NEXT-GENERATION OBESITY PIPELINE DRUGS
- 5.1. Phase III Agents
- Phentermine/Topiramate (Qnexa)
- Buproprion/Naltrexone (Contrave)
- Lorcaserin
- Cetilistat
- Phase III CB1 Inhibitors: Taranabant and CP-945,598
- Potential of Current Phase III Drugs
- 5.2. Phase II Agents
- Pramlintide/Metreleptin
- Liraglutide
- Zonisamide/Bupropion (Empatic)
- Tesofensine
- Peptide YY Nasal Spray
- Potential of Current Phase II Drugs
- Chapter 6
- SELECTED TRENDS IN EARLY-STAGE APPROACHES TO DEVELOPING OBESITY DRUGS
- 6.1. Drugs that Target Receptors in Core Hypothalamic Energy Balance Pathways
- Melanocortin Receptor Agonists
- Neuropeptide Y Receptor Antagonists
- Melanin-Concentrating Hormone Receptor Antagonists
- 6.2. Novel Drugs that Treat Both Obesity and Diabetes
- Protein Tyrosine Phosphatase 1B Inhibitors
- Adenosine Monophosphate-Activated Protein Kinase Activators
- Ghrelin Antagonists
- Prospects for Novel Obesity/Diabetes Drugs in Obesity
- 6.3. Might It be Possible to Develop Obesity Drugs that Increase Energy Utilization in Peripheral Tissues?
- A Potential Pharmacological Exercise Mimetic
- Treating Obesity by Increasing Brown Fat Deposits
- Chapter 7
- OUTLOOK FOR THE OBESITY PIPELINE
- 7.1. Insight Pharma Reports Obesity Drug Development Survey—July 2008
- 7.2. General Conclusions
- APPENDIX
- Expert Interviews
- Olivier Boss, PhD, Associate Director of Biology, Sirtris, Cambridge, MA
- Alice Izzo, Executive Director of Corporate Affairs, Amylin Pharmaceuticals, San Diego, CA
- Peter Y. Tam, Senior Vice President of Product and Corporate Development, VIVUS, Mountain View, CA
- David A. Walsey, Director, Corporate Communications, Arena Pharmaceuticals, San Diego, CA
- References
- Company Index with Web Addresses
AbstractThe prevalence of overweight and obesity is increasing at an alarming rate worldwide, driven by social and economic changes. Obesity is involved in the pathogenesis of major diseases, especially diabetes and cardiovascular disease. Yet there are no sufficiently safe and effective obesity drugs on the market today. This report analyzes:
- Product pipelines;
- Current obesity drugs and the need for novel therapies;
- Obesity drug markets;
- Challenges to the successful development of obesity drugs;
- The complex disease pathways of obesity and weight regulation.
Many public health experts classify the rise in obesity as an epidemic. Largely as the result of increased risk for diabetes and cardiovascular disease, obesity carries an increased risk of premature death. According to an estimate by the US Centers for Disease Control, approximately 112,000 deaths per year are associated with obesity. Obesity drugs, however, have been dogged by safety issues that, in some cases, have resulted in market withdrawal. Obesity Drug Pipeline: Developing Therapies for a Complex Disease examines the demand and potential market for novel obesity treatments that are safe and truly effective.
The report also describes why the physiology of weight control is so complex. Disease pathways of obesity are poorly understood and appear to be dependent on many genetic and environmental factors. Researchers and companies have been using what is known about energy balance pathways to design obesity drugs, as will be discussed. The report also describes efforts underway to better understand the complex genetics of human obesity and how these findings can inform obesity drug discovery.
General barriers to the successful development of obesity drugs are discussed, including the societal perception of obesity as a “lifestyle issue,” not a medical/pharmacological one. Despite the extensive basic science that indicates that obesity is a disease, which like other metabolic and cardiovascular diseases has a complex causation (i.e., genetic, physiological, lifestyle, environmental, etc.), the traditional view that obesity is merely an issue of willpower and lifestyle, and even a cosmetic issue, dies hard. In particular, the idea that obesity is a lifestyle issue and not a disease affects reimbursement, which may constitute a significant hurdle to the development of obesity drugs.
Luckily, not all experts agree that these factors constitute an insuperable hurdle to the successful development and commercialization of new obesity drugs. Only two drugs are approved in the United States for long-term treatment of obesity: sibutramine (Abbott’s Meridia/Reductil) and orlistat (Roche’s Xenical and GlaxoSmithKline’s low-dose, over-the-counter form, alli). Both are minimally efficacious and have significant side effects, which tend to discourage their use. Obesity Drug Pipeline: Developing Therapies for a Complex Disease reviews next-generation obesity drugs, including late-stage development programs as well as selected early-stage approaches to developing obesity drugs.
We conclude with expert interviews and an analysis of results from CHI’s Obesity Drug Discovery & Development Survey, conducted in July 2008.
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