An Obesity Drug Pipeline Report: The Development of Therapies for a Complex Disease

DUBLIN, Ireland--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/7cadbd/obesity_drug_pipel) has announced the addition of the "Obesity Drug Pipeline: Developing Therapies for a Complex Disease" report to their offering.

The 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.

Executive Summary:

Obesity has reached epidemic proportions in industrialized countries, especially the United States, and is rapidly increasing in prevalence worldwide, particularly in emerging economic powers such as India and China. With the increase in prevalence of obesity comes an increase in its co-morbidities, especially type 2 diabetes (which has also reached epidemic proportions) and cardiovascular disease.

Although obesity has traditionally been thought of as being due to a lack of “personal responsibility” or willpower, basic research shows that it is a disease that is driven by genetic, behavioral, and environmental factors. Obese or overweight individuals who attempt to lose significant amounts of weight fight a set of physiological factors that were designed to ward off starvation in our evolutionary past, and that have become dysfunctional in an age of abundant, cheap food and socioeconomic factors that discourage exercise and healthy eating habits. These social and economic changes are driving up the average weight of populations in country after country, with obese individuals falling at the top of the curve. Although many individuals have managed to lose significant amounts of weight via diet and exercise (and especially the loss of 5% to 10% of body weight, which wards off obesity’s co-morbidities), long-term weight regain, often with more weight gained than was originally lost, is the rule.

The above factors indicate that obesity drugs will be necessary, in addition to diet and exercise, to combat obesity, both on an individual and a population basis. However, the few drugs that are currently approved for long-term treatment of obesity are only marginally effective, and have significant adverse effects that limit their use. Clearly, new drugs are needed. However, it has been difficult to successfully develop obesity drugs, because of the complexity and inadequate knowledge of pathways that control energy balance in the human body, notable safety failures of several late-stage and marketed obesity drugs (such as the notorious case of Fen-Phen [fenfluramine/phentermine]), and the continuing perception that obesity is a “lifestyle” issue rather than a disease.

After a review of the physiology and genetics of obesity, and the factors that make development of obesity drugs difficult, this report focuses on the pipeline of Phase III and Phase II drugs that are under development in the biotechnology and pharmaceutical industry, their mechanisms of action, and the clinical evidence for their efficacy and safety. Drugs discussed include VIVUS Pharmaceuticals’ Qnexa (phentermine/topiramate), Orexigen Therapeutics’ Contrave (bupropion/naltrexone) and Empatic (zonisamide/bupropion), Arena Pharmaceuticals’ lorcaserin, Alizyme’s cetilistat, and several others. The report then goes on to explore leading early-stage approaches to developing succeeding generations of obesity drugs.

The report also includes the results of a survey of researchers and executives in corporate and academic organizations whose work involves discovery and development of obesity drugs. The survey results include information on the involvement of the respondents in obesity drug R&D programs and their views on the current state of the field and its future potential.

Finally, the Appendix includes expert interviews with four industry leaders: Olivier Boss, PhD, of Sirtris; Alice Izzo of Amylin Pharmaceuticals; Peter Tam of VIVUS; and David Walsey of Arena Pharmaceuticals.

Key Topics Covered:

• Introduction: Are Obesity Drugs Needed?
• Difficulties In Successful Development Of Obesity Drugs
• Current Drugs And Their Inadequacies
• History Of Failure In The Obesity Drug Field
• Next-Generation Obesity Pipeline Drugs
• Selected Trends In Early-Stage Approaches To Developing Obesity Drugs
• List Of Figures And Tables

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