Obesity Drug Pipeline: Developing Therapies for a Complex Disease
Author: Allan B. Haberman, PhD
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.
About the Author:Allan B. Haberman, PhD, is Principal of Haberman Associates, a consulting firm specializing in science and technology strategy for pharmaceutical, biotechnology, and other life science companies. He is also a Principal and Founder of the Biopharmaceutical Consortium (www.biopharmconsortium.com), an expert team formed to assist life science companies, research groups, and emerging enterprises to identify and exploit promising, breakthrough technologies. He is also the author of numerous publications on the pharmaceutical and biotechnology industries, their technologies and products, and on the major therapeutic areas for drug discovery and development. Formerly the associate director of the Biotechnology Engineering Center at Tufts University, he received his PhD in biochemistry and molecular biology from Harvard University.