Obesity Drugs Gain Attention on FDA Backing for Therapies

By Meg Tirrell - 2012-09-19T04:01:00Z

Obesity drugs are getting a lift after years of languishing even as populations around the globe get heavier. Rather than pharmaceutical giants, though, its small companies with an appetite for risk leading the charge.

Plagued with failures and side effects, drug development in obesity slowed to a near halt in the last decade as most large pharmaceutical companies abandoned efforts, leaving smaller biotechnology companies to forge ahead. This year, after 13 years with no new drug approvals, the U.S. Food and Drug Administration cleared two medicines for obesity, kick starting what many hope will be a rejuvenation for the field.

A few years ago we were in the darker days of obesity where the regulatory environment was uncertain and pharma was doubtful this would ever be a market segment, Kevin Starr, a partner at Boston-based venture capital firm Third Rock Ventures LLC, said in a telephone interview. Theres been a sea change at the FDA in their recent approvals.

Prospects brightened for obesity drug development this year as the FDA signaled it would be more willing to seriously consider drugs as a viable way to treat some forms of obesity, calling it a major public health concern. Now the betting is more approvals may follow.

Almost 36 percent of U.S. adults are obese, a condition that can lead to heart disease, Type 2 diabetes and stroke, according to the Centers for Disease Control and Prevention. Medical costs associated with obesity are estimated to have been $147 billion in 2008.

Third Rock Ventures is an early backer of Zafgen Inc., a biotechnology company in mid-stage trials of a therapy to treat obesity. The Food and Drug Administration cleared Belviq, from Arena Pharmaceuticals Inc. (ARNA) and Eisai Co. (4523), in June and Vivus Inc. (VVUS)s Qsymia in July, the first U.S. approvals for obesity drugs since 1999. They were shown to help obese patients lose about 5 to 10 percent of their body weight in clinical trials.

Thats a start, say many in the field. Still, the need for even more new drugs remains, they said.

The concern among clinicians is that the overall pipeline for new drugs is very, very small, said Carey Lumeng, an obesity researcher at the University of Michigan in Ann Arbor. We arent getting enough new ones to market.

Drug development will be among the topics discussed when the 30th annual meeting of the Obesity Society opens tomorrow in San Antonio, Texas. The program will touch on all areas of obesity research, from behavioral changes and exercise to surgery and therapeutics.

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Obesity Drugs Gain Attention on FDA Backing for Therapies