FDA clears obesity drugs

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NEW YORK — Obesity drugs are getting a lift after years of languishing even as populations around the globe get heavier.

But rather than pharmaceutical giants, it is small companies with an appetite for risk leading the charge.

This year, after 13 years with no new drug approvals, the Food and Drug Administration cleared two medicines for obesity, kick starting what many hope will be a rejuvenation for the field.

The FDA cleared Belviq, from Arena Pharmaceuticals Inc. and Eisai Co., in June and Vivus Inc.’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.

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.

“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,” said Kevin Starr, a partner at Boston-based venture capital firm Third Rock Ventures “There's 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 which can lead to other serious health conditions.Medical costs associated with obesity are estimated to have been $147 billion in 2008.

“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.

“It’s been the small companies that were willing to take the risks,” said Mike King, an analyst with Rodman & Renshaw. The approvals this year may draw some interest from larger drugmakers, he said.

Obesity “is one of the last kind of monolithic markets that’s out there right now. Given the numbers, you have to expect that these would be blockbuster drugs.”

“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. “We aren't getting enough new ones to market.”

Tom Hughes, chief executive officer of Cambridge, Mass.-based Zafgen, spent two decades at Novartis. He's led Zafgen since 2008, forging a battle against accepted perceptions of obesity as a lifestyle choice — the result of laziness or a lack of discipline. That view has kept many out of obesity drug development, he said.

“There are forces that keep people obese,” Hughes said in an interview. “People are fighting their physiology.”

An obese person's body processes food differently from a lean person's, Hughes said. One way is that the liver overproduces fat molecules, which get transported back to fat cells, or adipose tissue.

Zafgen's drug, beloranib, is designed to reset the way the body processes fat by inhibiting an enzyme tied to the liver's fat production. It also changes the production of hormones that control trafficking of fat and the use of fat as energy, Hughes said.

Zafgen, with five full-time employees including Hughes, uses contract researchers to run its clinical trials. Its small size is typical of companies still willing to work on obesity drug development, after larger companies concluded in recent years that getting approvals for such drugs would be too long and cumbersome a process.

Arena, based in San Diego, and Vivus, in Mountain View, Calif., were both small biotechs before their drugs were cleared. Both had market valuations of less than $1 billion at the start of the year; now, Vivus is worth about $2.5 billion and Arena, $2 billion.

“It's been the small companies that were willing to take the risks,” Mike King, an analyst with Rodman & Renshaw, said in a telephone interview. The approvals this year may draw some interest from larger drugmakers, he said. Obesity “is one of the last kind of monolithic markets that's out there right now. Given the numbers, you have to expect that these would be blockbuster drugs.”

_ With assistance from Shannon Pettypiece in New York and Anna Edney in Washington.

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