After FDA blessings for diet drugs, spotlight shines on biotechs' pioneering obesity meds

Pharma industry watchers are forecasting a comeback for weight-loss drugs after two FDA nods for diet pills in recent months, Bloomberg reports, and a crop of nimble biotech companies are among the leaders ushering in brand-new approaches to fighting obesity. The trend could create a wealth of opportunities for the developers because of the blockbuster market for weight drugs, one that Big Pharma is unlikely to neglect despite past failures with anti-obesity meds.

As biopharma becomes more upbeat about the obesity market, venture-backed biotech Zafgen (a 2009 Fierce 15 company) is pushing ahead with a 120-patient Phase II study of its experimental drug beloranib that blocks an enzyme involved in fat production, hoping to build on earlier weight-shedding results in severely obese patients, with data expected from the mid-stage study in 2013, Bloomberg reports. "The twin [FDA] approvals reinstated a lot of confidence in our path," Zafgen's Tom Hughes told the news service.

Indeed, regulators have recently shown a willingness to approve weight drugs despite safety issues of many such treatments that scared many Big Pharma groups from the market and contributed to a 13-year dry spell for FDA approvals. U.S. regulators green-lighted Arena Pharmaceuticals ($ARNA) and Eisai's Belviq in June and Vivus ($VVUS) gained the agency's nod for Qsymia the following month. Now industry analysts are watching how those approvals might stoke activity in a largely untapped blockbuster market, as the FDA recognizes the need for drugs to combat obesity, which affects about one in three Americans and can lead to diabetes, heart problems, and other complications.

"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 VC firm Third Rock Ventures in Boston, told Bloomberg. "There's been a sea change at the FDA in their recent approvals."

Third Rock, an investor in Zafgen, has also made an early bet on Boston-based Ember Therapeutics, a 2012 Fierce 15 company working on drugs that target brown fat pathways to the detriment of white fat that gathers around the waistlines of obese individuals. And even though Ember has yet to hit human studies with its brown fat-targeting drugs, the Boston startup has attracted interest from pharma players.

"Almost every large pharmaceutical company has approached us for discussions," Lou Tartaglia, Ember's interim CEO, told FierceBiotech, "and it makes sense that they would because they are trying to make decisions about whether to work with us or to try to compete in this area."

- check out Bloomberg's article

Special Reports: Ember Therapeutics – 2012 Fierce 15 | Zafgen – 2009 Fierce 15

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