FDA blamed for stymying new antibiotics

The FDA has pledged to do its part to revitalize the ailing antibiotics business, but industry watchers want to see some action from the agency after seeing the damage from measures that have hurt the economics of antibiotics development. Scientific American caught up with several veterans of the antibiotics game, some of whom haven't given up after past mishaps in developing new drugs to combat the growing threat of resistant infections.

Last week's FDA panel vote on Theravance's ($THRX) Vibativ for hospital-acquired pneumonia sent mixed signals to the industry. Nonagency advisers recommended approval of the drug to fight such cases after existing clinicians have exhausted other options, while they shot down the South San Francisco company's bid for use of Vibativ as a first line of defense for patients who get pneumonia in the hospital. Theravance has been made to jump through regulatory hoops along its journey to commercialize its antibiotic, which hasn't been a big seller and has taken a back seat to the company's main mission to advance a set of promising respiratory meds.

And believe it or not, Theravance could be considered fortunate for even getting Vibativ on the market in the U.S., where it's approved for skin infections. As Mark Leuchtenberger, CEO of antibiotics developer Rib-X, told Scientific American, FDA advisers picked apart four antibiotics under review in 2008 and only one of them made it onto shelves. Leuchtenberger was then leading one of the unfortunate companies, Targanta, whose antibiotic didn't make the cut, forcing the lackluster sale of the biotech to The Medicines Co.

Rib-X (a 2011 Fierce 15 company) could benefit from promises at the FDA that might reduce the regulatory burdens that have dogged the advance of new antibiotics to the market. The company raised $18.7 million of a proposed round of venture capital that could total $67.5 million, with the money earmarked for funding a Phase III trial for its lead drug delafloxacin to treat skin infections in hospitals.

The round followed investors' recognition of the FDA's moves to aid the advance of antibiotics in recent months, Leuchtenberger told the magazine. Janet Woodcock, head of the agency's Center for Drug Evaluation and Research, has been widely quoted for saying that her regulatory team wanted to "reboot" antibiotics development with its efforts to aid developers.

Yet talk is cheap in drug development, where data rule and point to an imbalance in approvals versus the need to combat bad bugs that are resistant to today's antibiotics.

"The agency has painted itself into a statistical corner," Scott Hopkins, Rib-X's medical chief, told Scientific American. "While the infectious-disease community was crying out for new antibiotics, the FDA seemed to be going in the opposite direction."

- get more in the magazine's article

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