Abstract
IT’S BEEN A TURBULENT few years for companies developing antibiotics. Several late-stage drug candidates have suffered setbacks, and companies claim the regulatory environment has become confusing at best. But the Food & Drug Administration is beginning to offer more clarity on data it needs to approve new antibiotics. And as more development programs reach late-stage trials, biotech firms with promising drugs are finding partners ready to pay big bucks for them. Since October 2009, AstraZeneca, Forest Laboratories, Novartis, and Cubist Pharmaceuticals have each spent hundreds of millions of dollars for access to antibiotics that have produced good data in Phase II or III clinical trials. Industry watchers hope the spate of deals will accelerate the launch of new weapons against dangerous infections. In recent years, superbugs, or bacteria resistant to current antibiotics, have stymied physicians and sent researchers in search of better drugs. Finding novel antibiotics outside currently approved compound ...
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