Antibacterials: Biotechs Fill the Big Pharma Void

The FDA's much delayed approval in April 2004 of Aventis SA 's antibiotic telithromycin (Ketek) was a reminder of why most Big Pharma have abandoned anti-bacterials research. Twenty years ago, anti-bacterials were hot. If a substance killed a bug in a petri dish, it would likely do the same in man, went the theory; such low-risk and high speed development was ideal. The glory didn't last though, because the industry soon ran out of new targets. The last three decades or more have seen only a couple of novel antibiotics reach the market: Pfizer Inc. 's linezolid (Zyvox), launched in 2000, and Ketek, launched in Europe three years ago. In part because of this paucity, the new antibiotics have been restricted because of fears over growing antibiotic resistance; physicians are anyway conservative about prescribing new agents unless nothing else works. What's more, the FDA muddied the waters several years ago by applying inconsistent approval standards in reviewing antibiotics. And, at least for a time, the agency's demands for big improvements over existing drugs meant larger, more expensive trials, and more delays—hence Ketek's ordeal. (See "The FDA and Antibiotics: An Unsettled Agency of Many Minds," IN VIVO, June 2002 Also see "The FDA and Antibiotics: An Unsettled Agency of Many Minds" - In Vivo, 1 June, 2002..)

In its search for new antibiotics, Big Pharma had switched its attention almost entirely to the new molecular sciences—genomics, proteomics. But these weren't easily applicable to anti-bacterials (as has proven...