Antibiotic makers have had a brutal year in front of the Food and Drug Administration. Over the last year, the agency has turned down the marketing applications for Wyeth's (NYSE:WYE) Tygacil, Theravance's (NASDAQ:THRX) Telavancin, and two antibiotics from Johnson & Johnson (NYSE:JNJ) -- Doribax and ceftobiprole.
It's difficult to tell exactly, but it looks like a random coincidence rather than a true crackdown on a treatment area as the diabetes drugmakers are experiencing. For instance, Theravance needs a Risk Evaluation and Mitigation Strategy (REMS) for approval while the agency asked Johnson & Johnson to audit the data from the clinical trials for ceftobiprole.
But maybe the tides are changing. Yesterday the FDA gave a green light to Wyeth's Tygacil -- yes, the same one that was rejected earlier. The drug was already approved to kill the bugs causing complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI) in patients. Now the FDA just approved it to treat community-acquired bacterial pneumonia (CABP).
My goodness -- cIAI, cSSSI, CABP -- those infectious disease docs really know how to give catchy names to the diseases they treat.
Long thought of as a dead treatment area, antibiotics are making a comeback thanks to superbugs that have become resistant to available treatments. Last year Cubist Pharmaceuticals' (NASDAQ:CBST) Cubicin and ViroPharma's (NASDAQ:VPHM) Vancocin saw sales jump 45% and 14% year over year, respectively.
Wyeth's approval is a nice start to resurrecting the approval of antibiotics (AoA). Maybe with AoA, FDA will CYA. (Certify Your Antibiotic, of course.)
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