Wyeth: Now Approved to Kill More Bugs!

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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