Oscient Pharmaceuticals Unlikely to Get Factive Acute Bacterial Sinusitis Approval From FDA

Drug maker Oscient Pharmaceuticals Corp. said Wednesday that an advisory panel to the Food and Drug Administration recommended the agency not approve the company's anti-infective drug Factive for the treatment of acute bacterial sinusitis.

Shares of Oscient fell 20 cents, or 17.5 percent, to 94 cents on the INET electronic exchange, after closing at $1.14 on the Nasdaq. Shares have traded between 60 cents and $2.81 over the past 52 weeks.

The FDA advisory panel voted 10 to 4 that data from the company's clinical trial showed that the treatment was not effective as a five-day treatment for acute bacterial sinusitis, or inflammation of the sinuses caused by bacteria. The panel also voted 11 to 2 that the benefits of the drug did not outweigh the risks in treating ABS.

The agency is set to rule on the company's application for ABS by Dec. 15. While the FDA is not bound by panel recommendations, it usually follows them. An approval doesn't look likely as the FDA earlier accepted the application under protest.

The company also has a Factive application on file as a five-day treatment for community-acquired pneumonia. The FDA is set to decide on that application by Sept. 21.

Factive is currently FDA-approved as a five-day treatment for worsening acute chronic bronchitis caused by bacteria, and as a seven-day treatment of mild to moderate community-acquired pneumonia.