Oscient to discuss Factive label expansion with FDA next week

By Jennifer Lanning Drey

Eugene, Ore., Sept. 6 - Oscient Pharmaceuticals Corp. is scheduled to discuss its plans for a possible label expansion of Factive (gemifloxacin mesylate) with a Food and Drug Administration advisory committee next week, according to Steven Rauscher, Oscient's president and chief executive officer.

The company wants to expand Factive's indications to include treatment of acute bacterial sinusitis in a five-day regimen, Rauscher said Wednesday during the Thomas Weisel health care conference.

The FDA has set an action date of Dec. 15 for making a decision on the supplemental application.

Factive is approved as a five-day treatment for acute bacterial exacerbations of chronic bronchitis and as a seven-day treatment of community acquired pneumonia.

Oscient has also filed a supplemental New Drug Application for Factive as a five-day treatment regimen for community acquired pneumonia of mild to moderate severity.

"The five-day capsule is important to us. We want to make Factive very easy for physicians to use, Rauscher said.

The FDA has set an action date of Sept. 21 for that decision.

Oscient has sublicensed the commercialization rights of Factive tablets in Mexico to Pfizer Mexico, and the company granted commercialization rights to the tablets in Canada to Abbott Canada.

During the next year, Oscient will pursue a partner in Europe in an effort to gain approval for Factive in that market, Rauscher said.

Oscient is a biopharmaceutical company based in Waltham, Mass.

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