SANOFI-AVENTIS TO ADDRESS KETEK FINDINGS AS COMPETITOR GETS READY TO STEP IN

A joint FDA advisory committee recommendation of narrower indications for, and increased warnings on, sanofi-aventis' antibiotic Ketek has the company taking steps to respond as a competitor may begin grabbing market share.

The company said it is preparing to meet with FDA staff following last week's vote by the Anti-Infective Drugs and Drug Safety and Risk Management advisory committees to recommend that Ketek (telithromycin) no longer be marketed for acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis. The committees also recommended a black box warning for the drug's other indication, community acquired pneumonia. While the agency is not required to follow an advisory committee's recommendation, it usually does.

Meanwhile, at least one financial analyst is predicting other companies may take sanofi-aventis' place in the market. The restriction of Ketek's use for community-acquired pneumonia, without a broader criticism of the class of drugs to which it belongs, opens the door for Advanced Life Sciences' drug cethromycin, an industry analyst said.

"A clear path has emerged for cethromycin to become a best-in-class ketolide," Matthew Osborne, vice president and biotechnology analyst at Lazard Capital Markets, said in a Dec. 18 report. Cethromycin is in the midst of a Phase III clinical trial. Ketolides, the family of drugs that includes Ketek, are semisynthetic antimicrobials.

Community-acquired pneumonia is the sixth most common cause of death in the U.S., affecting between 5 million and 6 million patients annually, Advanced Life Sciences said. (http://www.fdanews.com/did/5_246/)