Gilead Drug For Cystic Fibrosis Fails to Win FDA Approval

9/16/08Follow @xconomy

Gilead Sciences suffered a big blow this afternoon, when it got word that its inhalable antibiotic for cystic fibrosis failed to win FDA approval. The Foster City, CA-based company, which has research and development offices in Seattle, said U.S. regulators are saying that another study must be done before aztreonam lysine can be cleared for sale.

Analysts were bullish that aztreonam would win approval, and go on to generate more than $200 million a year in sales, after two Phase III clinical trials showed the drug could help patients breathe better. Gilead will continue talking with the FDA to see whether any further analyses of the existing data could lead to approval, which would obviously be better for the company than spending millions of dollars and many more months running an additional study.

Gilead’s R&D effort for the drug is based in Seattle, made up of the team it acquired in a purchase of Corus Pharma two years ago. Gilead has said it plans to double its Seattle respiratory R&D center based on its bullish predictions for other drugs in development, but a lot is clearly riding on what happens with aztreonam.

“Our goal is to work with the FDA to deliver this product to the medical community and to people living with cystic fibrosis as quickly as possible,” said John Martin, Gilead’s CEO. He noted that the FDA hasn’t raised any safety concerns about the drug, and that it will continue to offer it to needy patients before it is cleared for sale, through what is known as an expanded access program. The drug is also being reviewed by regulators in Europe, Australia, Turkey, and Canada, Gilead said.

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