Gilead Sciences Gets FDA Green Light To Sell Cystic Fibrosis Drug

2/23/10Follow @xconomy

Gilead Sciences paid $365 million to acquire Seattle-based Corus Pharma in 2006, and now it finally can see a way of getting a return on that investment in the U.S. The world’s leading marketer of HIV medicines said late Monday that the FDA has given it clearance to start selling an inhalable antibiotic to U.S. patients with cystic fibrosis.

Foster City, CA-based Gilead (NASDAQ: GILD) said it is now approved to start selling aztreonam lysine (Cayston) to help treat a nasty bacterial infection in the lungs called P.aeruginosa. The drug received clearance in Europe and Canada last September.

“All of us at Gilead extend our thanks to the investigators and to the people with cystic fibrosis who took part in the Cayston clinical trials,” said Norbert Bischofberger, Gilead’s chief scientific officer, in a statement. “We look forward to making Cayston available to the cystic fibrosis community as soon as possible.”

The FDA approval of the new cystic fibrosis drug isn’t expected to be a big profit driver for Gilead, but it’s a big deal for the Seattle crew, because it was their baby. Gilead is looking to diversify away from its heavy reliance on HIV drugs, and as part of that, has invested $50 million in a new Seattle research center with 150 employees concentrated on lung diseases. It’s also potentially meaningful for the 30,000 people in the U.S. who have cystic fibrosis, a genetic disease in which thick, sticky mucus builds up in the lungs, which can get infected, and which usually means patients don’t live to turn 40. The new drug is the first new antibiotic for cystic fibrosis patients in more than 10 years, Gilead said.

Gilead didn’t say how much the drug will cost in its news release, and a spokeswoman didn’t immediate respond to a request for comment late Monday.

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