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regulators that the drug’s benefits outweigh the risks, especially since an advisory panel recommended in a 15-2 vote that the drug be approved for sale in the U.S. The agency’s deadline to deliver its verdict is February 13.
So what did Gilead pay the $365 million for when it acquired Montgomery’s old company, Seattle-based Corus Pharma? Much of it was based on the prospects for aztreonam lysine, and the ability of the Seattle-based team to create more lung drugs like it. So Montgomery spent most of his talk reminding people about the idea for aztreonam and why he hopes it will be a useful advance for cystic fibrosis.
Montgomery, a pulmonologist, has spent a big chunk of his career thinking about cystic fibrosis. This is a genetic disorder that affects about 30,000 people in the U.S. It causes a buildup of thick, sticky mucus in the lungs, which can become a breeding ground for pseudomonas aeruginosa, a bacteria that can turn deadly.
Earlier in his career, Montgomery directed teams that developed two important advances for the field—Roche’s dornase alfa (Pulmozyme), and later, Novartis’s tobramycin for inhalation (TOBI). Montgomery pointed out that these drugs played a part in helping transform CF from a death sentence in children to a condition that people can live with into their late 30s on average.
“I’m pretty much responsible for the increase in the life expectancy of CF patients by about 15 years,” Montgomery said.
As good as an inhaled antibiotic like TOBI was for patients, Montgomery knew it had shortcomings. Patients had to take it through a nebulizer that delivers the drug as inhalable particles for 20 minutes, taken twice daily. Many of the patients are teenagers, and as Montgomery put it, “teenagers aren’t the most compliant people in the world.” So that meant that patients would take the drug when they felt sick, but wouldn’t consistently stick with the demanding regimen all the time. And also, bacteria can find ways to resist any one drug when it’s given repeatedly.
“Bacteria develop resistance to therapy. It’s a fact of life. Some view that as a problem,” Montgomery said. “I view it as a commercial opportunity.”
So the idea was to come up with a more convenient … Next Page »