Gilead’s Seattle Crew Awaits FDA Clearance of Cystic Fibrosis Drug, Catalyst for Future Growth

9/15/08Follow @xconomy

The people at Gilead Sciences in Seattle have been working toward this moment for seven years. Tomorrow is the FDA’s deadline to decide whether to approve aztreonam lysine, an inhalable antibiotic for cystic fibrosis. The drug was developed by Seattle-based Corus Pharma and led to its acquisition two years ago by Gilead for $365 million.

When Gilead (NASDAQ: GILD) bought Corus, it saw in aztreonam not just a product with the potential for decent sales in a couple years, but also a team of drug developers assembled by founder Bruce Montgomery who looked like a good bet to do it again. Since the acquisition, Gilead’s Seattle operation has grown from 100 employees to 130—and gotten new resources pumped into its respiratory disease programs at earlier stages of development, says company spokesman Nathan Kaiser. Gilead as a company plans to add 1,900 jobs over the next decade, and to double the size of its Seattle R&D center during that span, according to this story from the San Francisco Business Times.

Aztreonam is clearly expected to be a driver of that expansion. The drug could generate $233 million in U.S. sales in 2012, according to Tom Russo, an analyst with Robert W. Baird in Chicago. Most analysts expect the FDA to clear the drug, which was shown in two pivotal trials to help people with cystic fibrosis breathe better. It’s an inhalable antibiotic designed to kill bacteria that embed in the lungs of patients with CF, a genetic disease among children and young adults that affects about 30,000 patients in the U.S. And Montgomery, and several of his colleagues, know this disease well, having developed a different inhalable antibiotic called Tobi in the 1990s at Seattle-based Pathogenesis, which is now owned by drug giant Novartis.

“Aztreonam would be the first of what we hope would be, over the longer term, several new treatments for cystic fibrosis and other respiratory conditions,” Gilead’s Kaiser said in an email. “This fits well with both Gilead’s focus on and experience in specialty markets.”

From covering Gilead the past two years, I’ve learned it’s not the company’s style to tout a drug before it wins FDA clearance, or even talk much about its significance to the company. Montgomery, one of the more quotable biotech executives in town, wasn’t being made available for an interview before word arrives from the FDA.

Still, I was able to gather from Kaiser some detail about Gilead’s plans in Seattle. The crew here is charged with developing a new application of aztreonam for bronchiectasis, a disease in which part of the bronchial tree in the lung expands too much. The Seattle researchers will also see what they can do with ambrisentan for idiopathic pulmonary fibrosis, and to continue to push forward with a couple drugs in the pipeline—namely GS 9310 and 9311, which are in early human trials for bronchiectasis and cystic fibrosis, respectively, as well as another CF drug candidate called GS 9411 that’s in animal tests.

If any of those pan out, it would help fulfill a diversification strategy for the company. Gilead has grown in the last few years into the world’s third-most valuable biotech company, behind Genentech and Amgen, on the strength of its HIV medicines. It generates about three-fourths of its $4.1 billion in revenue from HIV drugs like Truvada and Atripla, which combine antiviral medications so patients can take fewer pills a day.

With aztreonam, patients take it through a nebulizer three times a day for about three minutes. That’s shorter than the 20- to 25-minute treatment period for current therapies. It sounds like something from the Gilead playbook in HIV—make a product with similar or better effectiveness to existing meds, in a more convenient form for patients. If the sales force can come even close to doing for cystic fibrosis what it did for HIV, then the folks in Seattle should be set up for a long run of developing more new drugs for respiratory diseases.

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  • http://www.coalitionforpf.org mshreve

    We applaud Gilead for aggressively pursuing the development of ambrisentan for IPF, given that there are currentl no FDA-approved treatment options for this devastating disease that claims the lives of 40,000 Americans ach year – as many as breast cancer. IPF is a relentlessly progressive and ultimately fatal lung disorder with a median survival rate of just 3 years. In an industry where focus on rare disease research is at best a challenge, we are thrilled that Gilead is investing in new approaches to treat this disease. On behalf of our patients, their families, and the healthcare pressioanls who treat IPF, thank you.

    Mark Shreve
    Founder
    Coalition for Pulmonary Fibrosis (CPF)
    http://www.coalitionforpf.org