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a startup drug developer like Cadence to harvest this late-stage product candidate in 2006, by shelling out $25 million upfront, agreeing to pay milestones of $40 million, plus royalties to Bristol on product sales that escalate to as much as 20 percent, Schroeder says.
The Cadence CEO comes to this job as a business guy by training. Before he co-founded Cadence in May 2004, he headed up North American sales and marketing for Irish drugmaker Elan. He specialized in selling drugs to hospitals at both Elan and at San Diego-based Dura Pharmaceuticals before it was acquired by Elan.
So Cadence’s strategy has been to acquire late-stage drug candidates that can be sold in bulk to hospitals. It will use a small group of focused sales reps who can pitch it, as opposed to marketing the next impotence drug for the masses that needs thousands of sales reps.
Cadence has a second drug candidate in its pipeline, omiganan pentahydrochloride topical gel, (Omigard), that should give its sales reps something else to promote to hospitals. The second drug is an antimicrobial agent designed to stop infections at the point in the body where catheters get injected. This drug is thought to have almost bleach-like killing power, wiping out bacteria, fungi, multi-drug resistant bacteria, yeasts, molds, you name it, Schroeder says. It kills within minutes, and isn’t absorbed into the body, so it doesn’t provoke an immune reaction, Schroeder says. Results from a final-stage clinical trial of this drug should be available before the end of March, and if successful, Cadence plans to ship off that second new drug application to the FDA within the following three months.
Yesterday, analysts tried to tease out more details on the safety profile of the IV acetaminophen to see if there’s some reason why the FDA might hold up this application. Cadence’s chief medical officer, James Breitmeyer, said the agency’s main concern is that excessive doses of acetaminophen can cause liver damage. This could theoretically happen during a communications mix-up in a hospital, so Cadence plans to propose an additional warning tab on its vials that remind doctors and nurses not to give the IV drug if the patient has already taken the pills.
One insightful question came on yesterday’s conference call from analyst Charles Duncan of JMP Securities. He asked whether the company collected data on secondary goals in its trials, like whether its product could actually help wean patients off opioids. This could be a big selling point to hospitals, which I’m told get really annoyed with treating the constipation that comes with prescribing these drugs. Breitmeyer ducked the question, because he said statisticians are still analyzing data on the secondary goals.
That answer, when it emerges next year, could speak to the drug’s ultimate commercial potential. But from listening to yesterday’s conference call, Schroeder made it seem unlikely the FDA will schedule a public advisory panel to review the drug, as it often does when wrestling with questionable drug candidates. “We don’t think there’s anything controversial here,” Schroeder says.