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of those goals now, and Acetavance provides a way to do that.”
But what about the danger of liver damage? That’s not a concern to Cadence, because its clinical trials showed effective pain relief at lower doses than the ones that raised safety concerns for the FDA panel, Schroeder says. The drug will be given by professionals in a hospital setting, so the odds are slim of a mix-up that causes dangerous overdoses, he says. Plus, the company has a database of 55 million patients who got the IV form of the drug in other countries where it already is approved, and while he didn’t disclose the number of overdoses, Schroeder says it is “remarkably low.”
The fundamental game plan really hasn’t changed much since Cadence’s CEO told me about it last December. Cadence plans to build up a sales force of about 150 people to call on some 2,000 U.S. hospitals—the ones who make up about 80 percent of the market for inpatient pain relievers. The price will likely be in a range of $8 to $10 a dose, he says.
One thing that has changed is the competition. Cadence will now have to face off with a new intravenous form of ibuprofen from Cumberland Pharmaceuticals that won FDA approval last month. Experience from competition in other countries suggests that the intravenous acetaminophen will grab the leading market share, Schroeder says, because of the potential for stomach bleeding that comes from excessive use of non-steroidal anti-inflammatory drugs like ibuprofen.
Cadence can’t actually start marketing this drug, because it just filed its application to the FDA for review back in May. Assuming it gets the normal 10-month review period for new drug applications, the drug could win clearance in March.
But since this drug is going to be sold to hospitals, it’s not as simple as shipping a box of drugs to every Rite-Aid and CVS store in the country, and waiting for the physician prescriptions roll in. Like all hospital- based drugs, Cadence will have to lobby the pharmacy and therapeutics committees at hospitals to review the cost-effectiveness of the new product, get on the hospital’s standard purchasing list, or formulary, and then watch the bulk orders come in. This process can take six months to a year before a drug gets established, and the company’s fortunes are more closely tied to actual prescription demand from physicians, Schroeder says.
“The second year for a drug like this is when you see the growth curve accelerate,” Schroeder says.
But lots of planning has to happen now to to get to those hopefully more prosperous days. Byrd is looking for a senior sales leader to report to him, and to start fleshing out a sales management team by the end of this year. Then it will start hiring and training the sales reps.
At least in the beginning, Cadence will only have the acetaminophen product for those people to sell. Last fall, the company was hopeful that it would also win FDA approval for a topical anti-infective drug, but that failed in a pivotal clinical trial. It’s still part of the plan to eventually get those sales reps a second drug to pitch, although that didn’t sound like the first item on Schroeder’s to-do list. More importantly, the company has told investors it should turn profitable by the later part of 2011, just as the growth curve on sales should start climbing.