Cadence Pharmaceuticals can now start turning even more of its energy toward doing what it takes to become a commercial drug company. The San Diego-based biotech (NASDAQ: CADX) said yesterday it passed all three clinical trials it says it needs to satisfy FDA requirements so a new intravenous form of an old standby pain reliever can be cleared for sale in the United States.
Full details on how this drug, acetaminophen, performed will be revealed at an upcoming medical meeting, or in a peer-reviewed journal, Cadence said. The company is working now to put together an application to the FDA, with a goal of submitting it for approval before the end of June. In the meantime, Cadence will start building a sales team to fully exploit this drug, to be marketed as Acetavance. The goal will be to pitch this to hospitals as a safer alternative to opioid-based pain relievers that can be addictive and cause constipation and other side effects. The Cadence product was tested in patients who undergo abdominal surgery, and therefore can’t swallow the usual tablets or capsules, commonly marketed as Tylenol.
Cadence discussed parts of its commercial game plan yesterday on a conference call with analysts. I also got a glimpse of the strategy when I interviewed CEO Ted Schroeder a few weeks ago. He wants to build a team of 150 to 200 sales reps who will reach out to about 2,000 U.S. hospitals—the ones who represent about 80 percent of the pain relief market Cadence is pursuing. Schroeder didn’t get into sales projections on today’s call, but the potential is huge. Acetaminophen is one of the most widely taken drugs in the world, with billions of doses a year. About 2 billion doses a year are given in U.S. hospitals alone. At a price of about $8 to $10 a dose, this product could generate greater than $800 million in peak annual sales in the U.S., he says.
The economic downturn could actually work a bit in Cadence’s favor, because it expects it will be able to recruit some highly experienced sales reps who have gotten axed by other drugmakers. “The competition for talent is not what it once was,” Schroeder said. “It helps us.”
The backstory of how Cadence got ahold of this drug is interesting. It acquired the drug from Bristol-Myers Squibb (NYSE: BMY), which did years of development work to get it toward the proving ground of final-stage clinical trials. When Bristol made a round of cutbacks in 2005, and limited its focus to 10 core therapeutic classes, pain wasn’t one of them, Schroeder says. This was in the wake of safety disaster with COX-2 inhibitor pain drugs, like Merck’s rofecoxib (Vioxx), so it was thought the FDA would apply extra scrutiny to new pain meds. That enabled … Next Page »