number of coronary events, it will take until about the end of 2011 to complete enrollment, Truex says. Results should be ready by the first half of 2012, and if all goes well, the company will be able to seek approval from the FDA by the end of 2012.
Since this would be coming online in the era of health reform, Anthera had better have a compelling reason for how prescribing the new drug can save the system money. Chief financial officer Chris Lowe was certainly ready for that question, although I’m sure that serious health economic studies will have to be done to make the argument really compelling. Just off the top, he noted that initial heart attacks cost the healthcare system between $20,000 and $40,000, but second ones tend to cost about three times as much because they are more damaging. If the Anthera drug can reach its primary goal, he says, “then you have a drug that will provide serious benefit to the healthcare system.”
There’s an interesting financial strategy at work here, too. Anthera is going it alone, with a team of just 25 employees, managing this pivotal trial and hoping to ship off to the FDA. Rather than hand over the majority control of the drug to a Big Pharma partner in exchange for cash, the board chose to raise more money through the IPO and retain 100 percent of the drug’s rights in North America and Europe. It was feasible to do this for a relatively small pivotal study for cardiology, which usually requires 10,000 or more patients followed over a fairly long period of time—a proposition that requires too much time and money for most biotechs. So if Anthera can hold on all the way through Phase III, and deliver the reduced risk of heart attack and stroke it foresees, then it could have a pretty valuable property to sell to one of those Big Pharma companies looking to fill holes in their pipelines left by the billion-dollar heart drugs of yesteryear. Anthera says it believes it has patent protection on its new drug out to 2019.
That would certainly provide Big Pharma companies many more opportunities to wine and dine doctors like the ones in Chicago this week, regaling them with stories about how this drug helps patients and reduces costs.
“We think this aligns the interest of payers, patients, and shareholders, ultimately,” Lowe says.
