Biotechs Have No Business in This Indication
Anthera Pharmaceuticals (NAS: ANTH) spiraled downward this week after announcing that it's stopping its acute coronary syndrome treatment varespladib because there was little chance the drug would be able to beat placebo during the remainder of the trial.
One has to wonder whether the company should have been running the trial in the first place, since heart drugs aren't very appropriate for biotechs. They're high-risk, high-reward prospects that require a lot of dough, and the FDA now requires drugmakers to show that heart drugs improve outcomes, in terms of things like heart attacks, strokes, and hospitalizations. Markers such as cholesterol levels aren't sufficient.
Anthera was treating sick patients with acute coronary syndromes, so it followed the patients for only 16 weeks for the primary endpoint. Even so, Anthera planned on enrolling some 6,500 patients into the trial. That's not as much as Merck (NYS: MRK) had to enroll in its phase 3 trials of vorapaxar or GlaxoSmithKline (NYS: GSK) for darapladib, but it's still no small feat for a biotech.
The company didn't give any hints as to what went wrong. It's possible that the markers used in the phase 2 trial didn't translate into improved outcomes, but it's also possible that Anthea just needed to run a longer (cha-ching) and/or larger (cha-ching) trial to demonstrate a difference in the population taking varespladib and Pfizer's (NYS: PFE) Lipitor from those taking Lipitor alone.
About the only positive is that the company was smart enough to build in futility monitoring so it didn't waste any more money on a trial that wasn't going to work. Presumably, Anthera will ditch varespladib at this point, but if it's able to figure out what went wrong, I'd suggest getting a partner to foot the bill. Pronto.
Anthera is left with blisibimod, which treats lupus, another high-risk, high-reward disease. Before Human Genome Sciences' (NAS: HGSI) Benlysta, there were a lot of drugs that failed to show an effect on the complicated disease. But it's still a more appropriate indication for a biotech to be developing a drug in, because the clinical trials required to demonstrate efficacy are much smaller; Benlysta's phase 3 trials enrolled 865 and 819 patients.
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