At first glance, Merck & Co. Inc.’s Cordaptive—the drug giant’s next hoped-for approval, slated for an end-April PDUFA—is everything Big Pharma knows it shouldn’t be doing anymore. It’s a line-extension. It’s a combination drug that marries Merck’s own long-acting version of now-generic niacin with a compound that reduces niacin’s irritating (but not dangerous) side-effect, flushing. It looks, then, like the kind of poorly differentiated me-too that payors, investors and, increasingly, regulators, can’t be doing with. A gift horse to industry critics that say drug firms are unethically squeezing money out of Treasury purses for barely new drugs, in other words.
Yet Cordaptive can also been seen as a very practical way to unlock the extraordinary medical benefits otherwise trapped in...