Heart Pill to Be Sold by Itself
Pfizer’s bold, but flawed, strategy to market only the combination formulation of its experimental CETP inhibitor, torcetrapib, with atorvastatin (Lipitor) has apparently been reversed late in the game. Although Pfizer never detailed its reasons for the initial strategy, it’s obvious that it was predicated on commercial rather than therapeutic considerations. Indeed, there was no therapeutic reason to limit development to a single combination tablet rather than pursue both the combination and separate tablets from the get-go. As this NYT article points out, Pfizer had earlier argued that the cost of developing both the combination and the stand-alone would be prohibitively expensive. Pfizer’s recent decision reveals this excuse for what it was.
Analogies of plausible combination tablet development scenarios abound in the cardiometabolic arena, especially in hypertension and diabetes. Typically, a stand-alone formulation is developed first, tested in combination with a number of different add-on therapies, and then a combination tablet is developed by bridging to the stand-alone data. The advantage to patients of the traditional development scheme is that the new drug is typically approved with broad combination claims (e.g. Actos plus any sulfonylurea), allowing the prescriber maximal flexibility to tailor therapy. Pfizer will be taking the opposite path now with torcetrapib, limiting prescriber flexibility initially to just the combination with Lipitor and only at the dose(s) of Lipitor Pfizer chooses to develop in combination.
