Pfizer plans to apply for marketing approval for heart drug torcetrapib as a single pill, rather than as a combo-drug with Lipitor, according to a company statement. Torcetrapib is being evaluated in clinical trials and is approximately a year and a half from potential approval. Clinical trials show that torcetrapib substantially raises the levels of high-density lipoproteins (HDL), the "good" cholesterol, providing a novel approach to preventing heart attacks and strokes. Analysts predict that it could reach sales of several billion dollars annually.
Previously, Pfizer planned to sell torcetrapib only in combination with Lipitor, one of several medicines called statins that lower levels of low-density lipoproteins (LDL), or "bad" cholesterol, according to the company. However, by offering torcetrapib only in a combination pill, the company would have forced patients taking other statins—such as Merck's Zocor—to switch to Lipitor to gain the benefits of torcetrapib.
Controversy around the combination plan consisted of cardiologists stating that not all patients can easily switch from one statin to another, and some cannot take statins at all. In addition, there were commercial and legal challenges relating to whether offering torcetrapib only with Lipitor might violate antitrust laws. Pfizer previously contended that, since the drug would almost always be prescribed in conjunction with a statin, it would be too costly to test each major statin with torcetrapib.
According to Dr. Joseph Feczko, Pfizer's chief medical officer, "Pfizer expects to offer torcetrapib as a stand-alone drug as well as in combination with Lipitor. The change comes in part because of the criticism Pfizer has faced. We didn't appreciate how this would be perceived." As a result, patients will be able to take torcetrapib alongside whatever statin they now use, or even as a stand-alone pill, although most doctors will likely prescribe it with a statin.
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