The demise of Pfizer’s torcetrapib
Read the press release announcing the halt of all torcetrapib clinical development here: Pfizer Media Center - News Releases. According to Pfizer spokesman Paul Fitzhenry, as reported by the AP, an interim DMC safety review discovered 60% more deaths (82 vs. 51) among the combination atorvastatin-torcetrapib arm as compared with the atorvastatin arm in the ca. 15,000-subject ILLUMINATE trial. Based on this “imbalance” the DMC recommended the study be stopped. Pfizer took this recommendation and further decided to stop all torcetrapib clinical studies.
Torcetrapib, a cholesterol-ester transfer protein (CETP) inhibitor, was one of the most eagerly anticipated drugs in development. It was also the costliest to develop; Pfizer reportedly was planning to spend over $800 million on its Phase 3 development alone. It was a drug many analysts, including this one, deemed crucial to Pfizer’s growth prospects after Lipitor loses US market exclusivity in early 2010.
A timeline of torcetrapib milestones is found in this 2005 Pfizer press release, which announced expansion of the Irish plant Pfizer was using to manufacture the torcetrapib/atorvastatin tablets. The drug had recently suffered a non-fatal setback when it was discovered that it raised blood pressure more than thought following Phase 2 studies.
I am neither a Pfizer investor, nor do I count Pfizer among consulting clients, yet I am terribly disappointed in this outcome. Besides being a stark demonstration of our industry’s inability to channel late-stage investments with more predictability than could be had by relying on a coin toss, the torcetrapib failure is a hard-lost opportunity to lessen the world’s ever-mounting burden of atherosclerotic cardiovascular disease (CVD). Whatever good comes from the torcetrapib “case” let’s not lose sight of this loss; it’s tragic in its proportions.
As for the potential good emanating from the news, surely the loss of such a large investment in time and money will serve as a reminder of the industry’s urgent needs to improve R&D decision-making and to take lessons from the financial-investment industry and practice sound product-portfolio risk management. Eight hundred million dollar Phase 3 bets that don’t pay off will ruin this industry more assuredly than government-mandated price controls, counterfeit products, and product “re-importation” combined could.
