Reversing a strategy that had drawn criticism from doctors, Pfizer says that it will apply for approval to sell a promising new heart treatment as a standalone pill — rather than only in combination with Lipitor, Pfizer’s best-selling cholesterol treatment.
The new drug, torcetrapib, is still being tested in clinical trials and is at least 18 months from federal approval.
But cardiologists say it has the potential to become a significant new treatment for heart disease.
Clinical trials show that torcetrapib substantially raises the levels of so-called good cholesterol, a novel approach to preventing heart attacks and strokes.
Wall Street analysts predict that it could become a blockbuster medicine, with sales of several billion dollars annually.
Previously, Pfizer had said it would sell torcetrapib only in combination with Lipitor, one of several medicines called statins that lower levels of LDL, or bad cholesterol. Cholesterol-reducing medicines are the largest prescription drug category, with worldwide sales of $32 billion last year.
By offering torcetrapib only in a combination pill, Pfizer would have forced patients taking other statins — like Zocor, from Merck — to switch to Lipitor if they wanted torcetrapib’s benefits.
In an interview last year, Dr. John L. LaMattina, Pfizer’s top scientist, defended the company’s plans, saying that the costs of testing torcetrapib alongside every statin would be prohibitive. Already, Pfizer says it is spending $800 million to develop torcetrapib. Pfizer is the world’s largest drug maker, with sales of $51 billion and a profit of $8 billion last year.
But Pfizer’s plan angered cardiologists, who said the company appeared to be putting its profits ahead of patients’ health. Not all patients can easily switch from one statin to another, and some patients cannot take statins at all. In June 2005, an article in The New England Journal of Medicine sharply criticized Pfizer’s strategy.
Besides complaints from doctors, Pfizer’s plan faced commercial and legal challenges. Some lawyers questioned whether offering torcetrapib only with Lipitor might violate antitrust laws. Meanwhile, Lipitor, though still the top-selling drug in the United States with sales last year of $7.4 billion, is losing market share to Zocor, whose price has plunged since it lost patent protection last month. As a result, Pfizer risked damaging torcetrapib by tying it to Lipitor, said Richard T. Evans, an analyst at Sanford C. Bernstein & Company.
Now Pfizer says it has changed its strategy. Dr. Joseph Feczko, Pfizer’s chief medical officer, said Monday that Pfizer expected to offer torcetrapib as a standalone drug as well as a combination with Lipitor.
The change comes in part because of the criticism that Pfizer has faced, Dr. Feczko said. “We didn’t appreciate how this would be perceived,” he said.
As a result, patients will be able to take torcetrapib alongside whatever statin they now use, or even as a standalone pill, though Pfizer expects that doctors will generally prescribe torcetrapib as a complement to statins, not by itself.
Whatever Pfizer’s motives for the change, the company’s action is positive, said Dr. Bruce M. Psaty, a professor of medicine and epidemiology at the University of Washington.
“This seems like an appropriate way to bring a potentially important drug to market,” he said. “Flexibility is important.”
Dr. Steven Nissen, president of the American College of Cardiology, lauded Pfizer for its decision. “They’re doing the right thing,” he said. “Pfizer is allowing physicians to make intelligent choices for patients.”
Dr. Nissen, interim chairman of the department of cardiovascular medicine at the Cleveland Clinic, is overseeing a 1,190-patient clinical trial to measure whether torcetrapib can slow, or even reverse, the growth of fatty plaques that narrow artery walls and can cause heart attacks. Dr. Nissen said he expected to present the results of that trial in early 2007.
Whether standalone torcetrapib and the combination pill will reach the market simultaneously is not clear. Pfizer expects to submit an application to the Food and Drug Administration to sell the combination pill in the second half of 2007, Dr. Feczko said.
The speed of the F.D.A. response will depend on the strength of the data that Pfizer presents about torcetrapib’s effectiveness and safety. If the drug works as well as Pfizer hopes, the F.D.A. could give its approval by the first half of 2008. If not, the F.D.A. may wait for data from a 15,000-patient trial that is testing whether the Lipitor-torcetrapib combination reduces heart attacks and strokes compared with Lipitor alone. Those results may not be available until 2010. Pfizer’s chemists. meanwhile, are working on a standalone torcetrapib pill that can be produced in commercially viable quantities. By September, Pfizer plans to submit an application to the F.D.A. for early-stage clinical trials that would combine torcetrapib with statins other than Lipitor, Dr. Feczko said.
Assuming the F.D.A. approves and those small trials do not reveal unexpected problems in combining torcetrapib with Zocor and other statins, Pfizer will then run larger trials to show that torcetrapib works with other statins as it does with Lipitor, Dr. Feczko said. But the company expects that the trials for torcetrapib with other statins will be quicker and cheaper than those it is performing for torcetrapib and Lipitor.
Pfizer’s plan is sensible, Dr. Nissen said. All statins are relatively similar, and the company does not need to replicate the huge clinical trials it is already running for the torcetrapib-Lipitor combination, he said. Also, shorter trials will make it easier to introduce standalone torcetrapib, he said.
“I would hope there wouldn’t be much of a lag between the launching of the combination and the launching of the standalone.”
