Against odds, Lipitor became world’s top seller

Anti-cholesterol drug » It became the top-selling statin barely three years after it was launched..

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"Those other companies didn’t even take us seriously. They didn’t think we could be a viable contender," said Adele Gulfo, then head of cardiovascular marketing at Warner-Lambert Co. who now heads Pfizer’s primary care drugs business.

Doctors said they were "quite satisfied with the medicines we have," she recalled recently.

Given that, marketing executives at Warner-Lambert were projecting Lipitor sales of $300 million a year at best, recalls the drugs’s inventor, chemist Bruce D. Roth.

"I wish someday you guys could make us a drug we could sell," the marketers told his team, recalls Roth, a research vice president for Genentech, a biotech pioneer now owned by Swiss drugmaker Roche.

They had, but didn’t see it.

"There was a lot of controversy at Warner-Lambert as to whether we should even take our molecule into the clinic" for human testing, Roth says. "It was kind of a big risk ... It’s millions of dollars."

But senior management was persuaded in 1990 to at least fund the initial round of testing on a couple dozen employee volunteers.

The results were far better than what had been seen in the animal tests.

"It tremendously, incredibly outperformed the other statins," Roth says. "It was as good at its lowest dose as the other statins were at their highest dose."

So Warner-Lambert partnered with much-larger Pfizer Inc., considered the industry’s top marketer, first to help fund the expensive late-stage testing of the drug in people and then to promote Lipitor after it was launched. Pfizer bought out Warner-Lambert in 2000 to block two other companies trying to acquire it and get control of Lipitor.

Pfizer benefited from some lucky timing: Lipitor went on sale in 1997, the year the Food and Drug Administration first allowed drug ads targeting consumers.

So Pfizer spent tens of millions on ads, including on the popular drama "ER," first urging patients to "Know Your Numbers" and then showing patients discuss how Lipitor helped them get their cholesterol numbers below guideline goals.

Meanwhile, health groups kept lowering the cholesterol targets in national guidelines, making millions more patients good candidates for statin treatment, as new research showed the link between cholesterol levels and consequences such as heart attacks. All those new patients boosted sales for the whole statin class, particularly Lipitor.

The Lipitor promotion team set new standards for a marketing campaign. They repeatedly visited family doctors as well as cardiologists, and blanketed patients with data showing that Lipitor was best at lowering cholesterol. They stressed to doctors nervous about safety that Lipitor’s lowest dose worked as well as rivals’ highest doses. They gave free samples of the white pills and sometimes bought lunch for the office staff.

In another savvy move, Lipitor was priced below rival drugs.

The company continued research on Lipitor, through this year conducting more than 400 studies, costing roughly $1 billion and including more than 80,000 patients. The studies have shown how Lipitor helped patients with heart problems, diabetes, stroke risk and other conditions, by preventing heart attacks and strokes and reducing plaque buildup in arteries.

Even with Zocor, Pravachol and Mevacor all going generic several years ago, and AstraZeneca PLC’s Crestor joining the market in 2003, Lipitor sales have remained strong. It’s the only brand-name drug among the 20 most-dispensed drugs in the U.S., according to data firm IMS Health.

But Pfizer, the world’s largest drugmaker by revenue, has struggled to develop another runaway blockbuster. Its bid to create a next-generation statin flamed out in 2007 when it had to abandon heavily touted compound torcetrapib, after roughly $800 million in testing, because it raised heart attack and stroke risk.

In recent years, Pfizer has focused on creating other types of drugs and on another unprecedented strategy — this one for hanging onto Lipitor revenue until June, when multiple new generic Lipitor versions will join one sold by Ranbaxy Laboratories and the authorized generic from Watson Pharmaceuticals Inc. Pfizer is offering patients and insurance plans big discounts and rebates, including cards giving patients a $4 monthly copayment, if they stay on Lipitor until then.

But branded Lipitor is by no means history.

Its patent is still in force in many major foreign countries and Pfizer is promoting it heavily in emerging markets such as China.

Pfizer’s strategy to keep U.S. patients on Lipitor appears to be working a little better than some analysts expected: The number of Lipitor prescriptions filled in the first full week after generics arrived only fell by half.

Sanford Bernstein analyst Dr. Tim Anderson forecasts Lipitor sales will decline from about $11 billion in 2009 and 2010 to $3.9 billion next year and just above $3 billion in 2015.

That would make it Pfizer’s No. 3 drug that year — and possibly still among the world’s 20 top-selling drugs by revenue, as half those on the current list also will have generic competition by then.

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