The results of the study, commissioned by the marketer, were reported at the American Heart Association conference in New Orleans. In the U.S. alone, as many as 7 million people not currently on the medications could benefit from taking so-called statins such as Crestor.
In the ultra-competitive $34 billion statin category, where Pfizer's Lipitor leads the way with $12.7 billion in sales last year, the results could be a boon for Crestor. Already AstraZenca's third best-selling drug with $2.8 billion in sales in 2007 and an estimated $3.45 billion this year, Crestor sales could double based on the results of the study, according to an analyst's note written by Steven Scala of Cowen & Co., Boston.
But increased sales -- and an increase in marketing -- might take a while.
"I would urge caution when forecasting the speed of such changes in medical practice," David Brennan, AstraZeneca's CEO, said on a conference call. "We will not be promoting the product until we get a label issued by regulatory agencies," including the Food and Drug Administration.
Julia Walker, senior director of cardiovascular and design for launch PR for AstraZeneca, told Advertising Age from New Orleans that the company will file for FDA label approval of this latest indication early next year, and expects to go to market in early 2010.
"The study has been presented here, and there has been generous media coverage," she said. "But beyond that, we can't do any promotion until label approval."
Crestor has been attacked over the years by various entities. The FDA asked AstraZeneca to cease advertising on the drug in 2005 because it made "false or misleading claims regarding the superiority of Crestor" in a series of direct-to-consumer ads. Dr. Sidney Wolfe, director of Washington-based Public Citizen's Health Research Group, has long been a critic of the drug, saying its side effects include kidney disease and muscle deterioration. But in 2005, the FDA responded by saying there is no evidence that Crestor poses a risk for either side effect.
Spending increased in '08
AstraZeneca has spent $78.2 million in measured media on Crestor through August of this year, according to TNS Media Intelligence, already far more than the $56.1 million it spent on the drug in all of 2007. Ms. Walker said the reason for the increased spending was that in late 2007 the FDA approved a new label that showed Crestor slowed the progression of atherosclerosis. Subsequently, in February, the company launched a new campaign handled jointly but Publicis Groupe's Digitas and Saatchi & Saatchi, New York.
"Once we got that label, we went live in late February," Ms. Walker said. "We had a new story to tell."
By contrast, spending on Lipitor was $187.3 million last year (but only $32.8 million through the first eight months of 2008), and the outlay on Vytorin was $132.8 million in 2007 ($52.7 million through August of this year), according to TNS.
This latest study was conducted on people who had high-sensitivity C-reactive protein, or CRP, which is a measure of inflammation that can lead to clogged arteries. It involved 17,802 people with high CRP and low cholesterol (below 130) in 26 countries. Cardiologists say they have been baffled by ways to prevent heart attacks in victims who have normal cholesterol levels and relatively few risks. In the study, one serious heart-related trauma was prevented for every 25 patients treated with Crestor, and one death was prevented for every 180 patients treated with Crestor.
About half of all heart attack victims had normal cholesterol and few risk indicators. Dr. W. Douglas Weaver, a Detroit cardiologist and president of the American College of Cardiology, told the Associated Press that "this takes prevention to a whole new level, because it applies to patients who we now wouldn't have any evidence to treat."
A Pfizer spokeswoman said studies have shown that Lipitor lowers CRP as well, but that the drug does not have FDA label approval to market the results. She did not say whether Pfizer will seek such approval for Lipitor.