Now you see why AstraZeneca didn't start SATURN earlier

Drugmaker AstraZeneca P.L.C.'s big gamble, an attempt to prove that its top-selling drug works better than rival cholesterol blockbuster Lipitor, appears to have backfired.

A study meant to show AstraZeneca's cholesterol drug Crestor prevents plaque buildup in heart arteries better than Pfizer Inc.'s Lipitor showed no clear advantage for Crestor. AstraZeneca released preliminary results of the study Friday.

Two generic versions of Lipitor, the world's top-selling drug for several years, are expected to hit the U.S. market Nov. 30. Analysts said the results would make it hard for AstraZeneca to argue patients would fare better on its Crestor than on much-cheaper generic versions of Lipitor.

AstraZeneca is based in Britain and has U.S. headquarters near Wilmington.

AstraZeneca shares fell $1.61, or 3.5 percent, to close at $45.08.

The study, known by the acronym SATURN, followed about 1,300 high-risk patients with hardening of the arteries, which can cause strokes or heart attacks, for two years. About half got a daily 40-milligram dose of Crestor, known generically as rosuvastatin, and the rest got a daily 80-milligram dose of Lipitor, known generically as atorvastatin.

Using ultrasound probes, study investigators measured plaque levels in a segment in the coronary artery of each patient, comparing levels at the study's beginning and end. Doctors believe reducing plaque thickness can cut chances of having a heart attack or stroke.

AstraZeneca said that preliminary results indicated Crestor showed a greater percentage reduction in the volume of plaque in the coronary artery - the study's main goal - but that the difference was not statistically significant, meaning it could have occurred by chance.

The study did produce a statistically significant reduction in a secondary goal, reduction of total plaque volume.

"The fact that this [AstraZeneca]-funded trial failed to definitively show a benefit in favor of Crestor will add to the negative pressure that Crestor is already destined to face from the imminent launch of generic Lipitor," Bernstein Research analyst Tim Anderson wrote in a report to investors. "Payers will be able to say that [AstraZeneca] itself has shown in a true head-to-head study, Crestor and Lipitor do about the same thing."

Anderson noted prior studies showing Crestor's benefit only tested it alone or compared it with a dummy pill, rather than another cholesterol medicine.

Jefferies & Co. analyst Jeffrey Holford wrote that the data did not provide a clear positive result that AstraZeneca could have used to continue arguing Crestor is superior to Lipitor.

 

via philly.com

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