An advisory committee voted unanimously last week to recommend approval for Crestor in doses of 5 milligrams to 40 milligrams, and the Food and Drug Administration usually follows the recommendations of its advisory panels. Approval is likely no later than Aug. 12.
AstraZeneca declined to comment on its marketing plans, as did Quantum, but executives close to the situation confirmed the spending range. Grey Global Group's Grey Healthcare is handling the professional launch.
Pfizer's Lipitor is the leading anti-cholesterol medication and the world's biggest-selling drug. Pfizer backed Lipitor with $80 million in spending last year, according to TNS Media Intelligence/CMR, and spent $27 million through April of this year. Worldwide sales of Lipitor in 2002 were $7.9 billion, according to IMS Health. Sales increased 13% in the first quarter of this year to $2.1 billion.
Pfizer will also have its erectile-dysfunction drug Viagra challenged this year on two fronts. Bayer and GlaxoSmithKline's Levitra is expected to receive FDA approval in time to leverage its new sponsorship with the National Football League (AA, May 26), while Cialis, a venture between Eli Lilly and Icos, is also expecting FDA approval this year.
Pfizer declined to comment on Crestor's expected approval, but some experts said the company will probably tweak its marketing for Lipitor to play up the fact that patients taking high dosages of Crestor are subject to monitoring. "In a subtle way, you might see Lipitor depicted as a safer alternative [than Crestor]," one executive said.
As if going up against the world's biggest-selling drug isn't enough, the sense of urgency to get Crestor to market is magnified by the expected 2005 introduction of another anti-cholesterol medication, Zocor-Zetia, a combination of Merck's Zocor and Schering-Plough's Zetia.
"It has to get out there and make a big splash in an 18-to-24-month window," one executive said.
Analysts, however, predict Crestor could do as much as $3 billion in sales by 2007, and at least one expects both drugs to cut into Lipitor's business. "Once Crestor and Zocor-Zetia are introduced, we expect Lipitor to lose its exclusive grip on newly diagnosed patients," Richard Evans, an analyst with Bernstein Research, recently wrote.
The expected FDA approval of Crestor has put AstraZeneca, Wilmington, Del., on a blockbuster roll. Its lung-cancer drug Iressa was approved earlier this year, and the company will file for marketing approval for Exanta, for deep vein thrombosis, in the fourth quarter.
Quantum Group is hot as well. The Parsippany, N.J., agency is also the DTC agency of record for Levitra, which is expected to have a launch in the $50 million range.