Megablockbuster at Last?

At the moment, there are too many uncertainties for an accurate estimate of how much JUPITER is likely to increase sales of Crestor in years to come. On the bullish end, JP Morgan estimates that a CRP indication could help Crestor hit $9 billion by 2016, when its patent expires. Analysts also point out that JUPITER is likely to boost sales of all statins. Pfizer's Lipitor could get a nice bump if health plans favor it over Crestor, whose patent doesn't expire until 2016.

AstraZeneca CEO David Brennan set a modest tone as the company prepares to negotiate this scientific, regulatory, and commercial minefield. "I would urge caution when forecasting the speed of such changes. For all the excitement, we need to remind ourselves that we are only at the starting gate," Brennan said when the story first broke.

Most experts agree that FDA is likely to approve Crestor's third indication, making it the first drug to be approved for lowering C-Reactive Protein. Since AZ makes its own CRP blood test, it is presumably eager to dispatch its sales reps to doctors nationwide for a show and tell. But Liao and others say a CRP indication is iffy because of the marker's nonspecificity.

Even if the CRP indication passes muster with FDA and NCEP, Astra must still face the formulary dance. Says Datamonitor's Anthony Nealon: "For insurers it may be a bridge too far. Crestor might end up on tier 2 or 3 with payers assuming it's a class effect. Astra will have to get physicians believing Crestor is unique—or at least uniquely effective in this way."

That belief in uniqueness is the very essence of a great brand. And prescriptions from doctors can adjust payers' attitude toward brands. According to AZ, in 2008 the number of formularies on which Crestor has moved from tier 3 to tier 2 nearly doubled. "Even on tier 3 Crestor was able to sell through last year," says The Amundsen Group's Mason Tenaglia. "The combination of JUPITER data and the problems with Vytorin have given Crestor more negotiating power in 2009."

Yet only the same hard science that got Crestor to this position will advance it further. Says Preston Henske, a partner in the healthcare practice at Bain & Company: "Crestor's continued growth will depend in large part on continuing to bring new trial data to market to differentiate it from the 800-pound generics gorilla."

In January, AZ pitted Crestor against Lipitor in an atherosclerosis trial, with data due in 2011, just when Pfizer's atorvastatin will start getting nibbled to death by copycats. Proving superiority to Lipitor would help Crestor own athero and defend against generics in high-risk patient territory. AZ is also sponsoring HOPE 3, testing whether Crestor's ability to lower blood pressure and LDL in 10,000 low-risk people can reduce heart attacks and strokes. If the outcomes are as positive as JUPITER's, the momentum to use statins as primary prevention in millions of healthy people may reach its tipping point. —With research by Cassandra Blohowiak