Ready to capitalize on the JUPITER trial success, AstraZeneca announced it is planning the first regulatory submissions for Crestor based on the outcomes trial in the second quarter, although the company still isn't elaborating on what specific claims it will seek.

Crestor (rosuvastatin) sales are riding high already, in part because of headline results from the study released last November, but AstraZeneca has held off on a full promotional push until the results get through FDA approval and into labeling. The trial showed Crestor demonstrated improved cardiovascular outcomes in a population with relatively normal LDL but high levels of C-reactive protein, a marker for inflammation (¹ Also see "Insurers View JUPITER With Caution; Can Benefit Be Achieved With Generics?" - Pink Sheet, 17 November, 2008., p. 8).

It's unclear whether AstraZeneca will try for a new indication in a population with cholesterol levels that are considered healthy based on a sole study, or whether the company will try to incorporate the clinical trial results in a more indirect manner.

The results already are having an impact. Payers certainly are reviewing the data; WellPoint already has moved to grant broader access to the statin (² Also see "WellPoint Expands Access To Crestor Based On JUPITER Review" - Pink Sheet, 12 January, 2009., p. 31). "We enter 2009 with our strongest position ever in managed care for Crestor in the U.S., and this has been achieved with pricing stability," Chief Financial Officer Simon Lowth stated during AstraZeneca's Jan. 28 year-end sales and earnings call.

Although the JUPITER results came late in the year, there are some early signs of greater Crestor utilization. The company attributed Crestor's strong performance to promotion of the atherosclerosis claim added in November 2007. "Crestor's position will be further strengthened on the back of the JUPITER results," Lowth commented, "but keep in mind ... promotional use will not start until sometime next year."

Market share increased 10.8 percent

On the earnings call, Lowth pointed out - once again - that the drug was the only branded statin to gain market share in 2008 (a claim that has been repeated frequently since simvastatin (Merck's Zocor )went generic): an increase of 10.8 percent, "well ahead of the statin market, which grew by 4.4 percent."

Crestor's share of total prescriptions reached 9.9 percent in December, up 1.25 percent over December 2007, according to IMS data. In contrast, Lipitor , which cornered 28.5 percent of the market, declined 4.29 percent from December 2007, while Vytorin (total market share of 6.9 percent) dropped 5.46 percent year over year.

In the fourth quarter, Crestor scripts jumped 17 percent, versus the market growth rate of 4 percent and a nearly 18 percent decline in total scripts for branded statins.

"Importantly in the dynamic market, we gained more than 2.5 points in share of new patient starts to over 12.5 percent in the weekly data at the end of December," Lowth reported. He also noted positive net switches from other statins. "Towards the end of the year, we even saw positive net switches versus simvastatin."

In terms of sales, Crestor did quite well in 2008. Total U.S. sales for the year increased 18 percent over 2007 to $1.7 billion. Fourth-quarter U.S. sales jumped 27 percent to $490 million. Worldwide sales were up 29 percent to $3.6 billion for the year.

The regulatory submission based on JUPITER is just one mark of a great coming year for Crestor. AstraZeneca has another line-extension project in the works: the fixed-dose combination of Crestor and Abbott's newly approved fenofibrate Trilipix for patients with mixed dyslipidemia is slated for the third quarter of 2009.

One trial was dropped from the clinical development program for the statin, which goes off patent in 2016; the company no longer will pursue an outcomes study in end-stage renal disease.

Crestor's double-digit increase in sales helped offset a 70 percent drop in sales in 2008 for the beta blocker Toprol XL , which went generic in August 2007. Overall, U.S. sales for all AstraZeneca cardiovascular products dropped 16 percent in 2008 compared with 2007 to $2.3 billion, but thanks to the resurgent Crestor, grew 20 percent in the fourth quarter to $661 million.

AstraZeneca restructuring to cut costs

CEO David Brennan updated investors again on the planned restructuring first announced in 2007. The company estimated it would lose approximately 7,600 jobs worldwide through 2010, but revised the figures in November last year to include an additional 1,400 positions.

"Today we are announcing that a further 6,000 positions will be eliminated by 2013," Brennan said. "Most of these cuts - all but 2,300 - are already known to our people," he added.

"I firmly believe that you cannot cost cut your way to success. But each dollar saved is allowing us to invest in pursuing more opportunities that will enhance our commercial competitiveness and deliver new innovative products."

AstraZeneca has four projects, including two new molecular entities, pending approval at FDA and EMEA, and has plans to file up to four new products for regulatory approval in 2009.

"Although the intermediate markers for progress are all pointing in the right direction," Brennan said, "it is successful registration and launch of new products that will ultimately be the measure on which we judge the progress of our pipeline."

- Becky Jungbauer (r.jungbauer@elsevier.com)

Crestor Star Continues To Rise, And Trajectory Looks Good

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