Category Archives: AstraZeneca Crestor AHA JUPITER v. Vytorin/Zetia Octobe

So — What Will AstraZeneca present to AHA about JUPITER?

On this morning’s Merck Q3 earnings conference call, the Barclays Capital analyst asked how the Vytorin/Zetia Joint Venture expected to shift its physician messaging points, once the expected Crestor-JUPITER presentation to the American Heart Association has been completed. The thought here is that Crestor now apparently shows a risk of morbidity benefit — a benefit Vytorin/Zetia cannot claim.

The question thus becomes “How does one sell a drug that does no better than a placebo — a placebo that costs five times a generic statin — and now, as compared to Crestor, given AstraZeneca will apparently shortly be able to truthfully claim a reduced risk of death from cardiovascular events — while taking Crestor?”

How? I dunno.

Now, just for background, here is the March 31, 2008 press release, from AstraZeneca, on the early halt of JUPITER:

Crestor Outcomes Study JUPITER Closes Early Due To Unequivocal Evidence Of Benefit

March 31, 2008

AstraZeneca today announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.

JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was designed to determine if treating patients with no evidence of pre-existing cardiovascular disease and low to normal LDL-C but elevated C-reactive protein (CRP) with CRESTOR 20mg once daily would reduce major cardiovascular events. CRP is a recognized marker of inflammation and is associated with an increased risk of atherosclerotic cardiovascular events.

The JUPITER study team has initiated activities to close this large multi-centre study. Over 15,000 trial participants will be scheduled by their investigator for final assessments at over 1,200 sites in 26 countries. Data from these visits will be collected and reviewed to allow a full and complete analysis and final results of the study will be published once the analysis is complete.

JUPITER is one study from the global research initiative known as the GALAXY programme, which has now recruited more than 64,000 patients from 55 countries worldwide, to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes. . . .

It certainly seems as though the Schering-Merck Cholesterol Joint Venture (to sell Vytorin/Zetia) is running out of runway, here. . . .