News flowing from the American College of Cardiology meeting has been dominated by Vytorin. And after the presentation analyzing results yesterday, Miller Tabak analyst Les Fundleyter says, â€œWeâ€™re done for the conference in terms of the important stuff. Vytorin is the story this year.â€
So what is Vytorinâ€™s story exactly? Industry watchers say they are still searching for answers, but expect docs to move away from prescribing the drug. Filling in the blanks is the familiar debate over Vytorinâ€™s cost/benefit ratio and the question: Does new necessarily mean better?
The heightened sensitivity to cost/benefit packs particular punch for Merck, and its cardiovascular disease (CVD) treatment Cordaptive. The drug is currently awaiting review, and is before FDA. Rumor has it that Merck is investing big into the launch of this potential blockbusterâ€”but just how much the cost/benefit discussions surrounding Vytorin affect this, remains to be seen. (Merck just announced that it would rollback a study for the drug for the hypercholesterolemia indication, but it will likely not need the study for approval.)
The cost/benefit theme is also playing out with Lillyâ€™s drug Prasugrel, which unveiled positive results at ACC. FDA has slated Prasugrel for priority review, with a PDUFA date at the end of June. (Which we know these days isnâ€™t saying much.) Still, â€œIs it much better than Plavix?â€ asks Fundleyter. â€œAnd how much better? After all, Plavix is going generic and there is not a lot of evidence of its benefit.â€
We are watching how these developments play out, particularly as share for Lipitor continues to erode (although some of Vytorinâ€™s share might go toward Lipitor) and Novartisâ€™ Tekturna picks up some momentum,
So where’s the excitement? Wait until 2009. That’s when the Phase III trials for apixaban wraps. BMS-Pfizer are studying the drug for the prevention of venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of stroke in patients with atrial fibrillation (AF).
“Thatâ€™s a place where you could see some improvementâ€”it’s my sense they are going after the warfarin market,” says Fundleyter. “Warfarin has been the standard for 40 or 50 years, and that has one of those drugs that has a lot of side effects. Finding a replacement for warfarin would be a big deal.”