PharmExec Blog

ACC News Echoes Cost/Benefit Concerns

accu.pngNews 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, “We’re done for the conference in terms of the important stuff. Vytorin is the story this year.”

So what is Vytorin’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 Vytorin’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 blockbuster—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 Lilly’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 isn’t saying much.) Still, “Is it much better than Plavix?” asks Fundleyter. “And how much better? After all, Plavix is going generic and there is not a lot of evidence of its benefit.”

We are watching how these developments play out, particularly as share for Lipitor continues to erode (although some of Vytorin’s share might go toward Lipitor) and Novartis’ 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).

“That’s a place where you could see some improvement—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.”

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One Comment

  1. Kent Wiggs
    Posted April 2, 2008 at 7:01 am | Permalink

    Comparing the two diseases states (high cholesterol and ACS) in regard to relative risk is an unfair comparison. Whereas the debate of which cholesterol marker needs to be mediated continues to be debated and resolve (i.e. HDL, LDL, total particle number, particle size, etc.), there is very little debate as to the importance of anticoagulation therapy in ACS. Furthermore the two studies (TRITON – Daiichi Sankyo Inc. & Eli Lilly versus ENHANCE – Merck) are both insufficient to draw broad conclusions regarding patient treatment.
    The key word in both instances is “prudence”. Is it prudent to ignore the LDL lowering effects of Zetia in all patient types based on ENHANCE? Is it prudent to niche the use Prasugrel before clinical use? Is it prudent to abandon development and marketing of all drugs until long term outcome studies are concluded? What about ACCORD? Is it prudent to abandon tight A1C control diabetics? My answer is emphatic “no” to all of the questions.
    The most damaging aspect to the media discussion of EHANCE, TRITON, and other phase 3 and phase 4 studies is public perception of our industry. Collectively the crisis of confidence of the American public impairs our industry both in the development, appropriate use and marketing of pharmaceuticals.

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