New rules for prescribing statin drugs could double the number of people taking them--or not. They could help AstraZeneca pump up sales of its high-powered Crestor--or not. What they will do--most likely--is undercut Merck's cholesterol drugs Vytorin and Zetia, along with AbbVie's fenofibrate-based lipid meds TriCor and Trilipix.
Merck cut its sales forecast and posted a 50% drop in quarterly earnings as it continues to absorb major hits to its once-blockbuster Singulair. The fact that profits beat analyst expectations says as much about those expectations as it does about Merck's performance for the quarter.
No question, statins are the big gorilla of the cholesterol-fighting drug market. And as Forbes reports today, that drug class is marking out an even bigger territory as time goes by. Over the past 5 years, statin prescriptions have grown by 17% to 214 million a year, while other cholesterol remedies lost 28% of their scripts. Now, those other drugs only account for 50 million prescriptions a year.
Merck will soon launch a new cholesterol combo that melds its Zetia drug with generic Lipitor. The Zetia-plus-statin approach isn't new, of course; Merck already sells Vytorin, a combination of Zetia and its own off-patent statin Zocor, known generically as Simvastatin.
The huge late-stage study that is seeking to determine once and for all if Merck's combo cholesterol drug Vytorin actually works and is safe will run its full course now that an independent safety board has signed off following a review of the data.
The Vytorin outcomes trial will go on. That's all the information we're getting out of the enormous Improve-It study for now. An independent data monitoring board looked at the trial's results so far and recommended that it continue.
Merck agreed to pay $688 million to resolve two securities-fraud lawsuits filed by irate shareholders. Pension funds and other institutional investors alleged that Merck--and Schering-Plough, which Merck bought in 2009--held back key information about the Enhance trial, which tested the combination drug Vytorin against one of its constituent parts, the statin drug Zocor.
After having to swallow a pretty bitter pill last week from a bad earnings report and sorry looking forecast, Merck investors got a taste of sugar, about $2 billion worth.
Merck CEO Kenneth C. Frazier today had to give shareholders the bad news and then he had to follow that up with the really bad news.
The Vytorin outcomes study is going ahead without a hint about how things are faring. The safety monitors of Improve-It, which is testing Merck's ($MRK) cholesterol-fighting drug Vytorin, say no new dangers have cropped up among the 18,000 patients enrolled.