Shares of Merck were sliding again this morning on the news that the FDA has turned thumbs down on MK-0524A, its new cholesterol therapy. The stock dropped eight percent after regulators announced that the experimental therapy, a combination of niacin and laropiprant that had been high up on the drug giant's list of potential blockbusters, failed to make the grade. Getting an approval on Cordaptive [1], as the therapy was dubbed, would have gone a long way to easing the sting from the massive fallout that has hit Merck since new Vytorin data cast doubt on its efficacy [2].
"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter Kim, executive vice president of the company and president of Merck Research Laboratories, in a prepared statement.
- see Merck's release [3]
- check out the report [4] in TheStreet.com
Related Articles:
Merck scores high in race for cholesterol drug [1]
Merck to delay filing on new cholesterol drug [5]
Merck presents pipeline update to analysts [6]
Fortune scolds Merck for "risky" programs [7]
Links:
[1] http://www.fiercebiotech.com/story/merck-scores-high-race-cholesterol-drug/2007-09-04
[2] http://www.fiercepharma.com/tags/vytorin
[3] http://www.fiercebiotech.com/press-releases/merck-receives-not-approvable-letter-fda-mk-0524a
[4] http://www.thestreet.com/s/merck-tumbles-after-fda-rejects-drug/newsanalysis/drugs/10414252.html?puc=googlen&cm_ven=GOOGLEN&cm_cat=FREE&cm_ite=NA
[5] http://www.fiercebiotech.com/story/merck-to-delay-filing-on-new-cholesterol-drug/2006-09-29?utm_source=related&utm_medium=internal
[6] http://www.fiercebiotech.com/story/merck-presents-pipeline-update-analysts/2007-12-12
[7] http://www.fiercebiotech.com/story/fortune-scolds-merck-risky-programs/2008-01-15