Niacin

Analyst predicts a long delay for Merck's Cordaptive

Tue, 06 May 2008 06:59:55 -0400

There's more bad news--or analysis--for Merck's drug development efforts. After the FDA turned down Cordaptive, Merck's new cholesterol medication, there was much head scratching over why. The drug giant never explained the reasons for the rejection. Now Pharmalot is highlighting a note from a Credit Suisse analyst who believes that the combination of niacin and the chemical component laropiprant--to prevent flushing--may have been doomed by cardiovascular signals emitted by the chemical.

The numbers of patients who demonstrated these signals may have been small, but Merck researchers couldn't explain just why they had them. With plenty of me-too alternatives on the market and an uncertain risk profile, the agency had little reason to provide an approval.

The kicker, for Merck, is that the analyst doesn't see any definitive new data on laropiprant coming from an ongoing study, leaving the drug giant to mount new trials if it wants to make its case to the FDA. And that could delay any approval for years.

- read the report from Pharmalot

ALSO: The axeman cometh to Merck's sales force. The drugmaker plans to lop off about 15 percent in the sales ranks, or 1,200 jobs. Layoff report

Merck shares hammered after FDA rejects Cordaptive

Tue, 29 Apr 2008 06:59:58 -0400

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, 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.

"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
- check out the report in TheStreet.com

Merck scores high in race for cholesterol drug

Tue, 04 Sep 2007 06:59:55 -0400

Merck is reporting success in its Phase III trial of a new cholesterol drug that combines a known ingredient with a new one that reduces the risk of an uncomfortable and common side effect. Cordaptive--which has been submitted for FDA approval--uses an extended-release form of niacin with another therapy that has significantly reduced the number of times patients experience "flushing," a reddening of the skin that is associated with a burning sensation. By week 24 in the study, patients taking Cordaptive reported one incident of flushing per month on average compared to one incident per week for patients taking niacin alone. Not surprisingly, the groups reported similar levels of cholesterol. Abbott, meanwhile, is advancing its own new version of Niaspan, which also is intended to reduce the number of incidences of flushing. The FDA is expected to make a decision on Cordaptive in the second quarter of '08.

- see the release
- read more on the data from MarketWatch
- and here's the analysis from the Wall Street Journal

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Pathway found to raise "good" cholesterol. Report
Penn researchers report success in cholesterol control. Report