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[DewDiligence]

MRK’s Cordaptive Delayed Until 2013

http://online.wsj.com/article/SB121397005351191867.html

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By MIKE BARRIS
June 20, 2008 10:24 a.m.

Merck & Co. might have to wait until 2013 to again seek approval of its Cordaptive cholesterol drug as the Food and Drug Administration may not consider additional data it wants before then.

January 2013 is the targeted completion date for the so-called Thrive study, in which Cordaptive's potential in lessening "vascular events" is being evaluated.

Cordaptive's potential FDA approval was set aside April 28 in the form of a "not approvable letter," in which the agency seeks additional data from the applicant.

Merck said Friday it recently met with the FDA to discuss the rejection, and that the agency suggested the company wait for Thrive's results before seeking approval. The drug maker said talks will continue in hopes of making an earlier filing, one which Merck admitted wouldn't take place until 2010.

Thrive, a Merck sponsored trial in partnership with University of Oxford, is planned to have about 20,000 patients - there are 12,000 currently. The trial compares Cordapitve plus simvastatin, a generic statin that is also marketed by Merck as Zocor, versus simvastatin alone and assesses heart attacks or coronary death, stroke or need for arterial bypass procedures.

Other studies for Cordaptive thus far have been only on its effect on cholesterol levels.

"We are disappointed, but continue to have confidence in the potential of MK-0524A to provide physicians with an important option to manage their patients' cholesterol," said Peter S. Kim, president of Merck Research Laboratories.

The FDA's rejection of the drug - one of the most promising in Merck's development pipeline - handed a big setback to efforts to reinvigorate Merck's turnaround and shore up its faltering share price. The company had hoped to get Cordaptive on the market this year.

Merck was counting on Cordaptive to bring in as much as $2 billion a year in sales, financial-services firm Raymond James & Associates estimated at the time.

Merck hoped to package Cordaptive with Zocor, which treats cholesterol in a different way and brought in $5 billion a year before losing its patent protection in 2006. But any plans to seek approval won't be made until Merck completes its Cordaptive response.

Merck's stock has taken a beating recently. It slid following the turn-down announcement. At the time, the stock had already fallen 30.7% since the company released unfavorable data from the study of another cholesterol drug, Vytorin, in January. Some analysts have theorized that the stock hasn't rebounded because of Wall Street's uncertainty about Cordaptive's FDA prospects.

Cordaptive combines the vitamin niacin with a new agent to make niacin easier for patients to tolerate. Niacin works to both reduce "bad" and raise "good" types of cholesterol, but comes with an uncomfortable side effect called flushing that can make patients' skin feel hot and tingly. To make Cordaptive, Merck adds a new agent, laropriprant, to turn down the flushing. But that add-on has drawn criticism because of a theoretical link to heart problems and because it hasn't been widely tested by itself.

In May, Merck discontinued a Cordaptive study after the trial's overseers concluded the patient population wasn't appropriate for the imaging technology being used to measure the drug's effectiveness. The study was using an imaging technique to measure the drug's effect on artery thickness.
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