From: Reuters
Published January 26, 2008 04:31 PM

FDA to review Vytorin cholesterol drug study

By Lisa Richwine

WASHINGTON (Reuters) - U.S. regulators said on Friday they would review a study showing a Merck and Schering-Plough cholesterol drug worked no better than a generic in preventing the build-up of arterial plaque.

The Food and Drug Administration said it was not advising doctors to stop prescribing Vytorin, but the agency's announcement unnerved investors and sent shares of the two companies lower.

The FDA said it could take up to six months to review final results of the study, called Enhance, and decide if any regulatory action was needed. A final report from the companies could be available within a couple months, FDA officials said.

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In the meantime, patients with questions about the Enhance study should talk with their doctors, the FDA advised.

"At this time, it is not clear why the lower levels of LDL cholesterol in the patients who took Vytorin did not lead to lesser amounts of plaque compared to patients treated with simvastatin alone," an FDA statement said.

Simvastatin is the generic name for Zocor. Vytorin combines Zocor with a newer cholesterol-fighting pill called Zetia. LDL is the "bad" cholesterol.

The agency's review put an even bigger spotlight on a debate over Vytorin's value in the wake of the Enhance results early last week and concern over a long delay in releasing the data.

Major medical groups, prominent cardiologists and U.S. lawmakers have weighed in, while prescriptions for the drug have slipped.

Merck & Co Inc's <MRK.N> shares closed down 3.6 percent at $47.79 on the New York Stock Exchange. They had earlier fallen as much as 14 percent.

Shares of Schering-Plough Corp <SGP.N>, which had dropped as much as 13 percent, closed down 5.7 percent at $19.02, also on the NYSE. The two stocks have fallen more than 20 percent since the results of the study were released.

NO IMMEDIATE ACTION

FDA officials said they may consider possible changes to the Vytorin label but felt no action was needed immediately.

"The FDA is attempting to buy time so noise can be filtered out and cooler heads can look at the Vytorin data, but it is unlikely even the FDA will be able to draw clear conclusions," said Viren Mehta, principal at Mehta Partners.

"For a clear picture, we will need to wait for outcomes data (data on heart attack and stroke risk) from larger Vytorin trials" due by 2010 or 2011, Mehta said.

Merck and Schering-Plough sell Vytorin and Zetia in a joint venture, and the products have combined annual sales of about $5 billion.

The Enhance study examined Vytorin against Zocor alone in patients with a rare genetic predisposition to dangerously high cholesterol levels. Vytorin failed to halt the clogging of neck arteries better than Zocor alone, but it did a better job of reducing LDL cholesterol.

Beyond Vytorin, the FDA said it also would review "whether any changes to FDA's current approach to drugs that lower LDL cholesterol are warranted." High LDL is commonly believed to be a major risk factor for heart disease.

FDA officials cautioned the public not to turn away from cholesterol-lowering drugs.

"I think we have to be very cautious and not overreact to this one study," Dr. John Jenkins, head of the FDA's Office of New Drugs, told reporters.

Drugs that cut LDL are among the largest selling drugs in the world, and also include Pfizer Inc's <PFE.N> Lipitor and AstraZeneca Plc's <AZN.L> Crestor. Shares of Pfizer and AstraZeneca were also lower after the FDA announcement.

Lipitor, Zocor and other drugs in the same statin class have consistently shown the ability to reduce heart attacks and strokes by up to 30 percent.

Merck and Schering-Plough have been criticized by doctors, industry analysts and lawmakers for delaying presentation of results from the trial, which was concluded in 2006.

Deborah Cohn, a professor of marketing at Touro College Graduate School of Business in New York, said the delay in releasing the results had caused an understandable backlash.

"Consumers feel like there may be something else they're not telling us," Cohn said. "Nobody likes feeling like they're being lied to and that's how everybody's reacting."

Spokesmen for Merck and Schering-Plough both welcomed the FDA's statement.

Merck spokesman Christopher Garland said the FDA announcement "appropriately communicates information about the Enhance trial as well as information about Vytorin and Zetia."

Schering-Plough's Lee Davies said the FDA statement "puts appropriate perspective to the Enhance trial as well as commentary regarding safety and efficacy of Vytorin and Zetia in lowering LDL."

(Additional reporting by Lewis Krauskopf, Bill Berkrot, Kim Dixon and Ransdell Pierson, editing by Tim Dobbyn)

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