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Reuters
Health Advisers Revive Merck's Vioxx
Friday February 18, 5:59 pm ET
By Lisa Richwine and Susan Heavey
GAITHERSBURG, Md. (Reuters) - Merck & Co. Inc.'s (NYSE:MRK - News) withdrawn arthritis drug Vioxx may return to the market after U.S. health advisers on Friday narrowly voted it was safe enough to be sold despite an increased risk of heart attack and stroke.
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Pfizer Inc.'s (NYSE:PFE - News) rival pain relievers Celebrex and Bextra, which had been under the same cloud of elevated risks of heart problems, were also regarded safe enough for sale by the Food and Drug Administration advisory panel.
The 17-15 vote on Vioxx's safety to go to market electrified Merck shares, which closed up 13 percent at $32.61 on the New York Stock Exchange. Pfizer gained 6.9 percent to close at $26.80.
It was a stunning turnaround for Vioxx, which was withdrawn in September by Merck after a study showed Vioxx doubled heart attack and stroke risk compared to a placebo.
"Merck has appreciated the opportunity to present data at this advisory committee meeting," the company said in a statement. "We look forward to discussions with the FDA."
Most of the advisers said Vioxx, Celebrex and Bextra should all have "black box" warnings -- the strongest warnings used for prescription drugs -- on their heart risks.
Many panelists also urged restrictions on Vioxx if it does return to the market, such as limiting sales to only the lowest dose and recommending it be a second choice after patients try another pain reliever.
One opponent to Vioxx sales, panel chairman Alastair Wood, said "there's a clear signal this drug appears substantially worse than the others" in its potential to damage the heart.
The FDA usually follows advice from its panels. Officials have said the agency will make final decisions on Celebrex and other pain relievers in a matter of weeks. All three drugs are part of a class called COX-2 inhibitors.
COX-2 inhibitors were designed to ease pain as effectively as older, nonprescription drugs known as nonsteroidal anti-inflammatory drugs, or NSAIDs, while being easier on the stomach. NSAIDs include ibuprofen and naproxen.
Only Vioxx has been shown to cause fewer serious stomach problems than the older NSAIDs.
Many of the older drugs also seem linked to heart damage, although data are limited, panel members said. They recommended a warning on the older drugs saying the effects on the heart had not been fully evaluated.
John Boris, an analyst with Harris Nesbitt, said Merck's stock rally "signals that Wall Street expects Vioxx to return to drugstores and that it has potential to achieve annual sales in the $1 billion range."
That's far below the $2.5 billion in annual sales Vioxx had before it was withdrawn in late September. Even so, Boris said the lower level of sales would be a boon to Merck, whose earnings were expected to fall this year because of the loss of Vioxx.
Merck is trying to win permission to sell another COX-2 inhibitor, Arcoxia, in the United States. Novartis also wants FDA approval to market a COX-2 drug called Prexige.
Some panel members said the FDA should require more research on heart risks with the COX-2 drugs in the pipeline.
"The patient and the physician now have a lot of choices, so it's OK to have a high bar," said Dr. Steven Nissen, a Cleveland Clinic cardiologist. (Additional reporting by Ransdell Pierson in New York) |
