Vioxx's Victory Lacks Key Safety Recommendation

Merck hoped the FDA panel would set their new drug apart from Celebrex with a better safety profile. It didn't.
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officials proclaimed victory after a

Food and Drug Administration

panel recommended approval of its would-be category-painkiller,


. Vioxx is a member of the new Cox-2 class of anti-inflammatory and painkilling drugs, the so-called superaspirins.

Edward Scolnick, Merck's head of research and development, opened a question-and-answer session after the meeting by doling out congratulations to various company employees who had a hand in developing Vioxx. And he projected bravado in the face of an imminent marketing battle with


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and the hated


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, the firms which co-market the hit Cox-2,



"I don't think this has any disadvantages to Celebrex and has some advantages," he said. "We have a real once-a-day drug and they don't." Scolnick said that difference would be clinically meaningful to patients. The drug starts working faster than Celebrex as well. "Not. Too. Shabby," he said, smiling for emphasis.

Winning the recommendation for approval from the panel was never in doubt. The question was whether the panel would regard Vioxx as safer than the widely used nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen. The promise of the Cox-2s is that they will cause fewer gastrointestinal complications, such as ulcers, than chronic use of NSAIDs does.

On that issue, the panel wasn't so convinced, indicating that it would recommend the same safety profile for Vioxx as the one given to NSAIDs. Analysts say that doctors widely believe that the drug is safer, hence the panel's safety recommendation may not have much of an impact.

The panel recommended that the drug be approved to treat osteoarthritis and acute pain, but it stopped short of recommending the drug for approval in chronic pain treatment. Celebrex doesn't have approval for acute pain, but it is recommended for rheumatoid arthritis, a clearance Vioxx will not get immediately.

The FDA, which has to rule on approval by May 23 to hit its deadline, usually takes its panels' advice.

The panel had some concerns with Merck's argument that Vioxx is as benign as a sugar pill. The drug can cause, in high doses, fluid retention and high blood pressure. The fluid retention, called edema, was a central issue for the bulk of the meeting.

Scolnick proclaimed after the meeting that edema was not a significant problem. "We don't have an edema problem. I'll stake my reputation on it." Which, in his case, actually means something.

Wall Street may find the panel vote a bit disappointing because some analysts foresaw that Vioxx would get a better safety recommendation than Celebrex.

"The primary difference between this drug and Celebrex is that Merck got acute pain," says Ira Loss, an FDA analyst for

HSBC Securities

. (HSBC hasn't participated in any underwriting for Merck.) "The side-effect and safety issues were decided similarly to Celebrex. The company directed the Street to expect a comparable-to-placebo side-effect profile."

The anticipated market reaction may only last for a short while, however. Merck desperately needs Vioxx to be a billion-dollar-a-year-plus drug and will fight like a cornered badger in the marketplace. Merck faces a potentially severe multi-billion-dollar hole in sales, as several products go off patent during the next couple of years. The company also faces intense competition to several of its major drugs, including its Drano for arteries


. And several recent launches, such as hair-loss remedy


, have been flops.

And so, Merck must make Vioxx into a major seller, or, in three years or so, Merck will have a hyphen attached to its name. Steve Tighe, analyst for

Merrill Lynch

, said that three years out, Vioxx and Celebrex "will be pretty close" in market share. (Merrill hasn't performed recent underwriting for Merck.) At peak, the Cox-2s will be a multi-billion dollar category, said Tighe. He projects Vioxx sales of around $250 million this year. Celebrex sales could reach over $1 billion in sales this year.