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Celebrex's FDA labeling coup?
Pfizer CEO says the Celebrex doesn't cause heart attacks or strokes, as the FDA label will show.
July 20, 2005: 7:27 PM EDT
By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - Pfizer chief executive officer Henry McKinnell said that Celebrex, an arthritis painkiller that has seen plunging sales, does not cause heart attacks and strokes and this will be reflected in its new FDA label.

"There's some reason for optimism here," said McKinnell told analysts during a conference call on second quarter earnings. "The FDA also concluded that the benefits of Celebrex outweigh its risks. Celebrex also, according to the FDA, does not cause heart attacks and strokes. All of this will be in the label."

In a separate interview, Pfizer (down $0.32 to $27.06, Research) spokeswoman Marianne Caprino said the drug maker is still in negotiations with the Food and Drug Administration and the new label has yet to be determined.

Celebrex works by blocking cox-2, an enzyme that causes inflammation in the joints. The class of cox-2 inhibitors, which includes Pfizer's Bextra and Merck's Vioxx, have been blamed for causing heart attacks and strokes. Merck voluntarily withdrew Vioxx on Sept. 30, 2004 and now faces more than 2,300 lawsuits from former Vioxx patients and their family members.

On April 7, the FDA asked Pfizer to remove Bextra from the market. The loss of the cox-2 inhibitors has hurt Pfizer and Merck, as each of the drugs were blockbusters and featured prominently in corporate earnings. Vioxx sales totaled $2.5 billion in 2003, the last complete year it was on the market, and Bextra sales totaled $1.3 billion in 2004.

Celebrex differs from the other cox-2 inhibitors because it was never taken from the market. However, the FDA said on April 7 it was considering a black box, the most serious type of warning, for Celebrex. Since then, Pfizer has been in negotiations with the FDA over the details of the label, which has not yet been changed.

Celebrex sales have been hurt as physicians backed away from the sole remaining cox-2 inhibitor. A Bernstein report issued on June 29 showed that Celebrex prescriptions dropped 40 percent since Sept. 30, when Vioxx was withdrawn.

McKinnell, without mentioning any specific drugs, criticized the media for "digging up" side effects and focusing on them too much.

"[The media] needs to inform the public without terrorizing the public," said McKinnell. "We're prepared to defend our products in the public domain."

In spite of the loss of Bextra and plunging sales for Celebrex, Pfizer beat analysts' consensus projections for the second quarter. Global sales rose 1 percent to $12.4 billion, Pfizer announced Wednesday, though prescription drug sales slipped 1 percent.

Based in New York City, Pfizer is the world's biggest drug maker, with $52.5 billion in 2004 sales.

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