BEXTRA™ (valdecoxib) - Pfizer™

BEXTRA NEWS AND INFORMATION

Pfizer pulls Bextra from market
FDA asks Pfizer to put 'black box' warning on Celebrex

By Val Brickates Kennedy & Tomi Kilgore, MarketWatch Last Update: 3:47 PM ET April 7, 2005

BOSTON (MarketWatch) - At the request of the Food and Drug Administration, Pfizer Inc. agreed to remove its pain reliever Bextra from the market and to slap a sterner warning label on Celebrex, a sibling drug.

The FDA said it asked that Pfizer's Bextra be taken off the market because its medical benefits don't outweigh various risks that the drug poses. Likewise, the agency said that while Celebrex carries fewer risks, it should still carry a "black box" warning to advise users that it can cause cardiac problems in certain patients.

A "black box" warning is the sternest warning a medication can carry in the U.S. and still remain on the market.

Bextra already carried a black box warning advising it can cause a rare but potentially fatal skin condition caused Stevens-Johnson syndrome. It also carries another warning that it can cause serious cardiovascular problems in patients who have recently undergone cardiac surgery.

The FDA move is the latest chapter in the saga of whether a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs) can trigger cardiac problems in some long-term users. Bextra and Celebrex, along with Merck's withdrawn drug Vioxx, all belong to a sub-class of NSAIDs called Cox-2 inhibitors, which are believed to carry an even greater cardiac risk.

Long-term use of many NSAIDs has long been linked to stomach bleeding in some patients. Cox-2 inhibitors were once considered superior NSAIDs in that they could be taken long-term without running as much of a risk of gastrointestinal bleeding.

The FDA began to take a much harder look at the safety of NSAIDs and Cox-2 drugs after a clinical study linked Merck's Vioxx with an increased incidence of heart attack and stroke in certain patients.

As a result, the FDA held an advisory panel meeting in February on whether the medical benefits of NSAIDs and Cox-2 inhibitors outweighed their cardiovascular risks. At that time, the panel recommended, in a controversial series of votes, that Bextra, Celebrex and Merck's Vioxx be allowed to remain on the market.

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," said Dr. Steven Galson, the acting director of the FDA's Center for Drug Evaluation and Research.

Pfizer said that while it disagrees with the FDA's position on Bextra's safety, it has agreed to suspend sales and marketing of the drug in the U.S. The company has also suspended Bextra sales in the European Union and is holding talks with regulators in other parts of the world.

Pfizer added that it plans to have further discussions with the FDA to determine if Bextra may be permitted back on the market for certain conditions. The company said that, in the meantime, it is advising Bextra users to stop taking the medication.

Meanwhile, analysts on Thursday said they believe Pfizer will have to revise its financial outlook further to reflect Bextra's removal from the market and a further erosion of Celebrex sales.

For 2004, Bextra had sales of $1.3 billion, while Celebrex took in $3.3 billion, according to Lehman Brothers.

Pfizer had just given new guidance on April 5 that lowered adjusted earnings estimates for 2005 to $2 a share. The company added that it expected adjusted earnings rebounding for 2005 and 2006, with growth being in the "double-digits." The company also proposed annual cost cuts of about $4 billion.

"The Bextra announcement comes as a surprise. Pfizer will have to lower guidance below $2," said Lehman analyst Anthony Butler on Thursday. "But they still can grow if they can do the cost cuts. Maybe they'll be more than $4 billion now."

"We view keeping Celebrex on the market as a success for Pfizer," wrote William Blair analyst Winton Gibbons. "We would now expect Pfizer to consider more substantive cost-cutting measures that may include reductions in headcount, specifically sales force, thus mitigating some of the revenue lost."

The FDA also said Thursday that it will "carefully review any proposal from Merck for resumption of marketing of Vioxx."

Merck said it hasn't yet decided whether it will put Vioxx back on the market, despite an FDA advisory panel's finding that the drug was still safe enough to be sold on the U.S. market, albeit with restrictions. The company added that it "looks forward" to meeting with the FDA to discuss the matter further.

The agency has also asked makers of NSAIDs, which include such popular pain relievers as ibuprofen and naproxen, to revise their labels to include a warning about possible cardiovascular risks.

"FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks," the FDA's Galson said.