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Pfizer: Celebrex shows risk in study

No. 1 drugmaker sees cardiovascular risk in some patients; no plans to
withdraw drug.
December 17, 2004: 11:54 AM EST

NEW YORK (CNN/Money) - Pfizer said Friday it suspended use of its
popular painkiller Celebrex in a long-term cancer study because
patients who used it over an extended time showed an increased
cardiovascular risk.

Pfizer Inc. Friday said it has no plans to withdraw arthritis drug
Celebrex after the medicine showed an increased risk of heart attack in
a cancer-prevention trial.

The heart attack findings for Celebrex come just over two months after
Merck & Co.'s recall of its similar arthritis drug Vioxx. A Vioxx study
found the drug doubled the incidence of heart attack and stroke among
patients taking it to prevent colon polyps that cause cancer.

"We have no plans to withdraw Celebrex from the market," a Pfizer
spokesman told Reuters.

The announcement sent Pfizer (down $4.29 to $24.69, Research) stock
tumbling in early New York Stock Exchange trading.

"It's definitely not positive," said Sena Lund, an ****yst for Cathay
Financial. "It has some of the same elements as (Merck's Vioxx),
especially if Pfizer has to recall Celebrex."

Lund said that prior to today's announcement, they had estimated that
Celebrex would account in 2005 for 9 percent of Pfizer's revenues.

Pfizer's rival Merck recalled Vioxx last September after a large trial
showed that long-term use of Vioxx, which is in the same class of
medicines as Celebrex, could cause heart attacks and stroke.

Merck is facing hundreds of lawsuits and potentially billions of
dollars in damages from Vioxx.

At least three times since the Vioxx scandal, Pfizer issued statements
affirming the safety of Celebrex.

But on Friday, Pfizer CEO Hank McKinnell cited new results from
clinical trials that he called "unexpected," and said the company was
taking "immediate steps to fully understand the results and rapidly
communicate new information to regulators, physicians and patients
around the world."

"These clinical trial results are new," McKinnell said in the
statement.

Celebrex, approved by the Food and Drug Administration in 1998 for
arthritis pain, has been prescribed to 27 million Americans and is the
world's most widely prescribed arthritis drug, according to Pfizer.

The medicine is approved for arthritis at doses of 100 to 200
milligrams a day, or double that for rheumatoid arthritis. Patients in
the cancer study were taking 400 to 800 milligrams of Celebrex daily.
The National Cancer Institute suspended the trial because the people on
Celebrex showed greater cardiovascular risk than those taking a
placebo.

New York-based Pfizer said in October that Bextra, another painkiller
similar to Vioxx, might raise heart attack risk in some patients having
heart bypass surgery.

But on Sept. 30 it said a recent FDA-sponsored study of 1.4 million
patients showed Celebrex patients showed "no increased" cardiac risk.

"Pfizer is confident in the long-term cardiovascular safety of
Celebrex," Dr. Joe Feczko, Pfizer's president of worldwide development,
said in a statement that day -- the same day Merck announced its recall
of Vioxx.

And on Nov. 4 and Nov. 30 Pfizer issued other statements vouching for
the safety of Celebrex.

Celebrex and Bextra were developed by Pfizer's Pharmacia division,
acquired in 2002. ****ysts have projected worldwide sales this year of
about $3.4 billion for Celebrex and $1.3 billion for Bextra.

When Merck pulled Vioxx on Sept. 30, citing a trial that showed
increased risk of heart attack and stroke, its stock tumbled 27
percent, erasing $25 billion from its market value.

Pfizer stock sank as much as 24 percent early Friday, and was off 14
percent in late morning trading


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