PFPC Daily - December 17, 2004

Celebrex seen raising risk of heart disease

THE WASHINGTON TIMES - December 17, 2004

By Marguerite Higgins

Celebrex, the nation's best-selling painkiller, raises the risk of
heart disease, the federal government said yesterday, the same
problem that led to the withdrawal of its competitor Vioxx.

Its manufacturer, New York pharmaceutical giant Pfizer Inc., said
it would not recall the arthritis drug, a spokeswoman said yesterday.
She would not comment further.

As of Sept. 30, more than 27 million U.S. patients had been
prescribed Celebrex, though that number jumped significantly after
Vioxx was pulled from pharmacy shelves, the company said.

The announcement comes 10 weeks after Merck & Co. Inc.
voluntarily recalled Vioxx, the nation's second-largest painkiller. A
report found the drug doubled the likelihood of heart attacks and
strokes in patients taking it to prevent colon polyps that cause
cancer.

Yesterday, the government suspended the use of Celebrex in a
study after a report found patients on the drug had an increased risk
for heart attacks and strokes.

The National Cancer Institute, which sponsored the Celebrex
trial, also stopped the use of Celebrex in 40 other clinical trials.

Shares of Pfizer, a component of the Dow Jones Industrial
Average, dropped 11 percent on the New York Stock Exchange to $25.75,
down $3.23 from Thursday's closing price of $28.98.

The long-term Celebrex trial had patients on daily doses of 200
milligrams, 400 milligrams and 800 milligrams to prevent colorectal
cancer.

Patients on the 200-milligram dose had a 250 percent higher risk
of heart attacks and strokes compared with those on placebos,
according to the institute's independent Data Safety and Monitoring
Board.

Patients taking 400 milligrams per day during the 33-month trial
had a 340 percent increased risk for cardiovascular problems, said
Dr. Ernie Hawk, director of the National Cancer Institute. He did not
say how much the risk increased for the 800-milligram daily dose.

A separate cancer study found no increased heart risks for
patients taking 400 milligrams of Celebrex per day, the monitoring
board reported.

"These clinical results are new. The cardiovascular findings in
one of the studies are unexpected and not consistent with the
reported findings in the second study," Pfizer Chairman and Chief
Executive Hank McKinnell said yesterday in a Securities and Exchange
Commission filing.

The Food and Drug Administration, which approved Celebrex for
osteoarthritis and rheumatoid arthritis in 1998, said it was
evaluating the information and would make an announcement in the next
few days.

FDA Acting Commissioner Dr. Lester Crawford said the agency "is
leaving all regulatory options open" at this point, including a
mandated recall of Celebrex and a black-box warning required on the
label. The agency also is investigating if it should withdraw all
Cox-2 inhibitor drugs from the market, he said.

Dr. Crawford advised patients using Celebrex and doctors
prescribing the drug to consider using other arthritis medicines or
the lowest dose of Celebrex if necessary.

Additionally, the National Institutes of Health is conducting a
full review of all studies involving drugs that work like Celebrex.

Several analysts downgraded their profit expectations and stock
ratings for Pfizer after the announcement.

Adam Greene, an analyst with Albany, N.Y., investment bank First
Albany Capital, dropped his rating from a "strong buy" to "neutral"
because of yesterday's announcement.

"While we had been cautious already on the Cox-2 [inhibitor]
market in light of Vioxx, this news is likely to significantly impact
market growth," he said.

Mr. Greene does not own any Pfizer stock, and First Albany has no
banking relationship with the company.

David Risinger, an analyst with New York investment bank Merrill
Lynch, lowered his earnings-per-share outlook but said he expected
Pfizer to keep selling Celebrex. "We do not believe Pfizer will pull
Celebrex or [painkiller] Bextra from the market," said Mr. Risinger,
who rated the company as "neutral."

He forecasted the company would make $2.5 billion in 2005 sales
instead of $3.9 billion. Mr. Risinger also reduced earnings per share
for the year to $2.14 from $2.26.

Mr. Risinger does not own any shares, but Merrill Lynch is
seeking business with Pfizer.

Merck spokeswoman Anita Larsen had no comment on Pfizer's drug
yesterday. The company continues to work on three large trials for
its newer arthritis drug, Arcoxia, which works like Vioxx.

The studies, which will determine if Arcoxia also increases the
risk of heart attacks and strokes, are expected to show results in
2006.

SOURCE:
http://washingtontimes.com/business/20041217-102836-8393r.htm