Dosing in Long-Term Cancer Studies Suspended Due to Increased Cardiovascular
Risk in One Study; Preliminary Analysis of Second Long-Term Cancer Study Shows
                      No Increased Cardiovascular Risks

    NEW YORK, Dec. 17 /PRNewswire-FirstCall/ -- Pfizer Inc said it received
new information last night about the cardiovascular safety of its COX-2
inhibitor Celebrex (celecoxib) based on an analysis of two long-term cancer
trials.
    As reported to Pfizer by the Data Safety and Monitoring Board, one of the
studies (the APC cancer trial) demonstrated an increased cardiovascular risk
over placebo, while the other trial (the PreSAP cancer trial) revealed no
greater cardiovascular risk than placebo.
    "These clinical trial results are new.  The cardiovascular findings in one
of the studies (APC) are unexpected and not consistent with the reported
findings in the second study (PreSAP).  Pfizer is taking immediate steps to
fully understand the results and rapidly communicate new information to
regulators, physicians and patients around the world," said Hank McKinnell,
Pfizer chairman and chief executive officer.
    Celebrex is approved for use in the United States for the treatment of
arthritis and pain, at recommended doses of 100mg to 200mg daily for
osteoarthritis and 200mg to 400mg a day for rheumatoid arthritis.  It is also
approved for a rare condition called familial adenomatous polyposis in doses
up to 800mg per day.  The APC cancer trial was studied Celebrex at doses of
400mg to 800mg per day.  In the PreSAP cancer trial the dose was 400mg per
day.
    "In placing this new information in context, it is important to understand
that the APC trial results differ from both the PreSAP cardiovascular results
as well as the large body of data that we and others have accumulated over
time, in which an increased risk of serious cardiovascular events in arthritis
patients, even at higher-than-recommended doses, had not been seen," said Dr.
Joseph Feczko, president of worldwide development for Pfizer.
    "Celebrex is an important medicine that provides necessary pain relief to
many patient.  Patients being treated with Celebrex should discuss appropriate
treatment options with their healthcare professionals.  Physicians should
factor this new information, as well as ulcer risks and gastrointestinal
bleeding seen with traditional NSAIDs, into their prescribing decision."
    In the Adenoma Prevention with Celecoxib (APC) trial, patients taking
400mg and 800mg of Celebrex daily had an approximately 2.5 fold increase in
their risk of experiencing a major fatal or non-fatal cardiovascular event
compared to those patients taking placebo, according to the National Cancer
Institute (NCI).  Based on these statistically significant findings, the
sponsor of the trial, the NCI, has suspended the dosing of Celebrex in the
study.
    In a separate long-term study, the Prevention of Spontaneous Adenomatopus
Polyps (PreSAP) trial, there has been no increased risk for Celebrex patients
taking 400mg daily compared with those taking placebo.  These findings are
based on an identical analysis used to assess cardiovascular risk in the APC
trial and conducted by the same independent safety review board.  The
information from this Pfizer sponsored trial was also received by Pfizer last
night and, as with the APC information, was immediately shared by the company
with the U.S. Food and Drug Administration.
    The two studies, which are following patients over a five-year period,
have enrolled a total of about 3,600 patients, some of whom have participated
for more than four years.  Pfizer estimates that about 2,400 patients
evaluated in the cardiovascular analysis have completed two years of
treatment.
    A third long-term study involving Celebrex in patients at high-risk for
Alzheimer's disease is also under way with about 2,000 patients enrolled,
about 750 of whom are on 400mg per day of Celebrex.  As with the cancer
studies, this study is monitored by independent safety experts who meet
regularly to assess adverse events.  A review by this board as recent as
December 10 did not result in any recommendations to change the conduct of
this study.
    In September and October, the Data Safety and Monitoring Boards of the APC
and PreSAP cancer trials conducted a preliminary review of all the then-
available data and determined to proceed with the studies.  With the
cooperation of Pfizer, the safety review boards convened a panel of
cardiovascular experts to conduct additional reviews and analyses of the data
from these two trials.  Last evening, Pfizer received preliminary information
resulting from the reviews.  The company has not yet received the full
analyses of these studies.
    As previously announced, Pfizer will continue to work with FDA on the
company's plans to sponsor a major clinical study to further assess Celebrex
in osteoarthritis patients at high-risk for cardiovascular disease.

    Additional Information on Celebrex
    Patients who have aspirin-sensitive asthma, or allergic reactions to
aspirin or other arthritis medicines or certain sulfa drugs called
sulfonamides, or who are in their third trimester of pregnancy should not take
Celebrex. As with all NSAIDs, serious gastrointestinal tract ulcerations can
occur without warning symptoms. Physicians and patients should remain alert to
the signs and symptoms of GI bleeding. Celebrex does not affect platelet
function and therefore should not be used for cardiovascular prophylaxis. As
with all NSAIDs, Celebrex should be used with caution in patients with fluid
retention, hypertension, or heart failure. In overall clinical studies the
most common side effects of Celebrex were dyspepsia, diarrhea and abdominal
pain, which were generally mild to moderate.

    DISCLOSURE NOTICE: The information contained in this release is as of
December 17, 2004. The Company assumes no obligation to update any forward-
looking statements contained in this release as a result of new information or
future events or developments.

    This release contains forward-looking information about the Company's
products that involves substantial risks and uncertainties. A description of
these risks and uncertainties can be found in the Company's Annual Report on
Form 10-K for the fiscal year ended December 31, 2003 and in its reports on
Forms 10-Q and 8-K.

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http://www.prnewswire.com/comp/688250.html
CONTACT:
Andy McCormick, +1-212-733-5469, or Mariann
Caprino, +1-212-733-4554, both of Pfizer Inc

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