Landmark Study Demonstrates Pfizer’s Celebrex (Celecoxib)Has Similar Cardiovascular Risk As Compared To Prescription Doses Of Ibuprofen and Naproxen

NEW YORK–(BUSINESS WIRE)– Results of the landmark Prospective Randomized
Evaluation of Celecoxib
Integrated Safety
vs. Ibuprofen Or
Naproxen (PRECISION) demonstrated similar
rates of cardiovascular risk in patients treated with prescription doses
of celecoxib, ibuprofen and naproxen who had a clinical diagnosis of
osteoarthritis (OA) or rheumatoid arthritis (RA), were at high risk for
cardiovascular disease, and required daily treatment with non-steroidal
anti-inflammatory drugs (NSAIDs) to control symptoms of arthritis. In
addition, patients treated with celecoxib experienced significantly
fewer gastrointestinal events as compared with those receiving
prescription doses of ibuprofen or naproxen. The PRECISION trial helps
to refute the assumption held by many physicians that naproxen treatment
results in better cardiovascular outcomes as compared to other NSAIDs,
including celecoxib. It is important to note that given the trial’s
design – prescription doses and chronic use in patients with
cardiovascular risk factors – no inferences are possible regarding the
safety of intermittent use of low-dose, over-the-counter NSAIDs.

The results of the PRECISION study were presented today at the annual
meeting of the American Heart Association in New Orleans by Dr. Steve
Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and
principal investigator of the PRECISION trial. In addition, the results
were published today in the New England Journal of Medicine.

PRECISION was a prospective, long-term non-inferiority trial of 24,081
patients designed to assess the cardiovascular safety of Celebrex
(celecoxib) versus prescription strength doses of ibuprofen and naproxen
in patients with chronic pain from OA or RA. The trial, designed in 2005
based on discussions with the U.S. Food and Drug Administration, was
funded by Pfizer but directed independently by the Cleveland Clinic and
governed by an executive committee composed of cardiology,
gastroenterology, and rheumatology specialists.

“We are pleased with the results of this landmark study. Questions about
the cardiovascular safety of prescription NSAIDs have persisted since
the withdrawal of Vioxx (rofecoxib) from the market in 2004,” said Ian
Read, chairman and chief executive officer of Pfizer Inc. “The study
demonstrated that patients treated with prescription doses of celecoxib,
ibuprofen or naproxen had similar rates of cardiovascular events and
dispels the long held perception of excess cardiovascular risk
associated with long term use of Celebrex.”

The primary objective of PRECISION was to assess the effects of
celecoxib (100-200 mg twice daily) compared to prescription strength
doses of ibuprofen (600-800 mg three times a day) or naproxen (375-500mg
twice a day) on the first occurrence of cardiovascular (CV) death,
non-fatal myocardial infarction (MI) or non-fatal stroke in subjects
with OA or RA and who have established cardiovascular disease or risk
factors for cardiovascular disease. Pre-specified secondary objectives
including assessments of additional cardiovascular endpoints,
significant gastrointestinal events, renal events and arthritis pain
improvement will be published at a later date. All subjects were
provided with esomeprazole, a proton pump inhibitor, to be taken once
daily as a gastro-protective agent. Patients also had the option of
continuing low-dose aspirin for additional cardio-protective effects
regardless of their CV risk.

Top-Line Results:

The final PRECISION trial results provide statistically strong evidence
that cardiovascular risk with approved doses of celecoxib is not greater
than that of prescription doses of ibuprofen and naproxen. The study
showed that patients with chronic arthritic conditions and CV risk
factors taking celecoxib experienced numerically fewer cardiovascular
events as compared to patients receiving prescription strength doses of
ibuprofen and naproxen. More specifically, a primary endpoint occurred
in 2.3 percent of patients receiving celecoxib as compared to 2.5
percent for patients receiving naproxen and 2.7 percent for patients
receiving ibuprofen.

In addition, regarding secondary analyses, significantly fewer GI events
occurred among patients treated with celecoxib as compared with those
receiving prescription doses of either ibuprofen or naproxen. More
specifically, serious gastrointestinal events occurred in 1.1 percent of
patients receiving celecoxib as compared to 1.5 percent for patients
receiving prescription doses of naproxen and 1.6 percent for patients
receiving prescription doses of ibuprofen. The gastrointestinal safety
findings were observed despite providing all patients enrolled in the
study with a proton pump inhibitor to reduce stomach acids. In addition,
the secondary endpoint involving renal events occurred with a lower
frequency in patients treated with celecoxib as compared to prescription
doses of ibuprofen.

“NSAIDs are an important treatment option for millions of arthritis
patients around the globe. The results of the PRECISION study underscore
the cardiovascular and gastrointestinal safety of Celebrex for the
long-term treatment of chronic arthritic conditions,” said Freda
Lewis-Hall, M.D., chief medical officer and executive vice president of
Pfizer Inc.

About Osteoarthritis and Rheumatoid Arthritis:

Arthritis is a chronic, progressive medical condition characterized by
inflammation, swelling and pain in and around the joints. The two most
common forms of arthritic disorders are OA and RA. According to the
Centers for Disease Control and Prevention, arthritic conditions affect
more than 50 million adults in the US and are a leading cause of
disability. Today, more than 80 percent of OA patients have limited
mobility and 25 percent of patients are unable to perform daily tasks.

NSAIDs:

Non-steroidal anti-inflammatory Drugs (NSAIDS) are among the most widely
prescribed medicines in the world due to their effective
anti-inflammatory and pain relieving properties which enable patients to
function more normally. However, there have been concerns over the
chronic, long-term use of prescription NSAIDs because of
potentially serious gastrointestinal (GI) complications such as major
and minor bleeding, ulcers, and perforations. GI complications resulting
from prescription NSAID use are among the most common drug side effects
in the United States due to the use of these medications for chronic
pain management in conditions such as OA and RA.

Important Celebrex (celecoxib) Safety
Information

All prescription NSAIDs, like CELEBREX, ibuprofen, naproxen, and
meloxicam, increase the risk of heart attack or stroke that can lead to
death. This may happen early in treatment and may increase with
increasing doses of NSAIDs and with longer use of NSAIDs.

CELEBREX should never be used right before or after a heart surgery
called “coronary artery bypass graft” (CABG).

Avoid taking NSAIDs after a recent heart attack, unless your healthcare
provider tells you to do so. You may have an increased risk of another
heart attack if you take NSAIDs after a recent heart attack.

NSAID medications, like CELEBREX, cause an increased risk of bleeding,
ulcers, and tears (perforation) of the esophagus, stomach, and
intestines, at any time during treatment, which can occur without
warning and may cause death.

Prescription CELEBREX should be used exactly as prescribed at the lowest
dose possible and for the shortest time needed.

Do not take CELEBREX if you have had an asthma attack, hives, or other
allergic reactions to aspirin, any other NSAID medicine, or certain
drugs called sulfonamides.

Before you take CELEBREX, inform your healthcare provider of any medical
conditions you may have and of all of the medications you take,
including prescription or over-the-counter medicines, vitamins, or
herbal supplements as they may increase the risk for serious side
effects.

Tell your doctor about all of your medical conditions, including if you:

• have liver or kidney problems
• have a history of ulcers or bleeding in the stomach or intestines
• have high blood pressure or heart failure
• have asthma
• are pregnant or plan to become pregnant—CELEBREX, and other NSAIDs
  should not be taken in late pregnancy (after 29 weeks)
• are breastfeeding or plan to breast feed

CELEBREX can cause serious side effects, including:

Other side effects of NSAIDs, including CELEBREX are stomach pain,
constipation, diarrhea, indigestion, heartburn, nausea, vomiting, and
dizziness.

Get emergency help right away if you have any of the following symptoms:
shortness of breath or trouble breathing, chest pain, weakness in one
part or side of your body, slurred speech, swelling of the face or
throat. Discontinue CELEBREX at first sign of skin rash, or blisters
with fever.

Click here for full prescribing
information, including BOXED WARNING and Medication Guide.

Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
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DISCLOSURE NOTICE: The information contained in this release is as of
November 13, 2016. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result of
new information or future events or developments.

This release contains forward-looking information regarding CELEBREX
(celecoxib) and the results of the PRECISION study, including
their potential benefits, that involves substantial risks and
uncertainties that could cause actual results to differ materially from
those expressed or implied by such statements. Risks and uncertainties
include, among other things, uncertainties regarding the commercial
impact of the results of the PRECISION study; the risk that clinical
trial data are subject to differing interpretations, including by
regulatory authorities; the uncertainties inherent in research and
development; and competitive developments.

A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2015 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results,” as well as in
its subsequent reports on Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available at www.sec.gov
and www.pfizer.com.

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