Bristol-Myers Squibb and Pfizer Provide Update on Apixaban Clinical Development Program

-- Apixaban Phase II Acute Coronary Syndrome Data to be Presented

at European Society of Cardiology Meeting on Sept. 2

-- U.S. Regulatory Filing for the Prevention of Venous

Thromboembolism will not be submitted in 2009, as previously

indicated

-- Other Clinical Programs Continue as Planned

Business Editors/Health/Medical Writers

PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Aug. 26,

2008--Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc (NYSE:

PFE) provided an update on the apixaban clinical development program

today. The companies announced that new Phase II data in acute

coronary syndrome patients (ACS) will be presented at the upcoming

meeting of the European Society of Cardiology (ESC). In addition,

Bristol-Myers Squibb and Pfizer reported that an early evaluation of

results from a Phase III study of apixaban for the prevention of

venous thromboembolism (VTE) in patients undergoing total knee

replacement indicates that the primary endpoint of this study was not

met.

The Phase III VTE prevention study known as ADVANCE-1 compared

apixaban, a novel, oral Factor Xa inhibitor given at a dose of 2.5 mg,

twice daily, to the FDA-approved dose of enoxaparin, 30 mg given twice

daily. The primary efficacy outcome was a composite of symptomatic or

asymptomatic deep vein thrombosis, pulmonary embolism, and death by

any cause. The rate of the primary efficacy endpoint on apixaban was

numerically similar to that observed with enoxaparin (9.0% vs. 8.9%,

p=.064), but did not meet the pre-specified statistical criteria for

non-inferiority compared to enoxaparin. The actual enoxaparin VTE rate

of 8.9 percent was lower than the expected VTE rate of 16 percent seen

in previous similar clinical trials, resulting in an inability to

demonstrate non-inferiority.

In ADVANCE-1, there were no unexpected findings in adverse events

for apixaban compared to enoxaparin. The major bleeding event rate for

apixaban was numerically lower, but was not significantly lower, than

enoxaparin (0.7% vs. 1.4%, p=.053). The composite rate of clinically

relevant non-major bleeding and major bleeding was significantly less

in patients who received apixaban than those who received enoxaparin

(2.9% vs. 4.3%, p =.034).

Full results of the ADVANCE-1 trial have been submitted to the

American Society of Hematology Meeting (ASH) for presentation in

December.

ADVANCE-1 results confirm the characteristics of apixaban as

reported previously in phase II studies. The companies are considering

further studies with different protocols in preventing VTE in knee

surgery and will not submit the U.S. filing for VTE prevention in the

2nd half of 2009, as previously communicated. The results of ADVANCE

-1 do not necessitate any changes in protocols of any other ongoing

apixaban studies. Programs directed towards prevention of VTE

including EMEA registrational studies, treatment of VTE, and in the

prevention of stroke in atrial fibrillation continue as planned.

"Bristol-Myers Squibb and Pfizer remain enthusiastic and committed

to the clinical development program for apixaban," said Jack Lawrence,

vice president, Research and Development, Bristol-Myers Squibb.

"Bristol-Myers Squibb and Pfizer anticipate that the results of

APPRAISE-1 being presented at ESC will provide important insight into

the potential use of apixaban for the secondary prevention of

cardiovascular events in patients with acute coronary syndrome, which

affects an estimated 2.7 million people around the world every year."

About the Apixaban Clinical Program

Apixaban, an oral, factor Xa inhibitor in a new class of agents

that have shown therapeutic potential to prevent and treat blood

clots, is currently being explored in the EXPANSE clinical trial

program which includes eight Phase III clinical studies involving

approximately 45,000 patients worldwide. The ADVANCE-2 and 3 trials

are investigating the safety and efficacy of apixaban 2.5 mg twice

daily compared to enoxaparin 40 mg once daily in patients undergoing

major orthopedic surgery. The ADOPT study is investigating apixaban

for one month compared to standard of care (enoxaparin 40 mg once

daily for at least 6 days followed by placebo) for the prevention of

VTE in hospitalized patients who are medically ill and at risk of VTE.

Apixaban is also in Phase III trials studying the prevention of

stroke and other thromboembolic events in patients with atrial

fibrillation (AF). The AF program consists of two trials. The

ARISTOTLE trial is investigating apixaban compared to warfarin in

approximately 15,000 patients with atrial fibrillation. The AVERROES

trial is investigating apixaban compared to aspirin in approximately

5,600 patients with atrial fibrillation who are ineligible for vitamin

K antagonists (VKA) treatment or haven't tolerated previous VKA

treatment.

The VTE treatment program consists of two trials. The AMPLIFY

trial is a 6-month trial investigating apixaban compared to enoxaparin

plus warfarin in approximately 4,800 patients with acute DVT or PE.

The AMPLIFY-EXT trial is a 12-month trial investigating apixaban

compared to placebo for extended treatment to prevent recurrent VTE in

approximately 2,400 patients who have completed 6 to 12 months of

treatment for DVT or PE.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose

mission is to extend and enhance human life. For more information

visit www.bms.com.

About Pfizer

Founded in 1849, Pfizer is the world's largest research-based

pharmaceutical company. Pfizer is taking new approaches to advancing

better health as it discovers, develops, manufactures and delivers

quality, safe and effective prescription medicines to treat and help

prevent disease for both people and animals. For more information

visit www.pfizer.com.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that

term is defined in the Private Securities Litigation Reform Act of

1995, regarding the research, development and commercialization of

products. Such forward-looking statements are based on current

expectations and involve inherent risks and uncertainties, including

factors that could delay, divert or change any of them, and could

cause actual outcomes and results to differ materially from current

expectations. No forward-looking statement can be guaranteed. Among

other risks, there can be no guarantee that the clinical trials

described in this release will support a regulatory filing or that the

product will receive regulatory approval. There can be no assurance

that if approved, the product described in this release will be

commercially successful. Forward-looking statements in the press

release should be evaluated together with the many uncertainties that

affect Bristol-Myers Squibb's business, particularly those identified

in the cautionary factors discussion in Bristol-Myers Squibb's Annual

Report on Form 10-K for the year ended December 31, 2007, its

Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K.

Bristol-Myers Squibb undertakes no obligation to publicly update any

forward-looking statement, whether as a result of new information,

future events, or otherwise.

Pfizer Forward-Looking Statement

The information contained in this release is as of August 26,

2008. 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 about a product

candidate, apixaban, including its potential benefits that involves

substantial risks and uncertainties. Such risks and uncertainties

include, among other things, the uncertainties inherent in research

and development; decisions by regulatory authorities regarding whether

and when to approve any drug applications that may be filed for such

product candidate as well as their decisions regarding labeling and

other matters that could affect its availability or commercial

potential; 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, 2007 and in its reports on Form 10-Q and Form 8-K.

--30--MD/ny*

CONTACT: Media:

BMS

Laura Hortas, 609-252-4587

laura.hortas@bms.com

or

Pfizer

Vanessa Aristide, 212-733-3784

vanessa.aristide@pfizer.com

or

Investors:

BMS

John Elicker, 212-546-3775

john.elicker@bms.com

or

Pfizer

Jennifer Davis, 212-733-0717

jennifer.m.davis@pfizer.com