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Bristol-Myers Squibb Company (BMY) And Sanofi-Aventis (France) (SASY.PA) Release: Results From Two Major Clinical Trials Presented At American College Of Cardiology


10/19/2005 5:12:58 PM

PARIS and PRINCETON, N.J., March 9 /PRNewswire-FirstCall/ -- Results of two major clinical trials showed that the antiplatelet agent clopidogrel, given on top of standard therapy, provided significant benefits to patients with acute ST-segment elevation myocardial infarction (STEMI), a certain kind of heart attack. Results of the COMMIT/CCS-2 (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) and CLARITY - TIMI 28 (CLopidogrel as Adjunctive ReperfusIon TherapY - Thrombolysis In Myocardial Infarction Study 28) trials, which included a total of nearly 50,000 patients, were presented today in Orlando, Florida at the 54th Annual Scientific Session of the American College of Cardiology (ACC).

In the CLARITY-TIMI 28 trial, clopidogrel added to standard therapy including fibrinolytics and ASA(aspirin) reduced the odds of acute MI patients having another occluded artery, or a second heart attack or death by 36 percent after one week of hospitalization (Event rate: 15.0% in clopidogrel arm vs. 21.7% in placebo; P<0.001). Additionally, at thirty days, clopidogrel reduced the odds of clinical events (cardiovascular death, recurrent myocardial infarction, recurrent ischemia leading to urgent revascularization) in these patients by 20 percent (Event rate: 11.6% vs. 14.1%; P=0.03). The results observed with clopidogrel in this clinical setting were consistent irrespective of patients' gender, the standard therapy they received (type of fibrinolytic or type of heparin) or the location of their MI. The CLARITY-TIMI 28 trial enrolled 3,491 patients at 319 sites in 23 countries in North America, Latin America and Europe. The trial was coordinated by the TIMI (Thrombolysis In Myocardial Infarction) Group, chaired by Eugene Braunwald, MD, Distinguished Hersey Professor of Medicine, Harvard Medical School and of Brigham and Women's Hospital.

"Re-occlusion of coronary arteries in acute MI patients has been shown to occur quite frequently," said Dr. Braunwald. "The CLARITY-TIMI 28 trial demonstrated treating acute MI patients with clopidogrel, on top of standard therapy including aspirin and fibrinolytics, resulted in a 36 percent reduction in the odds of a blocked artery or death or recurrent myocardial infarction by the time of angiography."

In the COMMIT/CCS-2 trial clopidogrel, on top of standard therapy including ASA, reduced mortality in acute MI patients. In the 28 days following randomization, clopidogrel reduced the relative risk of death in these patients by 7 percent (Event rate: 7.5% vs. 8.1%; P=0.03). In the same patient population, clopidogrel reduced the relative risk of the combination of recurrent MI, stroke or death by 9 percent (Event rate: 9.3% vs. 10.1%; P=0.002).

The COMMIT/CCS-2 trial, one of the largest randomized double-blind placebo-controlled clinical trials of drug therapy ever conducted in heart disease, enrolled nearly 46,000 patients at 1,250 sites in China. The trial was co-ordinated by Oxford University, UK and the Fuwai Hospital, the Chinese Academy of Medical Sciences, China, and was co-chaired by Rory Collins MD and LS Liu MD.

"The COMMIT/CCS-2 study findings showed that clopidogrel reduced mortality in an in-hospital setting," added Zheng Ming Chen, MD, University of Oxford. "The study also showed that there was no significant increase in the risk of fatal or transfused bleeding associated with clopidogrel therapy."

In both trials, the rates of major bleeding and intracranial hemorrhage were similar in both treatment groups. In the CLARITY - TIMI 28 study, there was no statistically significant difference in the incidence of major bleeding and primary intracranial hemorrhage. The rate of major bleeding in the clopidogrel group was 1.3 percent compared with 1.1 percent in the placebo group (p=0.64), on top of the standard therapy group (including fibrinolytics and ASA). In COMMIT/CCS-2, no significant increase in the risk of fatal or transfused bleed was observed. The rate of major, non-cerebral bleeding was 0.4 percent in the clopidogrel compared with 0.3 percent in the placebo on top of standard therapy group including ASA (p=0.52). Additionally, the rate of intracranial hemorrhage was very low and similar in the clopidogrel and placebo groups.

Of the 10 million estimated MIs per year worldwide, three million are STEMI. MI remains an early and long-term life-threatening condition.

The long-term efficacy and safety of clopidogrel has been established through landmark clinical trials in 100,000 patients and with clinical experience in 41 million patients treated worldwide since its launch.

Clopidogrel has demonstrated early and long term protection of the thrombotic patient in multiple trials: unstable angina and NSTEMI (CURE), thrombosis including recent MI, recent ischemic stroke, or symptomatic peripheral artery disease (CAPRIE).

Based upon these new clinical data sanofi-aventis and Bristol-Myers Squibb plan to meet with health authorities and discuss these study results and their support for an indication.

The CLARITY - TIMI 28 and COMMIT/CCS 2 trials were supported by grants from sanofi-aventis and Bristol-Myers Squibb.

Clopidogrel is marketed worldwide by sanofi-aventis (Paris Bourse: EURONEXT: SAN; New York: NYSE : SNY) and Bristol-Myers Squibb Company as Plavix(R) and Iscover(R).

About Plavix(R).(clopidogrel bisulfate)?3 PLAVIX is indicated for the reduction of thrombotic events as follows: -- Recent Myocardial Infarction (MI), Recent Stroke, or Established Peripheral Artery Disease (PAD) For patients with a history of recent MI, recent stroke, or established PAD, PLAVIX has been shown to reduce the rate of a combined end point of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. -- Acute Coronary Syndrome (ACS) For patients with ACS (unstable angina/non-Q-wave MI), including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or coronary artery bypass graft surgery (CABG), PLAVIX has been shown to decrease the rate of a combined end point of cardiovascular death, MI, or stroke as well as the rate of a combined end point of cardiovascular death, MI, stroke, or refractory ischemia. Important Risk Information: -- PLAVIX is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. As with other antiplatelet agents, PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin. (See CONTRAINDICATIONS and PRECAUTIONS.*) -- The rates of major and minor bleeding were higher in patients treated with PLAVIX plus aspirin compared with placebo plus aspirin in a clinical trial. (See ADVERSE REACTIONS.*) -- As part of the worldwide postmarketing experience with PLAVIX, suspected cases of thrombotic thrombocytopenic purpura (TTP), some with fatal outcomes, have been reported at a rate of about 4 cases per million patients exposed. TTP has been reported rarely following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition and requires urgent referral to a hematologist for prompt treatment. (See WARNINGS.*) -- In clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). (See ADVERSE REACTIONS.*)

* PLEASE SEE FULL PRESCRIBING INFORMATION ON PLAVIX BY VISITING WWW.PLAVIX.COM.

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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. Specifically, there can be no guarantee that health authorities will approve an additional indication as referenced above. Forward-looking statements in this 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, 2004 and in our Quarterly Reports on Form 10-Q. Bristol- Myers Squibb undertakes no obligation to publicly update any forward- looking statement, whether as a result of new information, future events or otherwise.

CONTACTS MEDIA INVESTORS Tracy Furey John Elicker Bristol-Myers Squibb Bristol-Myers Squibb 609-273-4697 212-546-3775 Jean-Marc Podvin Sanjay Gupta sanofi-aventis sanofi-aventis 33-1-53-77-4223 33-1-53-77-4545 212-551-4293

Bristol-Myers Squibb; sanofi-aventis

CONTACT: Media - Tracy Furey of Bristol-Myers Squibb, +1-609-273-4697,or Jean-Marc Podvin, sanofi-aventis, 33-1-53-77-4223; or Investors - JohnElicker, Bristol-Myers Squibb, +1-212-546-3775, or Sanjay Gupta ofsanofi-aventis, +33-1-53-77-4545, or +1-212-551-4293


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