| | | Geschrieben am 05-03-2008 New 300mg Loading Dose Tablet for Plavix(R) Receives Positive Opinion From the European Committee for Medicinal Products (CHMP)
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 Paris and Princeton, New Jersey (ots/PRNewswire) -
 
 - A New Step Forward May Help Increase Appropriate Early Use of
 Plavix(R) by Simplifying Administration in Acute Coronary Syndrome
 Patients
 
 Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers
 Squibb  Company (NYSE: BMY) announced today that the Committee for
 Medicinal Products  for Human Use (CHMP) of the European Medicines
 Evaluation Agency (EMEA) has issued a positive opinion recommending
 approval of the 300mg tablet of the antiplatelet Plavix(R)
 (clopidogrel bisulfate). This positive opinion from the CHMP needs to
 be ratified by the European Commission in the coming months before
 final approval.
 
 The new 300mg tablet will facilitate the use of the approved
 loading dose of Plavix(R) and the early initiation as recommended by
 national and international guidelines in appropriate patients with
 acute coronary syndrome (ACS), including those with unstable angina /
 non-ST segment elevation myocardial infarction (managed with
 percutaneous intervention (PCI) with or without stent or medically
 managed) and ST segment elevation myocardial infarction patients. The
 300mg tablet is bioequivalent to four 75mg tablets of Plavix(R).
 
 Sanofi-aventis and Bristol-Myers Squibb are committed to further
 studying the optimization of the Plavix(R) loading dose in ACS
 patients managed with an early invasive strategy in the ongoing large
 international clinical trial known as 'CURRENT'. CURRENT is the only
 randomized controlled trial designed to investigate in 14000
 patients, whether the use of a clopidogrel 600mg loading dose,
 followed by an intensified clopidogrel dosing regimen (6 days at
 150mg follow by 75mg) yields improved clinical outcomes as compared
 to clopidogrel 300mg loading dose followed by 75mg in ACS patients
 managed with an early invasive strategy. The primary endpoint of
 CURRENT is the reduction of a composite endpoint of cardiovascular
 death, stroke and myocardial infarct (MI) and the results are
 expected by the end of 2008.
 
 About Plavix(R)
 
 Plavix(R) is an antiplatelet agent which prevents platelets from
 sticking together and forming clots in the arteries and is the only
 widely available prescription antiplatelet approved to reduce the
 risk of heart attack and stroke across the entire spectrum of ACS.
 
 Plavix(R) is indicated for the reduction of atherothrombotic
 events in patients with a history of recent MI, recent stroke or
 established peripheral arterial disease (P.A.D.) Plavix(R) is also
 indicated for patients with NSTEMI ACS, including those who are to be
 managed medically and those managed with PCI (with or without a
 stent) or CABG. Additionally Plavix(R) is indicated in STEMI
 patients.
 
 For ACS patients, European Guidelines (ESC Guidelines for
 NSTEMI ACS 2007) recommend pre-treatment of unselected patients with
 Plavix(R) before angiography results for better outcome of PCI.
 
 The early and long term efficacy and safety profile of Plavix(R)
 is well established in clinical trials involving more than 100,000
 patients across the full spectrum of ACS, recent MI, recent ischemic
 stroke and established P.A.D, with real-world experience since its
 launch in more than 70 million patients worldwide.
 
 Plavix(R) is marketed worldwide by sanofi-aventis and
 Bristol-Myers Squibb Company as Plavix(R) and Iscover(R).
 
 About sanofi-aventis
 
 Sanofi-aventis, a leading global pharmaceutical company,
 discovers, develops and distributes therapeutic solutions to improve
 the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT
 PARIS: SAN) and in New York (NYSE: SNY).
 
 About Bristol-Myers Squibb
 
 Bristol-Myers Squibb is a global biopharmaceutical and related
 health care products company whose mission is to extend and enhance
 human life.
 
 Forward Looking Statements
 
 For sanofi-aventis
 
 This press release contains forward-looking statements as defined
 in the Private Securities Litigation Reform Act of 1995, as amended.
 Forward-looking statements are statements that are not historical
 facts. These statements include product development, product
 potential projections and estimates and their underlying assumptions,
 statements regarding plans, objectives, intentions and expectations
 with respect to future events, operations, products and services, and
 statements regarding future performance. Forward-looking statements
 are generally identified by the words "expects," "anticipates,"
 "believes," "intends," "estimates," "plans" and similar expressions.
 Although sanofi-aventis' management believes that the expectations
 reflected in such forward-looking statements are reasonable,
 investors are cautioned that forward-looking information and
 statements are subject to various risks and uncertainties, many of
 which are difficult to predict and generally beyond the control of
 sanofi-aventis, that could cause actual results and developments to
 differ materially from those expressed in, or implied or projected
 by, the forward-looking information and statements. These risks and
 uncertainties include among other things, the uncertainties inherent
 in research and development, future clinical data and analysis,
 including post marketing, decisions by regulatory authorities, such
 as the FDA or the EMEA, regarding whether and when to approve any
 drug, device or biological application that may be filed for any such
 product candidates as well as their decisions regarding labeling and
 other matters that could affect the availability or commercial
 potential of such products candidates, the absence of guarantee that
 the products candidates if approved will be commercially successful,
 the future approval and commercial success of therapeutic
 alternatives as well as those discussed or identified in the public
 filings with the SEC and the AMF made by sanofi-aventis, including
 those listed under "Risk Factors" and "Cautionary Statement Regarding
 Forward-Looking Statements" in sanofi-aventis' annual report on Form
 20-F for the year ended December 31, 2006. Other than as required by
 applicable law, sanofi-aventis does not undertake any obligation to
 update or revise any forward-looking information or statements.
 
 For Bristol-Myers Squibb
 
 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. Among other risks, there can be no guarantee that
 the European Commission will ratify the CHMP's positive opinion
 recommending approval of the 300mg tablet of Plavix(R) or that the
 timing of the ratification will occur in Europe as described in this
 release. Forward-looking statements in this press release should be
 evaluated together with the many risks and uncertainties that affect
 Bristol-Myers Squibb's business, including those identified in
 Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended
 December 31, 2007, particularly under "Item 1A. Risk Factors".
 Bristol- Myers Squibb undertakes no obligation to publicly update any
 forward-looking statement, whether as a result of new information,
 future events or otherwise.
 
 ots Originaltext: sanofi-aventis and Bristol-Myers Squibb Company
 Im Internet recherchierbar: http://www.presseportal.de
 
 Contact:
 Sanofi-aventis: MEDIA: Philippe BARQUET, +33-6-70-48-61-28,
 philippe.barquet@sanofi-aventis.com; INVESTORS: Sanjay Gupta,
 +33-1-53-77-45-45, sanjay.gupta@sanofi-aventis.com; Bristol-Myers
 Squibb Company: MEDIA: Ken Dominski, +1-609-252-5251,
 ken.dominski@bms.com; INVESTORS: John Elicker, +1-212-546-3775,
 john.elicker@bms.com
 
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