Navigation Links
Study Shows Otamixaban Substantially Reduced Complications of Invasive Management of Acute Coronary Syndromes

PARIS, August 30 /PRNewswire-FirstCall/ --

- SEPIA-ACS Multiple-dose Phase II Results Showing 27- 42% Risk Reduction in ACS Complications Presented in Plenary Session of European Society of Cardiology Congress and Published in The Lancet

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the investigational anti-Xa intravenous anticoagulant otamixaban reduced by 27 to 42 percent the odds of the composite primary endpoint of death, myocardial infarction, urgent revascularization or rescue GPIIb/IIIa use in 4 out of the 5 otamixaban tested doses, versus standard UFH/eptifibatide combination in [non-ST] ACS patients suitable for invasive strategy. The results of the SEPIA-ACS1/ TIMI-42 were presented today at the plenary session of the Annual European Society of Cardiology congress in Barcelona and simultaneously published online in The Lancet.

Otamixaban is a first in class, rapid onset antithrombotic compound, acting as a direct selective inhibitor of factor Xa. Otamixaban is originating from Sanofi-aventis world-class thrombosis research portfolio and is currently in phase IIb clinical development phase.

"The data show that intermediate dosages of otamixaban may offer substantial reduction in major coronary complications in patients presenting with acute coronary syndrome, with bleeding rate comparable to current therapy," said Dr Marc Sabatine, MD, MPH, an Investigator in the TIMI Study Group and a cardiologist at Brigham and Women's Hospital, Harvard Medical School. "This research is addressing an important medical need, by potentially significantly improving outcomes of ACS patients undergoing PCI while simplifying the treatment pattern of the acute management phase of the disease." he added.

The double-blind phase II SEPIA-ACS1/ TIMI-42 study randomized 3241 patients from 36 countries in 6 treatment arms. The study assessed the efficacy and safety of five different doses of otamixaban versus the standard unfractionated heparin plus Glycoprotein IIb/IIIa inhibitor (eptifibatide), on background of standard dual antiplatelet therapy, in patients with high-risk non-ST-elevation acute coronary syndromes. SEPIA-ACS1 study showed that otamixaban displayed clinically meaningful activity on the primary endpoint from the threshold dose of 0.070 mg/kg/h, the second tested dose, with a consistent antithrombotic effect up to the 5th highest tested dosage. The lowest studied dosage was prematurely stopped due to insufficient activity, based on recommendation by an independent data monitoring board. Moreover a combined analysis of the intermediate doses (0.105 and 0.140 mg/kg/h) of otamixaban arms showed that otamixaban reduced by approximately 46 percent (p=0.0198) the risk of the composite of death or a second myocardial infarction, a predefined study secondary efficacy endpoint.

The potent antithrombotic effect of otamixaban was also accompanied with a dose-dependent bleeding profile. Combined intermediate otamixaban dosages showed a safety profile not statistically different with regard to TIMI major or minor bleeding through 7 days, in comparison to UFH and GPIIb/IIIa inhibitor comparator (RR 1.20, 95% CI 0.64-2.27, p=0.5634).

"The SEPIA-ACS1 trial is providing very encouraging results for a new and more effective treatment approach," said Marc Cluzel, MD Senior Vice President Research and Development Sanofi-aventis. "We aim, on the basis of these findings to address through our development program remaining patients', practionners' and payers' needs for management of ACS."

Acute Coronary Syndromes is a general term used to regroup clinical symptoms related to acute myocardial ischemia. ACS represents an area of important medical need, as despite use of several antithrombotic therapies, death and myocardial infarction still occur in 5 to 8% of patients in the following week after an initial event.

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: SAN) and in New York (NYSE: SNY).

Forward Looking Statements

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 labelling 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, 2008. Other than as required by applicable law, Sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE Sanofi-aventis
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. New Large-Scale, Global Study Provides Additional Information About an Intensified Dose-Regimen of PLAVIX(R) in Acute Coronary Syndrome Patients Undergoing Angioplasty
2. Gen-Probe Begins U.S. Clinical Study of PROGENSA(R) PCA3 Assay, New Molecular Test to Help Assess Prostate Cancer Risk
3. Lurasidone Demonstrated Efficacy in Treating Patients With Schizophrenia in Pivotal Phase 3 Study
4. Cardium Completes Initial Patient Evaluation Period for MATRIX Phase 2b Excellarate Clinical Study
5. CardioDx Completes Validation Study of First-Of-Its-Kind Genomic Test for Coronary Artery Disease
6. R-Tech Ueno Completes Subject Enrollment in Phase 2 Clinical Study of 0.15% UF-021
7. WorldHeart Receives US Clinical Study Approval for the Levacor(TM) VAD
8. Impax Pharmaceuticals Selects OmniComm Systems to Provide eClinical Solutions for International Phase III Study in Parkinsons Disease
9. Study Links Fetal Fibronectin Testing with Changes in Management Decisions for Symptomatic and Asymptomatic Women at Risk for Preterm Birth
10. Study of Lacrisert(R) Dry Eye Insert Published in The Ocular Surface
11. Amarex Clinical Research Selects OmniComm Systems to Provide eClinical Solutions for Phase III Medical Device Study and Joins OmniComms CRO Preferred Program
Post Your Comments:
(Date:11/26/2015)... , 26 november 2015 ... kondigt de geplande investering aan van ten ... de laboratoria en het mondiale hoofdkantoor in ... uitbreiding zal resulteren in extra kantoorruimte en ... aan de groeiende behoeften van de farmaceutische ...
(Date:11/26/2015)... -- --> --> Juntendo ... optimal contrast weighting of MRI for patients with Multiple ... research agreement with SyntheticMR in order to use SyMRI in ... possible to generate multiple contrast images from a single scan ... thus making it possible to both fine tune images and ...
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 ... the addition of the "2016 Future Horizons ... Monitoring (TDM) Market: Supplier Shares, Country Segment Forecasts, ... offering. --> ... comprehensive analysis of the Japanese therapeutic drug monitoring ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... For the first time, Vitalalert ... Organizations, One Beat ” campaign. The partnership between the two groups began in 2014 ... MAP International’s cause. , MAP International was founded in 1954 and is an international ...
(Date:11/25/2015)... ... November 25, 2015 , ... On November 25, 2015, officials of ... Narconon network, announced the release of a new cutting edge recovery program that has ... been working with drug- and alcohol-addicted individuals with the purpose to free addicts from ...
(Date:11/25/2015)... ... , ... Smiles by Stevens is pleased to announce the addition ... many patients are aware of the benefits of Botox® in the treatment of moderate ... with discomfort, soreness, and pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) ...
(Date:11/25/2015)... ... , ... In an ongoing Clinical Study conducted by an independent physician, Andrew ... is evaluating the efficacy of its product and its disinfection protocol. This study is ... May 2014 through October 2015 at a 360-bed, acute-care, academic medical center located in ...
(Date:11/25/2015)... Silver Spring, Md (PRWEB) , ... November 25, ... ... the Pulmonary Hypertension Association (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups ... the history of this disease. The Periwinkle Pioneers, nominated by the public, will ...
Breaking Medicine News(10 mins):