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

PARIS, August 31 /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. Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA
2. Sanofi-aventis Stands Behind the Safety of Lantus(R)
3. Sanofi Pasteur Dengue Vaccine Enters Pediatric Efficacy Clinical Study
4. Sanofi Pasteur Starts a Phase II Study of a Vaccine Against Clostridium Difficile
5. Sanofi Aventis: People With Type 2 Diabetes Treated With LANTUS(R) and APIDRA(R) Achieved Greater Reductions in A1C Than Those Treated With Pre-mixed Insulin
6. Insulin Analogues From Novo Nordisk, Eli Lilly and Sanofi-Aventis Will Drive Growth in the Type 1 Diabetes Drug Market
7. Sanofi Pasteur Shipping First Doses of Influenza Vaccine for the 2008-2009 Season in the US
8. Sanofi Pasteur to Donate 60 Million Doses of H5N1 Vaccine to WHO Over 3 Years for its Influenza Vaccine Global Stockpile
9. Sanofi Pasteur Initiates Phase II Trial of Cell Culture-Based Seasonal Influenza Vaccine
10. Sanofi Pasteur Receives FDA Approval of Meningococcal Vaccine for Children
11. Vical Licensee Sanofi-aventis Initiates Phase 3 Trial to Reduce Amputations
Post Your Comments:
(Date:12/2/2015)... ) has ... Market by Product Type, Surgery Type, End ... 2020"  report to their offering.  --> ... of the  "Spine Biologics Market by Product ... - Global Forecast to 2020"  report to ...
(Date:12/2/2015)... , December 2, 2015 /PRNewswire/ ... announced the addition of the  "Global ... their offering.  --> ... the  "Global Laparotomy Sponge Market 2015-2019" ... Research and Markets ( ) ...
(Date:12/1/2015)... , Dec. 1, 2015 As enforcement ... Supply Chain Security Act (DSCSA) approaches, InfiniTrak ... and independent pharmacies comply with looming FDA regulations. ... InfiniTrak is entering endorsement agreements with State Pharmacy ... services administration organization (PSAO) to exclusively provide the ...
Breaking Medicine Technology:
(Date:12/2/2015)... Lewisville, TX (PRWEB) , ... December 02, 2015 , ... ... in the United States, named Dr. Robert J. Hitchcock, FACAP, as the Medical Director ... Hitchcock will be the facility medical director of our new Frisco- Eldorado location,” said ...
(Date:12/2/2015)... ... December 02, 2015 , ... Alco NJ Animal and Pest Control ... virus. According to an article by , released November 14, 2015 and ... backyards in increased numbers. Bats, skunks, and groundhogs have tested positive for the disease ...
(Date:12/1/2015)... ... December 02, 2015 , ... ... Sykora as a 2015-2016 inductee into its VIP Woman of the Year ... is the nation’s leading networking organization exclusively for professional women, boasting 850,000 members ...
(Date:12/1/2015)... ... 2015 , ... The North American Meat Institute today unveiled ... poultry play in a healthy, balanced diet. , includes a section about ... their “meat IQ,” a section offering straight talk on controversies, information on buying ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... announced its acquisition by Jordan Industries International, LLC (“JII”). , With support from ... rentals and maintenance services to hospitals, surgery centers, clinics, research labs and medical ...
Breaking Medicine News(10 mins):