Navigation Links
Sanofi Aventis: Study Shows Otamixaban Substantially Reduced Complications of Invasive Management of Acute Coronary Syndromes
Date:8/31/2009

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:
*Name:
*Comment:
*Email:
(Date:6/23/2016)...  In a startling report released today, National Safety Council ... a comprehensive, proven plan to eliminate prescription opioid overdoses. ... states are tackling the worst drug crisis in recorded U.S. history, ... Kentucky , New Mexico , ... the 28 failing states, three – Michigan , ...
(Date:6/23/2016)... , June 23, 2016 Research and ... News Issue 52" report to their offering. ... influenza treatment creates a favourable commercial environment for MedImmune to ... patient base that will serve to drive considerable growth for ... would serve to cap sales considerably, but development is still ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of ... Farma Brasil as the company,s second affiliate in Latin America . ... ... Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 2016 , ... PawPaws brand pet supplements owned by Whole Health ... the health of felines. The formula is all-natural and is made from Chinese herbs ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia ...
(Date:6/25/2016)... ... ... The temporary closing of Bruton Memorial Library on June 21 due to a possible lice ... overlooked aspect of head lice: the parasite’s ability to live away from a human host, ... a necessary one in the event that lice have simply gotten out of control. , ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of ... award to iHire in recognition of their exemplary accomplishments in worksite health promotion. , ... Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was ...
(Date:6/24/2016)... PASADENA, CA (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. ... he would lash out at his family verbally and physically. , “When something upset him, ... table, he would use it. He would throw rocks at my other children and say ...
(Date:6/24/2016)... ... ... of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum Wage’ ... 2020 and then adjusting it yearly to increase at the same rate as the median ... floor does not erode again, and make future increases more predictable. , The company is ...
Breaking Medicine News(10 mins):