New therapy significantly reduces risk of repeat heart attack and death

Paris, March 14, 2006 Dear Madam, Dear Sir, Please find herewith the press release sent today at the 55th American College of Cardiology entitled: “Brigham and Women’s Cardiac Group Finds Enoxaparin Strategy is Better Than Commonly Administered Blood Thinning Strategy For Heart Attacks - New therapy significantly reduces risk of repeat heart attack and death” Best regards, Media Relations Department Contact: Salah Mahyaoui +33 (0)6 73 68 78 88 174, avenue de France - 75013 PARIS - FRANCE - Tél. : +33 1.53.77.40.00 - Fax : +33 1.53.77.41.33 - www.sanofi-aventis.com Sanofi-aventis - Siège Social : 174, avenue de France - 75013 Paris - France - S.A. au capital de 2 784 562 864 € - R.C.S. Paris B 395 030 844 - Code APE 741 J Embargoed for Release: Tuesday, March 14, 2006 12:45pm ET Contact: Kevin C. Myron Brigham and Women’s Hospital 617.534.1605 kmyron@partners.org Brigham and Women’s Cardiac Group Finds Enoxaparin Strategy is Better Than Commonly Administered Blood Thinning Strategy For Heart Attacks New therapy significantly reduces risk of repeat heart attack and death Boston, MA – Doctors treating patients who have suffered an acute heart attack can now employ a better, more effective blood thinning strategy, using a medication called enoxaparin, to prevent blood clots from reforming in heart arteries. The use of enoxaparin in this strategy significantly reduced the risk of repeat heart attack or death, compared to the most commonly administered anticoagulant regimen in use today, according to findings from the Brigham and Women’s ExTRACT-TIMI 25 trial. The findings will be presented at the 2006 American College of Cardiology’s Annual Scientific Session in Atlanta GA., Tuesday, March 14, and in an early release paper to be published in the New England Journal of Medicine. The ExTRACT-TIMI 25 (Enoxaparin and Thrombosis Reperfusion for Acute Myocardial Infarction Treatment – Thrombolysis in Myocardial Infarction) trial was a randomized, double-blind, double-dummy comparison of two anticoagulant strategies in more than 20,000 patients in 48 countries whose primary treatment for heart attack was injection of a clot busting medication (fibrinolytic therapy). A new strategy using enoxaparin, a low molecular weight heparin, was used for the duration of the heart attack patient’s hospitalization and was compared with the current strategy of the commonly prescribed blood thinner, unfractionated heparin for at least 48 hours. The TIMI Study Group determined which of the two blood thinning strategies was more effective at preventing heart attack patients from either dying or having a second but nonfatal heart attack within one month after treatment. The results showed that the risk of death or recurrent non-fatal heart attack was significantly reduced by 17 percent for patients who were administered the enoxaparin strategy compared to those who received the unfractionated heparin strategy. The benefits of the enoxaparin strategy became apparent within 48 hours. At the end of one month, the risk of recurrent non-fatal heart attack was significantly reduced by 33 percent for patients given the enoxaparin strategy compared with those given the unfractionated heparin strategy. A total of 7.5 percent of patients who received unfractionated heparin died compared to 6.9 percent who were given enoxaparin. Elliott Antman, M.D. Director, Samuel A. Levine Cardiac Unit at Brigham and Women’s Hospital, Professor of Medicine, Harvard Medical School, and lead author of the ExTRACT-TIMI 25 study said, “The results of this trial are dramatic and significant; a strategy using enoxaparin prevents more patients from dying or having a second heart attack within 30 days of treatment compared to the strategy using unfractionated heparin, which up to now has been considered the standard blood thinner regimen used to support fibrinolytic therapy.” He continued, “Enoxaparin, a modified form of unfractionated heparin, interrupts the clotting system more efficiently and more reliably than unfractionated heparin. By doing so, enoxaparin prevents blood clots from forming again in arteries that carry blood to the heart muscle.” The rates of serious bleeding overall were lower than reported in previous trials. The patients who received the enoxaparin strategy compared with the unfractionated heparin strategy did have a small but significant increase in the risk of serious bleeding episodes. However, when the balance of benefits and risks where weighed (“net clinical benefit”) the results strongly favored the enoxaparin strategy. The study has critical importance for the treatment of most patients who suffer a heart attack. Dr. Antman said. “Although opening a blocked coronary artery with a balloon-tipped catheter, or percutaneous coronary intervention, has been shown to be an effective treatment for heart attack patients who come to specialized centers, the vast majority of patients worldwide receive clot-busting medications to treat their heart attack”. "Based on the results of the ExTRACT-TIMI 25 trial, we believe that the enoxaparin strategy is now the preferred anticoagulant regimen to use in heart attack patients who receive clot-busting drugs," said Eugene Braunwald, M.D., M.A.C.C., Chairman, TIMI Study Group, Brigham and Women's Hospital and Distinguished Hersey Professor of Medicine, Harvard Medical School. The research was supported by a grant from Sanofi-Aventis. Brigham and Women’s Hospital is a 747-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832 and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives, dedication to educating and training health care professionals, and strength in biomedical research. With $370M in funding and more than 500 research scientists, BWH is an acclaimed leader in clinical, basic and epidemiological investigation - including the landmark Nurses Health Study, Physicians Health Studies, and the Women's Health Initiative. For more information about BWH, please visit: www.brighamandwomens.org