Healthcare Industry News: bivalirudin
News Release - September 2, 2007
Angiox(R) (Bivalirudin) Alone Reduced Early Bleeding and Resulted in Similar One-Year Mortality Compared to Heparins Plus GP IIb/IIIa Combination Therapy in ACS Patients Undergoing AngioplastyResults Were Consistent in Patients Switched to Angiox from Other Antithrombin Therapy
VIENNA, Austria--(HSMN NewsFeed)--Patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), or angioplasty, experienced nearly 50 percent less bleeding at 30 days and comparable mortality at one-year when treated with Angiox® (bivalirudin) alone compared to unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor (GPI), according to data from the ACUITY trial. These findings were consistent in patients switched to Angiox monotherapy from unfractionated heparin or enoxaparin. These data were presented today at the European Society of Cardiology (ESC) Congress 2007. The Medicines Company (NASDAQ: MDCO ) recently re-acquired rights for Angiox in Europe and currently markets the product as Angiomax® in the United States.
"The ACUITY trial demonstrated that Angiox is the preferred antithrombotic strategy in moderate and high risk ACS patients undergoing PCI. The subgroup analysis presented today gives us compelling new information on the benefits of switching ACS patients to Angiox," said lead author of the study, Harvey D. White, MD, Director of Coronary Care and Cardiovascular Research at Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. "The reduction in early bleeding achieved with Angiox monotherapy is particularly important, as bleeding events are commonly linked to late mortality in these patients."
The ESC recently published guidelines for the treatment of ACS that recommend using Angiox to replace heparins (unfractionated or low-molecular weight) and GPIs in ACS patients undergoing PCI.
The subgroup analysis of the ACUITY trial in ACS patients undergoing PCI presented today are consistent with the overall ACUITY results. As previously reported, in ACS patients undergoing PCI, the risk of major bleeding at 30 days was significantly less - by nearly 50 percent - in patients who received Angiox alone compared to those who received unfractionated heparin or enoxaparin plus GPI: 4% vs. 7% (p less than 0.0001).(1) In his presentation at ESC, Dr. White showed that the clinical benefits of Angiox monotherapy compared to unfractionated heparin or enoxaparin plus GPI were consistent across subgroups of patients, including those at high-risk, those who received other previous antithrombin therapy and were switched to Angiox, and those who did not receive prior antithrombin therapy. Additionally, the new analysis showed that, after one year, there were no significant differences in the incidence of composite ischemic events or mortality between patients who had received Angiox monotherapy and those who had received unfractionated heparin or enoxaparin plus GPI. The mortality results observed at one-year with Angiox monotherapy were not dependent on the timing of clopidogrel administration. PCI patients experiencing a non-CABG (coronary artery bypass graft) major bleed had a significantly longer length of hospital stay, 5.0 days vs. 3.0 days (p less than 0.0001), compared with those that did not bleed. Further, a strong association was observed between bleeding events at 30 days and one-year mortality in ACS patients undergoing PCI.
ACUITY was one of the largest ACS clinical trials ever conducted to evaluate anti-thrombotic therapies and enrolled 13,819 high-risk patients in 450 centers worldwide. The trial design employed an early invasive strategy (angiography within 72 hours), starting anti-clotting therapy when ACS patients arrived at the emergency department and randomly assigning them to treatment with standard therapy of heparin (unfractionated or enoxaparin) plus GPI, Angiox plus GPI, or Angiox monotherapy. In the Angiox monotherapy group, selective use of GPI was permitted in limited circumstances and occurred in less than 10% of patients. Then, based on an evaluation in the cardiac catheterization laboratory, patients were treated for ACS through medical management, bypass surgery or PCI.
Angiox/Angiomax is currently approved in the European Union and the United States as well as several other territories. It is a direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiox has demonstrated efficacy plus reductions in bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in bleeding complications remain evident even in high-risk patients.
In the EU, Angiox is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA) and with provisional GPI in patients undergoing PCI. Angiox is also indicated in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. Angiox is intended for use with aspirin. The most common adverse events for Angiox in clinical trials comparing Angiox and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiox and heparin groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiox administration. Angiox is contraindicated in patients with active major bleeding or hypersensitivity to Angiox or its components. Please see full prescribing information available at http://www.angiox.com.
European regulatory authorities are currently reviewing an application for marketing authorization to expand the use of Angiox to include a proposed new dosage for immediate treatment of patients with acute coronary syndromes (ACS).
About The Medicines Company
The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The Company markets Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. In July 2007 the Company terminated its distribution arrangements with Nycomed and reacquired from Nycomed all development, commercial and distribution rights held by Nycomed for Angiox® (bivalirudin) in Europe. The Company also has two products in late-stage development, Cleviprex(TM) (clevidipine) and cangrelor. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company and Angiomax®/Angiox® that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," "estimates," "projects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Important factors that may cause or contribute to such differences include whether clinical trial results of the Company's product candidates will warrant submission of applications for regulatory approval on a timely basis or at all; whether the Company's product candidates will receive approvals from regulatory agencies on a timely basis or at all; and whether physicians will accept clinical trial results. Such factors and others are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on August 9, 2007, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company's estimates or views as of any date subsequent to the date of this press release.
(1) Stone GW, White HD, Ohman EM, Bertrand ME, Lincoff AM, McLaurin BT, Cox DA, Pocock SJ, Ware JH, Feit F, Colombo A, Manoukian SV, Lansky AJ, Mehran R, Moses JW; Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial investigators. bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial. Lancet. 2007 Mar 17;369(9565):907-19.
Source: The Medicines Company
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