Healthcare Industry News: bivalirudin
News Release - January 29, 2008
The Medicines Company's Angiox(R) Receives European Authorization for Expanded Use in Patients with Acute Coronary Syndromes (ACS)PARSIPPANY, N.J.--(HSMN NewsFeed)--The Medicines Company (NASDAQ: MDCO ) today announced the receipt of the European Commission Decision authorizing an expanded use for Angiox® (bivalirudin) in adult patients with acute coronary syndromes (ACS), specifically patients with unstable angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI) planned for urgent or early intervention, when used with aspirin and clopidogrel.
“With this new indication, Angiox can be used in patients experiencing ACS throughout the treatment paradigm, from arrival in the emergency department to the cardiac catheterization laboratory,” said Walter Desmet, MD, PhD, Department of Cardiology, University Hospital Gasthuisberg (Leuven, Belgium). “Angiox is a simple and effective option to meet the needs of ACS patients who require urgent or early.”
The approval is based on results from the ACUITY trial of 13,819 patients with ACS.1 ACUITY demonstrated that Angiox with or without a glycoprotein IIb/IIIa inhibitor (GPI) resulted in similar rates of ischemic clinical outcomes compared to standard therapy of heparin (unfractionated or enoxaparin) plus a GPI. Importantly, Angiox monotherapy was associated with 47% less major bleeding2 compared to standard therapy. Of the patients enrolled in ACUITY, 35% were treated at European hospitals.
“With the European Commission decision, the benefits of Angiox can now be extended to the ACS patient population,” said John Kelley, President and COO of The Medicines Company.
In the United States, an sNDA for Angiomax in ACS is being reviewed by the U.S. Food and Drug Administration (FDA). The Company expects FDA action in mid-2008.
Angiox is approved in Europe for the treatment of adult patients with acute coronary syndromes (unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI)) planned for urgent or early intervention when used with aspirin clopidogrel. Full prescribing information for Angiox is available at http://www.angiox.com.
In the United States, Angiomax 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. The most common non-bleeding adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax 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 Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information available at http://www.angiomax.com.
ACS is a term given to a group of symptoms including chest pain at rest or during mild exertion. ACS also refers to certain types of heart attack and unstable angina. ACS is caused by insufficient blood supply to the heart. This typically results from years of plaque build-up in an artery. Patients with ACS symptoms are at significant risk for heart attack or death.
The European Society of Cardiology (ESC) in June 2007 published guidelines for the treatment of ACS that state that anticoagulation should be selected according to the risk of both bleeding and ischemic events and recommend using Angiox, unfractionated heparin or enoxaparin for the treatment of NSTEMI patients undergoing an urgent invasive strategy.
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.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO ) is committed to delivering innovative, cost-effective acute care products in the worldwide hospital marketplace. The Company markets Angiomax(R) / Angiox(R) (bivalirudin) in the United States and other countries. The Company re-acquired the commercial rights to Angiox in Europe in July 2007, and assumed the marketing rights January 1, 2008 from Nycomed. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company and Angiomax(R)/Angiox(R) 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 the extent of the commercial success of Angiomax/Angiox; the Company's success in taking over the commercial functions previously performed by Nycomed in Europe; 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; whether physicians and other key decision-makers will accept clinical trial results; and the effects of exchange rate fluctuations and other international economic, political and other. 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 November 8, 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, G., et al. bivalirudin for Patients with Acute Coronary Syndromes, N Engl J Med 2006; 355;21
2 Reduced bleeding measured on both the ACUITY and TIMI scales
Source: The Medicines Company
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