PARSIPPANY, New Jersey and ZURICH, Switzerland, November 19 /PRNewswire/ --
- Positive Opinion Coincides with Expansion of The Medicines Company into Europe
The Medicines Company (Nasdaq: MDCO) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion to extend the indication for Angiox(R) (bivalirudin) to adult patients with acute coronary syndromes (ACS) planned for urgent or early intervention, specifically patients with unstable angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI). Angiox should be administered with aspirin and clopidogrel. Angiox is an anticoagulant currently approved in Europe for use in patients undergoing percutaneous coronary interventions (PCI), commonly referred to as angioplasty.
The positive opinion is based on results from the ACUITY trial of 13,819 patients with ACS, which found 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 bleeding compared to standard therapy. Of the patients enrolled in ACUITY, 35% were treated at European hospitals.
"The CHMP recommendation will accelerate our efforts to establish Angiox as the preferred anti-thrombotic strategy for patients who require PCI for coronary artery disease in Europe," noted John Kelley, President and Chief Operating Officer of The Medicines Company. "We believe the European Commission will approve expanded use of Angiox in ACS patients during the first quarter of 2008, which coincides with the expansion of our commercial operations into major European markets."
The Medicines Company re-acquired rights to Angiox in Europe in July 2007. Since then, the Company has been expanding its European presence and developing clinical and commercial plans for Angiox with input from European thought leaders in cardiology, thrombosis and health economics. The Company also has been working on clinical trials and expert advisory activities in Europe for the Company's Phase III development compounds, cangrelor and Cleviprex(TM) (clevidipine butyrate injectable emulsion). The Company is creating the legal infrastructure to support operations in Europe, is establishing supply chain capabilities for the territory, and has set up a central office in Zurich, Switzerland. The Medicines Company markets bivalirudin as Angiomax(R) in the United States.
The European Society of Cardiology (ESC) in June 2007 published guidelines for the treatment of ACS that recommend using Angiox in ACS patients undergoing PCI. The Company estimates that more than one million PCI procedures are performed annually in Europe.
The CHMP is the scientific committee of EMEA. The opinions of the CHMP generally serve as the basis for the European Commission approvals, which are valid in all Member States of the European Union and the European Economic Area.
In the United States, a similar Angiomax ACS filing is being reviewed by the U.S. Food and Drug Administration (FDA). The Company expects FDA action in mid-2008.
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 across the spectrum of patients undergoing interventional therapy.
In Europe, Angiox currently is indicated as an anticoagulant for patients undergoing PCI. Please see full prescribing information 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 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.
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 for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Company also has two products in late-stage development, CleviprexTM (clevidipine butyrate injectable emulsion) and cangrelor. 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.
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