FDA Accepts sNDA for Expanded Use of Angiomax (bivalirudin)
PARSIPPANY, N.J.--(BUSINESS WIRE)--Sep 24, 2007 - The Medicines Company (NASDAQ: MDCO) said today that the U.S. Food and Drug Administration (FDA) has accepted the Company's supplemental new drug application (sNDA) for a modified dosing regimen of Angiomax (bivalirudin) for the treatment of acute coronary syndromes (ACS), specifically in patients with unstable angina or non-segment elevation myocardial infarction (NSTEMI). The Company expects the FDA to act on this filing in the second quarter of 2008. Angiomax is currently approved for patients undergoing percutaneous coronary intervention (PCI), commonly referred to as angioplasty.
"The benefits of replacing heparin with Angiomax in patients undergoing angioplasty are clear and well documented: better clinical outcomes and lower costs," said John Kelley, President and Chief Operating Officer of The Medicines Company. "Data from the ACUITY trial in ACS patients are consistent with these findings. The proposed label change based on this data would expand the potential use of Angiomax beyond the cardiac cath lab into the emergency department."
The sNDA includes data from the ACUITY trial, 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 a drug called a glycoprotein IIb/IIIa inhibitor (GPI), Angiomax plus GPI, or the "Angiomax alone" treatment group. In the Angiomax alone group, selective use of GPIIb/IIIa inhibitor was permitted in limited circumstances, and occurred in less than 10% of patients in the ACUITY trial. Based on results of coronary angiography and the clinical judgment of the treating physician, patients were treated for ACS through medical management, bypass surgery or PCI.
ACS includes a range of conditions, such as chest pain and heart attack, which are caused by insufficient blood supply to the heart due to blockages in coronary arteries, usually caused by blood clots. Patients with ACS symptoms are at significant risk for heart attack or death. Each year in the United States, 5 million people go to the emergency department with chest pain, of which approximately 2 million are identified with UA and NSTEMI ACS.
About Angiomax (bivalirudin) for Injection
Angiomax is currently approved in the U.S. and the European Union, as well as several other territories. Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiomax has demonstrated comparable efficacy plus reductions in bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in bleeding complications persist even in high-risk patients.
In the United States, Angiomax with provisional GP IIb/IIIa inhibition is indicated in patients undergoing PCI and in patients with, or at risk of, HIT/HITTS undergoing PCI. In addition, Angiomax is indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. 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. Please see full prescribing information available at http://www.angiomax.com.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is committed to delivering innovative, cost-effective acute care hospital products in the worldwide hospital marketplace. The Company markets Angiomax (bivalirudin) in the United States and recently reacquired rights to the product in Europe, where it is marketed as Angiox (bivalirudin). European regulatory authorities are currently reviewing an application to expand the use of Angiox to include the emergency use of Angiox in ACS patients undergoing PCI. 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 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" and "expects" 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 these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision makers will accept clinical trial results, and such other factors as 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
The Medicines Company
Michael Mitchell, 973-656-1616
Executive Director, Corporate Affairs
Posted: September 2007