NEW YORK, NY--(Marketwired - October 09, 2013) - The Medicines Company (NASDAQ: MDCO) today reported enrollment of the first patient in a Phase III clinical trial comparing the anticoagulant Angiomax® (bivalirudin) to unfractionated heparin (UFH) in patients undergoing peripheral endovascular intervention (PEI). The Endomax Trial (ENDOvascular interventions with AngioMAX (bivalirudin)) is the first randomized, double blind, clinical trial to study pharmacology in patients undergoing Peripheral Endovascular Intervention (PEI). PEI is performed in approximately 500,000 patients in the United States each year. Angiomax is currently approved for use in patients undergoing angioplasty, also called percutaneous coronary intervention (PCI). The Medicines Company intends to pursue labeling expansion in the PEI setting.
The primary objective of the study is to demonstrate that anticoagulation with bivalirudin results in fewer major bleeding complications (at 48 hours post procedure) compared with UFH in subjects undergoing PEI. The secondary objective is to identify potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.
The Medicines Company will announce details of the trial at its Investor & Analyst Day in New York today from 8:30ET to noon. The meeting is webcast with a link available at http://www.themedicinescompany.com.
Principal Investigator for the trial, Barry Katzen, MD, Founder and Medical Director of Baptist Cardiac and Vascular Institute in Miami stated, "ENDOMAX is examining clinical endpoints critical to improving outcomes in PEI patients, including bleeding, amputations, stroke and mortality. Angiomax has been studied extensively in preventing clotting during PCI of the heart vasculature, however ENDOMAX is a new opportunity to look at the similar procedures in the peripheral vasculature.''
The trial will compare bivalirudin bolus and infusion to a bolus of UFH in a 1:1 double, blind, randomized design. The Medicines Company anticipates enrolling approximately 3,900 patients undergoing an endovascular procedure such as carotid artery stenting or lower extremity intervention, including those for Critical Limb Ischemia (CLI) or claudication. The trial is statistically powered to determine if Angiomax demonstrates superiority to heparin on a primary endpoint of bleeding assessed at 48 hours post procedure. Secondary endpoints of death, myocardial infarction, stroke, amputation and urgent revascularization will also be assessed at 30 days and 1 year. At 1-year, mortality and amputation data will be collected. Health economic outcomes including length of stay, time to sheath removal and time to ambulation will be assessed.
About Angiomax (bivalirudin) for Injection
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and a 25 minute half-life. In the United States, Angiomax is indicated in patients undergoing PCI with provisional use of glycoprotein IIb/IIIa inhibitor (GPI), and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is indicated for use as an anticoagulant in patients with unstable angina (UA) undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. 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 should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
Please see full prescribing information for Angiomax available at http://www.angiomax.com.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infection care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ USA and Zurich, Switzerland.
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 will make regulatory submissions for product candidates on a timely basis, whether the Company's regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, 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, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.