FOR U.S. AUDIENCES ONLY
The Medicines Company (NASDAQ:MDCO) -- today announced that 1-year clinical data from the HORIZONS-AMI trial, comparing Angiomax® (bivalirudin) vs. unfractionated heparin (UFH) plus glycoprotein IIb/IIIa Inhibitors (GPI), will be presented in a late-breaker presentation on October 15, 2008 in a session that begins at 11 am at the 2008 Transcatheter Cardiovascular Therapeutics (TCT) Conference, which is being held from Oct. 12 – Oct. 17, 2008, in Washington D.C. This marks another significant milestone in the release of new clinical data around the treatment of heart attacks.
TCT will host a press conference beginning at 9:00 a.m. EST on Wednesday, Oct. 15, 2008, featuring several late-breaking trials, first reports and registries. Among them, Roxana Mehran, M.D., Columbia University Medical Center and Cardiovascular Research Foundation, will present information on the following late-breaking clinical trial:
HORIZONS AMI: A Prospective Randomized Trial of Bivalirudin vs. Unfractionated Heparin plus Glycoprotein IIb/IIIa Inhibitors in Patients with Acute ST-Segment Elevation Myocardial Infarction: Long-Term Follow-up and Interaction with Stent Type
Media-credentialed press can join the press conference via teleconference prior to the late-breaker presentation. Media interested in the teleconference should contact Judy Romero at CRF via email at jromero@crf.org.
About the HORIZONS-AMI Trial
HORIZONS-AMI, co-funded by a grant from The Medicines Company, is the largest study to focus on the appropriate use of anticoagulation medications in patients experiencing STEMI and undergoing primary percutaneous coronary intervention (PCI), commonly known as angioplasty. The landmark trial was a prospective, single-blind, randomized, multi-center study conducted in 11 countries. Patients undergoing angioplasty were randomly assigned to receive either Angiomax® (bivalirudin) with provisional use of GPI or heparin plus GPI. Patients enrolled in the HORIZONS AMI trial also were assigned randomly to receive either TAXUS®drug-eluting stents or a bare-metal stent.
The two primary endpoints of the trial were major bleeding and net adverse clinical events, a composite of major adverse cardiovascular events (death, reinfarction, stroke or ischemic target vessel revascularization) and major bleeding at 30 days. The major secondary endpoint was major adverse cardiovascular events at 30 days.
About ST-Segment Elevation Myocardial Infarction (STEMI)
STEMI is the most severe type of heart attack and carries a substantial risk of death and disability. STEMI involves myocardial injury, as indicated by significant abnormalities on electrocardiogram called ST-segment elevations. Guidelines recommend that STEMI patients be treated with rapid intervention to help prevent further heart damage. According to the American Heart Association, an estimated 865,000 new and recurrent heart attacks occur every year, of which 400,000 are categorized as STEMI.
STEMI is part of a spectrum of acute coronary syndromes (ACS) caused by acute exacerbation of underlying coronary artery disease. ACS also includes non-ST elevation myocardial infarction (NSTEMI) and unstable angina (UA). NSTEMI is typically caused by partial obstruction of a coronary artery that results in some damage to heart muscle. UA is chest pain at rest or upon exertion, due to ischemia. Stable angina is characterized by predictable chest pain during exertion that resolves at rest, and is not considered a form of ACS. Each year in the United States, about five million people present to the emergency department with chest pain, of which an estimated 1.4 million are identified with ACS.
About Angiomax
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and 25 minute half-life. In clinical trials, treatment with Angiomax resulted in improved clinical outcomes with significantly reduced rates of major bleeding compared to heparin plus GPI across the entire spectrum of risk in patients undergoing PCI and numerically lower rates of 1-year mortality in patients undergoing PCI.
In the United States, Angiomax with provisional GPI is indicated in patients undergoing angioplasty, also called PCI, 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 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.
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About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax®(bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty and Cleviprex™(clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Company also has an investigational antiplatelet agent, cangrelor, in late-stage development and a serine protease inhibitor, CU-2010, in early-stage development. The Company's website is 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 11, 2008, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Contacts:
Lauren Friedman, 212-301-7217
lfriedman@wcpglobal.com
or
The
Medicines Company
Robyn Brown, 973-656-1616
investor.relations@themedco.com
