SOURCE: The Medicines Company

The Medicines Company

August 31, 2009 07:08 ET

The Medicines Company Announces New Publication of Data Showing Angiomax® Reduces Cardiac Mortality and Improves Overall Survival

HORIZONS-AMI Trial One-Year Results Published in The Lancet

PARSIPPANY, NJ--(Marketwire - August 31, 2009) - FOR U.S. AUDIENCES ONLY

The Medicines Company (NASDAQ: MDCO) today announced the publication of one-year results from the landmark HORIZONS-AMI Trial. The trial showed that patients who had suffered the most severe form of heart attack and received angioplasty were significantly less likely to suffer cardiac death and had significantly better overall survival if treated with Angiomax® (bivalirudin) compared with those treated with heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI).

The data, published in the August 30 issue of The Lancet, followed more than 3,000 patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

HORIZONS-AMI, the first trial of pharmacologic therapy to demonstrate a mortality benefit in STEMI patients undergoing PCI, showed that Angiomax reduced cardiac-related death by 43 percent (p=0.005), improved overall survival by 27 percent (p=0.037) and reduced major bleeding complications by 39 percent (p < 0.0001) compared with heparin plus a GP IIb/IIIa inhibitor. Angiomax showed an absolute reduction of 1.7 percent in cardiac-related death and 1.3 percent in all-cause death at one year.

"The past three decades have seen a steady march toward better and better outcomes for heart attack patients, and these findings mark the latest step forward. It's clear that STEMI patients undergoing angioplasty experience life-saving benefits with Angiomax, and this study should certainly influence how doctors approach this patient group," said Roxana Mehran, MD, Associate Professor of Medicine, Columbia University, Joint Chief Scientific Officer of the Clinical Trials Center at CRF and Director of Outcomes Research, Data Coordination and Analysis at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.

The multicenter, open-label, randomized HORIZONS-AMI Trial evaluated 3,602 patients presenting with STEMI undergoing a primary PCI strategy. Of patients in the Angiomax arm, the majority (93 percent) received Angiomax monotherapy. At one year, results showed that, compared with the control treatment, Angiomax:

--  Significantly reduced the incidence of cardiac-related death by 43
    percent (2.1 percent vs. 3.8 percent, HR 0.57 (95 percent CI 0.38-0.84);
    p=0.005),
    
--  Significantly reduced all-cause death by 29 percent (3.5 percent vs.
    4.8 percent, HR 0.71 (95 percent CI 0.51-0.98); p=0.037),
    
--  Significantly reduced the incidence of net adverse clinical events, a
    composite of major adverse cardiac events or major bleeding, by 17 percent
    (15.6 percent vs. 18.3 percent, HR 0.83 (95 percent CI 0.71-0.97);
    p=0.022),
    
--  Significantly reduced rates of major bleeding by 39 percent (5.8
    percent vs. 9.2 percent, HR 0.61 (95 percent CI 0.48-0.78); p less than
    0.0001),
    
--  Demonstrated no difference in rates of major adverse cardiac events
    (11.9 percent vs. 11.9 percent, HR 1.00 (95% CI 0.83-1.21); p=0.98).
    

"The bottom line is that in this population of heart attack patients undergoing PCI, Angiomax saves lives, and the degree of that benefit is striking," said John Kelley, President and Chief Operating Officer of The Medicines Company. "These results underscore our goal: to bring to doctors critical care medicines that change clinical practice for the better."

These data also support results of previous studies showing an association between reduced major bleeding in angioplasty patients with greater long-term survival. Nearly 25,000 patients have been studied in Angiomax clinical trials to date. Angiomax has been shown to result in less bleeding and similar rates of composite ischemia compared with heparin plus GPI in patients undergoing angioplasty for stable angina, unstable angina and non-ST-elevation myocardial infarction (NSTEMI).

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 and stents in patients experiencing STEMI and undergoing primary percutaneous coronary intervention (PCI), commonly known as angioplasty. This 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, 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 5 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 a 25 minute half-life. In clinical trials, treatment with Angiomax resulted in improved clinical outcomes with significantly reduced rates of major bleeding compared to treatment with heparin plus GPI across the entire spectrum of risk in patients undergoing PCI and numerically lower rates of one-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.

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 two products in late stage development: cangrelor, an investigational antiplatelet agent, and oritavancin, a semi-synthetic lipoglycopeptide antibiotic. The Company's pipeline also includes a serine protease inhibitor, CU2010, in early-stage development. The Medicines 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 10, 2009, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

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