Healthcare Industry News: bivalirudin
News Release - March 12, 2006
Angiomax(R) (bivalirudin) Monotherapy Superior to Heparins Plus GP IIb/IIIa Combination for Net Clinical Outcome in ACUITY TrialATLANTA--(HSMN NewsFeed)--March 12, 2006--Investigators today reported results of the ACUITY trial of The Medicines Company's (Nasdaq: MDCO ) Angiomax® (bivalirudin). The trial met its objectives in favor of Angiomax. The results were presented as a late-breaking trial at the American College of Cardiology Scientific Session.
"Results of ACUITY are clear cut and even more robust in favor of Angiomax than the findings of our most recent major Angiomax study, REPLACE-2," said Clive Meanwell, Chairman and CEO of The Medicines Company. "The ACUITY results reinforce the message that replacing heparin with Angiomax improves outcomes, even in high risk patients with acute coronary syndromes. The ACUITY outcome is simple and definitive - Angiomax can become a major element in the platform of contemporary ACS treatment."
Statistically, ACUITY employed a sequential analysis, and met all levels of testing, including all six of the main pre-specified endpoints.
"In ACUITY, we tested several different combinations of drug therapies and found that the simplest regimen was the best," said ACUITY's Principal Investigator, Gregg W. Stone, MD, Professor of Medicine and Director of Cardiovascular Research and Education at Columbia University Medical Center's Center for Interventional Vascular Therapy and Vice-Chairman of the Cardiovascular Research Foundation. "Previous ACS trials have added drug on top of drug to achieve better efficacy, sacrificing safety along the way. The ACUITY trial showed that Angiomax alone is as effective as more complicated dual drug regimens, and results in significantly less bleeding, which means improved outcomes for patients."
ACUITY enrolled more than 13,800 patients and was conducted at 448 clinical trial sites in 17 countries worldwide. Nycomed co-sponsored the trial in Europe, where more than 4,800 patients were enrolled. The trial employed three treatment arms.
In the Angiomax monotherapy arm (Arm C), Angiomax demonstrated superiority for the net clinical outcome endpoint versus the heparins (unfractionated or low-molecular weight) plus GP IIb/IIIa inhibitor control arm (Arm A). Net clinical outcome event rates include death, myocardial infarction, revascularization and major bleeding. Major bleeding rates were significantly lower among patients treated with Angiomax versus control. Comparison of ischemic event rates (death, myocardial infarction, revascularization) met the pre-defined criteria for "non-inferiority," a statistical term for establishing one regimen is the same as the other.
In the Angiomax combination arm (Arm B), in which patients received Angiomax plus a GP IIb/IIIa inhibitor, the endpoints were also met demonstrating Angiomax non-inferiority compared to the Arm A control arm. The ACUITY trial demonstrated that Angiomax and GP IIb/IIIa inhibitors can be combined safely, without any significant increase in either ischemic or bleeding complications compared to heparins (unfractionated or low-molecular weight) plus GP IIb/IIIa inhibitor. In ACUITY there was no ischemic benefit afforded by adding a GP IIb/IIIa inhibitor to Angiomax.
John Kelley, President and Chief Operating Officer of The Medicines Company said, "With ACUITY complete and now presented, our belief that there are two major platforms for Angiomax growth ahead of us is bolstered significantly. We expect continued Angiomax growth in the cath lab in 2006 and anticipate a future platform in the emergency department."
Conference Call Information
The Company has scheduled two investor conference calls for Monday, March 13, 2006 to discuss the ACUITY trial. The first will be on Monday, March 13 at 7:30 am, after primary results of the ACUITY trial. The second will be on Monday, March 13 at 4:00 pm, following presentation of the ACUITY timing trial.
The conference calls will be available via phone and webcast. The calls are being webcast by Thomson/CCBN and can be accessed at The Medicines Company's web site (http://www.themedicinescompany.com). The dial in information is listed below:
Monday, March 13 at 7:30 am Domestic Dial In: 800-599-9816 International Dial In: 617-847-8705 Participant Passcode: 52585333 (for both domestic and international)
Replay is available from 9:30 am EST following the conference call through March, 27, 2006. To hear a replay of the call dial 888-286-8010 (domestic) and 617-801-6888 (international). Passcode for both dial in numbers is 55520059.
Monday, March 13 at 4:00 pm Domestic Dial In: 866-700-6293 International Dial In: 617-213-8835 Participant Passcode: 59366190 (for both domestic and international)
Replay is available from 6:00 pm EST following the conference call through March 27, 2006. To hear a replay of the call dial 888-286-8010 (domestic) and 617-801-6888 (international). Passcode for both dial in numbers is 60915123.
About Angiomax: Angiomax® (bivalirudin) is currently approved in the U.S. and the European Union, as well as several other countries. In Europe, the product is marketed by Nycomed and Ferrer Grupo as Angiox®. Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiomax has demonstrated reductions in both ischemic and bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in ischemic and bleeding complications remain evident even in high-risk patients.
In the U.S., Angiomax is indicated for use as an anticoagulant with provisional GP IIb/IIIa inhibition in patients undergoing percutaneous coronary intervention (PCI). 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 meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The Company markets Angiomax®(bivalirudin), an anti-clotting therapy approved in the U.S. and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company and Angiomax 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 the extent of the commercial success of Angiomax, physicians' acceptance of Angiomax clinical trial results, whether the Company's products will advance in the clinical trials process, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approval for additional indications of Angiomax 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 November 8, 2005, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Source: The Medicines Company
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