Healthcare Industry News: bivalirudin
News Release - December 4, 2007
Journal of the American Medical Association (JAMA) Publishes One-Year ACUITY Trial ResultsAngiomax(R) / Angiox(R) (bivalirudin) anti-clotting therapy alone resulted in similar long term ischemic outcomes compared to heparin plus GP IIb/IIIa combination
PARSIPPANY, N.J., Dec. 4 (HSMN NewsFeed) -- The Journal of the American Medical Association (JAMA) today published one-year results of the ACUITY trial, which show that acute coronary syndrome (ACS) patients treated with Angiomax® (bivalirudin) alone had similar rates of ischemic clinical outcomes compared with a more complicated treatment regimen of heparin plus a glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa).(1) These findings confirm previously published ACUITY 30-day results, which showed similar ischemia at 30 days and nearly 50% fewer episodes of major bleeding.
"The significantly lower rate of bleeding with Angiomax demonstrated in the ACUITY trial is particularly important as physicians and hospitals seek to improve patient outcomes and implement quality care initiatives," said ACUITY principal investigator Gregg W. Stone, MD, Chairman of the Cardiovascular Research Foundation and Professor of Medicine, Columbia University Medical Center. "Long term findings from ACUITY confirm the durable efficacy of Angiomax supporting a simpler, more cost-effective option than the heparin plus GP IIb/IIIa combination."
"The one-year results from the ACUITY trial in conjunction with recent 30- day findings from the HORIZONS trial in heart attack patients further substantiate Angiomax as a replacement for heparin therapy across a broad range of patients undergoing angioplasty," said John Kelley, President and Chief Operating Officer of The Medicines Company (Nasdaq: MDCO ), which markets Angiomax. "ACUITY also adds important new information on the value of starting Angiomax treatment earlier, in the emergency department, before the patient enters the cath lab."
Based on results of the ACUITY trial, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) recently recommended extending the indication for Angiox® (the trade name for bivalirudin in Europe) to adult patients with ACS planned for urgent or early intervention. Angiox should be administered with aspirin and clopidogrel. In the United States, The Medicines Company expects the Food and Drug Administration (FDA) to act in the second quarter of 2008 on an application to expand the use of Angiomax to include the emergency use of the drug in ACS patients.
ACUITY (Acute Catheterization and Urgent Intervention Triage StrategY) was 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 open label 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 of heparin (unfractionated or enoxaparin) plus GP IIb/IIIa, Angiomax plus GP IIb/IIIa, or Angiomax monotherapy. In the Angiomax monotherapy group, selective use of GP IIb/IIIa was permitted in limited circumstances and occurred in less than 10% of patients. Then, based on an evaluation in the cardiac catheterization laboratory, patients were treated for ACS through medical management (e.g., various anti-clotting drugs), bypass surgery or angioplasty (also called percutaneous coronary intervention or PCI).
The one-year ACUITY analysis showed that, in patients undergoing treatment in the Angiomax alone group, the Angiomax plus GP IIb/IIIa group and the heparin plus GP IIb/IIIa group, respectively:
-- Death occurred in 3.8%, 3.9% and 3.9% of patients (differences not significant).
-- Composite ischemia events occurred in 16.2%, 16.0% and 15.4% of patients (differences not significant). Composite ischemia was defined as death, heart attack or unplanned revascularization for ischemia.
Previously reported findings from ACUITY showed that Angiomax was associated with significantly less bleeding at 30 days than heparin plus GP IIb/IIIa: 3.0% vs. 5.7% (p < 0.001).(2) The one-year results from ACUITY were initially presented at the American College of Cardiology annual meeting in March 2007.(2)
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 about 1.4 million are identified with ACS.
The American Heart Association and the American College of Cardiology recommend that moderate- and high-risk ACS patients undergo angiography and, based on the results, be treated through medical management, bypass surgery, or PCI. Heparin plus GP IIb/IIIa is often used as part of these treatments to reduce the risk of blood clotting and further ischemia. However, while heparin plus GP IIb/IIIa can reduce the risk of ischemia, heart attack and death in ACS patients, it also increases the risk of major bleeding, which ACUITY showed, increases the risk of death.
About Angiomax® / Angiox® (bivalirudin)
Angiomax® / Angiox® (bivalirudin) 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. Regulatory authorities in the United States are currently reviewing an application to expand the use of Angiomax / Angiox to include the emergency use of the drug in ACS patients.
For US Media
In the United States, Angiomax with provisional GP IIb/IIIa inhibition 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 unstable angina (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 www.angiomax.com.
For EU Media
In Europe, Angiox is currently indicated as an anticoagulant for patients undergoing PCI. Please see full prescribing information available at www.angiox.com.
About The Medicines Company
The Medicines Company (Nasdaq: MDCO ) is committed to delivering innovative, cost-effective acute care products in the worldwide hospital marketplace. The Company markets Angiomax® / Angiox® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Company also has two products in late-stage development, Cleviprex(TM) (clevidipine butyrate injectable emulsion) and cangrelor. 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 November 8, 2007, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Sloane Occhiuto, 212-845-5633
The Medicines Company
Executive Director, Corporate Affairs
Michael Mitchell, 973-656-1616
(1) Stone GW, Ware JH, Bertrand ME, Lincoff AM, Moses JW, Ohman EM, White HD, Feit F, Colombo A, McLaurin BT, Cox DA, Manoukian SV, Fahy M, Clayton TC, Mehran R, Pocock SJ; ACUITY Investigators. Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management: One-year results from the ACUITY trial. JAMA 2007 Dec 5; 298(21):2497-2506.
(2) Stone GW, Bertrand ME, Lincoff AM, Moses JW, Ohman EM, White HD, Pocock SJ, Ware JH, McLaurin BT, Cox DA, Feit F, Colombo A, Aylward P, Cequir AR, Darius H, Desmet W, Ebrahimi R, Hamon M, Rasmussen LH, Rupprecht HJ, Hoekstra J, Pollack C, Lansky AJ, Mehran R. A prospective, randomized trial of bivalirudin in acute coronary syndromes: one year results from the ACUITY trial. Presented at: 56th Annual Scientific Session of the American College of Cardiology, New Orleans, March 24-27, 2007.
Source: The Medicines Company
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.