ACUITY One-Year Findings Meet All Primary Endpoints in Favor of Angiomax(R) (Bivalirudin) Alone Treatment Group
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- Published on Tuesday, 27 March 2007 03:00
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NEW ORLEANS, LA, USA | Mar 26, 2007 | One-year findings from the landmark ACUITY trial show that acute coronary syndrome (ACS) patients in the "Angiomax(R) (bivalirudin) alone" treatment group had similar rates of ischemic clinical outcomes compared with more complicated standard therapy, confirming previous findings, which showed similar ischemia at 30 days, and nearly 50% fewer episodes of major bleeding. At one year, the mortality rate of patients treated in the Angiomax alone treatment group was 3.8%, compared to 4.4% in the control treatment group. A separate analysis found that, in patients with ACS, having a major bleeding episode within 30 days following treatment nearly triples the risk of death up to one year later, making major bleeding a more powerful predictor of mortality than even a heart attack.
The ACUITY one-year results were presented as late-breaking findings by investigators for the first time here at the i2 Summit at the 56th Annual Scientific Session of the American College of Cardiology. Collectively, the data showed that ACUITY met all primary one-year endpoints and confirmed previously published 30-day findings. The Medicines Company (Nasdaq: MDCO) markets Angiomax, an anti-clotting agent, in the United States.
"Our findings are important because they demonstrate that in high risk patients with ACS, Angiomax, the simplest and least expensive regimen, results in the overall best clinical outcomes," 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 chairman of the Cardiovascular Research Foundation.
The one-year ACUITY analysis showed that treatment in the Angiomax(R)(bivalirudin) alone group resulted in comparable clinical outcomes compared to standard therapy. Specifically, in patients treated in the Angiomax alone group, the Angiomax plus GPI group and the heparin plus GPI group, respectively:
* Death occurred in 3.8%, 4.2% and 4.4% of patients. There was an
observed numerical reduction (p=NS) in late mortality (after one month
to one year) in the Angoimax alone treatment group, and
* Composite ischemia events occurred in 16.4%, 16.5% and 16.3% of
patients. Composite ischemia was defined as death, heart attack or
unplanned revascularization for ischemia.
"We believe the one-year ACUITY results further substantiate Angiomax as a cornerstone therapy for the treatment of patients with ACS and add new information on treatment started in the emergency department to the wealth of data in the cardiac cath lab," said John Kelley, President and Chief Operating Officer of The Medicines Company. He said that MDCO anticipates submitting an sNDA for Angiomax for use in the treatment of patients with emergency ACS in the third quarter of 2007.
Additionally, the study found that major bleeding within 30 days following treatment increased the risk of death within one year even more than did a heart attack. The death rate among patients who suffered major bleeding compared to those who had a heart attack or neither was 12.5% vs. 8.6% vs. 3.4%, respectively. After adjusting for other variables, the risk of death for patients who had a major bleed or heart attack within 30 days following treatment was 2.89 and 2.47 times greater, respectively, than the risk for patients who did not experience either (p < 0.0001 for both comparisons).
"While heart attacks tend to happen in the hospital, we found the risk of death associated with major bleeding continues long-term," said Dr. Stone. "This makes major bleeding an even more powerful predictor of death than having a heart attack."
Enrolling 13,819 ACS patients in 17 countries, ACUITY is one of the largest ACS clinical trials ever conducted to evaluate anti-clotting therapies administered in the hospital. The trial design employed an early invasive strategy, starting anti-clotting therapy when ACS patients arrived at the emergency department and randomly assigning them to treatment with standard therapy of heparin (unfractionated or enoxaparin) plus a drug called a glycoprotein IIb/IIIa inhibitor (GPI), Angiomax plus GPI, or the "Angiomax alone" treatment group. In the Angiomax alone group, selective use of GPIIb/IIIa inhibitor was permitted in limited circumstances, and occurred in less than 10% of patients in the ACUITY trial. Then, based on an evaluation in the cardiac catheterization laboratory, patients were treated for ACS through medical management, bypass surgery, or angioplasty, also known as percutaneous coronary intervention or PCI.
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 (e.g., various anti-clotting drugs), bypass surgery, or PCI. Heparin plus a GPI is often used as part of these treatments to reduce the risk of blood clotting and further ischemia. However, while heparin plus GPI 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(R) (bivalirudin)
Angiomax is currently approved in the U.S. and the European Union, as well as several other territories. Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiomax has demonstrated efficacy plus reductions in bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in bleeding complications remain evident even in high-risk patients.
In the U.S., Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA) and with provisional GPIIb/IIIa inhibition in patients undergoing PCI. Angiomax is also indicated in patients with, or at risk of, HIT/HITTS undergoing 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.
Investor Conference Call
The Medicines Company management has scheduled a conference call with investors to discuss the late-breaking data on Monday, March 26 at 6:00 p.m. Eastern Time (5:00 p.m. Central Time in New Orleans). The conference call will be available via phone and webcast. The webcast can be accessed at The Medicines Company website at http://www.themedicinescompany.com.
The dial in information is listed below:
Domestic Dial In: 800-810-0924
International Dial In: 913-981-4900
Replay is available from 9:00 p.m. Eastern Time following the conference call through Monday, April 16th. To hear a replay of the call dial 888-203-1112 (domestic) and 719-457-0820 (international). Passcode for both dial in numbers is 3194796.
About The Medicines Company
The Medicines Company is committed to delivering innovative, cost- effective acute care hospital products in the worldwide hospital marketplace. The Company markets Angiomax(R) (bivalirudin) 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 Company also has two products in late-stage development, Cleviprex(TM) (clevidipine) and cangrelor. 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-K filed on March 1, 2007, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
SOURCE The Medicines Company