The Medicines Company Completes Enrollment of 6000-Patient REPLACE-2 Angioplasty Trial
Tuesday August 27, 9:23 am ET
PARSIPPANY, N.J.--(BUSINESS WIRE)--Aug. 27, 2002--The Medicines Company (Nasdaq:MDCO - News):
Primary Angiomax(R) post-marketing data results expected by end of 2002
The Medicines Company (Nasdaq: MDCO - News) has completed the target enrollment of 6,000 patients its REPLACE-2 study.
REPLACE-2 was conducted in patients undergoing percutaneous coronary intervention (PCI or "angioplasty") procedures. The study is evaluating the use of The Medicines Company's lead product, Angiomax®, as the foundation anticoagulant for angioplasty within in the context of modern therapeutic products and technologies, including coronary stents. The Cleveland Clinic and The Medicines Company coordinated REPLACE-2 with Eric J. Topol, M.D. as chairman and A. Michael Lincoff, M.D., as the principal investigator. The Company expects to announce the primary post-marketing data results by the end of 2002.
REPLACE-2 is a randomized double-blind trial that enrolled patients at 233 clinical sites in the United States, Canada, Western Europe and Israel. One randomized group of patients received heparin plus a GP IIb/IIIa inhibitor. A second randomized group of patients received Angiomax (bivalirudin) plus the provisional use of a GP IIb/IIIa inhibitor, administered to patients in certain circumstances. GP IIb/IIIa inhibitors are antiplatelet products commonly used in the modern angioplasty setting. Sites selected a GP IIb/IIIa inhibitor based on institutional practice, reflecting current practices in providing patient care.
The study will evaluate the standard clinical endpoints of death, myocardial infarction, revascularization and clinically significant bleeding at 30-days. The study is also examining the total cost of care of the two arms up to 30-days post PCI. Additional follow-up will be conducted at six months and one year.
About Angiomax: Angiomax is a small-molecule, reversible, direct thrombin inhibitor that has been shown in clinical trials to reduce the incidence of death, myocardial infarction, and the need for revascularization in patients undergoing balloon angioplasty. In addition, Angiomax has been associated with a significant reduction in bleeding complications in this patient group. Its benefits have been shown to remain consistent in high-risk patients, unlike other agents that show reduced efficacy in high risk patients. Reductions in these complications not only represent the opportunity for better patient care, but also the opportunity for cost-savings by institutions.
Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. The most common (= Greater than 10%) adverse events for Angiomax were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. 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.
About The Medicines Company: The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve specialized care. The Company markets Angiomax® (bivalirudin), an anticoagulant approved in the US and other countries for use in patients undergoing coronary angioplasty procedures. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators.
This press release contains forward-looking statements that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "intends," and similar expressions are intended to identify forward-looking statements. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2002 and incorporated herein by reference. These risk factors include risks as to the commercial success of Angiomax; how long the Company will be able to operate on its existing capital resources; whether the Company's products (other than Angiomax for its approved indication) will advance in the clinical trials process, the timing of such clinical trials, whether the clinical trial results will warrant continued product development, whether and when, if at all, the Company's products will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and for which indications, and, if such products receive approval, whether they will be successfully marketed; the Company's history of net losses; and the Company's dependence on third parties, including manufacturers, suppliers and collaborators. We do not assume any obligation to update any forward-looking statements.
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Contact:
The Medicines Company
Michael Mitchell, 973/656-1616
investor.relations@themedco.com |
