Results From The Medicines Company's CACHET Trial Published in American Heart Journal.Business Editors & Health/Medical Writers BIOWIRE2K The Medicines Company (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :MDCO) announced today that results from the Company's CACHET cachet /ca·chet/ (ka-sha´) a disk-shaped wafer or capsule enclosing a dose of medicine. ca·chet n. An edible wafer capsule used for enclosing an unpleasant-tasting drug. trial ("Comparison of Abciximab Complications with Hirulog for Ischemic Ischemic An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery. Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation ischemic Events") have been published in The American Heart Journal. The trial, which the Company completed in 2000, and which the Company has previously reported, analyzed the use of ANGIOMAX(R) (bivalirudin) versus low dose heparin. The results of the study demonstrated that ANGIOMAX may be safely combined with abciximab, a commonly used intravenous platelet inhibitor, and may enable use of such platelet inhibitors selectively. The authors of the study, led by Dr. A. Michael Lincoff of The Cleveland Clinic, concluded, "These data are the first randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. trial results to suggest that a provisional abciximab strategy, with bivalirudin as the underlying antithrombin agent, may be at least equivalent from an efficacy and safety standpoint to the practice of administering abciximab with heparin to all patients undergoing coronary intervention." The paper reported data from 268 patients undergoing angioplasty with stenting who were randomized to treatment with either ANGIOMAX or heparin to prevent thrombotic complications of the procedure. The first 60 patients enrolled in the trial were used to establish the safety of the ANGIOMAX when administered with abciximab. The remaining 208 patients were randomized to heparin with abciximab (64 patients), or to ANGIOMAX (144 patients) - including 32 (24%) also given abciximab and 112 (76%) who received Angiomax alone. In the trial, patients randomized to ANGIOMAX (with or without abciximab) had fewer procedural complications than those randomized to heparin with abciximab. The incidence of death, myocardial infarction myocardial infarction: see under infarction. , revascularization or clinically important bleeding fell from 10.6% for patients on heparin with abciximab to 3.4% for patients on ANGIOMAX with planned or selective use of abciximab (p-value = 0.018 by Fishers exact test). "We believe that the results of the CACHET trial provide a useful indicator for likely results of our ongoing 6,000-patient REPLACE-2 trial, which has now enrolled more than 4,000 patients," stated David Stack, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of The Medicines Company. "Dr Lincoff's data indicate that ANGIOMAX may be better than heparin for stented patients and also provide evidence that ANGIOMAX should enable selective use of GP2b3a inhibitors without compromising clinical outcomes. Importantly, this ANGIOMAX-based approach may well provide attractive economic advantages over heparin-based treatment." ANGIOMAX (bivalirudin) is indicated for use as an anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting). in patients with unstable angina un·sta·ble angina n. Angina pectoris characterized by pain of coronary origin that occurs in response to less exercise or other stimuli than usually required to produce pain. undergoing percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty n. Abbr. PTCA A procedure for enlarging a narrowed arterial lumen by peripheral introduction of a balloon-tip catheter followed by dilation of the lumen as the inflated catheter tip is (PTCA PTCA abbr. percutaneous transluminal coronary angioplasty PTCA Percutaneous transluminal coronary angioplasty, see there ). ANGIOMAX is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. The most common (=10%) adverse events for ANGIOMAX were back pain (42%), pain (15%), nausea (15%), headache (12%), and hypotension hypotension or low blood pressure Condition in which blood pressure is abnormally low. It may result from reduced blood volume (e.g., from heavy bleeding or plasma loss after severe burns) or increased blood-vessel capacity (e.g., in syncope). (12%). ANGIOMAX is contraindicated in patients with active major bleeding or hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to ANGIOMAX or its components. An unexplained fall in blood pressure or hematocrit Hematocrit Definition The hematocrit measures how much space in the blood is occupied by red blood cells. It is useful when evaluating a person for anemia. Purpose Blood is made up of red and white blood cells, and plasma. , or any unexplained symptom, should lead to serious consideration of a hemorrhagic Hemorrhagic A condition resulting in massive, difficult-to-control bleeding. Mentioned in: Hantavirus Infections hemorrhagic pertaining to or characterized by hemorrhage. event and cessation of ANGIOMAX administration. The Medicines Company was founded in 1996 to acquire, develop and commercialize selected pharmaceutical products in late stages of development and approved products. ANGIOMAX is approved in the United States for use as an intravenous anticoagulant in combination with aspirin in patients with unstable angina undergoing coronary balloon angioplasty, and is expected to be the cornerstone product of a planned acute-care hospital franchise. The Company is also developing another intravenous agent, clevidipine, for the short-term control of high blood pressure in the hospital setting. The Company's website can be found at www.themedicinescompany.com. 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 "Certain Factors that May Affect Future Results" in the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on June 25, 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; whether the Company will be able to develop or acquire additional products; 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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