Articles Published in the Medical Journals 'Anesthesiology' and 'Experimental Hypertension' Affirm Potential for Clevidipine.Business Editors & Health/Medical Writers BIOWIRE2K PARSIPPANY, N.J.--(BW HealthWire)--May 21, 2002 The Medicines Company (Nasdaq:MDCO) announced today the recent publication of two articles on clevidipine in peer-reviewed medical journals. In March, the Company announced it had entered into an agreement with AstraZeneca AB for the licensing, development and commercialization of clevidipine for the short-term control of high blood pressure in the hospital setting. The first publication, a dose-finding study for clevidipine, has been published in the journal Anesthesiology anesthesiology (ăn'ĭsthē'zēŏl`əjē), branch of medicine concerned primarily with procedures for rendering patients insensitive to pain, and for supporting life systems under the strains of anesthesia and surgery. . This article, titled "Clevidipine in Adult Cardiac Surgical Patients," by Dr. James M. Bailey et. al., reports data from a placebo-controlled study in 91 coronary artery bypass graft coronary artery bypass graft n. Abbr. CABG A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. patients with postoperative hypertension. The study found that clevidipine reduced high blood pressure after cardiac surgery Cardiac surgery is surgery on the heart and/or great vessels performed by a cardiac surgeon. Frequently, it is done to treat complications of ischemic heart disease (for example, coronary artery bypass grafting), correct congenital heart disease, or treat valvular heart disease , in a dose-dependent manner, with rapid onset, offset and clearance. Additionally, clevidipine did not cause reflex tachycardia tachycardia: see arrhythmia. tachycardia Heart rate over 100 (as high as 240) beats per minute. When it is a normal response to exercise or stress, it is no danger to healthy people, but when it originates elsewhere, it is an arrhythmia. , a common problem in nitroso-vasodilators often used to combat postoperative hypertension. The second article, in Experimental Hypertension by Drs. Stephens and Jandhyala, concluded that clevidipine was effective in preserving renal tubular function in a hypertensive hypertensive /hy·per·ten·sive/ (-ten´siv) 1. characterized by increased tension or pressure. 2. an agent that causes hypertension. 3. a person with hypertension. animal model. "Publication of these articles documents some of the basis of our belief that clevidipine has substantial clinical potential for the short-term management of acute hypertension with significant promise for collateral benefits in patients undergoing surgery," stated Clive A. Meanwell, M.D., Ph.D., Executive Chairman of The Medicines Company. The Medicines Company was founded in 1996 to acquire, develop and commercialize selected pharmaceutical products in late stages of development and approved products. ANGIOMAX(R) (bivalirudin), the Company's lead product, is approved in the United States for use as an intravenous anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting). in combination with aspirin 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 coronary balloon angioplasty balloon angioplasty: see under angioplasty. , and is expected to be the cornerstone product of a planned acute-care hospital franchise. 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 Annual Report on Form 10-Q Form 10-Q See 10-Q. filed with the Securities and Exchange Commission on May 15, 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 results from preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. and early clinical trials will be indicative of the results that will be obtained in later clinical trials; whether the Company's products (other than ANGIOMAX for its approved indication approved indication, n 1. reliable signs that a certain remedy should be used. Not synonymous with “authorized.” 2. FDA-approved condition for a drug or other treatment that allows labeling. ) 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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