Healthcare Industry News: bivalirudin
News Release - January 8, 2007
The Medicines Company's Cleviprex(TM) (Clevidipine) Phase III Safety Trials Meet Pre-Specified ObjectivesPARSIPPANY, N.J.--(HSMN NewsFeed)--The Medicines Company (NASDAQ: MDCO ) today announced that its three Phase III safety trials of Cleviprex(TM) (clevidipine) met their pre-specified objectives. Cleviprex is an intravenous, ultrashort-acting calcium channel blocker under development for the treatment of severely elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable.
Clive Meanwell, Chairman and CEO of The Medicines Company stated, "With successful completion of this program, we look forward to presentation of the data by investigators. We anticipate submitting an application for Cleviprex U.S. marketing approval in the first half of 2007 and also commencing Phase IV studies of Cleviprex in 2007."
The safety trials, called ECLIPSE, are a series of evaluations enrolling 1,500 patients in the perioperative treatment of hypertension. The three ECLIPSE studies compared Cleviprex to active comparators: nitroglycerin, sodium nitroprusside and nicardipine. For the primary safety objectives, investigators measured the incidences of death, stroke, myocardial infarction and renal dysfunction. The secondary objectives were to evaluate the adverse experiences with Cleviprex and its blood pressure lowering effect. Health economics parameters will also be assessed. The primary data have been reviewed with investigators and a full presentation of the trials is expected at a medical meeting in the first quarter of 2007.
If approved for marketing, Cleviprex IV emulsion would be the first of a third generation of intravenous dihydropyridine calcium channel blockers. It acts by selectively relaxing the smooth muscle cells that line small arteries, resulting in widening of the artery and reduction of blood pressure with minimal effect on the heart rate.
About The Medicines Company: The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The Company markets Angiomax® (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 Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company and Cleviprex 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, 2006, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Source: The Medicines Company
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