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The Medicines Company Completes Clevidipine Phase III Safety Trials and Initiates Phase III Severe Hypertension Trial; ECLIPSE Enrollment Complete, First Patient Enrolled in VELOCITY.


PARSIPPANY, N.J. -- 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) today provided an update of Phase III clinical trials of clevidipine, an intravenous, ultrashort-acting calcium channel blocker calcium channel blocker
n.
Any of a class of drugs that inhibit movement of calcium ions across a cell membrane, used in the treatment of cardiovascular disorders.
 intended for the treatment of severely-elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable. Investigators have completed patient enrollment and follow-up of the ECLIPSE trials, a series of safety evaluations in the perioperative perioperative /peri·op·er·a·tive/ (-op´er-ah-tiv) pertaining to the period extending from the time of hospitalization for surgery to the time of discharge.

per·i·op·er·a·tive
adj.
 treatment of hypertension. The Company also announced initiation of the VELOCITY trial in patients with severely-elevated blood pressure who are presenting to the Emergency Department or Intensive Care Unit.

VELOCITY is a multi-center, single arm, open-label Phase III clinical trial in 100 patients with severe hypertension. The objective is to evaluate the safety of a titration titration (tītrā`shən), gradual addition of an acidic solution to a basic solution or vice versa (see acids and bases); titrations are used to determine the concentration of acids or bases in solution.  dosing regimen of an intravenous infusion of clevidipine given continuously for at least 18 hours. The trials' co-principal investigators are Charles V Charles V, duke of Lorraine
Charles V (Charles Leopold), 1643–90, duke of Lorraine; nephew of Duke Charles IV. Deprived of the rights of succession to the duchy, he was forced to leave France and entered the service of the Holy Roman emperor.
. Pollack, MD, Chairman, Department of Emergency Medicine, at Pennsylvania Hospital and Frank Peacock, MD, Vice Chairman, ED Research, The Cleveland Clinic.

"Many of the patients treated in emergency situations have severely-elevated blood pressure that we need to bring down quickly," said Dr. Peacock. "The ideal antihypertensive antihypertensive /an·ti·hy·per·ten·sive/ (-ten´siv) counteracting high blood pressure, or an agent that does this.

an·ti·hy·per·ten·sive
adj.
Reducing high blood pressure.

n.
 drug in the hospital setting would act rapidly to reduce blood pressure to a desired range and go away rapidly to allow for fast and easy transition to an oral agent. Our patients are acutely ill with several co-morbidities and may need treatment for long durations -- even several days. In VELOCITY, we will evaluate clevidipine safety in a wide range of emergent patient types."

Two Phase III efficacy trials known as ESCAPE were completed previously and met their objectives. The three ECLIPSE studies compared clevidipine to active comparators; nitroglycerin nitroglycerin (nī'trōglĭs`ərĭn), C3H5N3O9, colorless, oily, highly explosive liquid. It is the nitric acid triester of glycerol and is more correctly called glycerol trinitrate. , sodium nitroprusside sodium nitroprusside
n.
A compound used as a reagent for the detection of organic compounds in the urine and as a potent agent for inducing hypotension through intravenous infusion.
, and nicardipine. The Company expects to review the completed ECLIPSE data in the fourth quarter of 2006. If these trials meet their objectives, The Medicines Company anticipates submitting an application for clevidipine U.S. marketing approval in the first half of 2007. The submission would include data from six Phase III safety and efficacy trials, including VELOCITY.

If approved for marketing, clevidipine would be the first of a third generation of intravenous dihydropyridine calcium channel blockers Calcium Channel Blockers Definition

Calcium channel blockers are medicines that slow the movement of calcium into the cells of the heart and blood vessels.
. 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.

John Kelley, The Medicines Company's President and Chief Operating Officer Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
, stated, "We expect clevidipine to be a cornerstone of our acute hospital care franchise. With the achievement of these milestones, we remain on track with our Phase III development goals."

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(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 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 clevidipine 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 Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 provisions under The Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians 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 Form 10-Q

See 10-Q.
 filed on August 8, 2006, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Sep 11, 2006
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