The Medicines Company (NASDAQ: MDCO) today provided an update of Phase III clinical trials of clevidipine, an intravenous, ultrashort-acting calcium channel blocker 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 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 dosing regimen of an intravenous infusion of clevidipine given continuously for at least 18 hours. The trials' co-principal investigators are Charles V. 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 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, sodium nitroprusside, 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. 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, 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 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, 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 filed on August 8, 2006, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.