MEDICINES COMPANY PROVIDES UPDATE ON SEVERE HYPERTENSION TRIALS

The Medicines Company has provided an update of its Phase III clinical trials of clevidipine, an intravenous, ultra-short-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 it has started a trial, called VELOCITY, in patients with severely elevated blood pressure who are in hospitals' emergency department or intensive care unit.

VELOCITY is a multicenter, single arm, open-label Phase III 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.

Two Phase III efficacy trials known as ESCAPE were completed previously and met their objectives. The three ECLIPSE studies compared clevidipine with 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, company anticipates submitting an application for marketing approval in the first half of 2007.