New Publication Shows Cleviprex is Effective for Rapid Treatment of Acute Hypertension After Cardiac SurgeryPARSIPPANY, N.J.--(BUSINESS WIRE)--Jul 14, 2008 - The Medicines Company (NASDAQ: MDCO) today announced that the results of ESCAPE -2, a pivotal Phase 3 efficacy trial of its investigational agent Cleviprex(TM) (clevidipine butyrate) injectable emulsion, were published in the July issue of the journal Anesthesia and Analgesia. The clinical trial demonstrated that Cleviprex is effective and safe in the rapid treatment of acute hypertension after cardiac surgery.
ESCAPE-2, a randomized, double-blind, placebo-controlled trial, examined the efficacy and safety of Cleviprex in treating patients with acutely elevated blood pressure after cardiac surgery. A total of 110 patients with a systolic blood pressure (SBP) greater than 140 mm Hg following cardiac surgery were randomized to a 30 to 60 minute infusion of Cleviprex or placebo. The primary end point was the incidence of treatment failure, defined as the inability to decrease SBP by 15% or more from baseline, or the discontinuation of study treatment for any reason within the 30 minute period after study drug initiation. The study demonstrated:
-- Treatment success (absence of treatment failure) was achieved in significantly more Cleviprex-treated patients than placebo-treated patients (91.8% vs. 20.4%, P <0.0001).
-- Median time to achieving target systolic blood pressure with Cleviprex was 5.3 minutes (95% confidence interval, 4-7 min).
-- No clinically significant increase in heart rate from baseline was observed, and adverse event rates were similar for both treatment groups.
"These additional data build upon the findings of the ESCAPE-1 trial, which indicated that Cleviprex was effective and safe in study patients with acute elevations of blood pressure prior to cardiac surgery," said lead investigator Neil Singla, MD, Department of Anesthesia, Huntington Memorial Hospital, Pasadena, California. "Together, both ESCAPE trials suggest that Cleviprex could be a promising drug for acute hypertension patients undergoing cardiac surgery."
"These data are an important piece of a large body of clinical information reinforcing our commitment to advancing the understanding and importance of acute blood pressure management in the critical care setting," said James Ferguson M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company.
Cleviprex is a novel investigational IV antihypertensive for acute blood pressure management in the critical care setting, when the use of oral therapy is not feasible or desirable. Cleviprex has a rapid onset and offset of action and can be titrated for predictable blood pressure control. Unlike current antihypertensive treatments which are metabolized by the kidney or liver, Cleviprex is metabolized in the blood and does not accumulate in the body.
Six Phase 3 trials of Cleviprex met all of their primary endpoints. The most common adverse reactions seen with Cleviprex use were headache, sinus tachycardia, hypotension, nausea, polyuria, flushing, dizziness and vomiting.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax(R) (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Company also has two products in late-stage development, Cleviprex(TM) (clevidipine butyrate) injectable emulsion and cangrelor. The Company's website is www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company 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 May 12, 2008, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Posted: July 2008