Medical Reading

Cleviprex Demonstrated Rapid, Precise Blood Pressure Control In High-Risk Patients, According To New Analyses

October 03, 2017

The Medicines Company (NASDAQ: MDCO) announced that its investigational agent, CleviprexTM (clevidipine butyrate injectable emulsion), rapidly achieved and maintained blood pressure control in patients with renal dysfunction (RD) and patients with acute heart failure (AHF), according to two new analyses from the Phase III trial VELOCITY1 presented at the annual meeting of the Society of Clinical Care Medicine (SCCM).

Target blood pressure control was achieved with Cleviprex, administered by intravenous (IV) infusion, by a median of 6.3 minutes for patients with RD and 11.3 minutes for patients with AHF, with 91 percent of RD patients (N=24) and 94 percent of AHF (N=19) patients reaching their target within 30 minutes. Most patients (88 percent RD, 84 percent AHF) transitioned smoothly to an oral antihypertensive after completing treatment with Cleviprex. In these analyses, there were no hypotensive events and Cleviprex was well tolerated.

"These findings are encouraging, as they show the potential benefits of Cleviprex in high-risk patients that often cannot tolerate currently available therapies," said James Ferguson, M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company. "If approved, Cleviprex is poised to be an important new treatment option, uniquely suited to meet the needs of hospital patients with acute blood pressure."

The Risk of Acutely Elevated Blood Pressure

An acute elevation of blood pressure, or acute hypertension, is a life-threatening condition that can cause permanent damage to the brain, heart, kidneys and blood vessels. It occurs in nearly 50 percent of patients presenting to the hospital with acute heart failure and is a common occurrence for patients with renal dysfunction. It is critical to rapidly manage and maintain optimal blood pressure to minimize risk of death and damage to vital organs.

Blood Pressure Excursions Significantly Linked to Poor Outcomes

Independent research from Duke University Medical Center, also presented at SCCM, of a Duke Heart Center database of 5,000 patients demonstrated that blood pressure (excursions) above or below a target range was significantly linked to 30-day mortality in cardiac surgery patients (P=0.0139).

"The impetus for the Duke database analysis were the ECLIPSE results, which showed that improved blood pressure control in cardiac surgery patients significantly reduced the risk of death within 30 days following the procedure," said Solomon Aronson, M.D., Professor of Anesthesiology, Duke University School of Medicine. "These data clearly demonstrate the need to reevaluate the management of acute blood pressure changes during surgery. Furthermore, these data alert us to an important and emerging unmet clinical need for new target therapies that better manage and control severe blood pressure excursions in the hospital."

About the VELOCITY and ECLIPSE trials

VELOCITY was an open-label, single-arm, multi-center study in 126 emergency department patients presenting with acutely elevated blood pressure. The ECLIPSE trial included a total of 1,512 cardiac surgery patients enrolled in one of three randomized, open-label studies comparing Cleviprex to current intravenous antihypertensive agents: nitroglycerin, sodium nitroprusside or nicardipine.

About Cleviprex

Cleviprex is a novel investigational IV antihypertensive for the treatment of acutely elevated blood pressure, 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, making it a suitable treatment for patients with end-organ damage.

Cleviprex has been studied in more randomized clinical trials and in more patients than any other intravenous antihypertensive agent. Six Phase III 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 committed to delivering innovative, cost-effective acute care products in the worldwide hospital marketplace. The Company markets Angiomax® /Angiox® (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™ (clevidipine butyrate injectable emulsion) and cangrelor. The Company's website is themedicinescompany.

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 November 8, 2007, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

1 EValuation of the Effect of ULtrashOrt-Acting Clevidipine In the Treatment of Patients With Severe HYpertension

The Medicines Company

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