New Publication Shows Cleviprex is Safe and Effective for Treatment of Acute, Severe Hypertension
PARSIPPANY, N.J.--(BUSINESS WIRE)--Aug. 26, 2008 - The Medicines Company (NASDAQ: MDCO) today announced that the results of VELOCITY, a pivotal Phase 3 safety and efficacy trial of its new intravenous (IV) therapy Cleviprex(TM) (clevidipine butyrate) injectable emulsion, were published in the August issue of the Annals of Emergency Medicine. The clinical trial demonstrated that Cleviprex is safe and effective for the treatment of acute, severe hypertension. Cleviprex was approved this month by the U.S. Food and Drug Administration (FDA) for the reduction of blood pressure when the use of oral therapy is not feasible or not desirable.
VELOCITY, a prospective, multicenter, open-label, single-arm study, evaluated the safety and efficacy of Cleviprex in 126 patients in the emergency room or intensive care unit who had acute, severe hypertension (defined as systolic blood pressure greater than 180 mm Hg and/or diastolic blood pressure greater than 115 mm Hg). Cleviprex was administered using non-weight-based dosing, and infusions were adjusted to rapidly bring blood pressure to a physician-specified target range using blood pressure cuff monitoring. The primary efficacy endpoint was the percentage of patients in whom systolic blood pressure was successfully reduced to the target range within 30 minutes of initiating therapy.
"The VELOCITY study demonstrates the ability of Cleviprex to control blood pressure rapidly and predictably in patients with acute, severe hypertension," said lead investigator Charles Pollack, MD, University of Pennsylvania, Department of Emergency Medicine. "With the recent approval of Cleviprex, physicians will have a valuable therapy to help effectively manage and maintain these patients in the critical care setting."
-- Study patients commonly presented with both acute hypertension and end-organ injury; 81% had demonstrable end-organ injury at baseline.
-- Within 30 minutes of starting clevidipine, 88.9% of treated patients were brought within the target range. The median time to reach the target range was 10.9 minutes.
-- Blood pressure was maintained within the target blood pressure range for at least 18 hours beyond the initial 30-minute period with simple dose titrations; during this time less than 2% of patients had blood pressure below their target range.
-- More than 90% of treated patients did not require any additional intravenous antihypertensive agents to achieve blood pressure control.
-- More than 90% of all patients were successfully transitioned to oral antihypertensive therapy.
"Previous studies like ESCAPE and ECLIPSE have shown the benefits of Cleviprex in surgical patients" said James Ferguson M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company. "The results of VELOCITY extend the benefits of Cleviprex in managing blood pressure beyond the peri-operative setting to the emergency department and intensive care setting."
Blood Pressure Management in Critical Care Settings
Poorly controlled blood pressure can be a life-threatening condition that can cause permanent damage to the brain, heart, kidneys and blood vessels. Poorly controlled blood pressure can occur in a broad range of patients; it is frequently found in patients undergoing surgery and in patients presenting in the emergency department.
Cleviprex is the latest-generation IV dihydropyridine calcium channel blocker. The first-cycle U.S. approval of Cleviprex was based on six Phase III trials involving 1,406 patients medical and surgical patients treated with Cleviprex. All Phase III trials met all of their primary endpoints.
Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis. Cleviprex may produce systemic hypotension and reflex tachycardia.
The most common adverse reactions (greater than 2%) seen with Cleviprex are headache, nausea and vomiting. Please see full prescribing information available at www.Cleviprex.com.
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 and Cleviprex(TM) (clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Company also has an investigational antiplatelet agent, cangrelor, in late-stage development and a serine protease inhibitor, CU-2010, in early-stage development. 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 physicians, patients and other key decision-makers will accept clinical trial results, 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, 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 11, 2008, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Posted: August 2008