FDA ACCEPTS NDA FILING FOR CLEVIPREXâ„¢ (CLEVIDIPINE BUTYRATE INJECTABLE EMULSION) FOR THE TREATMENT OF ACUTE HYPERTENSION
PARSIPPANY, NJ – September 14, 2007 – The Medicines Company [NASDAQ: MDCO] today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s new drug application (NDA) for Cleviprex™ (clevidipine butyrate injectable emulsion) for the treatment of acute hypertension. If approved, Cleviprex will be the first new treatment for acute hypertension in more than 10 years.
“Rapid and precise blood pressure control can help improve outcomes for millions of people who experience a hypertensive emergency or urgency, or high blood pressure during or after surgery,†said Jerrold Levy, M.D., Professor of Anesthesiology, Emory University School of Medicine. “In extensive clinical trials, Cleviprex provided fast-acting, predictable and rapidly reversible blood pressure control. This unique combination of properties is expected to help hospital physicians manage blood pressure without many of the limitations of available therapies.â€
“We developed Cleviprex specifically to address the needs of physicians in the hospital setting,†said John Kelley, President and Chief Operating Officer of The Medicines Company. “If approved, we look forward to making Cleviprex available in mid-2008. We expect Cleviprex to be a significant growth driver for The Medicines Company in the United States and global markets.â€Â
About Cleviprex
Cleviprex is a novel investigational IV antihypertensive for the treatment of acute hypertension for up to 72 hours, 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.Â
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. Â
About Acute Hypertension
Acute hypertension is a rapid and severe increase in blood pressure that can damage blood vessels, resulting in inflammation and leakage of fluid or blood into surrounding tissues or irreversible organ damage in the central nervous system, heart, vasculature and kidneys. It is critical to safely reduce blood pressure within minutes to hours to avoid morbidity and mortality. Approximately three million patients are treated with IV antihypertensive agents each year in U.S. hospitals. Acute hypertension often occurs in people who have untreated or inadequately controlled chronic hypertension, and can occur in a broad range of patients.
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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® (bivalirudin) in the United States and recently reacquired rights to the product in Europe, where it is marketed as Angiox® (bivalirudin). Angiomax is used in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. In addition to Cleviprex, the Company also has another product in late-stage development, cangrelor. The Company's Web site is http://www.themedicinescompany.com.  Â
Statements contained in this press release about The Medicines Company and Cleviprex 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 August 9, 2007, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.