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Published in Health and Fitness on Thursday, March 26th 2009 at 6:04 GMT, Last Modified on 2009-03-26 06:06:23 by Market Wire
PARSIPPANY, NJ--(Marketwire - March 26, 2009) - The Medicines Company (
The MAA for Cleviprex was submitted via the Decentralized Procedure (DCP), with the United Kingdom acting as the Reference Member State. Concerned Member States participating in the review are Austria, Belgium, France, Germany, Italy, Luxembourg, The Netherlands, Spain and Sweden.
"Cleviprex is likely to bring to clinicians the ability to treat acutely elevated blood pressure rapidly and predictably, essential properties when patients experience hypertensive emergencies or urgencies. This might, in turn, improve outcomes of patients in need of fast and accurate blood pressure control, such as during or after surgery," said Alain Vuylsteke, MD, Director of Critical Care, Papworth Hospital, Cambridge, England.
Cleviprex, a novel IV antihypertensive, represents an advancement over currently available therapies, providing rapid and precise control of blood pressure in the critical care setting. Backed by comprehensive data in the emergency department, operating room and intensive care unit, Cleviprex was launched in the United States in 2008, offering physicians an important new therapeutic option for the management of acutely elevated blood pressure.
"This regulatory submission is another step in our corporate strategy to build a leading global critical care medicines business that offers valuable, safe and effective medicines," said John Kelley, President and Chief Operating Officer of The Medicines Company. "If approved, Cleviprex will provide European physicians with an effective tool that could advance the management of blood pressure in the surgical and critical care settings."
The Medicines Company anticipates making Cleviprex available in the European Union in 2010.
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.
About Cleviprex
Cleviprex is the latest-generation IV dihydropyridine calcium channel blocker. The first-cycle U.S. approval of Cleviprex on August 1, 2008 was based on six Phase III trials, including the three ECLIPSE studies, and involved 1,406 medical and surgical patients treated with Cleviprex. All Phase III trials met all of their primary endpoints. Cleviprex may produce systemic hypotension and reflex tachycardia. The most common adverse reactions (greater than 2%) seen with Cleviprex are headache, nausea and vomiting. Cleviprex is contraindicated in patients with allergy to soy or eggs, defective lipid metabolism or severe aortic stenosis. Please see full prescribing information available at [ www.cleviprex.com ].
About The Medicines Company
The Medicines Company (
Cautionary Note Regarding Forward-Looking Statements
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," "expects" and "estimates" 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 will be able to obtain regulatory approvals; whether the Company's products and product candidates will advance in the clinical trial process on a timely basis or at all; whether clinical trial results will warrant submission of applications for regulatory approval; whether physicians, patients and other key decision-makers will accept clinical trial results; whether the Company will be able to successfully distribute and market its approved products; 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 Annual Report on Form 10-K filed on March 2, 2009, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
