The Medicines Company
(NASDAQ: MDCO) announced that the Marketing Authorization
Application (MAA) for Cleviprex has been accepted for review in the
European Union for the reduction of blood pressure when rapid and
predictable control is desired.
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.
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(R) (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. Through the acquisition of Targanta
Therapeutics, The Medicines Company's pipeline also includes
oritavancin, a semi-synthetic lipoglycopeptide antibiotic currently
awaiting EU regulatory approval.
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.
Source
The Medicines Company
View drug information on Cleviprex.