17.03.2005 15:33:00
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European Society of Cardiology Guidelines Recommend Bivalirudin -Angio
Business Editors/Health/Medical Writers
PARSIPPANY, N.J.--(BUSINESS WIRE)--March 17, 2005--The European Society of Cardiology, a leading independent cardiology body in Europe, this week published Guidelines for Percutaneous Coronary Interventions, recommending that the anticoagulant bivalirudin (tradename Angiox(TM) in Europe and Angiomax(R) in U.S.) replace heparins (unfractionated or low-molecular weight) in patients undergoing percutaneous coronary interventions (PCI).
In the Guidelines, the authors review data across a wide range of studies of bivalirudin in PCI, including the REPLACE-2 trial, which examined bivalirudin performance compared to the combination of heparin with platelet blockers known as GP IIb/IIIa inhibitors. The Guidelines state, "REPLACE-2 determined the efficacy and safety of bivalirudin monotherapy compared with heparin plus GP IIb/IIIa blockade with regard to protection from periprocedural ischaemic and haemorrhagic complications in patients undergoing PCI."
The Guidelines note death rates in REPLACE-2, stating, "...after 1 year, mortality showed a lower trend in the bivalirudin group (1.89%) compared with the heparin plus GP IIb/IIIa group (2.46%, P=0.16)."
Also regarding bivalirudin, the ESC Guideline authors, "unanimously recommended as a replacement for UFH (and LMWHs) in patients with heparin-induced thrombocytopenia (HIT)." HIT occurs when a patient exposed to heparin forms heparin antibodies, which may cause severe immune reactions if the patient is exposed to heparin again.
Bivalirudin is marketed as Angiox(TM) in Europe by Nycomed Group and Grupo Ferrer. The Medicines Company (NASDAQ: MDCO) markets bivalirudin as Angiomax(R) in the U.S.
"The favourable review and recommendation by the ESC is a recognition of the clinical evidence for Angiox(TM). It reflects that improved patient outcomes and simplified treatment has been demonstrated across several trials. We expect that this development will significantly and positively affect the continued introduction of Angiox(TM) in Europe," said Hakan Bjorklund, Nycomed CEO.
Editors Notes:
Guidelines for Percutaneous Coronary Interventions is published in the European Heart Journal March issue.
About Angiox(TM) and Angiomax(R) (bivalirudin)
Angiox(TM) (U.S. tradename Angiomax(R) (bivalirudin)) is currently approved in the U.S. and the European Union, as well as several other territories. Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiomax has demonstrated reductions in both ischemic and bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in ischemic and bleeding complications remain evident even in high-risk patients.
In the E.U., the approved indication for Angiox is as an anticoagulant for patients undergoing PCI. In the U.S., Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information available at http://www.angiomax.com.
About Nycomed
Nycomed is a pharmaceutical company dedicated to meeting needs in Europe. The company provides hospital products throughout the region and general practitioner and pharmacy medicines in selected markets.
New products are sourced through licensing agreements with research companies. Here Nycomed provides late-stage clinical development, registration and marketing.
Headquartered in Roskilde, Denmark, the company employs about 3,000 people throughout Europe and Russia/CIS. Nycomed is privately owned and had a 2004 revenue of EUR 644.6 million.
For more information visit www.nycomed.com.
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(R)(bivalirudin), an anticoagulant approved in the U.S. and other countries for use in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) procedures. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company, 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 the extent of the commercial success of Angiomax, physicians' acceptance of Angiomax clinical trial results, whether the Company will be able to obtain regulatory approval for additional indications of Angiomax, 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 14, 2005, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
--30--JC/ny*
CONTACT: The Medicines Company Michael Mitchell, 973-656-1616 investor.relations@themedco.com
KEYWORD: NEW JERSEY DENMARK INTERNATIONAL EUROPE INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY SOURCE: The Medicines Company
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