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The Medicines Company (MDCO) Release: German Researchers Reaffirm Utility of Angiomax(R)/Angiox(R) (Bivalirudin) in High Risk PCI Patients


11/14/2011 9:27:58 AM

ORLANDO, FL--(Marketwire - November 13, 2011) - The ISAR group, world leading cardiology researchers based in Munich, Germany, today simultaneously presented and published results of the 1,721-patient randomized, double-blind, active-controlled, multicenter ISAR-REACT-4 clinical trial in patients with evidence of evolving infarction (heart attack) undergoing percutaneous coronary interventions (PCI). The Medicines Company announced that the late breaking results were presented at the American Heart Association Scientific Sessions 2011 here today and published in The New England Journal of Medicine.

The study's purpose was to determine whether the combination of unfractionated heparin and abciximab (ReoPro®) is more effective than bivalirudin (Angiox® in Europe, Angiomax® in the United States) in preventing thrombotic and bleeding complications in patients suffering from a heart attack known as non-ST segment elevation myocardial infarctions (NSTEMI) and undergoing PCI.

Principal Investigator Adnan Kastrati, MD of Deutsches Herzzentrum Muenchen presented the results of ISAR-REACT-4, which tested how many patients in each group within 30 days of treatment died, had another major heart attack, required another procedure to unblock the same artery or suffered major bleeding.

They found:

  • 95 patients (11 percent) taking bivalirudin had at least one of those outcomes compared to 94 (10.9 percent) of those taking abciximab and heparin.
  • 22 patients (2.6 percent) on bivalirudin experienced major bleeding compared to 40 patients (4.7 percent) taking abciximab and heparin.

In 2006, the ISAR group reported results of the ISAR-REACT-2 trial that included NSTEMI patients undergoing PCI. In that trial, abciximab plus unfractionated heparin was associated with a significant reduction of ischemic events versus unfractionated heparin in patients with elevated troponin, a cardiac marker of infarction.

Dr. Kastrati stated, "Based on the ISAR-REACT-4 results, a bivalirudin-based strategy should be the standard of care in these high risk patients."

Efthymios Deliargyris, MD, Global Medical Director for The Medicines Company, commented, "The ISAR group has a history of independently minded trials that have driven changes in guidelines and practice across Europe and around the world. We expect that the results from this large trial in PCI patients with evidence of evolving infarction will once again impact the pharmacologic management of these patients."

About Angiomax® (bivalirudin) for Injection
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and a 25 minute half-life.

In the United States, Angiomax with provisional GPI is indicated in patients undergoing angioplasty, also called PCI, and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in ACS patients not undergoing PCI or PTCA. 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 Angiox®
In Europe, Angiox currently is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation MI planned for urgent or early intervention. Please see full prescribing information available at http://www.angiox.com.

About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients.

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," "plans" 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 such as the results described above, 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, including for additional patient populations, 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 November 9, 2011, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.


Contact:
Michael Mitchell
The Medicines Company
+973-290-6000
investor.relations@themedco.com


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