SOURCE: The Medicines Company

The Medicines Company

November 02, 2011 16:30 ET

The Medicines Company Announces Schedule of Events at Upcoming Transcatheter Cardiovascular Therapeutics (TCT) Conference

First Angiomax® (Bivalirudin) Data in Structural Heart Disease Procedures; Cangrelor Bridge Featured as Late Breaking Trial

PARSIPPANY, NJ--(Marketwire - Nov 2, 2011) - The Medicines Company (NASDAQ: MDCO) today announced its schedule of events at the Cardiovascular Research Foundation (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) meeting taking place from November 7-11 in San Francisco. TCT is the world's largest educational meeting specializing in interventional cardiovascular medicine. A fact sheet with a comprehensive list of activities is posted to themedicinescompany.com.

ANGIOMAX (BIVALIRUDIN) FOR INJECTION: 24 ABSTRACTS, NEW RESEARCH AREAS TO BE EXPLORED

Angiomax will be featured in 24 oral and poster abstract presentations throughout the meeting. Early results of new research programs now underway for Angiomax will also be presented.

Monday, November 7
7:00pm - Room 121
Special Twilight Sessions. Featured Clinical Research I. Transcatheter Valve and STEMI/Heart Failure Therapies

  • A Two-Center Registry Study Comparing Bivalirudin and UFH in Patients Undergoing Balloon Aortic Valvuloplasty. George D. Dangas, MD, PhD, Mount Sinai School of Medicine

This session will review the first data on Angiomax use in structural heart disease patients as part of the BRAVO (BivaliRudin to improve Aortic Valve intervention Outcomes) research program.

In addition, the Angiomax Endovascular Research Council (AERC) will meet for the first time. The AERC is convened by The Medicines Company to guide and initiate collaborative Angiomax projects in the peripheral vascular system.

CANGRELOR: BRIDGE TRIAL
Wednesday, November 9
12:35pm - Main Arena - Esplanade Ballroom

  • BRIDGE: A Prospective, Double-Blind, Multicenter, Randomized Placebo-Controlled Trial of Intravenous Cangrelor in Patients Awaiting Surgery. Dominick J. Angiolillo, MD, PhD, University of Florida-Shands

Cangrelor is an investigational intravenous antiplatelet agent currently undergoing phase III clinical trials. The purpose of the BRIDGE trial is to investigate whether patients receiving cangrelor infusion before coronary artery bypass grafting (CABG) have an acceptable safety profile and can undergo surgery without excessive peri-operative bleeding. The safety and efficacy of cangrelor has not been established or approved by the FDA or any regulatory agency for any use.

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. 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. Angiomax is not approved for use in ACS patients not undergoing PCI. Please see full prescribing information available at http://www.angiomax.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. The Medicines Company's website is www.themedicinescompany.com.

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" and "expects" and similar expressions, including the Company's preliminary revenue results, 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, the Company's ability to develop its global operations and penetrate foreign markets, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company is able to obtain or maintain patent protection for the intellectual property relating to the Company's products, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, risks associated with the establishment of international operations, 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 2, 2011, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

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