PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (NASDAQ:MDCO) today announced that investigators will present new analyses from high-risk percutaneous coronary intervention (PCI) patient subgroups from the CHAMPION PHOENIX study with its antithrombotic agent, KENGREAL® (cangrelor) for Injection at the 65th Annual Scientific Session of the American College of Cardiology, held April 2-4, in Chicago, IL. CHAMPION PHOENIX included 11,145 patients comparing KENGREAL to oral clopidogrel in patients undergoing PCI and provided the primary evidence of efficacy for the approval of KENGREAL®.
The results from the dedicated CHAMPION PHOENIX ECONOMICS sub-study on the cost implications of procedural thrombotic complications in patients undergoing PCI will also be presented during the meeting. The Company is also sponsoring the symposium, “Taking Control of Platelet Inhibition in PCI” during the Industry Expert Theater on Monday, April 4 at 9:45 am in Booth 24100. The session will be moderated by C. Michael Gibson, MD, Chief of Clinical Research in the Cardiovascular Division at Beth Israel Deaconess Medical Center, Harvard Medical School.
“We are very pleased with the early acceptance of KENGREAL at major catheterization laboratories in both the United States and Europe,” said Efthymios N. Deliargyris, MD, FACC, FESC, FSCAI, Global Medical Director, Acute Cardiovascular Care for The Medicines Company. “The new analyses presented at this meeting further enhance our understanding of how the clinical efficacy and value of KENGREAL can potentially improve clinical outcomes and streamline efficiency in certain PCI patients. With KENGREAL now available and ANGIOMAX, our anti-thrombin for certain patients undergoing PCI, The Medicines Company has solidified its position as the innovation leader in the cath lab.”
A list of key presentations is included below. The complete program of titles and abstracts can be accessed on the ACC 2016 site by clicking here.
| Time | Product | Event | Place | |||||||||
|
SATURDAY 2ND |
1:30pm - 4:30pm |
KENGREAL® (cangrelor) |
1133-16: Efficacy of Cangrelor in |
Poster Area, |
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|
SUNDAY 3RD |
9:30am - 12:30pm
|
KENGREAL® (cangrelor) |
1174-114: Impact of Prior |
Poster Hall |
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|
KENGREAL® |
1174-125: Cost Implications of |
Poster Hall |
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|
KENGREAL® (cangrelor) |
1174-129: In Vitro |
Poster Hall |
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|
12:30pm |
KENGREAL® (cangrelor) |
The Efficacy and Safety of Cangrelor |
Room Hall A-1203M |
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|
MONDAY 4TH |
9:45am - 10:45am
|
KENGREAL® |
MDCO-Sponsored INDUSTRY EXPERT |
Booth 24100 |
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About KENGREAL® (cangrelor) for Injection
Indication
KENGREAL® (cangrelor) for Injection is a P2Y12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.
Important Safety Information
KENGREAL® (cangrelor) for Injection is contraindicated in patients with significant active bleeding. KENGREAL® is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor or any component of the product.
Drugs that inhibit platelet P2Y12 function, including KENGREAL®, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL™ than with clopidogrel. Bleeding complications with KENGREAL® were consistent across a variety of clinically important subgroups. Once KENGREAL® is discontinued, there is no antiplatelet effect after an hour.
The most common adverse reaction is bleeding.
Please see full prescribing information for KENGREAL®, available at http://www.kengreal.com.
About ANGIOMAX® (bivalirudin) for Injection
Indication
ANGIOMAX® (bivalirudin) for Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients:
- Undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI);
- With, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI; and
- With unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
ANGIOMAX is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. The safety and effectiveness of ANGIOMAX have not been established in patients with acute coronary syndromes (ACS) who are not undergoing PCI or PTCA.
Important Safety Information
ANGIOMAX® (bivalirudin) for Injection is contraindicated in patients with active major bleeding and hypersensitivity (e.g., anaphylaxis) to ANGIOMAX or any of its components.
Hemorrhage can occur at any site. 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 should be used with caution in patients with disease states associated with an increased risk of bleeding.
Acute stent thrombosis (AST) (<4 hours) has been observed at a greater frequency in ANGIOMAX treated patients compared to heparin treated patients with ST segment elevation myocardial infarction (STEMI) undergoing primary PCI. Among patients who experienced an AST, one fatality (0.03%) occurred in an ANGIOMAX treated patient and one fatality (0.03%) in a heparin treated patient. These patients have been managed by Target Vessel Revascularization (TVR). Patients should remain for at least 24 hours in a facility capable of managing ischemic complications and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischemia.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of ANGIOMAX.
INR measurements made in patients who have been treated with ANGIOMAX may not be useful for determining the appropriate dose of warfarin. The most common adverse reaction for ANGIOMAX was bleeding (28%). Other adverse reactions (>0.5%) for ANGIOMAX were headache, thrombocytopenia, and fever.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
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 “potential” 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 physicians, patients and other key decision makers will accept clinical trial results, whether the Company can protect its intellectual property 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 with the SEC on February 29, 2016, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
