The Medicines Company Announces Participation at 2015 American College of Cardiology (ACC) Scientific Sessions in San Diego
The Medicines Company (NASDAQ:MDCO) today announced that new data from several clinical trials, including the late-breaking MATRIX trial of ANGIOX® (bivalirudin), from across its cardiovascular product and pipeline portfolio will be presented at the 64th Annual Scientific Session of the American College of Cardiology, held March 14-16, in San Diego.
“We support the important mission of the American College of Cardiology in transforming cardiovascular care and improving heart health through advanced, state-of-the-art treatments,” said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company.
“Our commitment to interventional cardiology over the last 18 years is unequivocal through our commitment to sponsoring large and informative clinical trials that have contributed to the optimization of acute cardiovascular care,” said Efthymios N. Deliargyris, MD, PhD, Vice President, Global Medical Director, The Medicines Company. “In addition to the late-breaker presentation of the MATRIX study, we will also have information presented on our investigational antiplatelet agent, Cangrelor, at the conference.”
“Our dyslipidemia program is progressing with the help of many investigators, some of whom we plan to meet with during the conference, and we look forward to the many studies being presented during the meeting on LDL cholesterol lowering through PCSK9 inhibition as well as new research on stimulating HDL function to reduce atherosclerosis,” said David Kallend, MBBS (Lon), Vice President and Global Medical Director for the Lipid Programs at The Medicine Company. “We expect to present new data on our dyslipidemia agents, ALN-PCSsc by mid-2015, and MDCO-216, by end of 2015.”
The Medicines Company also has a sponsored program, “Same-Day Discharge Strategy for PCI – What are Key Considerations?” during the Industry Expert Theater in Expo Hall #3545 on Monday, March 16 at 9:45 – 10:45 am. Sunil V. Rao, MD, Associate Professor of Medicine, Duke University Medical Center, will moderate the session (#4007).
Angiomax® (bivalirudin) Data
Several sessions and posters with results of comparisons of cardiovascular outcomes and bleeding with bivalirudin and heparin during PCI.
- Debate Session 2602 : Debating the Optimal Pharmacology for PCI in ACS – Saturday, March 14, 12:15 pm – 1:45 pm
- Session 612: Contemporary Antithrombotic Therapy for ACS – Saturday, March 14, 12:15 pm – 1:45 pm
- Session 2611: Optimal Primary PCI (PPCI) for STEMI State-of-the-Art; Debate: Optimal Periprocedural Anticoagulation – Saturday, March 14, 4:45 pm – 6 pm
- 402: Special Session – Joint Session ACC /JAMA Late-Breaking Clinical Trials (LBCT), Efficacy & Safety of REG1 Anticoagulation Syst vs Bivalirudin in PCI – Sunday, March 15, 8 am – 9:15 am
- Session 49: Recent Controversial Trials: Adopt Them or Ignore Them? – Sunday, March 15, 12:30 pm – 1:45 pm
- 410: TCT@ACC-i2 Interventional Cardiology – Late-Breaking Clinical Trials (LBCT) V – Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX (MATRIX) Trial Program – Monday, March 16, 10:45 am – 12 pm
- Poster 1139-100: Intracoronary Bivalirudin Administration in STEMI Improves Coronary Flow – Saturday, March 14, 1:30 pm – 4:30 pm
Cangrelor Data (Investigational Agent)
- Session 612: Contemporary Antithrombotic Therapy for ACS – Saturday, March 14, 12:15 pm – 1:45 pm
- Session 2616: Clinical Trial Update: ACSs 2014: CHAMPION – Cangrelor in Elective, Urgent, and Emergent PCI – Sunday, March 15, 10:45 am – 12:15 pm
- Session 2635: Integrating Device and Drug Care in STEMI – Monday, March 16, 10:45 am – 12:15 pm
- Poster 1139-083: The Efficacy, Safety, and Net Clinical Benefit of Cangrelor in Women Undergoing Elective or Urgent PCI: Insights from the CHAMPION-PHOENIX Trial. – Saturday, March 14, 1:30 pm – 4:30 pm
- Poster 2101-286: Cangrelor in Elderly Patients Undergoing PCI: Findings from CHAMPION-PHOENIX.—Saturday, March 14, 1:30 pm – 4:30 pm
- Poster 2104-275: Impact of Cangrelor Overdosing on Bleeding Complications in Patients Undergoing Percutaneous Coronary Intervention: Insights from the CHAMPION Trials, Monday, March 16, 9:30 am – 12:30 pm
In the United States, bivalirudin is marketed under the trade name Angiomax and is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also 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 patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.
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 .
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. 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.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
Please see www.angiomax.com for the full prescribing information.
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an immediately bioavailable and quickly reversible intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing PCI.
ALN-PCSsc is an investigational agent not approved for commercial use in any market. ALN-PCSsc is being developed with our partner, Alnylam, as a subcutaneously delivered RNAi therapeutic targeting PCSK9 for the treatment of hypercholesterolemia. ALN-PCSsc targets the gene proprotein convertase subtilisin/kexin type 9 (PCSK9), a target validated by human genetics that is involved in the metabolism of low density lipoprotein cholesterol. A Phase 1 trial of ALN-PCSsc is currently underway and the companies expect to report initial clinical data from the trial in mid-2015.
About MDCO-216 (ApoA-1 Milano/POPC)
MDCO-216, an investigational agent not approved for commercial use in any market. MDCO-216 is a complex of recombinant ApoA-1 Milano and phospholipid (POPC) manufactured by a new process to resemble a pre-beta-like high density lipoprotein (HDL) particle. It has the potential to modify atherosclerotic disease by promoting reverse cholesterol transport and may, in the future, be tested in trials to measure reductions in the risk of adverse atherothrombotic events. The Medicines Company expects to initiate a Phase 2 trial of MDCO-216 in 2015.
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.
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 Company's products will advance in the clinical trials process on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, 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, 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 March 2, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
Vice President, Communications
Neera Dahiya Ravindran, MD
Vice President, Investor Relations and Strategic Planning