The Medicines Company to Present New Data on Investigational Lipid-Modifying Agent MDCO-216 and Investigational Antiplatelet Agent Cangrelor at 2014 American Heart Association (AHA) Annual Scientific Sessions in Chicago
The Medicines Company (NASDAQ:MDCO) will present new data from studies involving the investigational lipid-modifying agent MDCO-216 and investigational intravenous antiplatelet agent cangrelor during the annual American Heart Association (AHA) Scientific Sessions in Chicago, November 15-19. The oral presentations and abstracts involve clinical data and analyses from two core areas of cardiovascular medicine for the Company: lipid-modifying therapies and acute cardiovascular care.
“The Medicines Company is privileged to support the leadership of the American Heart Association and its members in their impressive efforts to prevent and to improve care for millions of U.S. patients with or at risk for cardiovascular disease,” said Clive Meanwell, MD, PhD, Chairman and CEO, The Medicines Company. “AHA educational initiatives – including the Mission Lifeline Program which we are honored to support – have been responsible for saving countless lives nationwide. We have been committed alongside AHA to interventional cardiovascular patient care for many years through our ongoing research, development and educational activities with Angiomax and more recently for Cleviprex in the management of hypertension for patients in whom oral agents are not feasible or desirable. We also plan to continue our research and development programs with cangrelor, an intravenous antiplatelet agent for potential use in PCI and other investigational agents such as MDCO-216 (containing ApoA-1 Milano), which is undergoing clinical trials to determine its ability to increase cholesterol efflux/reverse transport, and PCSK9sc, which is undergoing clinical trials to determine its ability to inhibit the synthesis of PCSK9, potentially thereby reducing LDL. If these dyslipidemia programs are successful, we hope to reduce adverse cardiac outcomes and improve the economics of care for atherosclerotic disease, including coronary artery disease, as we have in interventional cardiology.”
MDCO-216 (ApoA-1 Milano/POPC) Data
- Abstract 2263: A SINGLE INFUSION OF MDCO-216 (APOA-1 MILANO/POPC) INDUCES MARKED CHANGES ON THE LIPID PROFILE INCLUDING ABCA1 MEDICATED CHOLESTEROL EFFLUX - Sunday, November 16, 09:30am – 11:00am
- Abstract 7696: SINGLE ASCENDING DOSE PHARMACOKINETICS AND PHARMACODYNAMICS OF MDCO-216 (APOA-1 MILANO/POPC) IN HEALTHY VOLUNTEERS - Wednesday, November 19, 09:30am – 11:00am
- Abstract 7697: MDCO-216 (APOA-1 MILANO/POPC) INDUCES REVERSE CHOLESTEROL TRANSPORT IN STABLE CORONARY ARTERY DISEASE PATIENTS WITH A DOSE PROPORTIONAL PHARMACOKINETICS AFTER SINGLE ASCENDING DOSES - Wednesday, November 19, 09:30am – 11:00am
- Abstract 18938: PROGNOSTICALLY IMPORTANT MYOCARDIAL INFARCTIONS ARE MARKEDLY UNDERREPORTED IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION: INSIGHTS FROM CHAMPION PHOENIX – Sunday, November 16, 09:00am – 11:00am.
About MDCO-216 (ApoA-1 Milano/POPC)
MDCO-216, an investigational product not approved for commercial use in any market, is a complex of recombinant ApoA-I 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.
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.
The cangrelor NDA filing was based on the results of a development program which included the data from four randomized, double-blind clinical trials conducted in 25,567 patients with coronary artery disease (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE). The PHOENIX study provided the primary evidence of efficacy for the proposed PCI indication for Cangrelor.
The results of PHOENIX, a 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company’s cangrelor to oral clopidogrel in patients undergoing PCI were reported in March 2013.
In 2011, The Medicines Company also reported results of the BRIDGE trial, a prospective, randomized, double-blind, placebo-controlled multicenter trial which evaluated cangrelor or placebo in 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent that were at increased risk of thrombotic events following discontinuation of oral platelet inhibition prior to coronary artery bypass graft (CABG) surgery.
In April 2014, the FDA issued a Complete Response Letter for the cangrelor NDA. For the PCI indication, the FDA stated that the NDA cannot be approved at the present time and the FDA suggested that the Company perform a series of clinical data analyses of the CHAMPION PHOENIX study, review certain processes regarding data management, and provide bioequivalence information on the clopidogrel clinical supplies for the CHAMPION trials. For the BRIDGE indication, the FDA concluded that a prospective, adequate and well-controlled study in which outcomes such as bleeding are studied, can result in the clinical data necessary to assess the benefit-risk relationship in this indication. The FDA also provided additional comments for the Company to address, stating that the comments are not currently approvability issues, but could affect labeling. The Company plans to resubmit an NDA for cangrelor by the end of 2014 with respect to the PCI indication.
About ANGIOMAX(R) (bivalirudin) for Injection
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 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 full prescribing information for Angiomax, available at http://www.angiomax.com.
About CLEVIPREX(R) (clevidipine) Injectable Emulsion
Cleviprex(R) (clevidipine) Injectable Emulsion is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
IMPORTANT SAFETY INFORMATION
Cleviprex(R) (clevidipine) Injectable Emulsion is contraindicated in patients with:
- Allergies to soybeans, soy products, eggs, or egg products;
- Defective lipid metabolism seen in conditions such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and
- Severe aortic stenosis.
Cleviprex is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture.
Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. If either occurs, decrease the dose of Cleviprex. There is limited experience with short-duration therapy with beta-blockers as a treatment for Cleviprex-induced tachycardia. Beta-blocker use for this purpose is not recommended.
Cleviprex contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism.
Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
Cleviprex is not a beta-blocker, does not reduce heart rate, and gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose.
Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.
There is no information to guide use of Cleviprex in treating hypertension associated with pheochromocytoma.
Most common adverse reactions for Cleviprex (>2%) are headache, nausea, and vomiting.
Please see full prescribing information for Cleviprex, available at www.cleviprex.com.
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,” “hopes” 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 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 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 with the SEC on November 7, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
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