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The Medicines Company Announces Participation at 2015 European Society of Cardiology (ESC) Congress in LondonThe Medicines Company today announced it will present results of recent clinical studies from its cardiovascular product portfolio at the 2015 European Society of Cardiology (ESC (News - Alert)) Congress in London, August 29 to September 2. The presentations at ESC 2015 will include a poster presentation of the Phase 1 results for ALN-PCSsc, a subcutaneously administered investigational RNAi therapeutic targeting PCSK9 being developed for the treatment of hypercholesterolemia. Alnylam Pharmaceuticals conducted this trial under a collaboration agreement with The Medicines Company and will present the results on Sunday, August 30 at 8:30 am British Standard Time (BST) (3:30 am Eastern Daylight Time (EDT)). Several posters and presentations focusing on The Medicines Company's novel intravenous antiplatelet agent, Kengreal™/Kengrexal™ (cangrelor) as well as the company's direct thrombin inhibitor, Angiomax®/Angiox® (bivalirudin), will also be presented during the meeting. Details for all activities are included in the grid below.
Conference Call ALN-PCSsc results will be discussed on a joint telephone and webex conference call with our partner, Alnylam, on August 30th at 2:30 pm BST (09:30 am EDT). This call is being webcast and can be accessed via Alnylam's website at www.alnylam.com as well as The Medicines Company's website at www.themedicinescompany.com. Domestic Dial-in: +1 (877) 312-7507 Ex-US Dial-in: +1 (631) 813-4828 Passcode for both Dial-in numbers: 18857833 Replay is available from 12:00 pm Eastern time following the conference call. To hear a replay of the call, dial +1 (855) 859-2056 (domestic) and +1 (404) 537-3406 (international). Passcode for both dial-in numbers is 18857833 In addition, the slides that will be used during the call can found on the event page of the Investor Relations section of our website at www.themedicinescompany.com. About KENGREXAL™ (cangrelor) In the European Union, cangrelor is marketed under the trade name KENGREXAL. KENGREXAL, a synthetic, small molecule, is 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 KENGREXAL™ is contraindicated in patients with significant active bleeding. KENGREXAL™ 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 KENGREXAL™, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREXAL™ than with clopidogrel. Bleeding complications with KENGREXAL™ were consistent across a variety of clinically important subgroups. Once KENGREXAL™ is discontinued, there is no antiplatelet effect after an hour. The most common adverse reaction is bleeding. About KENGREAL™ (cangrelor) In the United States, cangrelor is marketed under the trade name KENGREAL. KENGREAL is the first and only intravenous P2Y12 platelet inhibitor that blocks platelet activation and aggregation. KENGREAL, a synthetic, small molecule, is 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. In the CHAMPION PHOENIX study, compared to standard care, KENGREAL reduced the incidence of the composite endpoint of death, MI, IDR and ST by a significant 22% at 48 hours. KENGREAL has a pharmacologic profile that demonstrates:
KENGREAL is initiated at the time of PCI, and continued for 2-4 hours. KENGREAL, given as a rapidly administered bolus of 30µg/kg followed by an infusion of 4µg/kg/min, results in near maximum inhibition of platelet reactivity during PCI. No dosing adjustment needed for patients with renal impairment. KENGREAL is easily transitioned to all P2Y12 inhibitors. Important Safety Information Like other drugs that inhibit platelet P2Y12 function, KENGREAL can increase the risk of bleeding. The most common adverse reaction in clinical trials was bleeding (15.5%). In CHAMPION PHOENIX severe/life-threatening, moderate and mild bleeding events were more common with cangrelor than with clopidogrel and dyspnea was reported more frequently in patients treated with cangrelor than with clopidogrel. KENGREAL is contraindicated in patients with significant active bleeding. KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product. Overdose of KENGREAL does not result in increased adverse events/bleeding. KENGREAL can be administered with ticagrelor, aspirin, nitroglycerin, unfractionated or low-molecular-weight heparin, and bivalirudin. Please see full prescribing information for KENGREAL, available at http://www.kengreal.com. About Angiomax®/Angiox® 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 (News - Alert)) 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. About ALN-PCSsc (investigational product) ALN-PCSsc is a subcutaneously administered RNAi therapeutic targeting 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 (LDL-C, or "bad" cholesterol). ALN-PCSsc utilizes Alnylam's proprietary Enhanced Stabilization Chemistry (ESC)-GalNAc-siRNA conjugate delivery platform. ESC-GalNAc-siRNA conjugates are designed to achieve targeted delivery of RNAi therapeutics to hepatocytes through uptake by the asialoglycoprotein receptor, and enable subcutaneous dosing with increased potency and durability and a wide therapeutic index. Alnylam and The Medicines Company are collaborating in the advancement of ALN-PCSsc per the companies' agreement formed in early 2013. Under the terms of the agreement, Alnylam will complete certain pre-clinical studies and a Phase 1 clinical study of ALN-PCSsc and The Medicines Company is responsible for leading and funding development from Phase 2 forward as well as potential commercialization. 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" and "expects" and similar expressions, including the Company's preliminary financial results, are intended to identify forward-looking statements. These forward-looking statements involve important 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 our products, the Company's ability to develop its global operations and penetrate foreign markets, whether the Company's product candidates 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 the Company's ongoing and planned commercial launches will be successful, whether 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 Quarterly Report on Form 10-Q filed on August 7, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
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