PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company today announced it will present new data from both its established antithrombotic portfolio and investigational hypercholesterolemia pipeline at the 2015 Scientific Sessions of the American Heart Association, November 7-11 in Orlando, FL.
The presentations at AHA will include a late breaking clinical trial session where new interim findings will be unveiled from the Phase I program on ALN-PCSsc, an RNAi investigational therapy targeting PCSK9 for the treatment of hypercholesterolemia. Alnylam Pharmaceuticals conducted this trial under a collaboration agreement with The Medicines Company and will present the results on Wednesday, November 11th at 11:57 am EDT. Unlike anti-PCSK9 monoclonal antibodies that bind to the protein in blood, ALN-PCSsc impedes PCSK9 synthesis in the liver. Preliminary interim data on ALN-PCSsc were presented recently at the annual meeting of the European Society Cardiology in London.
Investigators will also present three abstracts on antithrombotic KENGREAL™ (cangrelor), including two new subgroup analyses from the landmark CHAMPION PHOENIX trial of patients undergoing percutaneous coronary intervention (PCI). The first CHAMPION PHOENIX subgroup analysis explores the performance of KENGREAL versus clopidogrel in reducing serious ischemic complications in PCI patients with peripheral artery disease (PAD). The second subgroup analysis evaluates ischemic risk reduction with KENGREAL versus clopidogrel in the U.S. as compared to non-U.S. patient subgroups.
Details for the key presentations are summarized below (all times in Eastern):
| Time | Product | Event | Place | ||
|
SUNDAY 8TH |
9:00 am - 10:15 am |
KENGREAL™ (cangrelor) |
POSTER S2088: Effect of Cangrelor on Cardiovascular & Bleeding Events in Patients with PAD - Insights From CHAMPION PHOENIX |
Posters A2 | |
|
2:00 pm |
KENGREAL™ |
SESSION 610: Variation in Patient Profiles and Outcomes in US and non-US Subgroups of the Cangrelor vs Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) |
Room A2 |
||
|
TUESDAY |
5:30 pm
|
KENGREAL™ |
POSTER T1132: Cangrelor’s Anti-infarct Effect Requires Phosphorylation of Sphingosine in Platelets: The Missing Link |
Posters A2 |
|
|
WEDNESDAY 11TH |
11:57 am |
ALN-PCSsc |
Late-Breaking Clinical Trials 04: Novel Therapies for Common Problems: ALN-PCSsc, an RNAi Investigational Agent That Inhibits PCSK9 With Potential for Effective Quarterly or Possibly Bi-Annual Dosing: Results of Single-Blind, Placebo-Controlled, Phase 1 Single-Ascending Dose & Multi-Dose Trial in Adults w/ Elevated LDL-C, on & off Statins |
Chapin Theater |
|
|
4:30 pm – 5:30 pm |
ALN-PCSsc |
CONFERENCE CALL : Joint telephone and WebEx conference call with our partner, Alnylam, to discuss ALN-PCSsc results |
See below for the |
||
Conference Call
ALN-PCSsc results will be discussed on a joint telephone and WebEx conference call with our partner, Alnylam, on November 11th at 4:30 pm 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: 76033533
Replay is available from 7:30 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 76033533.
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 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 KENGREAL™ (cangrelor) for Injection
Indication
KENGREAL™ 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™ 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 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 Quarterly Report on Form 10-Q filed with the SEC on August 7, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
