NEW YORK, NY -- (Marketwired) -- 10/09/13 -- The Medicines Company (NASDAQ: MDCO) today reported completion of two pharmacodynamic trials evaluating the transition of its investigational acute intravenous antiplatelet agent, cangrelor, to chronic oral therapy with ticagrelor (Brilinta®) or prasugrel (Effient®) in patients with coronary artery disease (CAD). Three prior trials assessed the transition from cangrelor to oral clopidogrel in 25,000 CAD patients undergoing percutaneous intervention (PCI). Ticagrelor and prasugrel are the newest commercially available agents that inhibit platelets via the P2Y12 receptor, the same receptor that is inhibited by cangrelor. These agents are administered with the goal of decreasing the risk of thrombotic events during and after PCI.
The Medicines Company will announce details of the trials at its Investor & Analyst Day in New York today from 8:30ET to noon. The meeting is webcast with a link available at http://www.themedicinescompany.com.
Simona Skerjanec PharmD, MBA, Senior Vice President and Innovation Leader for Antiplatelet Therapies at The Medicines Company stated, "Completion of both these studies evaluating the transition to newer oral agents enables us to add to the wealth of data that informs cangrelor dosing and administration which is under regulatory review. In addition, we anticipate the investigators will soon report the detailed data in peer review journals."
The ticagrelor and prasugrel transition studies were each conducted in 12 CAD patients to test the consistency of inhibition of platelet aggregation when oral ticagrelor or prasugrel were administered during or immediately after cangrelor infusion. The purpose of these pharmacodynamic trials was to demonstrate that patients treated with IV cangrelor can be directly transitioned to the oral drug without a significant decrease in the extent of inhibition of platelet aggregation.
The new pharmacodynamic studies add to clinical data from the CHAMPION PHOENIX trial that demonstrates that transition from cangrelor to clopidogrel 600mg administered immediately after cessation of the cangrelor infusion significantly reduces thrombotic events at 48 hours compared to clopidogrel alone (Death/MI/IDR/ST: 4.7% vs. 5.9%, 22% odds reduction, p=0.005).
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. Cangrelor is not approved for commercial use in any market. An increase in the incidence of access site bleeding and transient dyspnea was observed with cangrelor in CHAMPION PHOENIX, a 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company's intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing PCI.
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: acute cardiovascular care, surgery and perioperative care, and serious infectious disease 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" and "expects" 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 will make regulatory submissions for product candidates on a timely basis, whether the Company's 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 on August 9, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.