PARSIPPANY, NJ--(Marketwired - December 23, 2013) - The Medicines Company (NASDAQ: MDCO) today announced that the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational intravenous antiplatelet agent, cangrelor.
The filing is supported by the results of a comprehensive development program, including the data from four randomized, double-blind clinical trials (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE) conducted in more than 25,000 patients with coronary artery disease. Cangrelor is in development for use in patients undergoing percutaneous coronary intervention (PCI) and those that require bridging from oral antiplatelet therapy to surgery.
The acceptance of the MAA marks the beginning of the review process in the European Union for cangrelor. The Medicines Company announced July 1 the FDA accepted for review a New Drug Application (NDA) for cangrelor by the United States Food and Drug Administration (FDA).
"With the acceptance of the European filing, we look forward to working closely with the European Medicines Agency to advance the review process for cangrelor in Europe," said Simona Skerjanec, PharmD, MBA, Senior Vice President and Innovation Leader for Antiplatelet Therapies at The Medicines Company. "If the MAA review of cangrelor is successful, we anticipate the investigational product could be available to the European interventional cardiology community in 2015."
"There is a clear need for improved antiplatelet therapy for patients across Europe being treated in the acute cardiovascular care setting, and the cangrelor clinical program provides a comprehensive look at the potential impact on clinical outcomes," said Professor P. Gabriel Steg, MD, of Hôpital Bichat in Paris and an investigator in the CHAMPION program.
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 results of CHAMPION PHOENIX, a 11,145 patient Phase 3 randomized, double-blind clinical trial comparing The Medicines Company's intravenous antiplatelet 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.
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," "plans, "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, 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 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 on November 5, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.