PARSIPPANY, NJ--(Marketwire - July 02, 2012) - The Medicines Company (NASDAQ: MDCO) today announced it expects to complete patient enrollment of the pivotal Phase 3 CHAMPION PHOENIX trial of cangrelor in fourth quarter of 2012. The Company accepted the recommendation of a 10,900 patient sample size made by the trial's independent Data Safety Monitoring Board (DSMB), which conducted a pre-specified interim analysis on data from approximately 7,700 patients.
Dimitrios Goundis, DPhil, Senior Vice President and Head of Research and Development at The Medicines Company, said, "In our prior guidance, although the protocol was sized at 10,900 patients, we indicated our expectation that a sample size increase to 15,000 patients could be needed, depending on interim results. The DSMB has recommended that we do not need to increase the size of the CHAMPION PHOENIX trial. This means that enrollment for the trial is expected to be completed in the fourth quarter of 2012 -- about one year earlier than in our business plan."
Dr. Goundis added that, if results of CHAMPION PHOENIX are positive and there is continued affirmative dialogue with regulators, the Company expects to submit data both from the CHAMPION PHOENIX trial and from the BRIDGE trial for worldwide regulatory review. "We believe that cangrelor may have an important role to play both in patients undergoing percutaneous coronary intervention (PCI) and in patients who need to discontinue oral P2Y12 inhibitors prior to surgery," he said.
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting of the cardiac catheterization laboratory including in patients undergoing percutaneous coronary intervention (PCI). The CHAMPION PHOENIX trial is a double-blind parallel group randomized study, which compares cangrelor to a clopidogrel loading dose administered as soon as possible after it is determined that the patient will undergo PCI. In 2011, the Company 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 and receiving a thienopryidine awaiting coronary artery bypass graft (CABG) surgery.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients.
Statements contained in this press release about the 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's products will advance in the clinical trials process on a timely basis or at all, whether results of clinical trials will be indicative of results in later clinical trials, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers will accept clinical trial results whether or not the Company will offer the notes or consummate the offering, the anticipated terms of the notes and the offering, the anticipated use of the proceeds of the offering, whether and in what amount the Company may repurchase shares of its common stock and whether the convertible note hedge transactions and the warrant transactions (including the additional convertible note hedge transactions and the additional warrant transactions that the Company may enter into if the initial purchasers exercise their option to purchase additional notes) will become effective, 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 May 10, 2012, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.