The Medicines Company Announces Positive Results in a Phase 3

The Medicines Company Announces Positive Results in a Phase 3 Trial
of Cangrelor in the Treatment of Patients Undergoing PCI 
CHAMPION PHOENIX Trial Meets Protocol-Specified Predefined Efficacy
Endpoint; Intravenous Bolus and Infusion of Cangrelor Provided
Statistically Significant Improvement in Ischemic Events at 48 Hours
in Patients Undergoing PCI 
PARSIPPANY, NJ -- (Marketwire) -- 01/08/13 --  The Medicines Company
(NASDAQ: MDCO) today announced results for its pivotal Phase 3
clinical trial of cangrelor, which is in development to prevent
platelet activation and aggregation that leads to thrombosis in the
acute care setting, including in patients undergoing percutaneous
coronary intervention (PCI). 
Following the recommendation of the trial's Data Safety Monitoring
Board (DSMB) in July 2012 to continue the protocol as planned, the
CHAMPION PHOENIX trial completed enrollment in October 2012. After
successful data lock, the data analysis revealed that the protocol
defined primary composite efficacy endpoint of death, myocardial
infarction, ischemia driven revascularization and stent thrombosis at
48 hours was met. Cangrelor demonstrated statistically significant
improvement as compared to clopidogrel. Safety outcomes were similar
to those observed in prior trials. The trial results are planned to
be presented at a major upcoming scientific meeting. 
Commenting on the trial and its conduct, Dr. Robert A. Harrington,
MD, Professor of Medicine and Chairman of Medicine at Stanford
University and Co-Principal Investigator said: "The PHOENIX trial was
designed with careful consideration of the prior studies to determine
whether cangrelor is associated with improved ischemic outcomes
compared with the usual treatment of oral clopidogrel. We are
grateful to the many investigators around the world who enabled rapid
enrollment and the collection of high quality data. We are pleased
that the trial delivered such clear results." 
"We are looking forward to presenting detailed results to the medical
community as soon as the data are fully analyzed," said Dr. Deepak L.
Bhatt, MD, MPH, Chief of Cardiology at VA Boston Healthcare System,
Senior Physician at Brigham and Women's Hospital, Professor of
Medicine at Harvard Medical School and Co-Principal Investigator of
the CHAMPION Trials. 
Clive Meanwell MD, PhD, Chairman and Chief Executive Officer of The
Medicines Company added that the Company expects to submit data both
from the CHAMPION PHOENIX trial and from the BRIDGE trial in the USA
and EU for regulatory review in 2013. "We believe that fast acting
and rapidly reversible cangrelor may have an important role to play
both in patients undergoing PCI and in patients who need to
discontinue oral P2Y12 inhibitors prior to surgery," he said. 
About Cangrelor 
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
including in patients undergoing percutaneous coronary intervention
(PCI). The CHAMPION PHOENIX trial was 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
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, 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 9, 2012,
which are incorporated herein by reference. The Company specifically
disclaims any obligation to update these forward-looking statements. 
Michael Mitchell
The Medicines Company
Press spacebar to pause and continue. Press esc to stop.