SAN FRANCISCO, CA--(Marketwire - Mar 10, 2013) - The Medicines Company (NASDAQ: MDCO) today reported results of 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 percutaneous coronary intervention (PCI). Patients treated with cangrelor had a 22% (p=0.005) reduced odds of experiencing the primary endpoint, which was a composite incidence of death, myocardial infarction (MI), ischemia-driven revascularization (IDR) or stent thrombosis (ST) at 48 hours after randomization. Cangrelor also showed a 38% reduction in the odds of the key secondary endpoint, incidence of stent thrombosis at 48 hours.
Detailed findings include:
Endpoints at 48 hours
Cangrelor*
(n =5472)
Clopidogrel*
(n = 5470)
Odds Reduction
p-value
Primary Endpoint
Death/MI/IDR/ST
4.7%
5.9%
22%
0.005
Key Secondary
Stent thrombosis
0.8%
1.4%
38%
0.01
MI
3.8%
4.7%
20%
0.02
QMI
0.2%
0.3%
39%
0.19
IDR
0.5%
0.7%
26%
0.22
Death
0.3%
0.3%
0%
> 0.999
Death or ST
1.1%
1.6%
33%
0.02
Incidence of primary endpoint in selected subgroups:
Clopidogrel loading dose
300 mg (n=2806)
5.8%
6.8%
16% 0.27
600 mg (n=8133)
4.3%
5.6%
23%
0.009
Timing of loading dose
Before PCI (n=6902)
4.8%
6.0%
20%
0.033
After PCI (n=3976)
4.3%
5.4%
21%
0.12
*Modified Intention-to-Treat-Population
The findings were consistent across all analyzed subgroups of patients, including age, geography, diagnosis at presentation, and the choice of periprocedural anticoagulant. At 30 days, the rate of the composite primary efficacy end point remained significantly lower in the cangrelor group than in the clopidogrel group and the relative reduction in stent thrombosis also persisted.
Commenting on the results, Simona Skerjanec PharmD, MBA, Senior Vice President and Innovation Leader for Antiplatelet Therapies at The Medicines Company, said: "With successful completion and reporting of this Phase 3 trial, our next step is to submit for market approvals in the US and Europe. We anticipate submitting these data for a new drug application to the US Food and Drug Administration in the second quarter with findings of prior trials, including the BRIDGE trial in patients awaiting open heart surgery."
Safety findings
The primary safety end point was non-CABG-related severe bleeding, according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria, at 48 hours. Several other bleeding definitions were also applied. More sensitive measures did show an increase in bleeding with cangrelor, though there was no significant difference in the rate of transfusions.
Cangrelor*
(n =5529)
Clopidogrel*
(n = 5527)
Odds Ratio
95% CI
p-value
Bleeding
GUSTO
Severe
0.2%
0.1%
1.50(0.53-4.22)
0.44
Moderate
0.4%
0.2%
1.69(0.85-3.37)
0.13
TIMI
Major 0.1%
0.1%
1.00(0.29-3.45)
> 0.99
Minor
0.2%
0.1%
3.00(0.81-11.10)
0.08
Major or minor
0.3%
0.1%
1.75(0.73-4.18)
0.20
ACUITY
Major
4.3%
2.5%
1.72(1.39,2.13)
< 0.001
Major w/out hematoma
0.8%
0.5%
1.62(0.99,2.64)
0.05
Any blood transfusion
0.5%
0.3%
1.56(0.83-2.93)
0.16
Efficacy and safety: net adverse clinical events**
Death, myocardial infarction, ischemia-driven revascularization, stent thrombosis, or GUSTO-defined severe bleeding
4.8%
6.0%
0.80(0.67-0.94)
0.008
*Safety Population
**The primary efficacy and primary safety end points were combined to provide a composite end point of net adverse clinical events in the modified intention-to-treat population.
The rate of adverse events related to treatment was similar in the cangrelor and clopidogrel groups (20.2% and 19.1%, respectively; P = 0.13). There were significantly more cases of transient dyspnea with cangrelor than with clopidogrel (1.2% vs 0.3%, P < 0.001), a finding that was also observed in the prior CHAMPION studies.
Presentation and Publication of Results
The results were presented at the American College of Cardiology's 62nd Annual Scientific Session and Expo this morning by Co-Principal Investigator Deepak L. Bhatt, MD, MPH, director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital (BWH) and chief of cardiology at VA Boston Healthcare System, as well as professor of medicine at Harvard Medical School. The other Co-principal investigator of the CHAMPION Trials was Robert A. Harrington, MD, professor and chair of the Department of Medicine at Stanford. The results were concurrently published today in The New England Journal of Medicine.
Conference Call
There will be a conference call with MDCO management and experts today at 11:00 a.m. Pacific Time (2:00 p.m. Eastern Time) to discuss cangrelor trial results and outlook. The conference call will be available via phone and webcast. The webcast can be accessed at The Medicines Company website at www.themedicinescompany.com. The dial in information is listed below:
Domestic Dial In: 866 700.6067
International Dial In: 617 213.8834
Passcode for both dial in numbers: 54431050
Replay is available from 4:00 p.m. Eastern Time following the conference call through March 17, 2013. To hear a replay of the call, dial 888 286.8010 (domestic) and 617 801.6888 (international). Passcode for both dial in numbers is 17733784.
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 is a double-blind parallel group randomized study that 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 thienopyridine 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. The Medicines Company's website is www.themedicinescompany.com.
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's products will advance in the clinical trials process on a timely basis or at all, 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, risks associated with the establishment of international operations, whether the Company is able to obtain or maintain patent protection for the intellectual property relating to the Company's products; 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 Annual Report on Form 10-K filed on March 1, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Contact:
Michael Mitchell
The Medicines Company
973-290-6097michael.mitchell@themedco.com
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