The Medicines Company's Intravenous Cangrelor Demonstrates 22% Reduction in Ischemic Events Compared to Oral Clopidogrel

The Medicines Company's Intravenous Cangrelor Demonstrates 22% Reduction in 
Ischemic Events Compared to Oral Clopidogrel 
Late Breaking Phase 3 CHAMPION PHOENIX Trial Results Presented at
American College of Cardiology Scientific Session and Published in
The New England Journal of Medicine 
SAN FRANCISCO, CA -- (Marketwire) -- 03/10/13 --  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                  Cangrelor* Clopidogrel*    Odds              
  48 hours                      (n =5472)  (n = 5470)  Reduction   p-value  
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 Primary                                                                    
  Endpoint     Death/MI/IDR/ST    4.7%        5.9%        22%       0.005   
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                    Stent                                                   
 Key Secondary    thrombosis      0.8%        1.4%        38%        0.01   
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 MI                               3.8%        4.7%        20%        0.02   
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 QMI                              0.2%        0.3%        39%        0.19   
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 IDR                              0.5%        0.7%        26%        0.22   
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 Death                            0.3%        0.3%         0%     > 0.999  
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  Death or ST                     1.1%        1.6%        33%        0.02   
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 Incidence of primary endpoint in selected subgroups:                       
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 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   
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 Timing of        Before PCI                                                
  loading dose     (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. 


 
                                                                            
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                         Cangrelor* Clopidogrel*    Odds Ratio              
                          (n =5529)  (n = 5527)       95% CI        p-value 
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 Bleeding                                                                   
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 GUSTO       Severe         0.2%        0.1%      1.50(0.53-4.22)    0.44   
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             Moderate       0.4%        0.2%      1.69(0.85-3.37)    0.13   
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 TIMI        Major          0.1%        0.1%      1.00(0.29-3.45)  > 0.99  
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             Minor          0.2%        0.1%     3.00(0.81-11.10)    0.08   
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             Major or                                                       
             minor          0.3%        0.1%      1.75(0.73-4.18)    0.20   
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 ACUITY      Major          4.3%        2.5%      1.72(1.39,2.13)  < 0.001 
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             Major w/out                                                    
             hematoma       0.8%        0.5%      1.62(0.99,2.64)    0.05   
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 Any blood transfusion      0.5%        0.3%      1.56(0.83-2.93)    0.16   
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 Efficacy and safety: net adverse clinical events**                         
----------------------------------------------------------------------------
 Death, myocardial                                                          
  infarction, ischemia-                                                     
  driven                                                                    
  revascularization,        4.8%        6.0%      0.80(0.67-0.94)    0.008  
  stent thrombosis, or                                                      
  GUSTO-defined severe                                                      
  bleeding                                                                  
----------------------------------------------------------------------------

 
*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
973-290-6097
michael.mitchell@themedco.com