The Medicines Company Announces Positive Trial Results for

The Medicines Company Announces Positive Trial Results for
Oritavancin in the Treatment of Acute Bacterial Skin and Skin
Structure Infections (ABSSSI) 
SOLO-1 Trial Meets All Protocol-Specified Endpoints; One Single
Intravenous Dose of Oritavancin Is Non-Inferior to Twice-Daily
Vancomycin Intravenous Dosing for 7-10 Days 
PARSIPPANY, NJ -- (Marketwire) -- 12/20/12 --  The Medicines Company
(NASDAQ: MDCO) today announced results for its SOLO-1 Phase 3
clinical trial of oritavancin, which is under investigation for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI) caused by susceptible gram-positive bacteria, including
methicillin-resistant Staphylococcus aureus (MRSA). 
All protocol-specified primary and secondary efficacy endpoints of
the SOLO-1 trial were met. Oritavancin was shown to be non-inferior
to vancomycin in the efficacy analyses for the early clinical
evaluation (48-72 hour) endpoints required by the U.S. Food and Drug
Administration (FDA) and the later (7-14 days after end of treatment)
endpoint required by the European Medicines Agency (EMA). The
efficacy was similar in the overall population and in those patients
with microbiologically confirmed MRSA infections.  
Primary Results 


 
-----------------------------------------------------------------
-----------
Timepoint       Endpoint         Oritavancin   Vancomycin    % Difference   
                                  (n = 475)    (n = 479)        (95% CI)    
----------------------------------------------------------------------------
                FDA primary                                                 
Early clinical  endpoint:        82.3% (391)  78.9% (378)   3.4% (-1.6, 8.4)
endpoint (ECE)  Cessation of                                                
                spread, absence                                             
                of fever, no                                                
                rescue                                                      
                antibiotics                                                 
              --------------------------------------------------------------
                Greater than     86.9% (413)  82.9% (397)   4.1% (-0.5, 8.6)
                or equal to 20% 
                redu
ction of                                                
                lesion area                                                 
----------------------------------------------------------------------------
Post treatment  EMA primary      79.6% (378)  80.0% (383)  -0.4% (-5.5, 4.7)
endpoint (PTE)  endpoint:                                                   
                Investigator-                                               
                assessed                                                    
                clinical cure                                               
----------------------------------------------------------------------------

 
Results in patients with confirmed MRSA infections 


 
-----------------------------------------------------------------
-----------
Timepoint       Endpoint                             Oritavancin  Vancomycin
                                                      (n = 104)    (n = 100)
----------------------------------------------------------------------------
                FDA primary endpoint:                                       
Early clinical  Cessation of spread, absence of       80.8% (84)  80.0% (80)
endpoint (ECE)  fever, no rescue antibiotics                                
              --------------------------------------------------------------
                Greater than or equal to 20%          90.4% (94)  84.0% (84)
                reduction of lesion area
----------------------------------------------------------------------------
Post treatment  EMA primary endpoint:                 82.7% (86)  83.0% (83)
endpoint (PTE)  Investigator-Assessed Clinical Cure                         
----------------------------------------------------------------------------

 
Overall, safety profiles were similar: 60.0% of patients on
oritavancin and 63.8% of patients on vancomycin were reported to
experience at least one adverse event. Fewer treatment emergent
adverse events considered by investigators as related to study drug
were reported among patients treated with oritavancin than vancomycin
(22.8% vs. 31.4%; p value = 0.003). Results also included fewer skin
and subcutaneous tissue adverse events (11.6% vs. 19.1%; p value =
0.001) among patients treated with oritavancin. Apart from these,
adverse event rates were similar in both treatment arms, including
rates of phlebitis. 
The SOLO-1 trial design was agreed to through the Special Protocol
Assessment process with the FDA and was also reviewed formally by the
EMA. The trial is the first of two pivotal Phase 3 trials designed to
support the filing of a New Drug Application in the United States as
well as a Marketing Authorization Application (MAA) in Europe. The
SOLO-1 and SOLO-2 trials are identical multicenter, double-blind,
randomized clinical trials.  
In the SOLO-1 trial, 968 ABSSSI patients were enrolled at 46 clinical
sites worldwide. Treatment with a single intravenous dose of
oritavancin was compared with 7-10 days of twice daily intravenous
doses of vancomycin.  
Commenting on the results, Clive Meanwell MD, PhD, Chairman and Chief
Executive Officer of The Medicines Company, said: "These data show
that a single dose of oritavancin given on presentation of a patient
with ABSSSI to hospital can cure gram positive infections, including
MRSA infections, and be as efficacious as multiple days of vancomycin
infusions. The safety profile also appears potentially advantageous
over vancomycin. We believe that the SOLO-1 trial will become an
important element in our efforts to secure regulatory approval for
oritavancin in ABSSSI worldwide and we look forward to completing the
enrollment of the identical SOLO-2 trial in the first half of 2013." 
"Currently available intravenous treatment options for ABSSSI have
limitations, including multiple-day dosing and treatment-limiting
adverse events. The opportunity to manage patients with a single dose
of oritavancin may be a next source of innovation. Furthermore, the
microbiological spectrum and long half-life of oritavancin
potentially provide avenues of investigation in even more severe
infections, including those requiring prolonged periods of
treatment," said Ralph Corey MD, Professor of Medicine and Infectious
Disease at Duke University and Principal Investigator of the SOLO
Trials. 
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.  
Forward-looking Statements
 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, including the
Company's preliminary revenue results, are intended to identify
forward-looking statements. These f
orward-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, 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. 
Contact: 
Michael Mitchell
The Medicines Company
973-290-6097
michael.mitchell@themedco.com 
 
 
Press spacebar to pause and continue. Press esc to stop.