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The Medicines Company (MDCO) Announces Positive Results for Solo II Trial of Oritavancin in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)


7/2/2013 11:14:18 AM

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PARSIPPANY, NJ--(Marketwired - July 02, 2013) - The Medicines Company (NASDAQ: MDCO) today announced results for its Phase 3 SOLO clinical trial program 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). SOLO I and SOLO II are identical multicenter, double-blind, randomized clinical trials. The Company reported positive SOLO I results in December 2012 and report similar positive SOLO II results today.

In SOLO II, all protocol-specified primary and secondary efficacy endpoints were met. SOLO II demonstrated oritavancin to be non-inferior to vancomycin for both US and European regulators' required efficacy endpoints. All pre-specified endpoints were achieved, both for the Early Clinical Evaluation (ECE) (or 48-72 hour) required by the US Food and Drug Administration (FDA) and for the later Post Therapy Evaluation (PTE) (7-14 days after end of treatment) required by the European Medicines Agency (EMA). In SOLO II, adverse events were reported with similar frequencies on oritavancin and vancomycin.

The combined SOLO trial data demonstrated that oritavancin and vancomycin efficacy were similar for the ECE and PTE endpoints. However, in microbiologically confirmed MRSA patients, the target population for such therapies, oritavancin-treated patients achieved the FDA-proposed endpoint of greater than or equal to 20% reduction of lesion area at ECE more frequently than vancomycin-treated patients. Under the Special Protocol Assessment (SPA) agreed with the FDA, the protocols pre-specified that MRSA patients from the SOLO studies would be pooled for the evaluation of efficacy.

Commenting on the results, Clive Meanwell MD PhD, Chairman and Chief Executive Officer of The Medicines Company said: "SOLO trial data consistently 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 at least as efficacious as multiple days of twice-daily vancomycin infusions. The safety profile also appears potentially advantageous over vancomycin. We anticipate submitting an application for oritavancin US market clearance in the fourth quarter of 2013 and a European filing in 2014."

The combined SOLO studies represent the largest patient population (1,987 patients in intent-to -treat population) evaluating an anti-infective for the treatment of ABSSSI in controlled clinical trials and have assessed one of the largest subsets of patients with documented MRSA infection (405 patients).

"The SOLO clinical trials are compelling due to the size of the program, the range of severe skin infection patients enrolled and the powerful and innovative drugs studied," said Ralph Corey MD, Professor of Medicine and Infectious Disease at Duke University and Principal Investigator of the SOLO Trials. "Given the high rate of efficacy the vancomycin comparator demonstrated in this and other similar trials, the most compelling finding in SOLO is in the pre-specified pooled findings that more oritavancin-treated MRSA patients had a greater than or equal to 20% reduction in their skin lesion up to 48 to 72 hours after treatment initiation. The benefit of an early, definitive and aggressive treatment strategy in seriously infected patients warrants additional study in skin and other severe infections, including those requiring prolonged periods of treatment."

Primary Results in SOLO II (mITT population)

----------------------------------------------------------------------------
Timepoint      Endpoint             Oritavancin  Vancomycin   % Difference  
                                     (n = 503)   (n = 502)      (95% CI)    
----------------------------------------------------------------------------
               FDA primary                                                  
Early clinical endpoint:                                                    
evaluation     Cessation of spread,                                         
(ECE)          absence of fever, no                                         
               rescue antibiotics   403 (80.1%) 416 (82.9%) -2.7 (-7.5, 2.0)
               -------------------------------------------------------------
               Greater than or 
               equal to
               20% reduction                                         
               of lesion area       432 (85.9%) 428 (85.3%)  0.6 (-3.7, 5.0)
----------------------------------------------------------------------------
               EMA primary                                                  
Post therapy   endpoint:                                                    
evaluation     Investigator-                                                
(PTE)          assessed clinical                                            
               cure                 416 (82.7%) 404 (80.5%)  2.2 (-2.6, 7.0)
----------------------------------------------------------------------------

Results in patients with confirmed MRSA infections in SOLO II
(Microbiological ITT population)

----------------------------------------------------------------------------
Timepoint            Endpoint                         Oritavancin Vancomycin
                                                       (n = 100)   (n = 101)
----------------------------------------------------------------------------
                     FDA primary endpoint:                                  
Early clinical       Cessation of spread, absence of                        
evaluation (ECE)     fever, no rescue antibiotics      82 (82.0%) 82 (81.2%)
                     -------------------------------------------------------
                     Greater than or equal to 
                     20% reduction of lesion                         
                     area                              96 (96.0%) 91 (90.1%)
----------------------------------------------------------------------------
                     EMA primary endpoint:                                  
Post therapy         Investigator-assessed clinical                         
evaluation (PTE)     cure                              84 (84.0%) 86 (85.1%)
----------------------------------------------------------------------------

Safety profiles, measured at any point up to 60 days after treatment, were similar across treatment groups in SOLO II. Overall, 50.9% of patients on oritavancin and 50.2% of patients on vancomycin were reported to experience at least one adverse event. In SOLO II, treatment emergent adverse events considered by investigators as related to study drug were reported by similar proportions of patients treated with oritavancin and vancomycin (21.7% and 25.5%, respectively).

Primary Results in SOLO I and SOLO II Combined (mITT population)

----------------------------------------------------------------------------
Timepoint      Endpoint              Oritavancin  Vancomycin  % Difference  
                                      (n = 978)   (n = 981)      (95% CI)   
----------------------------------------------------------------------------
               FDA primary endpoint:                                        
Early clinical Cessation of spread,                                         
evaluation     absence of fever, no                                         
(ECE)          rescue antibiotics    794 (81.2%) 794 (80.9%) 0.2 (-3.3, 3.7)
               -------------------------------------------------------------
               Greater than or
               equal to
               20% reduction                                         
               of lesion area        845 (86.4%) 825 (84.1%) 2.3 (-0.9, 5.4)
----------------------------------------------------------------------------
Post therapy   EMA primary endpoint:                                        
evaluation     Investigator-assessed                                        
(PTE)          clinical cure         794 (81.2%) 787 (80.2%) 1.0 (-2.5, 4.5)
----------------------------------------------------------------------------

Results in patients with confirmed MRSA infections
in SOLO I and SOLO II Combined (MicroITT population)

----------------------------------------------------------------------------
Timepoint     Endpoint              Oritavancin  Vancomycin   % Difference  
                                     (n = 204)   (n = 201)      (95% CI)    
----------------------------------------------------------------------------
                                                                            
Early         FDA primary endpoint:                                         
clinical      Cessation of spread,                                          
evaluation    absence of fever, no                                          
(ECE)         rescue antibiotics    166 (81.4%) 162 (80.6%)  0.8 (-6.9, 8.4)
              --------------------------------------------------------------
              Greater than or
              equal to              
              20% reduction                                          
              of lesion area        190 (93.1%) 175 (87.1%) 6.1 (0.5, 11.6)*
----------------------------------------------------------------------------
Post therapy  EMA primary endpoint:                                         
evaluation    Investigator-assessed                                         
(PTE)         clinical cure         170 (83.3%) 169 (84.1%) -0.7 (-7.9, 6.4)
----------------------------------------------------------------------------

*p value=0.032

When the SOLO I and SOLO II studies are combined, the safety profiles were similar across treatment groups (safety population: 976 in oritavancin, 983 in vancomycin). Overall, 55.3% of patients on oritavancin and 56.9% 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 (22.2% vs. 28.4% p=0.002). Proportions of patients with adverse events leading to study drug discontinuation were low and comparable between oritavancin and vancomycin (3.7% and 4.2%, respectively).

The design of the Phase 3 SOLO clinical trial program was agreed to through the SPA process with the FDA and was also reviewed formally by the EMA. The pivotal Phase 3 trials are designed to support the filing of a New Drug Application in the United States as well as a Marketing Authorization Application in Europe.

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.

Conference call
There will be a conference call with management today at 9:00 a.m. Eastern Time to discuss SOLO trial results and outlook. This call is being webcast and can be accessed via The Medicines Company website at www.themedicinescompany.com.

The dial in information is listed below:
Domestic Dial In: 866 318.8614
International Dial In: +617 399.5133
Passcode for both dial in numbers: 17469621

Replay is available from 11:00 a.m. Eastern Time following the conference call through July 16, 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 21739780.

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 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 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 May 9, 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



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