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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

Dec 20, 2012 (Marketwire via COMTEX) --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
(n = 475)
Vancomycin
(n = 479)
% Difference
(95% CI)

Early clinical endpoint (ECE)
FDA primary endpoint:
Cessation of spread, absence of fever, no rescue antibiotics

82.3% (391)

78.9% (378)

3.4% (-1.6, 8.4)
≥20% reduction of lesion area 86.9% (413) 82.9% (397) 4.1% (-0.5, 8.6)
Post treatment endpoint (PTE) EMA primary endpoint:
Investigator-assessed clinical cure
79.6% (378) 80.0% (383) -0.4% (-5.5, 4.7)

Results in patients with confirmed MRSA infections

Timepoint Endpoint Oritavancin
(n = 104)
Vancomycin
(n = 100)

Early clinical endpoint (ECE)
FDA primary endpoint:
Cessation of spread, absence of fever, no rescue antibiotics

80.8% (84)

80.0% (80)
≥20% reduction of lesion area 90.4% (94) 84.0% (84)
Post treatment endpoint (PTE) EMA primary endpoint:
Investigator-Assessed Clinical Cure
82.7% (86) 83.0% (83)

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 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, 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