DENVER, CO--(Marketwired - September 10, 2013) - The Medicines Company (NASDAQ: MDCO) today announced presentation of results for its Phase 3 SOLO clinical trial program of oritavancin at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver. Oritavancin 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).
Oritavancin Phase 3 SOLO I and SOLO II trials are presented as part of poster presentations, with SOLO II as a late-breaking abstract by Ralph Corey MD, Professor of Medicine and Infectious Disease at Duke University and Principal Investigator of the SOLO trials.
Dr. Corey stated, "What is unique about this study is it is testing an antibiotic where the full course of treatment has been given to the patient through one administration. This study shows that a single 1200 mg dose of oritavancin was non inferior to 7 to 10 days of vancomycin in treating ABSSSI caused by gram-positive pathogens including methicillin-resistant Staphylococcus aureus, MRSA."
SOLO I and SOLO II were multicenter, double-blind, randomized trials, which evaluated the efficacy and safety of a single 1200 mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with ABSSSI, including MRSA infections.
The combined SOLO studies represent the largest patient population (1,959 patients in modified 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).
In both SOLO trials, all protocol-specified primary and secondary efficacy endpoints were met. Oritavancin was demonstrated to be non-inferior to vancomycin for both required efficacy endpoints. All pre-specified endpoints were achieved, both for the Early Clinical Evaluation (ECE) (or 48-72 hour) required by the U.S. 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).
Dr. Corey stated, "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."
Safety profiles, measured at any point up to 60 days after treatment, were similar across treatment groups in SOLO I and SOLO II. The most common adverse events reported were nausea, headache, vomiting and diarrhea.
In addition to the SOLO I & II trial presentations, nine oritavancin-related abstracts will be presented in posters at the conference.
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, 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 August 9, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.