NEJM publishes results from SOLO I Phase 3 clinical trial of ORBACTIV for ABSSSI

The Medicines CompanyJun 5 2014

The Medicines Company (NASDAQ:MDCO) today announced the publication of the results from the SOLO I Phase 3 clinical trial of ORBACTIV^TM (oritavancin), an investigational intravenous antibiotic treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), in the New England Journal of Medicine. The publication reported that a single 1200 mg intravenous dose of ORBACTIV^TM was non-inferior to twice-daily intravenous dosing of vancomycin given for 7 to 10 days in patients with ABSSSI caused or suspected to be caused by Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

"A publication in the New England Journal of Medicine reflects the quality of work of the SOLO investigators and the importance of new treatments for ABSSSI," said G. Ralph Corey, MD, lead author of the publication, Professor of Medicine and Infectious Disease at Duke University and Principal Investigator of the SOLO Trials. "We look forward to additional publications and presentations of ORBACTIV^TM studies."

An estimated 5.2 million patients in the US and Western Europe are admitted to hospitals with ABSSSI annually. Patients often receive intravenous therapies that require hospital admission and multiple-day dosing.

"We are committed to perform relevant and robust research and development of new anti-infective products," said Matthew Wikler, MD, Vice President, Infectious Disease Care at The Medicines Company. "Our work with the SOLO trials is the first in a series of major clinical trials that we are undertaking in the quest to take on difficult-to-treat infections - sometimes caused by so-called "superbugs" in patients in potentially life-threatening situations requiring admission and care in the hospital. Our product portfolio related research projects and development programs, and marketed products span the spectrum of such infections caused by Gram-positive infections including MRSA, and Gram-negative infections including Acinetobacter, carbapenem-resistant Enterobacteriaceae and other dangerous multi-drug-resistant pathogens."