BACTIVTM Phase 3 SOLO II Trial Results Published In The Journal Clinical Infectious Diseases

The Medicines Company

today announced the publication of the results from the SOLO II Phase 3 clinical trial of ORBACTIV (oritavancin) for injection in the journal Clinical Infectious Diseases. ORBACTIV, is the first and only single dose intravenous antibiotic approved by FDA for the treatment of adults with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused or suspected to be caused by susceptible isolates of designated Gram-positive pathogens. The publication reported that a single, once only, 1200 mg intravenous dose of ORBACTIVTM 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 single 1200 mg IV dose of ORBACTIV results in efficacy in ABSSSIs that is comparable and statistically non-inferior to vancomycin administered intravenously for 7-10 days. ORBACTIV had a safety profile comparable to vancomycin when monitored for up to 60 days following a single dose, with similar intensity, onset and duration of AEs. “The results from the SOLO II Phase 3 clinical trial reported in the journal of Clinical Infectious Diseases represents the second of the two pivotal Phase 3 clinical studies supporting the recent approval of ORBACTIVTM for the treatment of 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. “Our work with the SOLO trials is the first in a series of major clinical trials that we are undertaking to take on difficult-to-treat infections, or so-called “superbugs,” in patients with potentially life-threatening conditions requiring admission and care in the hospital,” said Dr. Michael Dudley, Senior Vice President and Head of Health Science in the Infectious Disease Global Innovation Group. “Our portfolio of research projects, development programs and marketed products span the spectrum of infections caused by Gram-positive bacteria including MRSA, and Gram-negative infections, including Acinetobacter spp, carbapenem-resistant Enterobacteriaceae, and other dangerous multi-drug-resistant pathogens.”