Phase 3 Data From The Medicines Company's Oritavancin Solo Trials Featured at
Positive Results for Solo I and Solo II Trial of Oritavancin in Acute
Bacterial Skin and Skin Structure Infections Including MRSA
DENVER, CO -- (Marketwired) -- 09/10/13 -- 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
nistration (FDA) and for the later Post Therapy Evaluation (PTE)
(7-14 days after end of treatment) required by the European Medicines
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
In addition to the SOLO I & II trial presentations, nine
oritavancin-related abstracts will be presented in posters at the
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.
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risk factors detailed in the Company's Quarterly Report on Form 10-Q
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