ORBACTIVTM (Oritavancin) Phase 3 Trial Results Published in New England Journal of Medicine
The Medicines Company (NASDAQ:MDCO) today announced the publication of the results from the SOLO I Phase 3 clinical trial of ORBACTIVTM (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 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 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 ORBACTIVTM 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.”
About the SOLO trials
ORBACTIVTM (oritavancin) was evaluated in two large randomized, well-controlled Phase 3 clinical trials (SOLO I and SOLO II). The combined SOLO studies represent the largest patient population (1,987 patients in intent-to -treat population) that evaluated 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). ORBACTIVTM was administered intravenously as a 1200 mg single dose in these studies. In February 2014, the U.S. Food and Drug Administration (FDA) accepted the filing of a new drug application (NDA) for ORBACTIVTM with priority review. The Medicines Company is seeking approval of ORBACTIVTM for the treatment of ABSSSI caused or suspected to be caused by susceptible Gram-positive bacteria, including MRSA, administered as a single dose. The FDA action date (PDUFA date) for ORBACTIVTM is August 6, 2014.
About ORBACTIVTM (oritavancin)
ORBACTIVTM (oritavancin) is an investigational intravenous antibiotic not approved for commercial use. The Medicines Company is seeking approval for 1200 mg single dose ORBACTIVTM in the treatment of ABSSSI caused or suspected to be caused by susceptible Gram-positive bacteria, including MRSA. In clinical trials, the most frequently reported adverse events associated with ORBACTIVTM were nausea, headache, vomiting and diarrhea. Hypersensitivity reactions have been reported with the use of antibacterial agents including ORBACTIVTM.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
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, 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 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 with the SEC on May 12, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
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