ORBACTIVTM (Oritavancin) Phase 3 SOLO II Trial Results Published in the Journal Clinical Infectious Diseases

09 Oct 2014

The Medicines Company (NASDAQ:MDCO) 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.”

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.

About The Medicines Company Infectious Disease Portfolio

The Medicines Company is well positioned to address the complex problems associated with multi-drug resistant infections. The 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 multi-drug resistant pathogens. The product pipeline includes Carbavance, RPX-602 (new formulation of MINOCIN® (minocycline) for injection, and a pre-clinical developmental program of novel investigational agents. ORBACTIV and MINOCIN are two antibiotics approved for use in the US. The product portfolio has the potential to offer clinicians and patients a suite of innovative new antibiotic approaches to tackle many of the most vexing problems in infectious disease today.

The Medicines Company is committed to becoming a leading provider of solutions for acute and intensive care hospitals, specifically focused on improving health and economic outcomes for life-threatening infections.

About ORBACTIVTM (oritavancin)

ORBACTIVTM (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin–resistant isolates),Streptococcus pyogenesStreptococcus agalactiaeStreptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosusS. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).

ORBACTIV is the first and only single-dose intravenous antibiotic approved for this use in the US. The EMA accepted for review the Marketing Authorization Application (MAA) for ORBACTIV in Q1 2014, for which the Company is seeking approval for the treatment of complicated skin and soft tissue infections (cSSTI). A decision from the European Commission is expected during the first half of 2015.

IMPORTANT SAFETY INFORMATION

Contraindications

Use of intravenous unfractionated heparin sodium is contraindicated for 48 hours after ORBACTIV administration because the activated partial thromboplastin time (aPTT) test results are expected to remain falsely elevated for approximately 48 hours after ORBACTIV administration.

ORBACTIV is contraindicated in patients with known hypersensitivity to ORBACTIV.

Warnings and Precautions

Concomitant warfarin use: Co-administration of ORBACTIV and warfarin may result in higher exposure of warfarin, which may increase the risk of bleeding. Use ORBACTIV in patients on chronic warfarin therapy only when the benefits can be expected to outweigh the risk of bleeding.

Coagulation test interference: ORBACTIV has been shown to artificially prolong aPTT for up to 48 hours, and may prolong PT and INR for up to 24 hours.

Hypersensitivity reactions have been reported with the use of antibacterial agents including ORBACTIV. Discontinue infusion if signs of acute hypersensitivity occur. Monitor closely patients with known hypersensitivity to glycopeptides.

Infusion-related reactions have been reported. Slow the rate or interrupt infusion if infusion reaction develops.

Clostridium difficile-associated colitis: Evaluate patients if diarrhea occurs.

Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.

Prescribing ORBACTIV in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions (? 3%) in patients treated with ORBACTIV were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.

Please see www.orbactiv.com for the full prescribing information.

About MINOCIN® IV (minocycline for injection)

MINOCIN® IV (minocycline for injection) is FDA-approved and indicated for the treatment of infections due to susceptible strains of designated microorganisms, including Acinetobacter spp. For the full list of indications and designated susceptible pathogens, please see the full prescribing information.

IMPORTANT SAFETY INFORMATION

Contraindications

MINOCIN is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.

Warnings

Minocin, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. The patient should be apprised of the potential hazard to the fetus if the patient becomes pregnant while taking these drugs or uses a tetracycline during pregnancy.

The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Tetracycline drugs, therefore should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated.

This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy.

Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with minocycline use. If this syndrome is recognized, the drug should be discontinued immediately.

The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours. If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline.

Central nervous system side effects including lightheadedness, dizziness or vertigo have been reported.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MINOCIN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

Precautions

As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.

Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility for permanent sequelae exists.

Hepatotoxicity has been reported with minocycline; therefore, minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with other hepatotoxic drugs.

Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated.

Prescribing MINOCIN in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

For a complete list of adverse reactions that have been observed in patients receiving tetracyclines, consult the full prescribing information for MINOCIN.

Please see www.minociniv.com for the full prescribing information.

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 3,000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease 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.

Forward-Looking Statements

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.


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