|The Medicines Company to Present Data at ASM Microbe 2017 on Infectious Disease Portfolio Including Late-Stage Investigational Antibiotic Meropenem-Vaborbactam|
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The Company will present data on its investigational antibiotic, meropenem-vaborbactam, from the TANGO 1 Phase III trial that compared it to piperacillin-tazobactam in the treatment of complicated urinary tract infections (cUTIs). Additional data on meropenem-vaborbactam’s in vitro activity against clinical isolates of carbapenem-resistant Enterobacteriaceae, and in experimental treatment models will also be presented. Data from studies of the Company’s marketed products Orbactiv® (oritavancin) and Minocin® (minocycline) for Injection will also be presented.
“ASM Microbe 2017 will display cutting-edge science and the latest
developments in the field of microbiology and clinical trials of
Meropenem-vaborbactam (formerly known as Carbavance), an investigational
agent not approved for commercial use in any market, is a combination of
the carbapenem, meropenem, and the novel beta-lactamase inhibitor,
vaborbactam administered as a fixed combination by IV infusion. It is
being developed to treat serious gram-negative infections, such as
complicated urinary tract infections, including those infections caused
by bacteria resistant to currently available carbapenems.
Meropenem-vaborbactam has been granted Fast Track status by the
Meropenem-vaborbactam was designed to address gram-negative bacteria
that produce new beta-lactamase enzymes that have spread in
About MINOCIN® (minocycline) for Injection
MINOCIN® (minocycline) for Injection is indicated for the treatment of infections due to susceptible strains of designated microorganisms, including Acinetobacter species bacteria. For additional indications and designated susceptible pathogens, please see the full prescribing information available at www.minociniv.com.
Important Safety Information
MINOCIN® for Injection is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.
Warnings and Precautions
MINOCIN® for Injection, like other tetracycline-class antibacterials, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy, or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus. 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).
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. This reaction was shown to be reversible when the drug was discontinued.
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 Effects
Central nervous system side effects including light-headedness, dizziness or vertigo have been reported. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.
Clostridium difficile Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MINOCIN® for Injection, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including MINOCIN® for Injection. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and MINOCIN® for Injection should be avoided because isotretinoin is also known to cause pseudotumor cerebri.
Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize.
As with other antibacterial preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibacterial should be discontinued and appropriate therapy instituted.
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 antibacterial therapy when indicated.
MINOCIN® for Injection contains magnesium sulfate heptahydrate. Because magnesium is excreted primarily by the kidney, serum levels of magnesium should be monitored in patients with renal impairment.
Because MINOCIN® for Injection contains magnesium, close monitoring is recommended in patients with heart block or myocardial damage.
Prescribing MINOCIN® for Injection 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.
For a complete list of adverse reactions that have been observed in patients receiving tetracyclines, consult the full US prescribing information for MINOCIN® for Injection.
Please see www.minociniv.com for the full US prescribing information.
About ORBACTIV® (oritavancin) for Injection
ORBACTIV® (oritavancin) for Injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and methicillin–resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).
Important Safety Information
Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV® administration because the activated partial thromboplastin time (aPTT) test results are expected to remain falsely elevated for approximately 120 hours (5 days) after ORBACTIV® administration.
ORBACTIV® is contraindicated in patients with known hypersensitivity to ORBACTIV®.
Warnings and Precautions
Coagulation test interference: ORBACTIV® has been shown to artificially prolong aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hours, ACT for up to 24 hours, and D-dimer for up to 72 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.
Concomitant warfarin use: Patients should be monitored for bleeding if concomitantly receiving ORBACTIV® and warfarin.
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.
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 The Infectious Disease Business
The Medicines Company’s Infectious Disease Business (MDCO IDC) is
committed to bringing life-saving antimicrobial products to
patients with the most serious drug-resistant infections – infections
caused by “super bugs” which are no longer treatable with available
antibiotics. MDCO IDC encompasses basic research and drug discovery
focused on bacterial mechanisms of drug resistance; drug development
focused on the most threatening bacterial diseases; and a distribution
and commercial infrastructure that serves the leading hospitals and
healthcare facilities in
The Medicines Company Forward-Looking Statements
Statements contained in this press release 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," "expects," “potential,” 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 clinical trials will advance on a timely basis, or at
all, or succeed in achieving their specified endpoints; whether
physicians, patients and other key decision makers will accept clinical
trial results; whether the Company will make regulatory submissions on a
timely basis, or at all; whether the Company’s regulatory submissions
will receive approvals from regulatory agencies on a timely basis, or at
all; 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