The Medicines Company to Present Data at IDWeek 2017 on Infectious Disease Portfolio Including Recently Approved Antibiotic VABOMERE™ (meropenem and vaborbactam)
– Eight posters presented on Friday and Saturday highlight comprehensive results of TANGO-2, a multi-center, randomized, open label clinical trial of VABOMERE vs. “best available therapy” in subjects with known or suspected CRE –
– VABOMERE was recently approved for the treatment of adult patients with complicated urinary tract infections, including polynephritis, caused by designated susceptible enterobacteriacea –
The Company will present data on VABOMERE™, its recently
Data from studies of the Company’s other marketed products ORBACTIV® (oritavancin) and MINOCIN® (minocycline) for Injection will also be presented.
“We are delighted to have the opportunity at IDWeek, the premier
gathering of the infectious disease community, to showcase our industry
leading portfolio of anti-infectives, including presentation of key data
for VABOMERE which was exquisitely designed to address the growing
problem of KPC-producing CRE,” said
IDWeek is a forum for health professionals of varied backgrounds
to collaborate, cooperate, and learn from each other’s expertise. With
common issues and challenges cutting across our four disciplines, IDWeek
provides an opportunity to learn from each other’s knowledge, experience
and expertise, for the improvement of patient care and public health.
Details of The Medicines Company’s presentations are provided below. The
complete program of titles, abstracts, and electronic versions of
posters can be accessed following their presentations on The
Date | Time | Product | Event | Details | ||||
Thursday October 5th | 3:03 PM | VABOMERE |
New Antibiotics: What's in the Pipeline
Overview of Meropenem-Vaborbactam Presentation author: M. Dudley |
Symposium
|
||||
Friday October 6th |
7:00 AM
to 8:15 AM |
VABOMERE |
Pipeline 2.0: New Antibiotics: What's in the Pipeline
Panelists: M. Dudley, The Medicines Company; S. Cammarata, Melinta Therapeutics; E. Ellis-Grosse, Zavante Therapeutics; , R. Echols, ID3C; I. Friedland, Friedland Strategic Consulting; P .McGovern, Paratek Pharmaceuticals; Steven P. Gelone, Nabriva Therapeutics AG; David Huang, Motif BioSciences; Amanda Paschke, Merck & Co., Inc.; P. Horn, Tetraphase Pharmaceuticals |
Panel Discussion and Q&A
|
||||
Friday October 6th |
12:30 PM to 2:00 PM |
VABOMERE |
Session: Expanded Spectrum - New
Antimicrobial Susceptibility Testing Activity of Meropenem-Vaborbactam Against Enterobacteriaceae Isolates Carrying blaKPC Collected Worldwide Presentation authors: M. Castanheira, R.E. Mendes, L.R. Duncan, L.N. Woosley, R.K. Flamm |
Poster 1234
|
||||
Saturday October 7th |
12:30 PM
to 2:00 PM |
VABOMERE |
Session: Clinical Study with New Antibiotics and Antifungals
Meropenem-Vaborbactam vs. Piperacillin-Tazobactam in TANGO I (a Phase 3 Randomized, Double-blind Trial): Outcomes by Baseline MIC in Adults with Complicated Urinary Tract Infections or Acute Pyelonephritis Presentation authors: T. Walsh, T. Bhowmick, R. Darouiche, V. Zaitsev, E. Giamarellos-Bourboulis, A. Shorr, E. Fedosiuk, T. File Jr., J. Loutit, O. Lomovskaya, M. Dudley, D. Perlin |
Poster 1866
|
||||
Saturday October 7th |
12:30 PM
to 2:00 PM |
VABOMERE |
Session: Clinical Study with New Antibiotics and Antifungals
Meropenem-Vaborbactam vs. Best Available Therapy for Carbapenem-Resistant Enterobacteriaceae Infections in TANGO II: Primary Outcomes by Site of Infection Presentation authors: R. Wunderink, E. Giamarellos-Bourboulis, G. Rahav, A. Mathers, M. Bassetti, J. Solomkin, E. Alexander, J. Loutit, S. Zhang, M. Dudley, K. Kaye |
Poster 1867
|
||||
Saturday October 7th |
12:30 PM
to 2:00 PM |
VABOMERE |
Session: Clinical Study with New Antibiotics and Antifungals
Clinical Outcomes of Serious Infections due to Carbapenem-Resistant Enterobacteriaceae (CRE) in TANGO II, a Phase 3, Randomized, Multi-National, Open-Label Trial of Meropenem-Vaborbactam (M-V) Versus Best Available Therapy (BAT) Presentation authors: K. Kaye, J. Vazquez, A. Mathers, G. Daikos, E. Alexander, J. Loutit, S. Zhang, M. Dudley, O. Cornely |
Poster 1862
|
||||
Saturday
October 7th |
12:30 PM
to 2:00 PM |
VABOMERE |
Session: Clinical Study with New Antibiotics and Antifungals
Assessment of MIC Increases with Meropenem-Vaborbactam and Ceftazidime-Avibactam in TANGOII (a Phase 3 Study of the Treatment of CRE Infections) Presentation authors: O. Lomovskaya, M. Castanheira, J. Vazquez, K. Kaye, K. Nelson, D. Sun, E. Alexander, M. Dudley, M. Yin |
Poster 1874
|
||||
Saturday
October 7th |
12:30 PM
to 2:00 PM |
VABOMERE |
Session: Clinical Study with New Antibiotics and Antifungals
Meropenem-Vaborbactam: Outcomes in Subjects with Renal Impairment in Phase 3 Studies TANGO I and II Presentation authors: A. Mathers, W. Hope, K. Kaye, J. Loutit, E. Alexander, M. Dudley, J. Vazquez |
Poster 1879
|
||||
Saturday
October 7th |
12:30 PM
to 2:00 PM |
VABOMERE |
Session: Clinical Study with New Antibiotics and Antifungals
Meropenem-Vaborbactam Pharmacokinetics in Subjects with Chronic Renal Impairment, Including Hemodialysis Presentation authors: C. Rubino, D. Griffith, S. Bhavnani, J. Loutit, B. Lohse, M. Dudley, P. Ambrose |
Poster 1835
|
||||
Saturday
October 7th |
12:00 PM
to 2:30 PM |
VABOMERE |
Session: Clinical Study with New Antibiotics and Antifungals
Meropenem-Vaborbactam vs. Best Available Therapy for Carbapenem-Resistant Enterobacteriaceae Infections in TANGO II:Outcomes in Immunocompromised Patients Presentation authors: D. Paterson, E. J. Kwak, T. Bhowmick, E. Alexander, J. Loutit, S. Zhang, M. Dudley, T. Walsh |
Poster 1868
|
||||
Saturday
October 7th |
12:00 PM
to 2:30 PM |
VABOMERE |
Session: Clinical Study with New Antibiotics and Antifungals
Meropenem-Vaborbactam Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses as Support for Dose Selection in Patients with Normal Renal Function and Varying Degrees of Renal Impairment Presentation authors: S. Bhavnani, M. Trang, D. Griffith, O. Lomovskaya, J. Hammel, J. Loutit, M. Dudley, P. Ambrose, C. Rubino |
Poster 1852
|
||||
Thursday October 5th |
12:30 PM
to 2:00 PM |
MINOCIN |
Session: Use of PK/PD to optimize existing antibiotics and
antifungal
Pharmacokinetics and Tissue Distribution of Minocycline following Intravenous Administration in Rabbits Presentation authors: V. Petraitis, R. Petraitiene, B. W. Maung, T. Nolan, D. Griffith, M. Dudley, T. Walsh |
Poster 804
Hall CD |
||||
Friday October 6th |
12:30 PM
to 2:00 PM |
ORBACTIV |
Session: Expanded Spectrum - New
Antimicrobial Susceptibility Testing Analysis of Oritavancin Activity against Gram-Positive Clinical Isolates Responsible for Bacterial Endocarditis in United States and European Hospitals (2008-2016) Presentation authors: M.A. Pfaller, H.S. Sader, D. Shortridge, R.K. Flamm, R.E. Mendes |
Poster 864
Hall CD |
||||
About VABOMERE™
VABOMERE™ (meropenem and vaborbactam) is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
Contraindications
VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs.
Warnings and Precautions
- Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with beta-lactam antibacterial drugs. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam antibacterial drug. If an allergic reaction to VABOMERE occurs, discontinue the drug immediately.
- Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity.
- Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including VABOMERE, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued.
- The concomitant use of VABOMERE and valproic acid or divalproex sodium is generally not recommended. Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. If administration of VABOMERE is necessary, consider supplemental anticonvulsant therapy.
- In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported.
- Alert patients receiving VABOMERE on an outpatient basis regarding adverse reactions such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment.
- Prescribing VABOMERE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of drug-resistant bacteria.
- As with other antibacterial drugs, prolonged use of VABOMERE may result in overgrowth of nonsusceptible organisms.
Adverse Reactions
The most frequently reported adverse
reactions occurring in ≥3% of patients treated with VABOMERE were
headache, phlebitis/infusion site reactions, and diarrhea.
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
Contraindications
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.
Dermatologic Reaction
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.
Anti-anabolic Action
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
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
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.
Adverse Reactions
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 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
Contraindications
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.
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 The Infectious Disease Business
The Medicines Company 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
In addition to the development and approval of VABOMERE, MDCO IDC has,
since 2014, successfully developed and launched two antibiotics against
serious infections: ORBACTIV® (oritavancin) for the treatment
of acute bacterial skin and skin-structure infections in adults, caused
by designated pathogens, including methicillin-resistant Staphylococcus
aureus, and a new formulation of MINOCIN® (minocycline) for
Injection, which is among the few
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Langan, (973) 290-6319
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Gorti, M.D., (973) 290-6122
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