Highlights from the VIBATIV presentations at ECCMID include:
Activity Against Global Collection of S. aureus Clinical Isolates
Results of a study showed that VIBATIV possessed the greatest in vitro activity of all antibiotics evaluated against a broad, global collection of difficult-to-treat S. aureus clinical isolates, including those considered to be methicillin-resistant (MRSA) and methicillin-susceptible (MSSA). This activity for VIBATIV was seen against 100% of the evaluated S. aureus clinical isolates regardless of their type or resistance profile, including those considered to be multidrug-resistant (MDR). Overall, the minimum inhibitory concentrations (MICs) for VIBATIV were eight- to 16-fold lower than for vancomycin, daptomycin and linezolid against the MRSA or MDR isolates. MICs are a measure used to express in vitro activity of an antibiotic against a pathogen.
Activity Against S. aureus in Murine Infection Models
Researchers presented findings from a study designed to examine and compare the pharmacokinetic and pharmacodynamic properties of VIBATIV and vancomycin againstS. aureus strains, including MRSA, in the neutropenic murine thigh and lung infection models. Results demonstrated greater in vivo potency for VIBATIV as compared to vancomycin against S. aureus in these models. Potency was measured by MICs and those measurements were determined to be excellent predictors of treatment efficacy against the target infections. The in vivo potency advantages seen in this study validate the ongoing use of VIBATIV in its approved indication of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible S. aureus isolates, including MRSA.
Pharmacokinetics of VIBATIV in Obese Subjects
In a third presentation, researchers reported results of a study that evaluated the pharmacokinetic profile of VIBATIV when delivered in a single, stratified, fixed weight-based dose. With the understanding that body weight can be a key determinant of patients' exposure to a drug, researchers were interested in examining the pharmacokinetics of VIBATIV in obese subjects. Study results demonstrated that moderately to severely obese subjects had higher VIBATIV distribution and clearance levels than normal weight or mildly obese subjects.
"We are excited to continue to build our extensive collection of scientific data highlighting the range of product advantages that we believe favorably position VIBATIV against competitor antibiotics. By highlighting the activity of VIBATIV in multiple in vitro S. aureus infection models, as well as against a range of S. aureus clinical isolates, the presented data at ECCMID confirm the in vivo potency of VIBATIV," said
About VIBATIV® (telavancin)
VIBATIV® was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including MRSA and
VIBATIV is also approved for marketing in
VIBATIV® Important Safety Information
Patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) who were treated with VIBATIV® for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk.
New onset or worsening renal impairment occurred in patients who received VIBATIV. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed.
Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment.
Intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after VIBATIV administration.
VIBATIV is contraindicated in patients with a known hypersensitivity to the drug.
Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin.
Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.
Infusion Related Reactions
VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause "Red-man Syndrome" like reactions including: flushing of the upper body, urticaria, pruritus, or rash.
Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval. In a study involving healthy volunteers, VIBATIV prolonged the QTc interval. Use of VIBATIV should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.
Most Common Adverse Reactions
The most common adverse reactions (greater than or equal to 10% of patients treated with VIBATIV) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine.
Full Prescribing Information, including Boxed Warning and Medication Guide in the
Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the
In addition, we have an economic interest in future payments that may be made by
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THERAVANCE®, the Cross/Star logo, and VIBATIV® are registered trademarks of the
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