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news.Theravance Biopharma has received approval from Health Canada for Vibativ (telavancin) to treat adults with hospital-acquired bacterial pneumonia (HAP) and ventilator-associated bacterial pneumonia (VAP).
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The drug is approved for patients with HAP and VAP known or suspected to be caused by susceptible isolates of Staphylococcus aureus including methicillin-susceptible and methicillin-resistant S. aureus (MSSA and MRSA).
Vibativ is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action.
Indicated against gram-positive bacteria, including difficult-to-treat pathogens such as MRSA, it inhibits both bacterial cell wall synthesis and disrupts bacterial cell membrane function.
Currently, the antibiotic is also approved in Canada to treat patients with complicated skin and skin structure infections (cSSSI) caused by susceptible strains of gram-positive microorganisms.
Pendopharm, a division of Pharmascience, will be responsible tomarket and sell Vibativ in Canada and the drug is expected to become commercially available in 2016.
Theravance Biopharma Development and Operations senior vice-president Frank Pasqualone said: "This important approval in Canada comes on the heels of the recent Vibativ marketing clearance in Russia for the treatment of multiple infections caused by Gram-positive bacteria, such as MRSA.
"These regulatory milestones, combined with our recent agreement with SciClone Pharmaceuticals to develop and commercialize Vibativ in China, highlight the significant momentum we are generating in efforts to build the Vibativ brand around the world.
"Vibativ has demonstrated efficacy against some of the difficult-to-treat and multidrug-resistant infections that are contributing to the rapid expansion of antibiotic resistance globally.
"As such, broadening the availability of the drug in key markets such as Canada and Russia may play an important role in combatting antibiotic resistance by providing healthcare practitioners in those countries with another important treatment option."
The marketing approval triggers a milestone payment to Theravance under terms of its development and commercialization agreement with Pendopharm.
Theravance will also be eligible to receive potential future contingent payments and a royalty on net sales of Vibativ from Pendopharm.
Image: Vibativ, a bactericidal, once-daily, injectable lipoglycopeptide antibiotic, will become commercially available in Canada from next year. Photo: courtesy of Baitong333/ freedigitalphotos.net.