Theravance Biopharma announced that Health Canada has approved Vibativ (telavancin) for the treatment of adult patients with hospital-acquired bacterial pneumonia (HAP) and ventilator-associated bacterial pneumonia (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 antibiotic with in vitro potency and a dual mechanism of action against Gram-positive bacteria, including difficult-to-treat pathogens such as MRSA. The antibiotic is also currently approved in Canada for the treatment of patients with complicated skin and skin structure infections (cSSSI) caused by susceptible strains of Gram-positive microorganisms.
Vibativ will be marketed and sold in Canada by Pendopharm, a division of Pharmascience Inc., and is expected to become commercially available in 2016. This marketing clearance triggers a milestone payment to Theravance Biopharma under terms of its development and commercialization agreement with PENDOPHARM. Additional terms of this agreement call for Theravance Biopharma to receive potential future contingent payments and a royalty on net sales of VIBATIV from PENDOPHARM.
“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,” said Frank Pasqualone, Senior Vice President, Development and Operations at Theravance Biopharma. “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.”
Vibativ is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. The drug’s proven efficacy against difficult-to-treat infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with MRSA infections studied to date. Additionally, there is extensive and well-documented evidence of the drug’s in vitro potency and in vitro activity against a broad collection of bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.
Vibativ was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including MRSA. Vibativ is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. VIBATIV for injection is approved in the U.S. for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable. In addition, VIBATIV is approved in the U.S. for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.
Theravance Biopharma plans to market Vibativ outside the United States through a network of partners. To date, the company has secured partners for Vibativ in the following geographies — Europe, Canada, Middle East, North Africa, Israel, Russia, and China.
